Clinical Research Regulation For Canada and Mexico

Last content review/update: July 18, 2025

Overview

In accordance with the CanadaFDA, Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products. HC also approves the sale or importation of drugs for use in clinical trials. (See the Manufacturing & Import section for additional information on importation.) As delineated in the CanadaFDR and the G-CanadaCTApps, institutional ethics committee (EC) review is required for each clinical trial site and may occur in parallel with HC’s clinical trial application (CTA) review and approval. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. See CAN-23 and CAN-19 for background information on HC’s scope of assessment.

Per the CanadaFDA, a “therapeutic product” is defined as a drug or device, or any combination of drugs and devices, but does not include natural health products; and “therapeutic product authorization” refers to a license that is approved for the import, sale, advertisement, manufacture, preparation, preservation, packaging, labeling, storage, or testing of a therapeutic product. As per the G-CanadaCTApps, a drug is defined as a pharmaceutical, biologic, gene therapy, blood product, vaccine, and radiopharmaceutical for human use that is to be tested in a clinical trial. HC’s scope of assessment includes clinical trials (Phases I - III) using:

Drugs not authorized for sale in Canada in development and in comparative bioavailability studies
Marketed drugs where the proposed use of the drug for one (1) of the following is different: indication(s) and clinical use; target patient population(s); route(s) of administration; or dosage regimen(s)

Clinical Trial Review Process

As set forth in the G-CanadaCTApps and CAN-23, HC’s Health Products and Food Branch (HPFB) coordinates the CTA approval process. The G-CanadaCTApps and CAN-23 state that prior to initiating the trial, the sponsor must file a CTA to the appropriate HPFB Directorate. CTAs involving pharmaceutical drugs should be sent to the Pharmaceutical Drugs Directorate (PDD), and CTAs involving biologics and/or radiopharmaceuticals should be sent to the Biologic and Radiopharmaceutical Drugs Directorate (BRDD).

The G-CanadaCTApps indicates that upon receipt of a CTA, the HPFB Directorate (PDD/BRDD) screens the application package for completeness. If deficiencies are found, the Directorate sends the sponsor a Request for Clarification or a Screening Rejection Letter. If the Directorate finds the application complete, an acknowledgement letter is issued to indicate the 30-day default review period commenced on the date of receipt. See CAN-23 for more information.

Per the G-CanadaCTApps, once a clinical trial is authorized, the sponsor is allowed to sell or import a drug for use in a trial, if a CTA has been filed with HC and has not received an objection within 30 days. If the clinical trial is authorized, a No Objection Letter (NOL) is issued. If the CTA is rejected, a Not Satisfactory Notice (NSN) is issued. During the review period, the Directorate may request additional information from the sponsor, who has two (2) calendar days to provide such information. Please see the G-CanadaCTApps for special requirements regarding reviews of comparative bioavailability studies and joint reviews of clinical trials covering a combination of devices, biologics, and pharmaceuticals. See the Submission Process section for detailed application submission requirements. See CAN-23 for more information.

Per the G-CanadaCTApps, soon after HC issues an NOL, it will publish the following information about the clinical trial in HC’s publicly accessible database:

Protocol number
Protocol title
Drug name
Medical condition
Study population
Authorization date
Sponsor name
HC control number
Trial start and end dates, if known

The CanadaFDR and the G-CanadaCTApps also delineate that a clinical trial application-amendment (CTA-A) is required for proposed changes to a previously authorized study when the changes to clinical trial drug supplies affect the quality or safety of the drug, or when the changes to an authorized protocol alter the risk to clinical trial participants, or both. CTA-As must be authorized by HC prior to implementation of the changes. However, if the sponsor is required to immediately implement changes because the clinical trial or the use of the clinical trial drug endangers the health of participants or other persons, the sponsor may immediately make the amendment without prior review by HC. Sponsors must notify HC of this change, provide the relevant rationale in support of the immediate implementation, and file a CTA-A that clearly identifies the change and rationale for immediate implementation of the change within 15 days after the amendment implementation date. In addition, sponsors may make the following changes immediately if it notifies HC in writing within 15 days after the date of the change: a change to the chemistry and manufacturing information that does not affect the quality or safety of the drug; or a change to the protocol that does not alter the risk to the health of a participant.

As delineated in the CanadaFDA and the G-Inspections, HC is authorized to implement an inspection strategy and to ensure compliance with CanadaFDA. The G-Inspections states that HC’s Regulatory Operations and Enforcement Branch (ROEB) monitors compliance, which is assessed through inspections and other compliance and enforcement activities, such as compliance verifications. Compliance verifications of clinical trials may be initiated when there are reasonable grounds to believe that non-compliance may have occurred or is occurring and that enforcement measures may be necessary (e.g., complaints received regarding specific trials, reports of adverse drug reaction(s), or reports from other regulatory authorities). The Clinical Trial Compliance Program within ROEB is responsible for clinical trial site selection for inspections in collaboration with the PDD and the BRDD. A risk-based approach is applied in the site selection process to minimize the potential health risks inherent to clinical trials involving human participants. The selection of sites for inspection is based on a variety of criteria to select sites throughout all levels of the drug assessment and regulatory approvals process.

Per the CanadaFDR, HC will suspend the authorization to sell or import a drug for clinical trial purposes if it has reasonable grounds to believe that:

The sponsor has contravened any relevant laws or regulations
Any information submitted in respect of the drug or clinical trial is false or misleading
The sponsor has failed to comply with good clinical practices
The sponsor has failed to provide information or samples as required by the regulation

See the CanadaFDR for additional details on HC’s suspension and cancellation responsibilities.

What is the Health Products and Food Branch?

Clinical Trial Site Information form

1.2, 2.1, 2.3-2.7, and Appendix 1

5.1, 5.2, 5.5, and 5.6

3 and 4

2 and Part II (Sections 22 (1) and 30 (1.2))

Part C (Division 5 (C.05.001, C.05.002, C.05.005-.008, and C.05.016-.017))

Last content review/update: October 31, 2025

Overview

In accordance with GenHlthLaw, Reg-COFEPRIS, HlthResRegs, NOM-012-SSA3-2012, and COFEPRIS-GCP, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is the regulatory authority responsible for reviewing, evaluating, and approving all requests for research protocol authorization in human beings and/or their biological samples using registered or unregistered investigational products (IPs). Per NOM-257-SSA1-2014, COFEPRIS requires biotechnological drugs used in clinical research studies to follow the same protocol authorization procedure as is required for all IPs. COFEPRIS-GCP and HlthResRegs specify that the scope of COFEPRIS’s assessment includes all clinical trials (Phases I-IV). (Note: COFEPRIS refers to applications as requests or procedures and refers to official procedure codes as homoclaves).

As indicated in HlthResRegs, NOM-012-SSA3-2012, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, COFEPRIS’s review and approval of a protocol authorization request is dependent upon obtaining a favorable decision from the health institution’s Research Ethics Committee (REC) and Research Committee where the study is being conducted, and when applicable, the Biosafety Committee. Therefore, the COFEPRIS and EC reviews may not be conducted in parallel. In addition, per NOM-012-SSA3-2012, the REC’s favorable decision is only later submitted to COFEPRIS with the protocol authorization request. Refer to the Ethics Committee section for detailed information on the REC, and the Initiation, Agreements & Registration section for additional information on the Research Committee and Biosafety Committee.

Clinical Trial Review Process

As delineated in GenHlthLaw, Reg-COFEPRIS, Agrmnt_ResProtProcs, G-DIGIPRiS-Prots&Amdts, and MEX-88, COFEPRIS’s Health Authorization Commission (Comisión de Autorización Sanitaria (CAS)) is responsible for issuing, extending, or revoking requests for human research protocol authorizations. According to Agrmnt_ResProtProcs, G-DIGIPRiS-Prots&Amdts, G-HumResProt, MEX-88 and MEX-104, CAS’s technical review and approval of research protocol submissions and amendments are managed through COFEPRIS’s digital procedures and services platform, DIGIPRiS: Online Regulation (MEX-86). See MEX-104 for a flowchart of CAS’s review and approval process via MEX-86.

Per Agrmnt_ResProtProcs, which simplifies COFEPRIS’s administrative review process, requests for human research protocol authorization have been merged into a single procedure, the Application for Authorization of a Research Protocol on Human Beings (Homoclave COFEPRIS-04-010). The merged requests include those for medicines, biologicals, and biotechnologicals; medications (bioequivalence studies); new non-pharmacological medical methods or materials; and risk-free research (observational studies).

Agrmnt_ResProtProcs and G-DIGIPRiS-Prots&Amdts specify that protocol modification applications (Homoclave COFEPRIS-09-012) must be submitted to CAS to amend the underlying documents including the research protocol, the investigator’s brochure (also known as researcher’s manual in Mexico), and the informed consent/assent form. Other types of amendments include: the inclusion of research centers, research center address and/or name changes, principal investigator (PI) changes, research team changes, emergency center address and/or name changes, evaluation committee changes (REC, Research Committee, or Biosafety Committee), security amendment(s), authorization holder (or owner) address and/or name changes, sponsor address and/or name changes, importer change or addition, and other modifications. See Agrmnt_ResProtProcs and MEX-87 for additional information.

As indicated in G-DIGIPRiS-Prots&Amdts, CAS will begin its evaluation process once the applicant submits an application via DIGIPRiS (MEX-86) to request protocol authorization or to modify/amend a protocol authorization. The stages involved in this process are as follows:

Request (user submits an authorization application request under Homoclave COFEPRIS-04-010 or COFEPRIS-09-012)
Evaluation (CAS reviews and processes the application)
Verification (CAS verifies the draft resolution to confirm whether to approve, deny, or request additional information)
Signature (CAS signs the resolution)
Resolution (Signed resolution is released to the user)

G-DIGIPRiS-ResProts and G-DIGIPRiS-Prots&Amdts further note that once COFEPRIS issues an official authorization, some of the data provided by an applicant via DIGIPRiS (MEX-86) is automatically migrated to its National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos (RNEC v2.0)) database (MEX-68). Per MEX-88, MEX-68 was integrated into MEX-86 as RNEC v2.0. See Submission Process section for detailed DIGIPRiS (MEX-86) submission requirements.

(Note: COFEPRIS has not yet updated MEX-84, G-ResProtocolAmd, and G-DIGIPRiS-ResProts to align with the Agrmnt_ResProtProcs requirements. However, the ClinRegs team is regularly monitoring the COFEPRIS website for new developments and will post the most current sources when they become available.)

In addition, per Reg-HlthProd, applicants must submit a request to COFEPRIS to obtain a health registration for biosimilar biotechnological drug products. The specific requirements for the approval of each biosimilar biotechnological drug (e.g., in vitro studies, preclinical study reports, and comparative pharmacokinetic study reports) will be determined by the Ministry of Health, who will take into consideration the opinion of the Committee of New Molecules. When there is no relevant information in the Pharmacopoeia of the United Mexican States (Farmacopea de los Estados Unidos Mexicanos (FEUM)) and its supplements, nor in national guides or monographs, the Ministry may evaluate biosimilar tests using clinical data obtained from biosimilar biotechnological drug studies conducted in other countries. However, clinical trials are required to be conducted in Mexico when an applicant requests the renewal of an approval for a biosimilar biotechnological drug product.

Additionally, per NOM-177-SSA1-2013 and NOM-177-SSA1-2013-Mod, COFEPRIS requires interchangeability and biocomparability studies for generic and biosimilar (biocomparable) drugs; these studies maybe conducted in Mexico or in other countries and must be performed by authorized third parties in accordance with applicable testing and procedural requirements. See NOM-177-SSA1-2013, NOM-177-SSA1-2013-Mod, and MEX-120 for details.

Reliance Reviews

Under Agrmnt_FRAAuth, COFEPRIS issued an agreement establishing the list of Foreign Regulatory Authorities (FRAs) and the criteria for recognizing prior FRA authorizations of research protocols involving human beings using the regulatory “reliance” model. In evaluating applications, COFEPRIS will use reliance to consider the regulatory decisions submitted and approved by one (1) of the following FRAs:

Agrmnt_FRAAuth also notes that human research protocol applications must only include:

Phase III research protocol submissions
Trials authorized through regulatory processes under an ordinary evaluation scheme (i.e., this does not include trials approved by reliance, accelerated, or expedited methods)
Trials with non-adaptive trial designs or designs that do not allow planned changes or that do not correspond to master protocols
Trials that correspond to the following areas: oncology, endocrinology, cardiology, rheumatology, allergology, neurology, dermatology, pulmonology, gastroenterology, hematology, ophthalmology and nephrology, and/or those that address pathologies of high epidemiological impact in Mexico (e.g., diabetes mellitus, hypertension, lung cancer, melanoma, colon cancer, B cell lymphoma)
Active trials (i.e., trials that are not suspended or cancelled)
Investigational product (IP) trials that do not have special alerts or warnings from other regulatory authorities or the World Health Organization (WHO)
Trials of drugs that have not been withdrawn from the market in any country for reasons of safety, efficacy, and quality

See Agrmnt_FRAAuth the additional details. See also the Submission Process and Timeline of Review sections for information on application submission procedures and review timelines.

UHAP Evaluations

Per HlthResRegs, prior to submitting an authorization request, applicants may also obtain a pre-assessment evaluation by an authorized third party that helps to facilitate COFEPRIS’s review. MEX-21 and MEX-10 explain that rather than submitting the application directly to COFEPRIS, the applicant has the option of first choosing to obtain a pre-assessment (third party) evaluation of the application through an Enabled Pre-Assessment Support Unit (Unidad Habilitada de Apoyo al Predictamen (UHAP)) (MEX-69) within the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad (CCINSHAE)) (referred to as the UHAP-CCINSHAE) or a UHAP within the Mexican Social Security Institute (Instituto Mexicano del Seguro Social (IMSS)). MEX-9 states that the CCINSHAE oversees (12) UHAPs. According to MEX-90, the Faculty of Medicine of the Autonomous University of Nuevo León (Facultad de Medicina de Universidad Autónoma de Nuevo León (UANL)) UHAP is another third-party unit authorized by COFEPRIS to assist in the evaluation and assessment of human research protocols. Refer to MEX-19, MEX-69, and MEX-70 for detailed information on the CCINSHAE, the IMSS, and the UANL UHAP application submission requirements and evaluation process. See also HlthResRegs for information on the third party authorization process by the Secretariat, and MEX-10 and MEX-98 for additional information on authorized third parties. See Timeline of Review section for timeline information on submitting UHAP applications.

According to MEX-10, the UHAP has a maximum of 30 calendar days to respond to an evaluation request. See the Scope of Assessment and Submission Process sections for detailed UHAP information.

Inspections

As outlined in MEX-88, COFEPRIS carries out health surveillance inspections (known as health verification visits) of all the parties responsible for conducting, developing, and monitoring authorized research protocols (e.g., sponsors, owners/authorization holders, RECs, Research Committees, Biosafety Committees, the PI, research centers, emergency care centers, and contract research organizations). The inspections are intended to:

Confirm compliance with applicable legislative requirements
Obtain information and identify health anomalies in the establishment’s physical and sanitary conditions
Verify the clinical research studies are carried out in accordance with the provisions of authorized research protocols, as well as national and international regulations
Ensure compliance with standards regarding ethics in clinical research, good clinical practice (GCP) and good manufacturing practice (GMP)

Refer to MEX-93 for the verification report health inspectors use to ensure compliance in clinical trial sites. See also MEX-92 for a complete list of verification reports related to medicines and other health supplies.

9.2

Actors Involved in the Supervision of Clinical Trials in Mexico, Procedures for Submitting Applications for Authorization of Research Protocols, and Health Surveillance

“Process for handling procedures 04-010 and 09-012 in DIGIPRiS”

Data Classification and Access to Information, Status and Actions allowed for an Application or Procedure, Application for Authorization of Research Protocol on Human Beings (COFEPRIS-04-010), and Classification of Amendments and Modifications within the platform

XIII. Specific Sections of the Procedure on the Platform (IX and XI-XIII)

Preamble, 1.3, 1.7, and 2

Requirements (9) and Additional Information

Title II (Chapter II, Article 17 Bis), Title III (Chapter III, Article 41 Bis), Title V (Chapter I, Articles 98 and 102), and Title XVI (Chapter III, Article 391 Bis)

Preamble, Articles Two-Six, Transients (Fifth), and Single Annex (Single Committee Format)

Preamble, Chapters I (Articles 1-2) and II (Articles 4-6)

Chapter I (Articles 1-3) and Chapter IV (Article 14)

Article 177

Title II (Chapter I, Article 14), Title III (Chapter I, Article 62) and (Chapter II, Articles 65-66 and 69), and Title V (Chapter I, Articles 99, 102, and 109-111)

7

4.2, 5.2, 6.3, 9.2, and 10.3

1-2

2.1-2.2

Regulatory Fees

Last content review/update: July 18, 2025

According to CAN-33, there are no fees to submit a clinical trial application in Canada.

Question 5

Last content review/update: October 31, 2025

Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)

As indicated in G-HumResProt, G-ResProtocolAmd, MEX-84, G-DIGIPRiS-ResProts, the applicant is responsible for paying a non-refundable fee to submit a request for research protocol authorization to the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)).

G-HumResProt, G-ResProtocolAmd, and MEX-11 delineate the following fees (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Research protocol authorization (medicines, biological, and biotechnological in humans): 7,896 Mexican Pesos
Research protocol amendment, modification, or addition of new research centers: 5,922 Mexican Pesos

For health permit authorization, the fees are as follows:

Health permit to import investigational products for research purposes: 7,033.09 Mexican Pesos (G-UnregDrugImprts)
Health permit to import cells and tissues including blood, its components, and derivatives: 866.45 Mexican Pesos (G-ImprtPermit)
Health permit modification to import cells and tissues including blood, its components, and derivatives: 649.84 Mexican Pesos (G-ImprtPermitMod)
Health permit to export cells and tissues including blood, its components, and derivatives: 866.45 Mexican Pesos (G-ExprtPermit)

As indicated in MEX-10, the fee for requesting a pre-assessment application evaluation through an Enabled Pre-Assessment Support Unit (Unidad Habilitada de Apoyo al Predictamen (UHAP)) (MEX-69) within the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad (CCINSHAE)) (referred to as the UHAP-CCINSHAE) is 60,000 Mexican Pesos. The cost is the same for obtaining a review from any of the UHAPs within CCINSHAE. In addition, if the applicant selects a scientific committee within an institution that has a UHAP, the cost is 40,000 Mexican Pesos. The cost for each amendment is 3,500 Mexican Pesos, and corrections to the pre-assessment document are free.

Payment Instructions

As explained in G-HumResProt, G-ResProtocolAmd, G-UnregDrugImprts, G-ImprtPermit, G-ImprtPermitMod, and G-ExprtPermit, fees must be paid to the applicant’s preferred bank. See G-ResProtocolAmd, G-UnregDrugImprts, G-ImprtPermitMod, and MEX-84 for access to a procedure-based form to pay fees at a chosen banking institution.

Refer to G-ResProtocolAmd, MEX-84, and G-DIGIPRiS-ResProts for additional information on this process.

2. General Requirements (2.2 Proof of Payment of Fees)

Other Permits or Authorizations – Health Supplies (p.10)

Costs

XIII. Specific Sections of the Procedure on the Platform (III)

Requirements (4) and Costs

Costs

Requirements (10) and Costs

Requirements (2) and Costs

Ethics Committee

Last content review/update: July 18, 2025

Overview

As indicated in the CanadaFDR and the G-CanadaCTApps, Canada has a decentralized process for the ethical review of clinical trial applications, and requires the sponsor to obtain institutional ethics committee (EC) approval for each participating trial site. (Note: institutional ECs are referred to as Research Ethics Boards (REBs) in Canada.) Canadian provinces may have varying requirements, and, therefore, the sponsor should consult with the applicable province(s) for more information.

Per CAN-35 and CAN-13, all proposed or ongoing research involving human participants carried out by, funded by, or otherwise under the auspices of Health Canada (HC) or the Public Health Agency of Canada (PHAC) must obtain approval from a joint EC representing those two (2) agencies—as well as complying with the CanadaFDR and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50. This joint EC is known as the HC-PHAC REB. Further, if an institution is conducting an HC- or PHAC-funded project, the HC-PHAC REB must review and approve the research even if it has been previously reviewed and approved by another EC. See CAN-35 for details on the HC-PHAC REB’s development, responsibilities, and composition. HC’s operational policy (CAN-13) outlines policies and procedures that the joint HC-PHAC REB must follow when reviewing clinical trials.

Institutional ECs are required to comply with the provisions delineated in the CanadaFDR, the G-CanadaCTApps, and CAN-52. Note that per CAN-50, HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. In addition, institutional ECs are guided by the G-TCPS2. Jointly developed by Canada’s three (3) federal research agencies: the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council (SSHRC), the G-TCPS2 is a policy that sets the ethical benchmark for all Canadian institutional ECs. However, only CIHR-, NSERC-, and SSHRC-funded institutions are required to comply with this guideline as a condition of funding. According to CAN-14, the CIHR, the NSERC, and the SSHRC created the Panel on Research Ethics (PRE) to promote the ethical conduct of research involving human participants. The PRE develops, interprets, and implements the G-TCPS2.

Ethics Committee Composition

As delineated in the CanadaFDR and the G-CanadaCTApps, institutional ECs must have at least five (5) members representing a mixed gender composition, the majority of which are Canadian citizens or permanent residents, and must include:

Two (2) members from a scientific discipline, with broad experience in the relevant research methods and areas, one (1) of whom is from a medical or dental discipline
One (1) member knowledgeable in ethics
One (1) member knowledgeable in relevant Canadian biomedical research laws
One (1) member from a nonscientific discipline
One (1) community representative

The G-TCPS2 mirrors these EC composition requirements, and also requires a Chair who is responsible for ensuring that the ethics review process conforms to the requirements of G-TCPS2. The Chair provides overall leadership for the EC and facilitates the review process based on institutional policies and procedures and the G-TCPS2. The Chair should monitor the EC’s decisions for consistency and ensure that these decisions are recorded accurately and communicated clearly to researchers in writing as soon as possible by the Chair or designate. Institutions must provide the necessary resources and adequate administrative support to enable the EC Chair to fulfill his or her responsibilities. As mentioned earlier, only CIHR-, NSERC-, and SSHRC-funded institutions are required to comply with this guidance as a condition of funding.

Also, see CAN-52 for additional guidance on ECs.

Terms of Reference, Review Procedures, and Meeting Schedule

According to CAN-52, institutional ECs must establish written standard operating procedures (SOPs) to cover the entire review process. The SOPs should include EC composition, meeting schedules, notifications, frequency of reviews, protocol deviations, reporting to the EC, and recordkeeping. Further, ECs should make decisions at announced meetings where a quorum is present. Only those members who participate in the EC review and discussion should vote, provide their opinion, or advise. For detailed EC procedures and information on other administrative processes, see CAN-52. For examples of EC SOPs, see CAN-13 for the HC-PHAC REB operational policy.

2 and 3

Introduction, 1.24, 1.27, and 2.6, 3

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

About the REB and Policies, Guidelines, and Resources

1.2, 1.4, 2.1, and 2.7

5.1, 5.2, 5.5, 5.6, and 5.10

Introduction and Chapter 6 (Articles 6.4, 6.8, and 6.10)

Part C (Division 5 (C.05.001, C.05.002, C.05.005, C.05.006, and C.05.010))

Last content review/update: October 31, 2025

Overview

As delineated in GenHlthLaw, HlthResRegs, REC-Op, REC-Op-Ref, G-RECs-Op-2018, and NOM-012-SSA3-2012, Mexico has a decentralized process for the ethics review and approval of clinical trial research. Accordingly, every health care institution which carries out research activities in human beings is required to have a Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) that is responsible for evaluating and ruling on research protocols in human beings. RECs are subject to current legislation and the criteria established by the National Bioethics Commission (Comisión Nacional de Bioética (CONBIOÉTICA)).

RECs must also comply with guidelines for the ethical evaluation of research involving human beings as delineated in GenHlthLaw, G-RECs-Op-2018, HlthResRegs and NOM-012-SSA3-2012. Pursuant to G-RECs-Op-2018, RECs must adhere to international guidelines relevant to research with human beings including the Declaration of Helsinki (MEX-76) and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MEX-22)). (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing MEX-22).

In addition, per GenHlthLaw, HlthResRegs, and NOM-012-SSA3-2012, every health institution where research is conducted is required to establish a Research Committee and a Biosafety Committee. Per HlthResRegs, NOM-012-SSA3-2012, MEX-84, and G-DIGIPRiS-ResProts, REC and Research Committee approval is required for each trial site where a study is being conducted, and when applicable, Biosafety Committee approval is required as well.

GenHlthLaw further notes that in addition to establishing a REC, public, social, or private sector health care establishments of the National Health System must have a Hospital Bioethics Committee for the resolution of problems arising from medical care along with engaging in other bioethical and ethical related activities.

As per HlthResRegs, REC-Op, REC-Op-Ref, G-RECs-Op-2018, and NOM-012-SSA3-2012, Hospital Bioethics Committees also operate through CONBIOÉTICA. MEX-47 specifies that CONBIOÉTICA is responsible for registering RECs and Hospital Bioethics Committees. See the Oversight of Ethics Committees section for details on ethics committee registration.

Ethics Committee Composition

Research Ethics Committee Composition

As indicated in GenHlthLaw, RECs must be interdisciplinary, gender-balanced groups composed of medical personnel from different specialties; professionals from psychology, nursing, social work, sociology, anthropology, philosophy, or law fields who have bioethics training; and community representatives affected by the health condition under study or other health services users who may or may not be attached to the health unit or institution. In addition to the previously stated criteria, G-RECs-Op-2018 indicates that these professionals should have a professional license and accredited training and experience in research ethics, good clinical practice, bioethics, and have experience related to the research area they will be evaluating. HlthResRegs further notes that the REC must consist of at least three (3) scientists including both genders and recommends that at least one (1) of them be based outside the health institution. The medical professionals should also represent the moral, cultural, and social values of the research groups. By comparison, NOM-012-SSA3-2012 states that REC health professionals should have expertise in the subjects investigated at the institution, regardless of whether the professionals have experience in the scientific methodology applied to the research. Further, the community representatives should embody the moral, cultural, and social values of the research participants.

Per REC-Op and REC-Op-Ref, the REC members must also be recognized and able to document their professional excellence in research/research bioethics, have personal records that prove ethical suitability and conduct, and advanced knowledge in qualitative and quantitative methodology. Additionally, GenHlthLaw, G-RECs-Op-2018, and NOM-012-SSA3-2012 state that REC members may or may not be based at the associated institution where the study is being conducted.

Additionally, NOM-012-SSA3-2012 specifies that the REC should be composed of a minimum of three (3) scientists, plus community representatives, as deemed necessary, with a total of at least six (6) members and a maximum of 20. G-RECs-Op-2018, REC-Op, and REC-Op-Ref note that the REC should comprise a president, at least four (4) members, one (1) of whom will serve as secretary, a representative from the affected study group or other health services users, with at least one (1) member who has expertise in bioethics and research ethics, and internal or external specialists to be included on an as needed basis. G-RECs-Op-2018 also notes that the member acting as a representative is not required to have a professional license in research or medical care and may include individuals with basic education or technical training.

Hospital Bioethics Committee Composition

Per GenHlthLaw and G-CHBs-Op, Hospital Bioethics Committees must be multidisciplinary, diverse, gender-balanced groups composed of medical personnel from different specialties and the health team; professionals from psychology, nursing, social work, sociology, anthropology, and philosophy fields; lawyers with knowledge in health matters, and community representatives affected by the health condition under study or other health services users who may or may not be attached to the health unit or institution. G-CHBs-Op notes that the members must have previous bioethics training or receive the training within six (6) months after joining the Committee. See G-CHBs-Op for additional information.

Terms of Reference, Review Procedures, and Meeting Schedule

Research Ethics Committees

Per NOM-012-SSA3-2012, the constitution and operation of the REC will be subject to the provisions of current legislation and, where appropriate, to the criteria referred to in article 41 Bis of the GenHlthLaw. REC-Op, G-RECs-Op-2018, NOM-012-SSA3-2012, and COFEPRIS-GCP specify that RECs should operate within written standard operating procedures (SOPs) to conduct their reviews. REC-Op and G-RECs-Op-2018 indicate that the health institution owner must approve the SOPs and issue a certificate of appointment to each REC member. HlthResRegs, G-RECs-Op-2018, and NOM-012-SSA3-2012 note that members must hold office for three (3) years and may be approved for an equal period.

Per REC-Op, G-RECs-Op-2018, NOM-012-SSA3-2012, and COFEPRIS-GCP, the following minimum requirements must be met (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

RECs must meet at least six (6) times a year, and at least once every two (2) months
The minimum number of members required to complete a quorum must be greater than 50% of the members, and the president and/or secretary must be present to form a quorum
In the evaluation of multicenter studies and when otherwise warranted, the REC may meet jointly with other RECs that belong to other establishments in the country, for the assessment and opinion for these protocols
Minutes must be prepared for legal and administrative purposes in meetings
An annual activities report should be presented to the institutional head in the first 30 calendar days of the year
Conflicts of interest in protocol evaluations should be avoided or be declared disqualified for that particular review
Participation is required in initial training and bioethics continuing education
Liaisons with other RECs within and outside the country conducted to better carry out its functions
A general policy on the confidentiality of information for reviewed protocols must be established and implemented
A code of conduct for REC members must be established and implemented
Members must refrain from participating in the evaluation and opinion of their own research
Members will remain in office for the time established in each committee’s installation act and may be ratified at the end of each period, if applicable. Members may be replaced in a staggered manner, for which documentary evidence must be kept
The committee will designate the person who will occupy the position of president and who will be responsible to the head of the institution or establishment and for the committee’s activities
In the committee sessions, members of external committees may participate or have the support of external advisors, who will have a voice but no vote. In these cases, researchers from the institution or establishment itself may also participate as long as they work in areas related to the project or research protocol subject in the opinion phase
It is the responsibility of the committee to issue the technical opinion on ethics, according to the nature of the proposed investigations

For detailed REC procedures and information on other administrative processes, see REC-Op, G-RECs-Op-2018, NOM-012-SSA3-2012, and COFEPRIS-GCP. See also MEX-72 for information on CONBIOÉTICA’s REC follow-up monitoring reports.

As per G-RECs-Op-2018, the REC should also keep documentation related to its integration, operation, and registration activities for up to three (3) years after the conclusion of the committee’s activities. The committee should also define the procedure for transferring the files and appoint the responsible person at the institution where the REC registration was granted. In addition, the REC will keep all the essential documents reviewed and related to each evaluated investigation, up to five (5) years following the end of the investigation or during the period established in the applicable provisions.

See G-RECs-Op-2018 for additional REC recordkeeping requirements.

Hospital Bioethics Committees

As indicated in G-CHBs-Op, Hospital Bioethics Committees must establish operating rules, which specify member functions as well as the internal mechanisms and procedures for operations during the sessions. Per G-CHBs-Op and GenHlthLaw, the Committee promotes, with the head of the hospital, the dissemination, elaboration, and implementation of institutional bioethical guidelines and guides for medical care and teaching. GenHlthLaw notes the Hospital Bioethics Committees must comply with current legislation and CONBIOÉTICA guidelines. For detailed Hospital Bioethics Committee procedures and information on other administrative processes, see G-CHBs-Op.

9.2

Search for the Status of Implementation of ICH Guidelines by ICH Members

XIII. Specific Sections of the Procedure on the Platform (XI-XIII)

2

1.2-1.3, 2-3, 3.1, 3.3, 4.1, 4.3, 5.1-5.2, 6.1-6.2, 8.1, 9, 11, and Annexes 1 and 2

Integration, Operation, Sessions, Minutes, Quorum, Issuance of Recommendations, and Information and Files

Title III (Chapter III, Article 41 Bis) and Title V (Chapter I, Articles 98 and 100)

Preamble, Fourth, Sixth-Tenth, and Twelfth

Preamble, Article One (Twelfth, Twelfth Bis 1, Twelfth Bis 2, and Sixteenth)

Title II (Chapter I, Articles 13-14), Title V (Chapter I, Articles 99-102, 104, and 108-109)

0-1 and 9

Scope of Review

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

Health Canada’s implementation of the ICH Harmonised Guideline for Good Clinical Practice E6(R3) will go into effect on April 1, 2026, and stakeholders are expected to be in full compliance by that date. See the Health Canada notice for more details.

Overview

According to the CanadaFDR, the G-CanadaCTApps, the G-TCPS2, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), the primary scope of information assessed by institutional ethics committees (ECs) (called Research Ethics Boards (REBs) in Canada) relates to maintaining and protecting the dignity and rights of human research participants and ensuring their safety throughout their participation in a clinical trial. ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed vulnerable. (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations.) Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

CAN-52, which Canada has implemented per CAN-50, also states that ECs must ensure an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. See CAN-52 for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the CanadaFDR and CAN-52, HC must approve a clinical trial application (CTA) and an institutional EC(s) must give ethical clearance prior to a sponsor initiating a clinical trial. In addition, as delineated in the CanadaFDR and the G-CanadaCTApps, institutional EC review for each clinical trial site may occur in parallel with HC’s CTA review and approval. Once HC completes its review, the department issues a No Objection Letter (NOL) if the CTA is approved. However, per the CanadaFDR, the G-CanadaCTApps, CAN-6, and CAN-30, HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval for each participating trial site is submitted. The sponsor should use the Clinical Trial Site Information Form (CAN-6) to submit the required information. The CanadaFDR also states that the EC must review and approve any protocol amendments prior to those changes being implemented. For HC’s interpretation of the relevant provisions of CanadaFDR, see the G-FDR-0100.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, requires EC review and approval of research involving living human participants and human biological materials. Further, ECs must have procedures in place to receive and respond to reports of new information, including, but not limited to, safety data, unanticipated issues, and newly discovered risks.

See TCPS2-InterpReview for the Panel on Research Ethics (PRE)’s interpretations of the G-TCPS2, including on the EC’s review of secondary use of non-identifiable information, delegated review of minimal risk studies, and ongoing review.

The G-TCPS2 lays out options, procedures, and considerations for the ethics review of multi-jurisdictional research either entirely within Canada, or in Canada and other countries. An institutional EC may approve alternative review models for research with multiple ECs and/or institutions but remains responsible for the ethics and conduct of research in its jurisdiction or under its auspices regardless of where the research is conducted. The SingleECRev provides guidance on the G-TCPS2’s single EC review model for multi-jurisdictional minimal risk, which seeks to streamline the research ethics review process where additional ethics reviews are not expected to add greater participant protections. In line with a proportionate approach to research ethics review, if research is of minimal risk and spans multiple jurisdictions, institutions that have approved the use of the single EC review model authorize the review of the research by one (1) EC. See the G-TCPS2 for more information about the various review models for multi-jurisdictional research.

Per CAN-8, an attestation must be completed by the EC that reviewed and approved the clinical trial. The completed attestation must be retained by the clinical trial sponsor for a period of 15 years. The attestation should not be submitted to HC unless requested. (See the Submission Process section for detailed submission requirements.)

The G-TCPS2 directs the researcher to submit an annual report to enable the EC to evaluate the continued ethical acceptability of the research. Per the G-CanadaCTApps, in the event that an EC terminates or suspends any prior approval or favorable opinion, it must document its views in writing, clearly identifying the trial, the documents reviewed, and the date for the termination or suspension.

1.27, 2, 3, and 5.11

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

1.2, 1.4, 2.1, 2.5, and 2.7

5.1, 5.2, 5.5, 5.6, and 5.10

Introduction, and Chapters 1-2, 6, 8, and 11

Part C (Division 5 (C.05.001, C.05.005, C.05.006, and C.05.010))

Last content review/update: October 31, 2025

Overview

According to HlthResRegs, REC-Op, and G-RECs-Op-2018, the primary scope of information assessed by the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) relates to maintaining and protecting the dignity and rights of human research participants and ensuring their safety throughout their participation in a clinical trial. Per HlthResRegs and G-RECs-Op-2018, RECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed vulnerable. (See Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations.)

HlthResRegs and G-RECs-Op-2018 also state that RECs must ensure an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. See HlthResRegs and G-RECs-Op-2018 for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

Per HlthResRegs, NOM-012-SSA3-2012, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, the applicant must obtain a favorable decision from the REC and the Research Committee at the health institution where the study is being conducted, and when applicable, a favorable decision from the Biosafety Committee. As per COFEPRIS-GCP, HlthResRegs, and NOM-012-SSA3-2012, the REC must provide a favorable decision for the research protocol and informed consent form prior to the applicant submitting a request for protocol authorization to the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)). Consequently, the REC and COFEPRIS reviews may not be conducted in parallel.

HlthResRegs and GenHlthLaw, explain that the REC provides ethics recommendations on protocols for research in human beings, including a review of the research risks and benefits. HlthResRegs further notes that RECs also prepare ethics guidelines for conducting research in humans.

As delineated in G-RECs-Op-2018, the REC agenda and documents corresponding to each session should be delivered at least seven (7) days prior to the meeting. It is then recommended that the REC’s decision be sent within a period not exceeding five (5) working days after the committee has met, or if applicable, not to exceed 30 calendar days from the review request date. G-RECs-Op-2018 and G-DIGIPRiS-ResProts also state that the approval of a new application is valid for one (1) year.

After obtaining a favorable opinion from the REC that validated the initial project or protocol, per NOM-012-SSA3-2012, the principal investigator (PI) must submit an amended protocol to the Ministry of Health (Secretaría de Salud) to request a new authorization for any amendments to be made to the methodological design of the initial research project. In those cases where the lives of research participants are endangered, amendments can be applied immediately, prior to approval by the REC and authorization by the Ministry of Health. However, in these situations, it will be necessary for the PI to provide documentary evidence following the event to the REC and the Ministry.

In addition, G-RECs-Op-2018 indicates that the REC should establish procedures for monitoring approved studies, from the point at which the decision was made until the completion of the investigation and reporting of results. Per NOM-012-SSA3-2012 and G-RECs-Op-2018, the REC must assess and approve the research protocol at the beginning of the project, and periodically throughout the project’s duration to ensure conformance with ethical principles and applicable regulations. NOM-012-SSA3-2012 further specifies that the REC must propose to the head of the institution or establishment where health research is carried out that the research be suspended or cancelled in the presence of any adverse effect that is an impediment from an ethical or technical point of view to continue with the study.

(See Submission Process and Timeline of Review sections for detailed REC submission process and timeline details.)

9.2

XIII. Specific Sections of the Procedure on the Platform (XI-XIII)

2

3.1-3.3, 4.3-4.4, 7.2, 8.1-8.2, 11, and Annexes 5 and 6

Requirements (9) and Additional Information

Title V (Chapter I, Article 100)

Article Four and Single Annex (Single Committee Form)

Preamble and Fifth

Preamble, Title II (Chapter I, Article 13 and Chapter II, Article 29), Title III (Chapter I, Article 61-62), and Title V (Chapter I, Articles 99-102, 104, and 108-109)

0, 6.3, 8.4, 9.2, and 10.3

Ethics Committee Fees

Last content review/update: July 18, 2025

Institutional ethics committees (ECs) may independently decide whether to charge fees to conduct protocol reviews. For example, an institutional EC may require industry sponsors or other for-profit organizations to pay a fee. See specific examples of institutional fee requirements in CAN-3 and CAN-1.

REB Review Fees

Last content review/update: October 31, 2025

As set forth in G-RECs-Op-2018, COFEPRIS-GCP, and REC-Op, Research Ethics Committees (RECs) (Comités de Ética en Investigación (CEIs)) do not charge sponsors/investigators for their review. Rather, the health institution must finance REC operating expenses, without this causing any conflict of interest in the committee’s functions.

G-RECs-Op-2018 further states that the institution may also receive support from external sources for evaluating protocols. However, this funding should not be given directly to any of the REC members, and the contributions should not lead to a conflict of interest between the funding source and the REC’s functions. Similarly, the committee’s evaluations should not result in financial gains as a result of these contributions.

Per G-RECs-Op-2018, REC financial support should not be used for purposes other than for its operation, and all activities should be handled with full transparency. Support is provided for the following activities:

Time for participation in committee meetings
Work recognition for their performance in the REC
Support for training in bioethics and research ethics inside and outside the institution
Physical space for the REC headquarters, both for meetings and receipt of documents, and safeguarding of documentation protocols, opinions, and minutes
Administrative assistance for REC activities

No information is available on Hospital Bioethics Committee fees.

2.7

4.2

Seventh, Ninth, and Eleventh

Oversight of Ethics Committees

Last content review/update: July 18, 2025

There are no applicable regulations or guidance regarding the registration, auditing, and accreditation of institutional ethics committees (ECs).

Last content review/update: October 31, 2025

Overview

The National Bioethics Commission (Comisión Nacional de Bioética (CONBIOÉTICA)) was established as a decentralized entity of the Ministry of Health (Secretaría de Salud) in 2005, as specified in D-CONBIOETICA. According to D-CONBIOETICA and MEX-55, the agency has technical and operational autonomy in defining and establishing national bioethics policies in medical care and health research. Per D-CONBIOETICA, GenHlthLaw, G-RECs-Op-2018, and MEX-57, CONBIOÉTICA is also responsible for promoting the organization and operation of Research Ethics Committees (RECs) (Comités de Ética en Investigación (CEIs)) and Hospital Bioethics Committees in public and private health institutions, for establishing and disseminating criteria to support development of REC activities, and for providing committee member training support.

In addition, per D-CONBIOETICA, CONBIOÉTICA’s other roles include:

Exercising the Commission’s legal authority and head Commission operations
Presiding over the Commission’s Advisory Council
Issuing positions on bioethical issues relevant to society
Establishing links with federal entities to promote the creation and operation of state bioethics commissions
Signing and implementing collaborative agreements with organizations and opportunities that favor the development and consolidation of bioethical culture
Carrying out activities assigned by the Secretary of Health
Providing information and technical cooperation required by the Ministry of Health’s administrative units and other dependencies/entities within the Federal Public Administration

Registration, Auditing, and Accreditation

Research Ethics Committees

As delineated in HlthResRegs, REC-Op, REC-Op-Ref, REC-Op-Amd, G-RECs-Op-2018, G-RECReg, and MEX-57, all RECs are required to register with CONBIOÉTICA in order to conduct health research in humans.

G-RECs-Op-2018, and G-RECReg further state that CONBIOÉTICA has 10 working days from the business day following application receipt to accept the application, or require the applicant to correct omissions in the application within 15 working days from the business day following the date when the applicant is notified. If the applicant fails to respond within this timeframe, the application must be deemed not filed. Once the application has been admitted for processing, the Commission has 30 working days to notify the applicant of receipt, and if appropriate, to issue the corresponding registration certificate, which will be valid for three (3) years. The registration record must also be visibly displayed in the institution where REC operations occur and on its website, if applicable. Additionally, the registration number must be included in all official committee communications.

Per REC-Op-Amd, MEX-58, and G-RECReg, the REC registration form (MEX-29) is available for completion or download via MEX-58 or G-RECReg, and should be submitted in person according to the requirements outlined in REC-Op-Amd, MEX-58, and G-RECReg. The application must include the REC’s health institution identification data, an email address in order to receive Commission notifications, and the name and signature of the responsible person heading the REC. G-RECReg specifies that the applicant may request an appointment by phone or email to deliver all the documentation in printed form to CONBIOÉTICA, or send the application documentation via certified mail.

Refer to REC-Op-Amd, G-RECs-Op-2018, MEX-58, and G-RECReg for detailed registration application instructions and documentation requirements. See also MEX-57 for a list of registered RECs. See MEX-100 for REC registration renewal instructions.

As delineated in REC-Op-Amd, G-RECs-Op-2018, and G-RECRegRenew, a registration renewal application must be submitted by the principal or owner of the health establishment or by the legal representative to CONBIOÉTICA within 45 working days prior to the expiration of the validation period covered by the registration certificate. From this point, the timing requirements are the same as for the initial application. See REC-Op-Amd, G-RECs-Op-2018, and G-RECRegRenew for detailed registration renewal application requirements and the application form.

In addition to CONBIOÉTICA’s REC registration requirement, per GenHlthLaw, G-RECs-Op-2018, REC-Op, and REC-Op-Ref, RECs must be installed under the responsibility of the head of the health institution where the study is taking place. They are required to sign a REC Installation Certificate (MEX-27), which stipulates its characteristics and functions. Refer to G-RECs-Op-2018 for detailed certificate requirements. See also MEX-72 for information on CONBIOÉTICA’s REC follow-up monitoring reports.

According to NOM-012-SSA3-2012, the research institution owner must also register the REC with the Ministry of Health (Secretaría de Salud), and report on the modification, designation, or substitution of any of its members. Additionally, an annual report documenting the integration and activities of these committees must be submitted to the Ministry during the first 10 business days of June each year.

Hospital Bioethics Committees

G-CHBs-Op indicates that Hospital Bioethics Committees must also register with CONBIOÉTICA, who is, in turn, required to issue a registration record within a maximum of 15 business days. However, G-CHBReg states that CONBIOÉTICA is required to issue a registration within 25 days. CONBIOÉTICA’s registration is valid for three (3) years. Per G-CHBs-Op, the Hospital Bioethics Committee registration form must be submitted electronically through CONBIOÉTICA’s website. The application for registration renewal can be submitted one (1) month prior to the registration’s expiration date. Refer to G-CHBs-Op, MEX-56, MEX-59, and G-CHBReg for additional Hospital Bioethics Committee registration information.

Registration Process of Research Ethics Committees (CEI) and List of Registered CEI

Preamble, Articles One-Three and Seven

Requirements, Who Can Apply?, Legal Basis, Steps, Response Time, Validity, and Additional Information

5.3, 11, and Annex 4

Registry of the Hospital Bioethics Committees, Proof of Registration, Validity of the Registration, Renewal of the Registration, and Appendix 1

Title III (Chapter III, Article 41 Bis) and Title V (Chapter I, Article 98)

Preamble, Article One (Twelfth and Twelfth Bis 1), and Transients (Third)

Preamble, Fourth, Sixth-Tenth, Twelfth, and Annex 1

Article One (Seventh, Twelfth, Twelfth Bis 2, and Sixteenth), and Annex 1

Title V (Chapter I, Articles 99-102, 104, and 108-109)

4.8 and 9.1.4

Submission Process

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

An updated version of G-MDSA went into effect on October 1, 2025. See the announcement for a summary of updates.

Overview

In accordance with the CanadaFDR and the G-CanadaCTApps, Canada requires the sponsor to obtain clinical trial authorization from Health Canada (HC) prior to initiating the trial. The sponsor must file a clinical trial application (CTA) to the appropriate Directorate within HC’s Health Products and Food Branch (HPFB). In addition, as delineated in the CanadaFDR and the G-CanadaCTApps, the sponsor may submit a CTA for clinical trial authorization to the HC in parallel with its submission to an institutional ethics committee (EC) (known as a Research Ethics Board (REB) in Canada) for a favorable ethical opinion. However, per the CanadaFDR, the G-CanadaCTApps, CAN-6, and CAN-30, HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval (provided in the required Clinical Trial Site Information (CTSI) form (CAN-6)) for each participating trial site is submitted. The HCNotice-CTSIForm indicates that the CTSI form improves efficiencies and supports the submission of CTAs using the electronic Common Technical Document (eCTD) format. See CAN-30 for instructions on filling out and submitting CAN-6.

CAN-19 provides a full list of HC’s forms for drug-related applications and submissions. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Regulatory Submission

Per the G-CanadaCTApps, CTAs (CAN-4) should be sent directly to the appropriate HPFB Directorate for review—the Pharmaceutical Drugs Directorate (PDD) for pharmaceutical drugs or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) for biological drugs and radiopharmaceuticals. The outer label should be clearly identified with "Clinical Trial Application." According to the G-MDSA, HC does not accept paper copies of CTAs, CTA amendments, and CTA notifications.

The G-MDSA and the G-CanadaCTApps indicate that sponsors may request a pre-submission/application meeting with the appropriate Directorate within the HPFB if they have any questions or concerns prior to filing a CTA. Additional details on requesting a meeting and meeting procedures are available in the aforementioned guidance documents. According to CAN-4, the submission can be in French or English. For CTAs that use pharmacometric approaches, sponsors should consider the policy statements in G-Pharmacometrics. Pharmacometrics is the science of using quantitative analysis and modelling and simulation approaches to inform and enhance drug development and regulatory review. In addition, see the G-CTACell for guidance on preparing CTAs for use of cell therapy products in humans.

Per the CanadaFDR, an application by a sponsor for authorization to sell or import a drug for the purposes of a clinical trial must be submitted to HC, signed and dated by the sponsor’s senior medical or scientific officer in Canada and senior executive officer. The sponsor’s clinical trial attestation must be submitted with the application (CAN-4). For guidance on completing CAN-4, see the G-DrugApp.

eCTD Electronic Submission

As indicated in the G-eCTD, clinical trial applications in eCTD format are recommended, not mandatory. However, once a sponsor files a regulatory activity in eCTD format, all additional information and subsequent regulatory activities for the same dossier must be filed in eCTD format. CAN-36 explains that prior to filing the first regulatory transaction for a dossier in eCTD format, the sponsor must request a dossier ID using the online dossier ID request. Per the ElecSubms, CAN-20 is the request form for biological clinical trial dossiers and CAN-21 is for pharmaceutical clinical trial dossiers. A request for a dossier ID should be sent a maximum of eight (8) weeks prior to submitting the CTA. In addition, applicants should review the Rules-eCTD for validation rules before submission. (Note: As per ElecSubms, G-eCTD and CAN-36 are only available upon request at no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure the text 'Request for eCTD Guidance Document' is in the subject line of the email.)

Per the G-eCTD and CAN-28, all regulatory transactions in eCTD format must be sent via the Common Electronic Submissions Gateway (CESG) (CAN-25), except for those exceeding 10 gigabytes (GB) in size. The CESG allows users to submit secure regulatory transactions electronically to HC, including CTAs. The G-eCTD and CAN-36 describe how to file CTAs and other clinical trial regulatory transactions (e.g., CTA amendments, responses to requests for information, and other in-scope activities) in eCTD format to CESG. The G-eCTD clarifies that prior to using the CESG for sending transactions, sponsors must register as a trading partner. To access and use CESG, CAN-34 instructs sponsors to follow these steps:

Register as a trading partner with the US Food & Drug Administration (FDA) at the FDA Electronic Submissions Gateway Next Generation (ESG NextGen) (CAN-51) to be able to send a regulatory transaction (Note: CAN-54 indicates that the new version of the platform, ESG NextGen, continues to support HC submissions.)
Send regulatory transactions to HC by selecting “HC” as the center on the FDA ESG system; CTAs intended for HC will be automatically redirected.

For detailed information on how to become a trading partner and send regulatory transactions, refer to CAN-54, CAN-51, and CAN-25.

As indicated in the G-eCTD, the following media formats are acceptable for eCTD transactions greater than 10 GB: Universal Serial Bus (USB) 2.0 or 3.0 drive; or portable external hard drive with USB 2.0 or 3.0 interfaces. (Contact HC at hc.ereview.sc@canada.ca for other media formats that may be acceptable at the time of filing.) A paper copy of the cover letter must accompany the media (unless otherwise indicated), and a pre-paid envelope must be provided if the media is to be returned. The complete regulatory transaction must be provided on a single drive, and the label on the drive should contain the following information:

Stakeholder Name
Brand Name
Dossier ID, which is based on the protocol number
Sequence (regulatory transaction) number

Media must be mailed to HC at the address below:

Health Canada
Finance Building
101 Tunney’s Pasture Driveway
Address Locator: 0201A1
Ottawa, Ontario
K1A 0K9

See the G-eCTD, CAN-54, CAN-34, CAN-36, CAN-25, and CAN-28 for details on registering as a trading partner for CESG transactions, how to use CESG, and submitting CTAs in eCTD format.

Non-eCTD Electronic Submission

For non-eCTD electronic submissions, G-Non-eCTD indicates that HC requires both PDF and MS-Word formats for the CTA (CAN-4). The PDF documents must be generated from electronic sources (not scanned material), except when access to an electronic source document is unavailable or where a signature is required. It is important that PDF files be properly bookmarked and hyperlinked. Documents that legally require signatures may be signed with an electronic signature, or the signature page can be printed, signed, scanned, and saved as a PDF file. The cover letter does not require a signature, but should include a printed name, phone number, and email address. All regulatory submissions should be validated prior to transmitting to HC. For validation rules, see the Rules-Non-eCTD. The ElecSubms contains a zip file of the folder structure for clinical trial non-eCTD submissions. (Note: As per ElecSubms, G-Non-eCTD is only available upon request at no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure the text 'non eCTD Guidance Document' is in the subject line of the email.)

Per the G-Non-eCTD, CTA submissions to the appropriate Directorate within HC’s HPFB must be in one (1) of these accepted media formats:

Compact Disc-Recordable (CD-R) conforming to the Joliet specification
USB 2.0 or 3.0 drive
Digital Versatile Disc (DVD-RAM and DVD+R/-R) in Universal Disk Format (UDF) standard

All media should be labelled and contain the following information:

Stakeholder Name
Brand Name
Dossier ID (if known)

Subsequent to burning the CD/DVD or transferring data to a drive, applicants should ensure that all files can be opened, files are not corrupted, and that "Thumb.db" files are removed.

As per the G-Non-eCTD, CAN-18, and CAN-17, non-eCTD CTAs involving pharmaceutical drugs should be sent to PDD, and CTAs involving biologics and/or radiopharmaceuticals should be sent to BRDD at the addresses listed below.

Office of Clinical Trials
Pharmaceutical Drugs Directorate
Health Canada
5th Floor, Holland Cross, Tower B
1600 Scott Street
Address Locator: 3105A
Ottawa, Ontario, Canada
K1A 0K9
General Inquiries E-mail: oct.enquiries-requetes.bec@hc-sc.gc.ca

Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
Ground Floor, Health Canada Building 6
100 Eglantine Driveway
Address Locator: 0601C
Ottawa, Ontario, Canada
K1A 0K9
General Enquiries E-mail: brdd.ora@hc-sc.gc.ca

Per the HCNotice-CTSIForm, questions related to pharmaceutical CTSI forms should be sent to: oct.enquiries-requetes.bec@hc-sc.gc.ca and questions related to biologic CTSI forms should be sent to brdd.ora@hc-sc.gc.ca.

Per the G-Non-eCTD, if an applicant submits a non-eCTD CTA via email, they should meet the following requirements:

The maximum email size accepted by the corporate mail server is 20 megabytes. If the clinical trial submission is larger than 20 megabytes, the submission may be split and sent as separate emails (e.g., an email for Module 1, and another email for Module 2/3). The subject line of the emails should clearly link to each other (e.g., "Email 1 of 2" in the relevant subject line)
A duplicate copy must not be provided by mail
The submission should be organized in folders and the body of the email should only contain the zipped regulatory submission
Zipped files and documents contained in the email should not be password protected

The G-Non-eCTD provides additional information on emailing other clinical trial submissions, including responses to a clarification request, responses to a no objection letter, notifications, and development safety update reports.

Ethics Review Submission

As indicated in the CanadaFDR and the G-CanadaCTApps, all research involving human participants in Canada must be reviewed by an institutional ethics committee (EC). (Note: institutional ECs are referred to as Research Ethics Boards (REBs) in Canada.) Because the submission process at individual institutional ECs will vary, applicants should review and follow their institution’s specific requirements. Further, Canadian provinces may have varying requirements, and, therefore, the sponsor should consult with the applicable province(s) for more information. CAN-35 delineates submission requirements to the joint HC-Public Health Agency of Canada (PHAC)’s EC. This joint EC reviews all research involving human subjects that is carried out by HC or PHAC researchers on the premises or in collaboration with external researchers.

Submissions (Does ESG NextGen support Health Canada)

Research Ethics Board (Apply for Ethics Review)

1.2, 2.2, 2.3, and 2.7

5.2, 5.4, and 5.5

3.1-3.4 and Appendix B

Guidance documents, notices, and supporting documents

7.1, 8.1, and 8.2

1.3 (Table 1), 3.2, and 5

Part C (Division 5 (C.05.002, C.05.004, C.05.005))

Last content review/update: October 31, 2025

Overview

In accordance with GenHlthLaw, Reg-COFEPRIS, HlthResRegs, and NOM-012-SSA3-2012, Mexico requires the applicant to submit a request to obtain research protocol authorization from the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)). Per HlthResRegs, NOM-012-SSA3-2012, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, the applicant must also obtain a favorable decision from the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) and the Research Committee at the health institution where the study is being conducted, and when applicable, a favorable decision from the Biosafety Committee. Because COFEPRIS’s review and approval of a protocol authorization request is dependent upon obtaining a favorable decision from the REC and Research Committee, the COFEPRIS and ethics committee (REC and Research Committee) reviews may not be conducted in parallel.

Regulatory Submission

Pre-submission Registrations

As delineated in G-DIGIPRiS-Regis, prior to submitting a protocol authorization request to COFEPRIS, an applicant must first register in COFEPRIS’S digital procedures and services platform, DIGIPRiS: Online Regulation (MEX-86), using an e.signature (also known as e.firma) digital certificate. An e.signature can be obtained from the Tax Administration Service (Servicio de Administración Tributaria (SAT)) as described in MEX-83. See G-DIGIPRiS-Regis, G-DIGIPRiS-SystAccess, and MEX-89, for additional details on registering in MEX-86. See also MEX-106 for an instructional tutorial on registering in MEX-86, and see G-DIGIPRiS-FAQs for frequently asked questions on using MEX-86.

DIGIPRiS Submissions

As per Agrmnt_ResProtProcs, G-DIGIPRiS-Prots&Amdts, G-HumResProt, and MEX-89, research protocol authorization and amendment/modification requests must be submitted electronically via DIGIPRiS (MEX-86). MEX-89 specifies that an exception to this requirement is if the user is required to present printed documents with a handwritten signature, or a physical inspection is required. Per G-DIGIPRiS-Prots&Amdts and MEX-89, the application request will be considered active when the documentation is signed and submitted, otherwise it will only remain in the system for 90 calendar days. According to G-DIGIPRiS-SystAccess, G-DIGIPRiS-Prots&Amdts, and MEX-89, once the procedure has begun, the user will be notified in MEX-86 of all request-related administrative acts (known as resolutions) (e.g., approvals, denials, and requests for additional information). Additionally, per G-DIGIPRiS-SystAccess, multiple requests and procedures can be in process simultaneously in MEX-86. Refer to G-DIGIPRiS-DocComp for instructions on validating and comparing research protocol documents issued through MEX-86. See also MEX-106 for additional DIGIPRiS user guides. (Note: COFEPRIS refers to applications as requests or procedures).

Agrmnt_ResProtProcs and MEX-87 further indicate that COFEPRIS will not request documentation in its physical or electronic files if the information was previously obtained in paper or electronic form. Per Agrmnt_ResProtProcs, once the research protocol has been authorized, applicants must submit the required documentation within 15 business days (See the Submission Content section for details.) Applications that do not include all required and accurate information outlined in Agrmnt_ResProtProcs may be revoked. If this occurs, applicants must resubmit their application to prevent delays in processing.

Per Agrmnt_ResProtProcs, for protocol authorization and protocol modification/amendment requests, the application must also include the original proof of payment along with two (2) copies of the receipt, as well as one (1) copy of a simple power of attorney for natural persons (i.e., a third-party signature, validation, certification, authorization, or approval), or, a public instrument which accredits legal representation must be presented for legal entities, if applicable. The G-HumResProt also indicates the same requirements for protocol authorization.

Per G-DIGIPRiS-ResProts, all documents uploaded to DIGIPRiS (MEX-86) must be in “.pdf” format (unrestricted text file), unless another format is specified. In addition, G-HumResProt and G-ResProtocolAmd indicate that all documentation related to submitting applications for research protocol authorization and protocol modification/amendment must be in Spanish. MEX-84 also specifies that the protocol, investigator’s brochure (known as the researcher’s manual in Mexico), and the informed consent forms should be in Spanish.

(Note: COFEPRIS has not yet updated MEX-84, G-ResProtocolAmd, and G-DIGIPRiS-ResProts to align with the Agrmnt_ResProtProcs requirements. However, the ClinRegs team is regularly monitoring the COFEPRIS website for new developments and will post the most current sources when they become available.)

In addition, as specified in Agrmnt_FRAAuth, research protocol applications relying on prior authorizations from Foreign Regulatory Authorities (FRAs) under the regulatory “reliance” model must be submitted exclusively via DIGIPRiS (MEX-86). A certified, legalized, or apostilled copy (with Spanish translation) of the FRA’s authorization to conduct the clinical protocol must be attached under “Other documents.” The authorization must be issued within one (1) year to ensure document traceability. Copies of the protocol and the investigator’s brochure (IB) in English with Spanish translations must also be provided; only the Spanish versions require approval by the respective committees in Mexico. See the Scope of Assessment section for additional requirements governing the FRA reliance model.

As per MEX-71, for technical inquiries related to submitted procedures, applicants may contact the Comprehensive Service Center (Centro Integral de Servicios (CIS):

Call Center (CAT) Phone: 800 033 5050 (toll free within Mexico) or 55 53 40 09 96 (international calls) (per MEX-37)
Email: contactociudadano@cofepris.gob.mx

See also MEX-37, G-CIS, and G-CISMod for additional information on the CIS.

Enabled Pre-Assessment Support Unit (UHAP) Evaluation Submissions

Per MEX-21 and MEX-10, rather than submitting an application directly to COFEPRIS, an applicant may choose to have their application pre-assessed through an Enabled Pre-Assessment Support Unit (Unidad Habilitada de Apoyo al Predictamen (UHAP)) (MEX-69). A UHAP may be selected from the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad (CCINSHAE)) (referred to as the UHAP-CCINSHAE) or from the Mexican Social Security Institute (Instituto Mexicano del Seguro Social (IMSS)). See Scope of Assessment section for detailed information on UHAPs.

Ethics Review Submission

As earlier stated, per HlthResRegs, NOM-012-SSA3-2012, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, all requests for research protocol authorization in human beings and/or their biological samples in Mexico require the applicant to obtain a favorable decision from the REC and the Research Committee, and when applicable, a favorable decision from the Biosafety Committee. Because the submission process at individual institutional RECs will vary, applicants should review and follow their institution’s specific requirements.

9.2

Contact Information

Access with Electronic Signature of the SAT

Introduction and General Application Information

Access to the platform, profiles and roles, and Accessing the system and creating a profile

Introduction, XIII. Specific Sections of the Procedure on the Platform (IX and XI-XIII)

Requirements (1 and 9-10), Steps, and Additional Information

Requirements (1-2) and Additional Information

Title II (Chapter II, Article 17 Bis) and Title III (Chapter III, Article 41 Bis), and Title V (Chapter I, Article 98)

Articles Two – Five, Transients, and Single Annex (Single Committee Form)

Chapters I (Article 1) and II (Article 7), and Transitional Provisions (Second)

Chapter I (Articles 1 and 3) and Chapter IV (Article 14)

Title III (Chapter II, Article 65) and Title V (Chapter I, Articles 99 and 109-111)

5.2, 6.3, and 9.2

Submission Content

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

Health Canada’s implementation of the ICH Harmonised Guideline for Good Clinical Practice E6(R3) will go into effect on April 1, 2026, and stakeholders are expected to be in full compliance by that date. See the Health Canada notice for more details.

Regulatory Authority Requirements

As set forth in the CanadaFDR, the G-CanadaCTApps, and CAN-31, Health Canada (HC) requires the sponsor to apply for clinical trial authorization by submitting a clinical trial application (CTA) to HC. As specified in the G-CanadaCTApps and the G-QCM-PharmCTAs, the CTA should be organized into three (3) modules in Common Technical Document (CTD) format:

Module 1 - Administrative and clinical information about the proposed trial
Module 2 - Quality (Chemistry and Manufacturing) summaries about the drug product(s) to be used in the proposed trial
Module 3 - Additional supporting quality information

Per the CanadaFDR, the clinical trial application form (CAN-4) and the following information and documents must be submitted:

Protocol
Summary of potential risks/benefits
Clinical trial attestation that includes drug information (chemistry, names, classifications, dosage, therapeutic purpose, human-sourced excipient, drug identification number or notice of compliance, manufacturing information); sponsor’s contact information; if the drug is to be imported, contact information for the sponsor’s representative in Canada who is responsible for the sale of the drug; and contact information for the qualified investigator at each site, if known at the time of submittal
Contact information for each institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) that approved the protocol, if known at the time of submitting the application
Contact information of any institutional EC that previously refused to approve the protocol, its reasons, and refusal date
Investigator’s Brochure (IB)
Informed consent form (ICF)
Information about use of a human-sourced excipient
Chemistry and manufacturing information
Proposed date for trial commencement at each site, if known

Refer to the CanadaFDR, the G-CanadaCTApps, the G-DrugApp, the G-QltyBioCTs, and the G-QCM-PharmCTAs for detailed submission information.

Ethics Committee Requirements

Each institutional EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies to be supplied and application format requirements. However, the following requirements comply with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, and are basically consistent across all Canadian ECs:

Clinical protocol
ICFs and participant information
Participant recruitment procedures
IB
Safety information
Participant payments and compensation
Investigator(s) current curriculum vitaes (CVs)
Additional required institutional EC documentation

See section 3.1.2 of CAN-52 for additional submission content requirements.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, requires clinical trial researchers to include a plan for monitoring safety, efficacy/effectiveness (where feasible), and validity in their proposal for EC review. See the G-TCPS2 for additional details on the plan’s required contents.

See CAN-35 for submission requirements to the joint HC-Public Health Agency of Canada (PHAC)'s REB. This joint EC reviews all research involving human subjects that is carried out by HC or PHAC researchers, on the premises, or in collaboration with external researchers.

Clinical Protocol

As delineated in CAN-52, the clinical protocol should include the following elements:

General information
Background information
Trial objectives and purpose
Trial design
Participation selection/withdrawal
Participant treatment
Efficacy assessment
Safety assessment
Statistics
Direct access to source data/documents
Quality control/quality assurance procedures
Ethical considerations
Data handling and record keeping
Financing and insurance
Publication policy
Supplements

For complete protocol requirements, see section 6 of CAN-52.

3.1.2, 6, and 7

Efficacy guidelines

Apply for Ethics Review

2.3 and 2.7

I Introduction, S Drug Substance, and P Drug Product

Chapter 11 (Article 11.6)

Part C (Division 5 (C.05.001, C.05.004, and C.05.005))

Last content review/update: October 31, 2025

Regulatory Authority Requirements

As delineated in Agrmnt_ResProtProcs, G-HumResProt, and G-DIGIPRiS-Prots&Amdts, the following documentation must be submitted to the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) as part of the approval process (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Online application form (Authorization, Certificates and Visits form) (MEX-25) (see MEX-18 for instructions on completing MEX-25)
Simple power of attorney, for natural persons (i.e., a third-party signature, validation, certification, authorization, or approval), or a public instrument which accredits legal representation for legal entities, if applicable
Payment receipt and request letter
Duly completed single form by institutional/establishment head where research will be conducted (one (1) copy) (See form in Single Annex in Agrmnt_ResProtProcs)
Duly completed single form by principal investigator (PI)/research team (including certificates of studies accrediting technical competence, good clinical practice (GCP), and specialized experience by PI/research team (one (1) copy)) (See form in Single Annex in Agrmnt_ResProtProcs)
Duly completed single form by sponsor (See form in Single Annex in Agrmnt_ResProtProcs)
Single Committee form which consolidates approvals from applicable committees, duly required (one (1) copy) (See form in Single Annex in Agrmnt_ResProtProcs)
Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) Registry (one (1) copy)
Research protocol (one (1) copy)
Study schedule (one (1) copy)
Investigator’s Brochure (IB) (also known as Researcher’s Manual in Mexico) or equivalent document (one (1) copy)
Informed consent form
Research site(s)
Emergency care center (See form in Single Annex in Agrmnt_ResProtProcs)
Certificate of compliance with Good Manufacturing Practice (GMP) for investigational products (IPs) or equivalent document, stability report, and IP/placebo results, except for risk-free research (observational studies) (one (1) copy)

(Note: COFEPRIS has not yet updated MEX-84, G-ResProtocolAmd, and G-DIGIPRiS-ResProts to align with the Agrmnt_ResProtProcs requirements. However, the ClinRegs team is regularly monitoring the COFEPRIS website for new developments and will post the most current sources when they become available.)

In addition, Agrmnt_ResProtProcs states that once the research protocol has been authorized, applicants must submit within 15 business days, the following:

Consent and/or informed assent, previously approved by the Research Ethics Committee
Study insurance (Policy/Certificate) or current financial fund that certifies coverage for research participants, and
Standard form for medical emergencies and the agreement or contract for the care of medical emergencies, if applicable

Risk-free research (observational studies) only requires the REC-approved consent and/or informed assent form to be submitted per Agrmnt_ResProtProcs.

Refer to Agrmnt_ResProtProcs, G-HumResProt, and G-DIGIPRiS-Prots&Amdts for more detailed submission information. See also MEX-36 for information on obtaining a certificate of GMP.

As outlined in Agrmnt_ResProtProcs, for any protocol authorization amendment or modification (COFEPRIS-09-012), applicants must submit a Single Amendment or Modification Request Form (See form in Single Annex in Agrmnt_ResProtProcs) and proof of payment. If applicable, a simple power of attorney for natural persons (i.e., a third-party signature, validation, certification, authorization, or approval), or a public instrument which accredits legal representation for legal entities, if applicable, must also be provided. In addition, per Agrmnt_ResProtProcs and G-DIGIPRiS-Prots&Amdts, specific documentation are required depending on which of the following amendment/modification categories is being updated:

Protocol, informed consent/assent, or IB
Center inclusion
Research center change
PI change
Research team changes
Emergency care center changes
Evaluation committee changes
Security amendment
Establishment owner change
Sponsor change
Change/addition of importer
Other modifications

See also Scope of Assessment and Timeline of Review sections for additional COFEPRIS review process and timeline information.

Ethics Committee Requirements

As indicated in MEX-84 and G-DIGIPRiS-ResProts, the following documentation should be submitted to obtain the favorable opinion of the REC, the Research Committee, and where appropriate, the Biosafety Committee:

Full title and number of the research protocol
Research protocol with the version and date in Spanish
IB with the version and date in Spanish
Full name of the IP corresponding to the research center
Research center company name and address
Informed consent forms with the version and date in Spanish
Protocol summary
Detailed description of the documents evaluated and approved in Spanish, citing version and date
Validity of the approval opinion (not greater than one (1) year)
Name, position, and signature of the person responsible who supports the opinion
Confirmation of the evaluation of aspects of a scientific nature, the risk/benefit of the protocol as well as the guarantee and well-being of the participants

Additionally, a signed opinion issued on letterhead should be submitted that includes:

Committee name and address (in accordance with its current registration)
Date the opinion was issued
PI name
Company name and address of the research center
Title of the study and protocol number
Status/result of the evaluation of the documents (must be approved)
Date of issue of the opinion (day, month, and year)
Name and position of the signatory who supports the opinion (must be the President or the Secretary Member)

G-DIGIPRiS-ResProts, also notes that only the opinions with the signature of the President of the REC (or, where appropriate, the Secretary-Vocal) will be accepted with a letter attached stating “NO VOTE” or a justification for the absence of the president. See MEX-84 and G-DIGIPRiS-ResProts for additional ethics committee requirements.

However, per Agrmnt_ResProtProcs, COFEPRIS has published a Single Committee form, which merges the REC, Research Committee, and where applicable, Biosafety Committee documentation requirements into a single form. The form includes a section for the appropriate committee to provide information concerning its review and approval of the research protocol based on the following elements:

PI and research center names
Committee session data (including folio, protocol number, session data, approval date, session type (ordinary/extraordinary), and minutes number)
Research protocol data (including protocol number, study phase, title, short title, study risk level, research sponsor)
List of approved documents (including document names, versions, and dates)
List of committee members (including names, professions/disciplines, and positions)
Committee registration data (including establishment name or business name, address, registration number, start of validity or issue date, validity, expiration date)
Declaration of no conflict of interest and confidentiality
Research monitoring (periodic and continuous monitoring)
Express declaration of no vote for each member who is part of the research team

See Agrmnt_ResProtProcs for detailed requirements.

G-HumResProt also indicates that the Single Committee form should provide information related to the tests performed on the IP for a specific period of time under the influence of temperature, humidity, or light in the container that contains it, to ensure its shelf life from the date of manufacture to the date of the last administration.

Clinical Protocol

As set forth in MEX-84 and G-DIGIPRiS-ResProts, which are in compliance with the Guideline for Good Clinical Practice E6(R2) (MEX-22) and NOM-012-SSA3-2012, the research protocol should include the following elements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Title, acronym, and protocol number (corresponds to the opinion of the committee(s) evaluators)
Document version and date, and amendments (if applicable) (corresponds to the opinion of the committee(s) evaluators)
Sponsor name/address and monitor, if different from sponsor
Theoretical framework (IP name/description, preclinical findings summary, etc.)
Definition of problem
Participant selection and withdrawal criteria
Statement that the clinical trial will be conducted in accordance with the protocol, good clinical practices, and local regulatory requirements
Background
Rationale
Hypotheses (if applicable, includes statistical hypotheses)
General objective (if applicable, includes specific, primary, secondary, or exploratory objectives)
Materials and methods
Study design (e.g., inclusion/exclusion and elimination criteria; information input, processing, analysis, and interpretation)
Phase and type of study
Study duration
Sample size (global and local, as appropriate)
Countries where the research will be carried out
Health conditions or problems studied
Capture, processing, analysis, and interpretation of the information obtained
Route of administration, dose, dosing regimen, and treatment period(s) and justification
Accountability procedure for handling the IP and placebo (if applicable)
Mechanisms for maintaining randomization and blinding (if applicable), and codes for breaking them (e.g., criteria for premature unblinding, etc.)
Statistical considerations
Ethical considerations
Efficacy and safety assessments
Study schedule (document detailing activities to be carried out during the investigation)
Bibliographic references and relevant trial data
Names and signatures of PI and associate researchers (no more than five (5), classified according to their involvement in the research project)
Other documents related to the research project or protocol
Optional pre-assessment evaluation opinion (See Scope of Assessment and Submission Process sections for details on pre-assessment evaluations)

In addition to the protocol submission, per NOM-012-SSA3-2012, an additional letter should accompany the application. Please refer to NOM-012-SSA3-2012 for more specific letter instructions. See also MEX-84 and G-DIGIPRiS-ResProts for more detailed protocol requirements. (Note: Per MEX-2, COFEPRIS is in the process of implementing MEX-22).

2-10

6. Clinical Trial Protocol and Protocol Amendment(s)

Search for the Status of Implementation of ICH Guidelines by ICH Members

Application for Authorization of Research Protocol on Human Beings (COFEPRIS-04-010) and Classification of Amendments and Modifications within the platform

Change Control, V. Application Procedures for Authorization of Research Protocols, X. Sections that Make Up a Request for Research Protocols in Human Beings, and XIII. Specific Sections of the Procedure on the Platform (I - XV)

Requirements

Article Two, Article Five, and Single Annex (Single Committee Form, Single Form for the Principal Investigator and the Research Team, Single Form for Medical Emergencies, Single Sponsor Form, Single Form of the Head of the Institution or Establishment Where the Research will be Conducted, and Single Amendment or Modification Request Form)

6.1-6.3

Timeline of Review

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

An updated version of G-MDSA went into effect on October 1, 2025. See the announcement for a summary of updates.

Overview

As delineated in the CanadaFDR and the G-CanadaCTApps, the review and approval of a clinical trial application (CTA) by Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) may be conducted in parallel. However, per the CanadaFDR, the G-CanadaCTApps, CAN-6, and CAN-30, HC will not authorize the sponsor to begin the clinical trial until an institutional EC approval (provided in the required Clinical Trial Site Information (CTSI) form) for each participating trial site is submitted. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Regulatory Authority Approval

According to the CanadaFDR and the G-CanadaCTApps, an authorized clinical trial is one that has been filed with HC and has not received an objection within 30 days. All CTAs are subject to the 30-day default period from the date of receipt of the completed application at the appropriate Directorate within HC’s Health Products and Food Branch (HPFB). While the Directorates can establish shorter administrative targets of seven (7) days for the review of bioequivalence trials, the 30-day default system remains the regulatory requirement. Applications to conduct Phase I clinical trials using somatic cell therapies, xenografts, gene therapies, prophylactic vaccines, or reproductive and genetic technologies are not included in the seven-day target system. Please see the G-CanadaCTApps for special requirements regarding reviews of comparative bioavailability studies and joint reviews of clinical trials covering a combination of devices, biologics, and pharmaceuticals.

As specified in the G-CanadaCTApps and the G-MDSA, during the review period, the Directorate may request additional information from the sponsor, who has two (2) calendar days to provide such information. The G-MDSA clarifies that, where warranted, HC can adjust the timelines to be longer or shorter based on the complexity of the request, dialogue with the sponsor, and/or circumstances of the review, including pausing the clock during the scientific review. According to the G-CanadaCTApps and the G-MDSA, if HC authorizes the CTA, then it issues a No Objection Letter (NOL). If HC rejects the CTA, it sends a Not Satisfactory Notice (NSN). HC will issue an NSN if it identifies significant deficiencies, or, if a timely response to requested information has not been provided. The sponsor may resubmit the information and material at a future time, and it will be processed as a new CTA.

Ethics Committee Approval

The EC review and approval process timeline varies by institution. However, according to the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the institutional EC should review a proposed clinical trial within a reasonable time. The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, recommends a proportionate approach to ethics review—the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). In either case, pursuant to the G-TCPS2, the institutional EC should make its decisions in an efficient and timely manner. See CAN-35 for ethics review timelines with the joint HC-Public Health Agency of Canada (PHAC)'s EC. This joint EC reviews all research involving human subjects that is carried out by HC or PHAC researchers, on the premises, or in collaboration with external researchers.

Governance

CAN-35 states that PHAC researchers must obtain departmental approval of research involving humans before submitting their application to the joint HC-PHAC EC. For further information and to obtain the necessary form, contact the Office of the Chief Science Officer at email ocso.ethics-ethique.bcsc@phac-aspc.gc.ca.

3.1.2

Efficacy guidelines

Apply for Ethics Review

2.1, 2.3.3, 2.5, and 2.7

5.5 and 5.6

Chapter 2 (Articles 2.8 and 2.9) and Chapter 6 (Article 6.13)

11.1, 12.1, and 13.3-13.4

Part C (Division 5 (C.05.005 and C.05.006))

Last content review/update: October 31, 2025

Overview

As delineated in HlthResRegs, NOM-012-SSA3-2012, G-HumResProt, Agrmnt_ResProtProcs, MEX-84, and G-DIGIPRiS-ResProts, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS))’s review and approval of a protocol authorization request is dependent upon obtaining a favorable decision from the health institution’s Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) and the Research Committee, and where applicable, the Biosafety Committee. Therefore, COFEPRIS and ethics committee (REC, Research Committee, and Biosafety Committee) reviews may not be conducted in parallel. However, per HlthResRegs, the REC, the Research Committee, and the Biosafety Committee may meet together to decide whether to authorize a protocol to conduct research on humans, as appropriate.

Regulatory Authority Approval

Pursuant to HlthResRegs, COFEPRIS must approve a request for research protocol authorization within 30 business days from the day following an application’s filing. However, according to Agrmnt_ResProtProcs and G-HumResProt, COFEPRIS is required to complete its review of research protocol authorization requests within 30 calendar days. Agrmnt_ResProtProcs further specifies that this timeline applies to the review of human research protocols that have already been authorized by a foreign regulatory authority, as well as to research protocol modifications or amendments.

In addition, per G-HumResProt, during the prevention period, COFEPRIS has 10 calendar days to notify an applicant of any deficiencies or request additional information, and an applicant must respond within five (5) business days. If COFEPRIS does not respond within the 30-day timeline, the application will be deemed denied.

See the Scope of Assessment section for additional information on COFEPRIS’s evaluation process, and see Submission Process section for details on tracking submitted procedures via COFEPRIS’s digital procedures and services platform, DIGIPRiS: Online Regulation (MEX-86).

Also, as specified in Agrmnt_FRAAuth, COFEPRIS must issue a decision within 45 calendar days for research protocol applications involving human beings submitted under the regulatory “reliance” model, which are based on prior authorization from a Foreign Regulatory Authority (FRA). See the Scope of Assessment and Submission Process sections for additional requirements governing the FRA reliance model and submission procedures.

Per Reg-HlthProd and G-UnregDrugImprts, COFEPRIS has 10 days to approve import requests for investigational drug products. If COFEPRIS does not respond within this timeframe, the request is deemed approved. G-UnregDrugImprts also notes that COFEPRIS has eight (8) business days to send the applicant a prevention notification regarding missing or additional information required. The applicant, in turn, has five (5) business days to respond.

Enabled Pre-Assessment Support Unit (UHAP) Evaluations

Per HlthResRegs, prior to submitting an authorization request, applicants may also obtain a pre-assessment evaluation by an authorized third party that helps to facilitate COFEPRIS’s review. Per MEX-21 and MEX-10, third parties are also known as Enabled Pre-Assessment Support Units (Unidad Habilitada de Apoyo al Predictamens (UHAPs)) (MEX-69) within the Coordinating Commission of National Institutes of Health and High Specialty Hospitals (Comisión Coordinadora de Institutos Nacionales de Salud y Hospitales de Alta Especialidad (CCINSHAE)) (referred to as the UHAP-CCINSHAE) or UHAPs within the Mexican Social Security Institute (Instituto Mexicano del Seguro Social (IMSS)). According to MEX-10, the UHAP has a maximum of 30 calendar days to respond to an evaluation request. See MEX-10 and MEX-98 for additional information on authorized third parties. See the Scope of Assessment and Submission Process sections for detailed UHAP information.

Ethics Committee Approval

As delineated in G-RECs-Op-2018, the REC agenda and documents corresponding to each session should be delivered at least seven (7) days prior to the meeting. It is then recommended that the REC’s decision be sent within a period not exceeding five (5) working days after the committee has met, or if applicable, not to exceed 30 calendar days from the date of request for its review. G-RECs-Op-2018 and G-DIGIPRiS-ResProts also state that the approval of a new application is valid for one (1) year.

In addition, G-RECs-Op-2018 indicates that the REC should establish procedures for monitoring approved studies, from the point at which the decision was made until the completion of the investigation and reporting of results. RECs should conduct at least one (1) review a year.

9.2

10

XIII. Specific Sections of the Procedure on the Platform (XI-XIII)

Term

3.3, 6.2, 8.1, and 8.2

Requirements (9), Term, and Additional Information

Articles Four and Six, Transients (Sixth), and Single Annex (Single Committee Form)

Chapters I (Article 1) and II (Article 8)

Title VI (Chapter IV, Article 196)

Title III (Chapter I, Article 62) and (Chapter II, Articles 65 and 69) and Title III Bis

5.2, 6.3, 9.2, and 10.3

Initiation, Agreements & Registration

Last content review/update: July 18, 2025

Overview

In accordance with the CanadaFDR and the G-CanadaCTApps, a clinical trial can only commence after the sponsor receives authorization from both Health Canada (HC) and an institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada). No waiting period is required following the applicant’s receipt of these approvals. CAN-30 specifies that for purposes of the Clinical Trial Site Information (CTSI) Form (CAN-6), the trial commencement date is the date when the clinical trial site is ready to enroll participants. The commencement date is a date after which the sponsor has both the HC authorization from the appropriate Directorate (date on the No Objection Letter (NOL)) and approval from the relevant EC. Further, the commencement date would be the date when the sponsor implements the protocol, which includes the screening period that occurs prior to the check-in date. See the Scope of Review section for detailed institutional EC requirements, and the Submission Content section for additional HC approval information. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

In addition, per the G-CanadaCTApps, if a sponsor (Canadian or foreign) wants to import a drug into Canada to conduct a clinical trial, a copy of HC’s clinical trial authorization (i.e., the NOL) must be included with the drug shipment. According to the G-CanadaCTApps and CAN-32, if a sponsor plans to import investigational drugs directly to each trial site, then the sponsor must also authorize the importer (i.e., the clinical trial site) when submitting the clinical trial application using Appendix I of HC’s Drug Submission Application Form (CAN-4). See the Manufacturing & Import section for detailed import requirements.

Clinical Trial Agreement

Prior to initiating the trial, as delineated in the G-FDR-0100 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor must sign an agreement between all involved parties, including ECs, Qualified Investigators (QIs), contract research organizations, and others, to ensure full compliance with the regulatory requirements. Further, the sponsor should obtain the investigator’s/institution's agreement:

To conduct the trial in compliance with good clinical practice, with the applicable regulatory requirement(s), and with the protocol agreed to by the sponsor and given approval/favorable opinion by the EC
To comply with procedures for data recording and reporting
To permit monitoring, auditing, and inspection
To retain the trial-related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

In accordance with the G-CanadaCTApps, prior to initiating a clinical trial, the sponsor must ensure that a Qualified Investigator Undertaking (QIU) form (CAN-37 or similar documentation that meets the CanadaFDR requirements) has been completed and is kept on file by the sponsor. Per the CanadaFDR, the form certifies that the QI will conduct the clinical trial in accordance with good clinical practice and will immediately inform trial participants and the institutional EC of trial discontinuance and the reason for this discontinuance. If there is a change in the QI at a site, a new CTSI Form must be submitted to HC, and a new QIU form must be maintained by the sponsor.

See CAN-6, CAN-8, and CAN-19 for additional clinical trial forms.

Clinical Trial Registration

As per the G-CanadaCTApps, sponsors should register their clinical trials on one (1) of two (2) publicly accessible registries accepting international clinical trial information and recognized by the World Health Organization (WHO), ClinicalTrials.gov (CAN-45), and the International Standardized Randomized Controlled Trial Number (ISRCTN) Registry (CAN-46). According to HCNotice-CTRegDisc, clinical trial registration is not a mandatory requirement at this time. However, per the G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, clinical trials must be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the WHO or the International Committee of Medical Journal Editors (ICMJE). In addition, following registration, researchers are responsible for ensuring that the registry is updated in a timely manner with: new information; safety and, where feasible, efficacy reports; reasons for stopping a trial early; and the location of findings.

1.17, 5.1.2, 5.6.3, and 8.2.6

Efficacy guidelines

1.2 and 2.7

5.6

Chapter 11 (Articles 11.10-11.11)

Part C (Division 5 (C.05.006))

Last content review/update: October 31, 2025

Overview

In accordance with GenHlthLaw, Reg-COFEPRIS, HlthResRegs, NOM-012-SSA3-2012, COFEPRIS-GCP, Agrmnt_ResProtProcs, G-HumResProt, G-DIGIPRiS-Prots&Amdts, and MEX-84, a clinical trial can only commence after an applicant receives authorization from Mexico’s Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)). Per HlthResRegs, NOM-012-SSA3-2012, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, the applicant must also obtain a favorable decision from the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) and the Research Committee at the health institution where the study is being conducted, and when applicable, a favorable decision from the Biosafety Committee. No waiting period is required following the applicant’s receipt of these approvals.

As per GenHlthLaw, an applicant must be a resident of Mexico and is required to obtain an import license from COFEPRIS for the shipment of an investigational product to be used in the trial. The applicant must be a resident of Mexico or have a legal representative submit the application on their behalf. (See the Manufacturing & Import section for additional information).

As set forth in NOM-220-SSA1-2016, the health record holder, principal investigator (PI), sponsor, or person responsible for a study authorized by COFEPRIS must also issue a notice of a study’s commencement (e.g., first visit of the first patient) and a notice of its completion (e.g., last visit of the last patient).

Clinical Trial Agreement

While NOM-012-SSA3-2012, MEX-84, and G-DIGIPRiS-ResProts state that prior to initiating the trial, if applicable, the sponsor must sign a letter of acceptance that serves as an agreement to assume the project obligations and rights stated in the letter, Agrmnt_ResProtProcs, has eliminated this requirement as of June 2025.

Additionally, as of June 2025, Agrmnt_ResProtProcs has eliminated the requirement stated in MEX-84, G-DIGIPRiS-ResProts, and NOM-012-SSA3-2012 that the sponsor must sign a letter to ensure there are no conflicts of interest that could lead to the interruption of treatment for the research participant.

According to COFEPRIS-GCP, COFEPRIS requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32) for conducting clinical trials. COFEPRIS-GCP indicates that the sponsor must establish in writing each of the research team member functions and responsibilities, and the financial agreement with the PI. The sponsor or the CRO must also establish a declaration of financing, sponsorship, affiliations, contracts of agreements with other institutions involved, and procedures for handling any conflict(s) of interest, and a system for providing incentives and quantity/payments to research participants. MEX-32 specifies that the financial aspects of the trial should be documented in an agreement between the sponsor and the investigator and the institution.

Further, per MEX-32, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure and should provide sufficient time for the investigator and institution to review the protocol and the information provided.

COFEPRIS-GCP further states that in the case of delegating investigation-related activities to a CRO, the sponsor must also establish in writing each of the activities that are delegated. However, the ultimate responsibility for all CRO activities remains with the sponsor. Additionally, COFEPRIS-GCP indicates that the sponsor or the CRO must establish a declaration of financing, sponsorship, affiliations, contracts, or agreements with other institutions involved, handling of any conflicts of interest, incentives, and quantity and payments to the research participants.

According to MEX-32, the sponsor or the CRO must also obtain the investigator(s)’s and the institution(s)’s agreement to:

Conduct the trial in compliance with MEX-32 and the protocol agreed to by the sponsor and approved by the ethics committee
Comply with data recording and reporting procedures
Permit monitoring, auditing, and inspection
Retain essential documents until the sponsor informs them that they are no longer needed

Per MEX-32, the sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Clinical Trial Registration

Per G-DIGIPRiS-ResProts and G-DIGIPRiS-Prots&Amdts, once COFEPRIS approves an authorization request, some of the data provided by the applicant in COFEPRIS’s digital procedures and services platform, DIGIPRiS: Online Regulation (MEX-86), is automatically migrated to COFEPRIS’s National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos (RNEC)) database (MEX-68). Per MEX-88, RNEC was integrated into MEX-86 as RNEC v2.0.

Governance

Per GenHlthLaw, HlthResRegs, and NOM-012-SSA3-2012, every health institution where research is conducted is required to establish a Research Committee and a Biosafety Committee. Per HlthResRegs, NOM-012-SSA3-2012, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, REC and Research Committee approval is also required for each trial site where a study is being conducted, and when applicable, Biosafety Committee approval is required as well.

HlthResRegs explains that the Research Committee evaluates the technical quality and scientific merit of the proposed research, and its opinion must contain the REC opinion and, where applicable, the Biosafety Committee opinion. The Biosafety Committee, in turn, is responsible for determining and regulating the use of ionizing radiation or genetic engineering techniques within the health institution as indicated in HlthResRegs, GenHlthLaw, and NOM-012-SSA3-2012. Pursuant to HlthResRegs and NOM-012-SSA3-2012, the Biosafety Committee issues a technical opinion on the biosafety aspects of the proposed research and ensures that research study staff, research participants, the community, and the environment are protected against radiological risks.

Additionally, per MEX-47, COFEPRIS is responsible for registering Research Committees and Biosafety Committees. Refer to MEX-47, G-BiosafetyReg, G-ResCommReg, and MEX-102 for detailed Research Committee and Biosafety Committee registration requirements. See MEX-26 for COFEPRIS’s Research Committee and Biosafety Committee registration form.

2, 4.1, 4.5, and 9.2

4.9, 5.6, and 5.9

Data Classification and Access to Information and Status and Actions allowed for an Application or Procedure

IX. General Considerations for Capturing Information and Uploading Documentation, XIII. Specific Sections of the Procedure on the Platform (IX and XI-XIII)

Preamble, 2, 4.1, 4.9-4.11, 4.13, and 5.7

Preamble, Requirements (9), Term, and Additional Information

Title V (Chapter I, Article 98), Title XII (Chapter I, Articles 194 and 194 bis) and (Chapter XIII, Articles 238-239 and 283-285), and Title XVI (Chapter I, Articles 368-369 and 371-372)

Preamble; Articles One, Four, and Six; and Single Annex (Single Committee form)

Chapter I (Articles 1 and 3) and Chapter IV (Article 14)

Title I (Chapter I, Articles 9 and 10), Title III (Chapter I, Article 62 and Chapter II, Articles 65 and 69), Title V (Chapter I, Articles 99-102 and 110-111), and Title VI (Chapter I, Articles 113 and 117)

7.4

5.2, 6.3, 7.4, and 9.1-9.2

Safety Reporting

Last content review/update: July 18, 2025

Safety Reporting Definitions

According to the CanadaFDR and G-CanadaCTApps, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), the following definitions provide a basis for a common understanding of Canada’s safety reporting requirements:

Adverse Event (AE) – Any adverse occurrence in the health of a clinical trial subject who is administered a drug that may or may not be caused by the administration of the drug, and includes an adverse drug reaction.
Adverse Drug Reaction (ADR) – Any noxious and unintended response to a drug that is caused by the administration of any dose of the drug.
Serious Adverse Drug Reaction (SADR) or Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or causes a congenital anomaly/birth defect.
Serious, Unexpected ADR – A serious ADR that is not identified in nature, severity, or frequency in the risk information set out in the investigator’s brochure or on the label of the drug.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ethics committees (ECs), requires researchers to promptly report new information revealed during the conduct of the trial that might affect the welfare or consent of participants to the EC, to a publicly accessible registry, and to other appropriate regulatory or advisory bodies. In addition, when new information is relevant to participants’ welfare, researchers must promptly inform all participants to whom the information applies (including former participants). Researchers must work with their ECs to determine which participants must be informed, and how the information should be conveyed.

For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Safety Reporting Requirements

Investigator Responsibilities

Per CAN-52, which Canada has implemented per CAN-50, all SAEs should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports. The immediate and follow-up reports should identify participants by unique code numbers assigned to the trial subjects rather than by their names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious ADRs to the regulatory authority(ies) and the EC. AEs and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol. For reported deaths, the investigator should supply the sponsor and the EC with any additional requested information (e.g., autopsy reports and terminal medical reports).

Sponsor Responsibilities

As delineated in the CanadaFDR, the G-CanadaCTApps, and CAN-22, the sponsor is required to expedite reports of ADRs to HC that meet these three (3) criteria: serious, unexpected, and having a suspected causal relationship. ADR reports that are expected or unexpected, but not serious, should not be reported to HC, but rather monitored and tracked by the sponsor. Further detail and clarifications on AE/ADR reporting criteria can be found in CAN-22. As specified in the G-CanadaCTApps, when evaluating whether an AE is serious and unexpected, the Qualified Investigator’s (QI) and sponsor’s determination of causality is important. Only serious and unexpected ADRs found to have a reasonable suspected causal relationship to the drug should be reported by the sponsor to HC.

Per the CanadaFDR and the G-CanadaCTApps, during a clinical trial, the sponsor is required to inform HC of any serious, unexpected ADR that has occurred inside or outside Canada. An ADR report must be filed in the following specified timelines:

When the ADR is neither fatal nor life-threatening, within 15 days after becoming aware of the information
When it is fatal or life-threatening, immediately when possible and, in any event, within seven (7) days after becoming aware of the information
Within eight (8) days after having informed HC of the ADR, submit a report that includes an assessment of the importance and implication of any findings

Other Safety Reports

The G-DSUR delineates that the development safety update report (DSUR) and the DSUR Checklist (CAN-38) should be provided when requested by HC. A DSUR may be submitted voluntarily to HC when important new safety information on a drug needs to be conveyed by a clinical trial sponsor. In these cases, a rationale/justification for the filing of the DSUR should be included in the cover letter. For additional details, see the G-DSUR.

The G-DSUR-CanUK describes the region-specific requirements for DSURs submitted to the regulatory authorities of Canada and the United Kingdom. This guidance applies to both marketed and non-marketed drugs that are used in clinical trials and applies to DSURs prepared by the manufacturer and/or marketing authorization holder of the investigational drug.

Form Completion & Delivery Requirements

As per the G-CanadaCTApps and CAN-22, all serious and unexpected ADRs should be reported individually to HC. According to CAN-48 (which Canada adopted pursuant to CAN-50), at a minimum, the report should include an identifiable patient, the name of a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. The G-CanadaCTApps requires the sponsor to complete the expedited reporting form (CAN-5) and the CIOMS Form I (CAN-7) and fax them to the appropriate HC Directorate: BRDD Fax: 613-957-0364; PDD Fax: 613-941-2121.

Additionally, the G-DSUR indicates that HC recommends that DSURs in electronic Common Technical Document (eCTD) format be submitted via the Common Electronic Submission Gateway (CESG). For information on eCTD format, refer to the ElecSubms. For technical questions on eCTD filings, contact ereview@hc-sc.gc.ca as instructed in the G-DSUR.

1.1, 1.2, 1.50, 1.60, and 4.11

Efficacy guidelines

2.1 and 2.8

5.14

Chapter 11 (Article 11.8)

Notice, 1.2, and 2.4

Part C (Division 5 (C.05.001 and C.05.014))

Last content review/update: October 31, 2025

Safety Reporting Definitions

In accordance with NOM-220-SSA1-2016, NOM-012-SSA3-2012, G-ClinResPV, and G-PharmPerSafRpt, the following definitions provide a basis for a common understanding of Mexico’s safety reporting requirements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Adverse Event/Experience (AE) – Any undesirable medical event that may occur in a research participant during the clinical investigation stage of a drug/vaccine, but does not necessarily have a causal relationship to it
Adverse Drug Reaction or Adverse Reaction (ADR) – An unwanted response to a drug, in which the causal relationship with it is, at least, reasonably attributable
Unexpected Adverse Drug Reaction – One whose nature or severity is inconsistent with the applicable product information, or in the documentation presented for its health registration
Suspected Adverse Drug Reaction (SRAM) – Any clinical or laboratory manifestation that occurs after administration of one (1) or more drugs

Safety Reporting Requirements

As specified in NOM-220-SSA1-2016-Mod, for clinical study related incidents involving health professionals (public and private) or institutions conducting health research, notifications to the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS))’s National Pharmacovigilance Center (CNFV) must be submitted according to the following timelines:

Serious SRAMs or serious AEs/ADRs must be reported within a maximum of seven (7) calendar days, if fatal, and within a maximum of 15 days, if not fatal (severe cases from abroad should only be included in the final study safety report, if the study has a research center in Mexico)
Not serious SRAMs or AEs/ADRs must be reported at the end of the study
Two (2) or more serious cases, in the same place with the same drug and the same batch, must be reported immediately, and no later than 48 hours
When a review of scientific literature shows a safety issue, it should be reported within a maximum of 30 calendar days from first knowledge of the AE/ADR

HlthResRegs and NOM-012-SSA3-2012 state that the institution must notify and provide a report to the Ministry of Health (Secretaría de Salud) within a period of 15 days after the suspension or cancellation of the research has been agreed upon. The report should specify the effect(s) detected, all medical care steps adopted, and the consequences produced. A detailed report on the research participant(s) physical condition should also be included. NOM-012-SSA3-2012 indicates that all serious or deadly adverse reactions or effects must be immediately reported to the Ministry. Per NOM-012-SSA3-2012, the principal investigator (PI), the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)), the institutional head(s), or the Ministry of Health must also suspend or cancel the research as soon as any AE representing an ethical impediment to research is identified.

Additionally, per NOM-220-SSA1-2016, institutions must notify the CNFV of a study’s suspension or cancellation within a maximum of 15 days. If the study is resumed, the CNFV must also be notified within a maximum of 15 working days following the study’s recommencement.

Per MEX-2, COFEPRIS has also implemented the following International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines:

Guideline E2B(R3) on Electronic Transmission of Individual Case Safety Reports (ICSRs) – Data Elements and Message Specification – Implementation Guide (MEX-79)
E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files (MEX-101)
ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (MEX-80)
ICH Harmonised Tripartite Guideline: Pharmacovigilance Planning (E2E) (MEX-82)

Investigator Responsibilities

As specified in HlthResRegs, NOM-012-SSA3-2012, and COFEPRIS-GCP, the PI must report to the REC all probable AEs or any AEs directly related to the research study. Per NOM-012-SSA3-2012, the investigator is also responsible for submitting safety reports to the CNFV.

Other Safety Reports

As indicated in NOM-220-SSA1-2016, a pharmacovigilance study protocol should be prepared and submitted to the Executive Director of Pharmacopeia and Pharmacovigilance through COFEPRIS’s Comprehensive Service Center (Centro Integral de Servicios (CIS)) (MEX-37).

Per NOM-220-SSA1-2016, a clinical safety report is also required to be submitted to the CNFV for all trials, sponsored or not, that have at least one (1) site or research center in Mexico. In addition, G-ClinResPV explains that a final safety report must be submitted to the CNFV in the following circumstances:

A study is completed that has included at least one (1) research center in Mexico
A study has been cancelled, discontinued, or permanently suspended
A bioequivalence, bioavailability, and pharmacokinetics study is concluded

Refer to G-ClinResPV and G-PharmPerSafRpt for additional report writing instructions and criteria that align with the safety reporting requirements delineated in NOM-220-SSA1-2016 and NOM-220-SSA1-2016-Mod. See also G-PharmRptReq for detailed pharmacovigilance reporting guidelines and to extend health registrations for drug products.

Form Completion & Delivery Requirements

G-ClinResPV specifies that clinical safety reports must be written in Spanish and submitted electronically (in PDF format) to the CNFV. In addition, reports should be submitted by either the health record holder or the sponsor or the legal representative to avoid sending duplicate information to the CNFV. G-PharmPerSafRpt states, in turn, that the safety report must be written in Spanish in the sections delineated in Annex 1 of G-PharmPerSafRpt and submitted electronically via CD or USB in editable PDF format. As indicated in G-ClinResPV and G-PharmPerSafRpt, the annual safety report submission date is determined by the date of the study’s first national authorization by COFEPRIS.

As per MEX-117, the E-Reporting Industry platform, which is linked to VigiFlow (MEX-43), was developed by the World Health Organization (WHO)’s Uppsala Monitoring Centre for the pharmaceutical industry to manage individual case safety reports at the national level. Reports are submitted by pharmaceutical industry professionals including health registration holders or their legal representatives and institutions/establishments where research is conducted as well as contract research organizations, distributors, and marketers. MEX-117 also specifies the CNFV is responsible for granting access to the E-Reporting Industry tool, and requests can be made via email: xmlvigiflow@cofepris.gob.mx. Refer to MEX-117 for details. Additionally, per MEX-77, state centers, institutional coordinating centers, institutional centers, and pharmacovigilance units of the National Health System should also report AE/ADRs, SRAMs, adverse events following immunization (ESAVIs), and other safety issues via MEX-43.

MEX-78, in turn, provides patients, consumers, and health professionals instructions on reporting ADRs via VIGIRAM (MEX-118). See MEX-12 for instructions on using MEX-118 and see MEX-30 for the form to be completed via MEX-118. See also G-ADR-PatientRpt for information on how patients, consumers, and/or family members report suspected ADRs.

Refer to NOM-220-SSA1-2016 for detailed reporting requirements, and the G-AENotif, MEX-44, and MEX-117 for submitting safety reports via VigiFlow (MEX-43). See also MEX-54 for additional CNFV issued pharmacovigilance guidelines and requirements.

1. Generalities, 3. Content Development (3.1), and 5. Annex A

3.6

2-6

1, 4, 6, Table 1, and Annex 1

1-5

Title III (Chapter I (Article 64))

4.21, 4.44-4.45, 4.53, 4.55-4.56, 4.59, 4.72, 7.5, 7.7, and 8.1-8.3

8.1.2, 8.1.11, and 8.2.1-8.2.10

4.5, 8.7-8.10, and 10.9

Progress Reporting

Last content review/update: July 18, 2025

Interim and Annual Progress Reports

Pursuant to the CanadaFDR, the G-CanadaCTApps, CAN-22, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), investigators and sponsors share responsibility for submitting interim and annual reports on the status of a clinical trial. The investigator is required to provide annual progress reports to the institutional ethics committee (EC) and submit interim progress reports to the EC and Health Canada (HC) if there are any significant changes affecting the trial or risk to participants. The sponsor is required to submit annual reports (in the form of an updated Investigator’s Brochure (IB)) to HC. Note that per CAN-50, HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

As per CAN-52, which Canada has implemented per CAN-50, the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

According to the G-TCPS2, investigators must report new information that may affect the welfare or consent of participants to the institutional EC, HC, and other appropriate regulatory or advisory entities. When new information is relevant to participants’ welfare, researchers must promptly inform all participants to whom the information applies (including former participants). Researchers should work with their ECs to determine which participants must be informed, and how the information should be conveyed. New information may comprise a range of issues, including, but not limited to:

Changes to the research design
Evidence of any new risks
Unanticipated issues that have possible health or safety consequences for participants
New information that decisively proves the benefits of one (1) intervention over another
New research findings, including relevant non-trial findings
Unanticipated problems
Closure of trials at other sites for reasons that may be relevant to the welfare or consent of participants in the ongoing trial

Pursuant to CAN-52, the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested.

Final Report

Upon completion of the trial, as delineated in CAN-52, the investigator is required to submit a final report to the institutional EC summarizing the trial’s outcome. The CanadaFDR does not require submission of a final study report to HC.

Per the G-CanadaCTApps, the sponsor should notify the HC Directorate when a clinical trial is completed or a clinical trial site is closed. A study is considered to be completed after the last participant globally completes the "end of study" visit as defined in the protocol. The "end of study visit" is the final visit for study-related tests and procedures, including the capture of any final potential study-related adverse events, and usually occurs after the participant has completed/discontinued study drug administration. The "end of study visit" is normally an in-person visit, but for some studies it can also be carried out over the telephone. There may be certain scenarios (e.g., gene therapies, drugs with very long half-lives) where a study may be considered to be ongoing well beyond the period of study treatment, i.e., where long-term safety monitoring and reporting would be required. The reporting requirements with regards to such long-term follow-up of safety are normally specified in the study protocol and agreed to between the sponsor and HC prior to the authorization of the clinical trial in Canada.

4.10 and 4.13

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

2.8

5.12 and 5.13

Chapter 11 (Article 11.8)

Part C (Division 5 (C.05.012 and C.05.013))

Last content review/update: October 31, 2025

Interim and Annual Progress Reports

Per HlthResRegs and NOM-012-SSA3-2012, the principal investigator (PI) must prepare and submit a progress report (also referred to as a partial technical or technical-descriptive report) (MEX-31) to the Ministry of Health (Secretaría de Salud) at any time, but at least once a year, to communicate progress and partial research study results. In addition, per NOM-012-SSA3-2012, information related to any investigation that the PI submits to the Ministry of Health must be classified as confidential. The PI must also provide a copy of every report to the head of the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) and the Research Committee, and if applicable, the Biosafety Committee of the institution where the research takes place.

NOM-012-SSA3-2012 and MEX-31 specify that the progress reports should describe the results obtained and at a minimum should include the following elements (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Study data
Participating research centers
Amendments and modifications authorized during study development
Partial technical-descriptive reports (include official responses to the partial/annual technical-descriptive reports carried out) (see Annex I of MEX-31)
Materials and methods
Summary of adverse event (AE) reports identified during study development (include a simple copy of the response letters (or a simple copy of the CIS entry form for the AE reports) issued by Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS))’s National Pharmacovigilance Center (CNFV), which corresponds with the reports submitted) (Annex I)
Results
Conclusions
Bibliographic references (include only those references that served as the basis for the planning and execution of the research)
Any relevant exhibits

MEX-31 also indicates the following annexes must be submitted:

Annex I – A simple copy of the COFEPRIS’s Comprehensive Service Center (Centro Integral de Servicios (CIS)) entry form for the Free Letter of Notification of AE(s) (submitted to the CNFV); and a simple copy of the official authorization letter of the respective Security Amendment (Homoclave COFEPRIS-09-012), when applicable
Annex II – A simple copy of the Technical Sheet of the National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos (RNEC)), duly completed and in its entirety (except for the section referring to results, which must be presented in the Final Technical Report submission)
Annex III – A simple copy of the PI’s signed Delegation of Responsibilities Letter, which was submitted with the initial authorization process for the research protocol and/or inclusion of the research center (including a simple copy of the amendment/modification letter, if applicable)
Annex IV – Patient materials (documents that do not require COFEPRIS authorization, but which are acknowledged and are the same as those approved by the evaluation committees) generated from the authorization of the protocol’s implementation until the clinical study’s conclusion
Annex V – A simple copy of the signed letters from the REC (CEI), the Research Committee, and the Biosafety Committee (as applicable) of each center where the study is carried out; the letters should notify or acknowledge receipt of each research center’s annual activities report
Other Annexes – The researcher may include any annexes deemed necessary to support the partial technical-descriptive report, or those documents required by the institution or establishment where the research is carried out. This section must also indicate which and how many annexes are attached to the form.

Additionally, in accordance with NOM-012-SSA3-2012, a report should be submitted annually to the Ministry of Health on the integration and activities of the REC, the Research Committee, and, if applicable, the Biosafety Committee, during the first 10 business days of June.

Final Report

As set forth in HlthResRegs and NOM-012-SSA3-2012, the PI is required to submit a final report to the Ministry of Health in order to communicate the final results of a research protocol or project as well as the major findings obtained throughout the course of the study. Per NOM-012-SSA3-2012, the PI must also deliver a copy of this report to the research team members, the REC (CEI), the Research Committee, and the Biosafety Committee, as applicable, where the study was conducted.

However, per MEX-94 and MEX-28, the sponsor/the sponsor’s contract research organization (CRO) and the PI share responsibility for submitting the final report to the CIS (MEX-37). Once the final report is submitted, MEX-94 specifies that the CIS assigns an entry number to the submitted application along with the procedural code, “ES45”. The CIS’s acknowledgement of the receipt of information submitted should not be interpreted as an official authorization.

As per NOM-012-SSA3-2012 and MEX-94, the final reports should include the same basic requirements as those indicated in the Interim and Annual Progress Reports, with the following differences: they must also contain a clinical study synopsis with the main research results (including the corresponding analysis and interpretation), conclusions, and bibliographic references (including only those sources that served as a basis for planning and executing the research, as well as for analyzing the results).

Additionally, per MEX-94, the following annexes must also be submitted:

Annex I – A simple copy of the CIS Entry Slip of the Final Safety Report Entry Form submitted to the CNFV
Annex II – A simple copy of the RNEC Technical Data Sheet, duly completed and in its entirety
Annex III – A simple copy of the PI’s signed Letter of Delegation of Responsibilities, which was submitted with the initial authorization process for the research protocol and/or inclusion of the research center (including a copy of the amendment/modification letter, if applicable)
Annex IV – Patient materials (documents that do not require COFEPRIS authorization, but which are acknowledged and are the same as those approved by the evaluation committees) generated from the authorization of the protocol’s implementation until the clinical study’s conclusion
Annex V – A simple copy of the signed letters from the REC (CEI), the Research Committee, and the Biosafety Committee (as applicable) of each center where the study was carried out, specifying that they are aware of the study’s completion
Annex VI – Letters signed by each PI, notifying them of the study’s completion, the closure of the center's activities, and the conclusion and follow-up of the research participants enrolled at their respective research center
Other Annexes – The researcher may include any annexes deemed necessary to support the technical-descriptive report or those required by the institution or establishment where the research is carried out. This section must also indicate which and how many annexes are attached to the form.

See section 7.4 of NOM-012-SSA3-2012 and MEX-94 for additional required report information.

HlthResRegs further states that the PI is also required to submit a final report to the Research Committee at the institution where the study was conducted. Refer to MEX-94 for the reporting form.

Title VI (Chapter I (Articles 116 and 119-120))

4.8-4.10, 7.1, 7.4, 10.10, and 12.1

Definition of Sponsor

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

Health Canada’s implementation of the ICH Harmonised Guideline for Good Clinical Practice E6(R3) will go into effect on April 1, 2026, and stakeholders are expected to be in full compliance by that date. See the Health Canada notice for more details.

As per the CanadaFDR and the G-CanadaCTApps, a sponsor is defined as an individual, corporate body, institution, or organization that conducts a clinical trial. The International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, expands on this definition to include individuals, companies, institutions, or organizations that take responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with CAN-52, Canada also permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

According to the CanadaFDR and G-CanadaCTApps, a sponsor may be domestic or foreign. A foreign sponsor is required to have a senior medical or scientific officer who is residing in Canada who will represent the sponsor, and sign and date the application and the clinical trial attestation form.

For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

1.53, 5.1, and 5.2

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

2.1

5.1 and 5.5

Part C (Division 5 (C.05.001, C.05.005, C.05.015))

Last content review/update: October 31, 2025

As set forth in NOM-012-SSA3-2012, COFEPRIS-GCP, and MEX-84, a sponsor is defined as an individual or corporation willing to undertake responsibilities to participate and finance a research project or protocol, in full or in part.

According to COFEPRIS-GCP, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32) for conducting clinical trials. Per COFEPRIS-GCP and MEX-32, a sponsor is an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. A sponsor may also hire a CRO to conduct one (1) or more of the activities related to health research that are sponsored in the country. The sponsor must specify in writing any trial-related duty and function that is transferred to and assumed by a CRO. However, the ultimate responsibility for all CRO activities remains with the sponsor. Additionally, MEX-32 notes the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor, and any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor. COFEPRIS-GCP also indicates that CROs of foreign origin must also have a registered address in Mexico, and an authorization to carry out clinical research activities in the country.

4.1

1.53 and 5.2

1.5-1.6, 4.1-4.2, and 4.15

4.18

Site/Investigator Selection

Last content review/update: July 18, 2025

Overview

As set forth in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor should select the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s). Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

In accordance with the G-CanadaCTApps, prior to initiating a clinical trial, the sponsor must ensure that a Qualified Investigator Undertaking (QIU) form (CAN-37) (or similar documentation that meets the CanadaFDR requirements) has been completed and kept on file by the sponsor; it should be retained by the sponsor for 15 years. Per the CanadaFDR, the form certifies that the qualified investigator will conduct the clinical trial in accordance with good clinical practice, and will immediately inform trial participants and the institutional ethics committee (EC) (known as Research Ethics Boards in Canada) of trial discontinuance, and the reason for this discontinuance. (See the Submission Content section for additional information on clinical trial application requirements). For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Per CAN-11, the Canadian Clinical Trials Asset Map (CCTAM) (CAN-26) is a pan-Canadian research inventory of investigators, clinical research sites, and other resources across the country. Sponsors can use CCTAM to identify potential sites and investigators, which may expedite study feasibility and start-up timelines. To view the CCTAM, the user must register and create an account.

Foreign Sponsor Responsibilities

According to the CanadaFDR and the G-CanadaCTApps, a sponsor may be domestic or foreign. A foreign sponsor is required to have a senior medical or scientific officer residing in Canada to represent the sponsor, and sign and date the application and the clinical trial attestation form.

Data and Safety Monitoring Board

Although not specified as a sponsor requirement, CAN-52 states that a Data and Safety Monitoring Board (DSMB) (known as an Independent Data-Monitoring Committee in Canada) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

The G-TCPS2 provides the following considerations to help researchers and ECs determine whether a DSMB is needed:

The magnitude of foreseeable research-attributable harms to participants
Whether the circumstances of the participants make them vulnerable in the context of research
The feasibility of interim data analysis
The complexity of the study
Conflicts of interest

Multicenter Studies

Per CAN-52, if a multicenter trial will be conducted, the sponsor must organize a coordinating committee or select coordinating investigators. In addition, the sponsor must ensure that:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by HC
The EC has given approval to the protocol
The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial
All investigators are given instructions on following the protocol, on complying with a uniform set of standards to assess clinical and laboratory findings, and on completing the CRFs
Communication between investigators is facilitated

The CanadaFDR and the G-CanadaCTApps, require the sponsor to complete and retain the Research Ethics Board (REB) Attestation (CAN-8) and Qualified Investigator Undertaking (QIU) (CAN-37) forms at each trial site, while submitting in electronic format the Clinical Trial Site Information Form (CAN-6) to the appropriate HC Directorate for each trial site.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, provides that in multi-site clinical trials, a lead principal investigator (PI) is a designated PI who is responsible for the ethical conduct of the study for all sites. The lead PI is responsible for communicating any changes to the study, new information, and/or unanticipated events to the EC, to the sponsor, and to local site PIs.

Per CAN-50, Canada has implemented the ICH Guidance E17: Multi-Regional Clinical Trials (CAN-40), which describes general principles for the planning and design of multi-regional clinical trials with the aim of increasing the acceptability of these trials in global regulatory submissions. HC recognizes that the scope and subject matter of current HC guidance may not be entirely consistent with ICH guidance. In such circumstances, HC-implemented ICH guidance takes precedence.

1.25, 5.5, 5.6, and 5.23

Canadian Clinical Trials Asset Map

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

2.1 and 2.7.2

5.5

Chapter 11 (Article 11.7)

Part C (Division 5 (C.05.005))

Last content review/update: October 31, 2025

Overview

According to COFEPRIS-GCP, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6 (R1) (MEX-32) for conducting clinical trials. COFEPRIS-GCP states the sponsor or the CRO is responsible for selecting each research center and ensuring that COFEPRIS has authorized its operation as well as the human and material resources needed to conduct research. MEX-32 indicates the sponsor should ensure the investigator(s) have adequate resources to properly conduct the trial for which they are selected. Additionally, MEX-32, explains the investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

Per COFEPRIS-GCP, the sponsor must establish in writing each of the research team member functions and responsibilities, and the financial agreement with the principal investigator (PI). G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts also note the sponsor or the CRO must specify in a letter the human and material resources that will be allocated for the research and the way in which they will be provided and distributed to the research sites.

As stated in the HlthResRegs and NOM-012-SSA3-2012, all investigators must possess appropriate qualifications, training, and experience. Per COFEPRIS-GCP, the PI is also responsible for selecting a research team with knowledge, education, and training in MEX-32, and in the process of the investigation in which the investigator is involved. Per MEX-32, the sponsor must ensure each investigator is qualified by education, training, and experience to assume responsibility for the proper conduct of the trial; meets all the qualifications specified by the applicable regulatory requirement(s); and provides evidence of such qualifications through updated curriculum vitae (CV) and/or other relevant documentation requested by the sponsor, the ethics committee (EC), and/or COFEPRIS. Agrmnt_ResProtProcs, G-HumResProt, and MEX-84 also specify the PI should provide legally issued and registered documentation (e.g., certificates of studies and professional licenses) delineating appropriate academic training and experience appropriate to the research to be conducted, which includes academic preparation, representative scientific production, and good clinical practice (GCP).

Additionally, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts indicate that institutions in charge of providing medical care for study related medical emergencies are required to sign an agreement or contract to provide these services, and provide a letter stating the institution’s acceptance, authorization, and description of the available resources. The agreement must comply with NOM-027-SSA3-2013, which establishes the criteria for the operation and care in providing emergency services in health care institutions.

Foreign Sponsor Responsibilities

COFEPRIS-GCP indicates that foreign CROs must have a registered address in Mexico, and an authorization or notice specifying the activities to be carried out in the country.

Data Safety Monitoring Board

According to COFEPRIS-GCP, the sponsor or the CRO is responsible for the continuous monitoring of the study which should be established based on the nature of the study, and must ensure study monitoring is carried out in compliance with MEX-32. Per MEX-32, the sponsor or the CRO may consider establishing an independent data monitoring committee to assess the progress of a clinical trial, the safety data, the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. The committee should have written operating procedures and maintain written records of its meetings.

Multicenter Studies

As delineated in MEX-32, in the event of a multicenter clinical trial, the sponsor or the CRO must ensure that:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and if required, by COFEPRIS, and given ethics committee approval
The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
Investigator responsibilities are documented prior to the start of the trial
All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
Communication between investigators is facilitated

4.6, 7.2-7.3, and 8.2

1.25, 4.1-4.2., 5.5-5.7, and 5.23

XIII. Specific Sections of the Procedure on the Platform (IV, VIII, and IX)

Preamble, 3.8, 4.14.7, 4.10-4.11, 4.13, and 4.15

Requirements (5-6), and Additional Information

Articles One, Two, and Five and Single Annex (Single Form for the Principal Investigator and the Research Team and Single Form for Medical Emergencies)

Title III (Chapter I, Article 62) and Title VI (Chapter I, Articles 113 and 117)

10.1

0-2

Insurance & Compensation

Last content review/update: July 18, 2025

Insurance

The CanadaFDR does not require the sponsor to provide insurance coverage to investigators, institutions, or trial participants. However, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, guides sponsors on providing insurance. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

Compensation

Injury or Death

The Canadian regulations do not require compensation for trial participants in the event of trial-related injuries or death. However, CAN-52 indicates that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

The Canadian regulations do not require compensation for trial participation. However, as per the G-TCPS2 and CAN-52, the informed consent form (ICF) should contain a statement with a description of the anticipated prorated payment to the participant(s) that is reasonably expected for participation in the trial. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants or cause them to overlook important facts and risks. CAN-35 further states that the ICF should describe any compensation, incentives, or reimbursements to be paid or given to participants and how participant withdrawal will affect the offered compensation (e.g., prorated remuneration). If no compensation will be provided, this should be stated.

4.8 and 5.8

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Policies, Guidelines, and Resources, Consent Process (Consent Form Template)

Chapter 3 (Article 3.2)

Last content review/update: October 31, 2025

Insurance

As set forth in COFEPRIS-GCP, the sponsor or the contract research organization (CRO) must establish a financial fund or have insurance to cover serious adverse events that result from the medication or the research study.

Additionally, COFEPRIS-GCP requires the sponsor or the CRO to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32), which states that the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/institution against claims arising from the trial, except for those claims arising from malpractice and/or negligence. Per MEX-32, if required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator and the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.

Compensation

As specified in COFEPRIS-GCP, the sponsor or the designated CRO must establish a statement of funding and describe the quantity and payments to be allocated for research participants.

Per MEX-32, the ethics committee (EC) should review both the amount and method of payment to participants to ensure that neither presents problems of coercion or undue influence on the trial participants. Payments to a participant should be prorated and not wholly contingent on the completion of the trial by the participant.

Injury or Death

Per Agrmnt_ResProtProcs, once the research protocol has been authorized, applicants must provide the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) with a policy or certificate of study insurance or a copy of the current financial fund that certifies coverage for research participants. G-DIGIPRiS-ResProts also indicates the sponsor should provide COFEPRIS with a copy of the financial fund or current insurance policy, which guarantees the continuity of the medical treatment and the compensation to which the participant will be legally entitled in the event of suffering damages directly related to the development of the research. MEX-84 specifies that the insurance policy or current document from the financial fund should cover all study participants at the local level. The document guarantees coverage to the participant in case of any injury or damage related to the research. The insurance policy and certificate, which must be on behalf of the license holder and the sponsor, must indicate the number of participants that will be covered, the study title, and the protocol number.

(Note: COFEPRIS has not yet updated MEX-84, G-ResProtocolAmd, and G-DIGIPRiS-ResProts to align with the Agrmnt_ResProtProcs requirements. However, the ClinRegs team is regularly monitoring the COFEPRIS website for new developments and will post the most current sources when they become available.)

Although NOM-012-SSA3-2012 does not specifically ascribe responsibility to the sponsor, it indicates that the research budget must include the availability of a financial fund as well as mechanisms to guarantee continuity of medical treatment and indemnity of the research participant, in the event of trial-related injuries. Additionally, the head of the institution or establishment, the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)), Research Committee, or Biosafety Committee, the PI, and, where applicable, the sponsor, will be responsible in accordance with their area of competence, for the damage to health resulting from the development of the research as well as damage resulting from the interruption or early suspension of treatment for reasons not attributable to the research participant. HlthResRegs and GenHlthLaw also specify that the health care institution and the sponsor or the CRO must provide medical attention to injured participants, and where appropriate, legally required compensation, if the injuries are directly related to the study. Medical attention that is provided to such participants will not prejudice the compensation that may be legally due from the study.

MEX-32 explains the sponsor's policies and procedures should address the costs of treatment of trial participants in the event of trial-related injuries in accordance with the applicable regulatory requirement(s). In addition, when study participants receive compensation, the method and manner of compensation should comply with applicable regulatory requirement(s).

Trial Participation

Per COFEPRIS-GCP, the sponsor or the CRO must ensure that each and every treatment, clinical analysis procedure, and other study procedures are delivered in a timely manner, in good condition, and free of charge to the research participant.

4.3

3.1 and 5.8

XIII. Specific Sections of the Procedure on the Platform (IV)

Preamble, 4.1, 4.8, and 4.13-4.14

Title V (Chapter I, Article 100)

Article Five

Title II ((Chapter I, Article 14), (Chapter II, Article 21), and (Chapter V, Article 58))

5.14 and 7.2

Risk & Quality Management

Last content review/update: July 18, 2025

Quality Assurance/Quality Control

Per the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. Per CAN-50, Canada implements the ICH Guidance E8(R1): General Considerations for Clinical Studies (CAN-49), which provides guidance on conduct during the clinical trial. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

As indicated in CAN-52, the quality management system should use a risk-based approach that includes:

During protocol development, identifying processes and data that are critical to ensure participant protection and the reliability of trial results
Identifying risks to critical trial processes and data
Evaluating the identified risks against existing risk controls
Deciding which risks to reduce and/or which risks to accept
Documenting quality management activities and communicate to those involved in or affected by these activities
Periodically reviewing risk control measures to ascertain whether the implemented quality management activities are effective and relevant
In the clinical study report, describing the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken

As stated in the CanadaFDR and CAN-52, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, CAN-52, and the applicable regulatory requirements. The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A written agreement must be signed by both the sponsor and the investigator or any other parties involved with the clinical trial, verifying that both parties agree to the trial protocol, the monitoring and auditing practices, the SOPs, and their respective duties.

Per CAN-50, HC adopted and implements the ICH guidance on statistical principles for clinical trials (CAN-53), as well as the ICH addendum on estimands and sensitivity analysis (CAN-39), which presents a framework for defining an appropriate estimand for a clinical trial and conducting sensitivity analyses.

Monitoring Requirements

As part of its QA system, CAN-52 notes that the sponsor should ensure the trial is monitored and audited. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, CAN-52, and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditors’ qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with their own SOPs and the auditor observations are documented. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Per the HCNotice-ICH-E19, HC adopted and implements ICH guidance on selective safety data collection in specific late stage pre-approval or post-approval clinical trials (CAN-15). Selective safety data collection refers to the recording of certain data by investigators in case report forms. It does not affect the monitoring and clinical care of individual trial participants or documentation of their adverse events in medical records. See the HCNotice-ICH-E19 and the CAN-15 for more information.

Per G-Inspections, regulated parties (sponsors, qualified investigators, contract research organizations, and any other party involved in the conduct of clinical trials) have mandatory responsibilities under the CanadaFDA and can be inspected. Foreign entities that conduct regulated activities in Canada, or in relation to a product imported in Canada, are also subject to Canadian law. During an inspection or a compliance verification, a regulated party is required to provide all reasonable assistance and information necessary for the HC inspector to perform their duties, including providing evidence that its facility, equipment, and practices and procedures meet the applicable requirements.

Premature Study Termination/Suspension

The CanadaFDR and the G-CanadaCTApps state that if a trial is prematurely terminated or suspended, the sponsor should inform HC no later than 15 days after the termination or suspension. In addition, the sponsor should provide HC with the reason(s) for the termination or suspension and its impact on the proposed or ongoing clinical trials related to the drug in Canada by the sponsor. The sponsor should also promptly notify the qualified investigators of the termination or suspension and advise them in writing of any potential risks to the participants’ health. Further, the G-CanadaCTApps states that the sponsor’s notification to HC should include confirmation that the sale or importation of the drug to the discontinued sites has been stopped and that reasonable measures to ensure the return of all unused quantities of the drug will be taken. This notification must also be submitted for premature discontinuation of a clinical trial or clinical trial site outside Canada where there are ongoing trials with the drug in Canada.

According to CAN-52, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the ethics committee (EC) should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

5.0-5.2, 5.18, 5.19, 5.21, and 6.10

Purpose and Scope, and Glossary

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

2.8.1

2 and 4

Part C (Division 5 (C.05.007-008, C.05.010, and C.05.015))

Last content review/update: October 31, 2025

Quality Assurance/Quality Control

According to COFEPRIS-GCP, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32), and to ensure and control the quality of the research during a study. Per COFEPRIS-GCP and MEX-32, the sponsor or the CRO is also responsible for establishing written standard operating procedures (SOPs) for each stage of the investigation. In addition, the sponsor or the CRO must implement and maintain quality assurance (QA) and quality control (QC) systems to make certain the trial is conducted, and data are generated, recorded, and reported in compliance with the protocol.

MEX-32 further delineates the sponsor or the CRO is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. The sponsor and investigator(s) agreement should be confirmed in writing prior to the trial. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed.

Monitoring Requirements

According to COFEPRIS-GCP, the sponsor or the CRO must ensure and control the quality of the research through periodic monitoring visits and audits to verify compliance with the protocol and the SOPs, and if necessary, compliance with reports derived from inspections or verifications by COFEPRIS. The principal investigator (PI) is responsible for reporting and guaranteeing the quality and validity of the data obtained during the investigation. MEX-32 indicates the sponsor should ensure that the trials are adequately monitored and determine the appropriate extent and nature of monitoring, which should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial.

Additionally, per MEX-32, the sponsor should also appoint monitors who should be appropriately trained, and have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented. Monitors should also be thoroughly familiar with the investigational product(s), the protocol, written informed consent form, any other written information to be provided to research participants, the sponsor’s SOPs, COFEPRIS-GCP, and the applicable regulatory requirement(s).

MEX-32 further indicates the sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct audits and ensure the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented. The sponsor should also ensure the auditing of clinical trials/systems is conducted in accordance with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports. The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial submissions to regulatory authorities, the number of study participants, the type and complexity of the trial, the level of risks to the study participants, and any identified problem(s). Auditor(s) observations and findings of the auditor should be documented.

Pursuant to MEX-32, noncompliance with the protocol, SOPs, good clinical practice (GCP), and/or applicable regulatory requirement(s) by an investigator/institution, or by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance. If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution, the sponsor should terminate the investigator's/institution’s participation in the trial and notify promptly the regulatory authority(ies). Also, upon the request of the monitor, auditor, ethics committee (EC), or COFEPRIS, the investigator/institution should also make available for direct access all requested trial-related records. See MEX-32 for detailed monitoring and auditing requirements.

Per NOM-012-SSA3-2012, the institutional head, the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)), the Research Committee, or the Biosafety Committee (where applicable), the PI, and the sponsor, must be responsible, in accordance with their area of competence, for monitoring the research. Agrmnt_ResProtProcs specifies that the sponsor is required to submit a monitoring and audit plan to ensure that clinical trial oversight mechanisms are in place to verify that all trial-related activities are subject to quality and other controls to reduce errors, increase objectivity, and ensure consistent processes. However, NOM-012-SSA3-2012, MEX-84, and G-DIGIPRiS-ResProts require the sponsor or the CRO to provide a letter to COFEPRIS describing the monitoring and auditing plan to be carried out during the investigation. MEX-84 and G-DIGIPRiS-ResProts specify the letter must contain the following (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Type of plan: audit or monitoring
Frequency of application
Responsibility for monitoring, and where appropriate, cite the third party to carry out the activity
Objective and scope of monitoring
Evaluation tools and methodology implemented
Methodology to carry out scientific, technical, and ethical monitoring
Communication and notification strategies between the investigator, sponsor, ECs, and COFEPRIS
Profile of the monitor or auditor
Classification of findings and decision-making
Decision-making derived based on severity classification
Notification mechanism to the PI, ECs, and COFEPRIS
Design of the Action Plan: Corrective, Improvement, or Preventive
Reporting results through the partial and annual technical report (See MEX-31 for the partial reporting form)

Note: COFEPRIS has not yet updated MEX-84, G-ResProtocolAmd, and G-DIGIPRiS-ResProts to align with the Agrmnt_ResProtProcs requirements. However, the ClinRegs team is regularly monitoring the COFEPRIS website for new developments and will post the most current sources when they become available.

COFEPRIS-GCP also states that the PI is responsible for reporting and guaranteeing the quality and validity of the data obtained during the investigation.

Premature Study Termination/Suspension

Per HlthResRegs the PI, the REC (CEI), the institutional head or other authorized institutional officers, or the Ministry of Health (Secretaría de Salud) must order the immediate suspension or cancellation of a research study as soon as any adverse effect is identified that might become an ethical or technical impediment to continuing with the study. The health care institution will submit a report to the Secretariat within 15 business days following the day in which the suspension or cancellation of the study was agreed to, specifying the effect noticed, the measures adopted, and consequences produced. NOM-012-SSA3-2012 similarly states the head of the institution or establishment, the REC (CEI), the Research Committee, the Biosafety Committee (where applicable), or the PI must order the immediate suspension or cancellation of research, in the presence of any severe adverse effects, which become an ethical or technical impediment to continue with the study and notify the Secretariat in detail. The institutional head must notify the Secretariat of any adverse effect resulting from the experimental research within a maximum period of 15 working days from the event occurrence, including the care measures adopted, the identified sequelae, as well as a detailed report on the physical condition of the patient, which mentions whether the patient is free of any risk at the time of notification. In such case, the resumption of the research will require a new authorization. The investigator is also responsible for suspending the investigation if there is a risk of serious injury, disability, or death of the research participant in accordance with GenHlthLaw. Additionally, per NOM-220-SSA1-2016, institutions must notify the National Pharmacovigilance Center (CNFV) of a study’s suspension or cancellation within a maximum of 15 days. If the study is resumed, the CNFV must also be notified within a maximum of 15 working days following the study’s recommencement. The investigator is responsible for submitting safety reports to the CNFV.

MEX-32 delineates if a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the applicable regulatory requirement(s). The EC should also be provided with a detailed written explanation of the termination or suspension.

MEX-32 further indicates that if the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial participants, ensure appropriate therapy and follow-up for the participants, and, where required by the applicable regulatory requirement(s), inform the regulatory authority(ies). If the investigator terminates or suspends a trial without the sponsor’s prior agreement, the investigator should inform the institution where applicable, and the investigator/institution should promptly inform the sponsor and the EC and provide the sponsor and the EC with a detailed written explanation of the termination or suspension. If the EC terminates or suspends its approval/favorable opinion of a trial, the investigator should inform the institution where applicable, and the investigator/institution should promptly notify the sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.

4.2 and 7

4.9, 4.12, 5.1, 5.12, and 5.18-5.21

XIII. Specific Sections of the Procedure on the Platform (IV)

Preamble, 3.5, 4.1, 4.6, 4.9, and 4.13

Title V (Chapter I, Article 100)

Article Two and Single Annex (Single Sponsor Form)

Title III (Chapter I, Article 64)

7.5

7.2, 8.7-8.8, 9.2, and 10.5

Data & Records Management

Last content review/update: July 18, 2025

Electronic Data Processing System

Per the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, when using systems for electronic trial data handling, the sponsor must ensure and document that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. To validate such systems, the sponsor should use a risk assessment approach that takes into consideration the system’s intended use and potential to affect human subject protection and reliability of trial results. In addition, the sponsor must maintain standard operation procedures (SOPs) that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. With respect to the use of these computerized systems, the responsibilities of the sponsor, investigator, and other parties should be clear, and the users should receive relevant training. Note per CAN-50, HC-implemented ICH guidelines take precedence over other HC guidance when they are not consistent. Refer to CAN-52 for additional information.

The G-FDR-0100 provides that if electronic records are generated during a clinical trial, then the electronic system must be validated to confirm that the system’s specifications meet the goals and requirements for the clinical trial. This evidence of validation should be kept for the required record retention period and available for inspection by Health Canada (HC) inspectors. See the G-FDR-0100 for additional details.

Records Management

As set forth in the CanadaFDR and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. The CanadaFDR requires the sponsor to maintain all trial-related records for a period of 15 years. Per the G-FDR-0100, sponsors may also be required to maintain records under provincial law, institutional policies, and contractual agreements with investigators, ethics committees (ECs), or others. Where it is not possible to comply with both sets of requirements, the CanadaFDR would govern and the records must be maintained for 15 years.

Pursuant to CanadaFDR1024, the sponsor must submit requested records to HC within 48 hours if safety concerns arise. Additionally, to facilitate inspection of a site, the sponsor must submit information to HC within seven (7) days of a request. Per CAN-8, an attestation must be completed by the EC that reviewed and approved the clinical trial. The completed attestation must be retained by the clinical trial sponsor for a period of 15 years. The attestation should not be submitted to HC unless requested.

In addition, CAN-52 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

1.65, 5.5, 6.10, and 8

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

5.12

Regulatory Impact Analysis Statement

Part C (Division 5 (C.05.012))

Last content review/update: October 31, 2025

Electronic Data Processing System

According to COFEPRIS-GCP, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) requires the sponsor or the contract research organization (CRO) to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32) for conducting clinical trials. Per MEX-32, the sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.

In addition, per MEX-32, when using electronic trial data processing or handling systems or remote electronic trial data systems, the sponsor should:

Ensure and document that the electronic data processing system(s) conform(s) to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance
Maintain standard operating procedures (SOPs) for using these systems
Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data
Maintain a security system that prevents unauthorized access to the data
Maintain a list of the individuals who are authorized to make data changes
Maintain adequate backup of the data
Safeguard the blinding, if any

See MEX-32 for additional data processing requirements.

Records Management

As indicated in MEX-32, the sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents pertaining to the trial (see section 8 of MEX-32). The sponsor should retain all sponsor-specific essential documents in conformance with the applicable regulatory requirement(s) of the country(ies) where the investigational product (IP) is approved, and/or where the sponsor intends to apply for approval(s). If the sponsor discontinues the clinical development of an IP (i.e., for any or all indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific essential documents for at least two (2) years after formal discontinuation or in conformance with the applicable regulatory requirement(s).

MEX-32 also states the essential documents should be retained until at least two (2) years after the last marketing approval or at least two (2) years have elapsed since the formal discontinuation of clinical development of the IP. These documents should be retained for a longer period, however, if required by the applicable regulatory requirement(s) or if needed by the sponsor. The sponsor should inform the investigator(s)/institution(s) in writing of the need for record retention and should notify the investigator(s)/institution(s) when trial-related records are no longer needed.

In addition, as delineated in COFEPRIS-GCP, the principal investigator (PI) is responsible for preparing, integrating, using, filing, and ensuring the safekeeping of the research participant’s clinical file for a minimum of five (5) years in accordance with NOM-004-SSA3-2012, MEX-32, and Good Documentation Practices per NOM-164-SSA1-2015.

Per NOM-004-SSA3-2012, clinical records are the property of the institution or the medical services provider that generates them. However, the patient/participant has ultimate ownership rights over this information to protect their health and the confidentiality of their data. Consequently, because the documents are prepared in the interest and benefit of the patient/participant, they must be kept for a minimum period of five (5) years, which is calculated from the date of the last medical procedure/visit.

4.9, 5.5, and 8

3.7 and 4.1

4.1, 5.1, and 5.2

5.4

Personal Data Protection

Last content review/update: July 18, 2025

Responsible Parties

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ethics committees (ECs), states that where researchers seek to collect, use, share, and access different types of information or data about participants, they should determine whether the information or data proposed in research may reasonably be expected to identify an individual. Researchers and ECs must consider whether information is identifiable or non-identifiable.

Data Protection

Per CAN-42, the Office of the Privacy Commissioner of Canada provides advice and information for individuals about protecting personal information, and enforces the two (2) federal privacy laws that set out the rules for how federal government institutions and certain businesses must handle personal information, including health data. The PrivAct covers the personal information-handling practices of federal government departments and agencies in Canada, and the PIPEDA regulates private businesses’ data protection practices. In addition, some provinces and territories have laws that deal specifically with protection of personal health information. See CAN-43 for a list of provincial and territorial privacy laws and webpages.

Per the G-TCPS2, in the research context, the most simplified method to protect participants is through the collection and use of anonymous or anonymized data. When anonymized data is not possible or desirable, a next best alternative is to use de-identified data, which is provided to the researcher in de-identified form and the existing key code is accessible only to a custodian or trusted third party who is independent of the researcher. Where it is not feasible to use anonymous or anonymized data for research, the ethical duty of confidentiality and the use of appropriate measures to safeguard information become paramount. Researchers should consult their ECs if they are uncertain about whether information proposed for use in research is identifiable (e.g., when proposing to link anonymized or coded data sets).

Consent for Processing Personal Data

Both PIPEDA and the PrivAct require consent for the use of personal data, including health data, except under prescribed conditions, such as for research or during emergencies. Also see CAN-43 for provincial and territorial privacy laws.

Chapter 2 (Article 2.1) and Chapter 5 (A. Key Concepts)

Part I (2, 6.1, and 7)

3, 7, and 8

Last content review/update: October 31, 2025

Responsible Parties

For the purposes of data protection in Mexico, PDP-PrivateLaw and PDP-Public delineate responsibilities of the “data controller.” In PDP-PrivateLaw, which regulates the right of private individuals and legal entities to protect their personal data, the data controller who carries out the processing of personal data is the “responsible” party (or “regulated subject”). The “person in charge” is a natural or legal person who, alone or jointly with others, processes personal data on behalf of the controller.

In comparison, in PDP-Public, which regulates personal data held by public entities, the data controller who decides on the processing of the data is the “responsible” party (or “obligated subject”). The “person in charge” is a natural or legal person, public or private, outside the organization of the responsible person, who alone or jointly with others, processes personal data on behalf of and for the account of the responsible person. Public entities that process personal data include government authorities at all levels (federal, state, municipal, and Mexico City), the three (3) branches of government (executive, legislative, judicial), autonomous bodies, political parties, and public trusts and funds.

In addition, PDP-Trnspcy, which guarantees access to public information and promotes transparency and accountability, also addresses personal data protection. It requires public entities to manage and safeguard personal data as part of their broader mandate to ensure access to publicly available information. Oversight is carried out by “guarantor authorities,” which are the federal and local authorities that oversee compliance across the executive, legislative, and judicial branches, and independent constitutional bodies.

Data Protection

PDP-PrivateLaw and PDP-Public provide the requirements, responsibilities, and restrictions for handling personal data in the private and public sectors respectively. Under both laws, the data controller or responsible party must comply with the principles of data protection: legality, purpose, loyalty, consent, quality, proportionality, information, and responsibility in the processing of personal data. The data controller or responsible party must also ensure that the personal data contained in the databases are accurate, complete, correct, and updated for the purposes for which they were collected.

According to both PDP-PrivateLaw and PDP-Public, the data controller or responsible party must also establish and maintain administrative, physical, and technical security measures to protect personal data against damage, loss, alteration, destruction, or unauthorized use, access, or processing. Under PDP-Public, the controller must also guarantee the confidentiality, integrity, and availability of the data. PDP-PrivateLaw requires the data controller or responsible party to report immediately any security breaches occurring at any stage of personal data processing that significantly affect the property or moral rights of the data owners, so that they can take appropriate measures to defend their rights. Additionally, the data controller or responsible party must establish controls or mechanisms to ensure that all persons involved in processing maintain confidentiality. This obligation must continue even after their relationship with the data controller ends.

PDP-Public further provides that the data controller or the responsible party must analyze the causes of the breach and implement preventive and corrective actions in its work plan to adapt security measures and the processing of personal data, if applicable, to prevent the breach from recurring. The data controller or responsible party must promptly inform the data owner, and as appropriate, the Secretariat and the guarantor authorities (i.e., government bodies that oversee compliance with data protection obligations), of any violations that significantly affect property or moral rights. Notification must be made as soon as the violation is confirmed and once the responsible party has begun to take steps to initiate a comprehensive review of its impact, so that the affected data owners can take the appropriate measures to defend their rights.

PDP-PrivateLaw and PDP-Public also both delineate that any time, a data owner, or where applicable, their legal representative, may exercise their rights of access, rectification, cancellation, and opposition, known as ARCO rights. The exercise of any of the ARCO rights is not a prerequisite, nor does it prevent the exercise of any other rights. The data owner must have the right to:

Access their personal data, as well as to know information related to the conditions and generalities of their processing
Request the rectification or correction of their personal data when they are found to be inaccurate, incomplete, or outdated
Request the erasure of their personal data from the files, records, files, and systems, so that they are no longer in the data controller’s or responsible party’s possession
Object to the processing of their personal data or demand its cessation when: even if the processing is lawful, to prevent it from causing harm or damage; or, the personal data is subject to automated processing, which produces undesired legal effects or significantly affects the data owner’s interests, rights, or freedoms, and is intended to evaluate, without human intervention, certain personal aspects of their data, or to analyze or predict, in particular, their professional performance, economic situation, health status, sexual preferences, reliability, or behavior

Per PDP-PrivateLaw, the data owner’s right to object will not be exercised in cases where processing is necessary for compliance with a legal obligation imposed on the data controller. Additionally, the data controller should not be obliged to erase personal data when:

The data relate to the parties of a private, social, or administrative contract and are necessary for its development and fulfillment
The data must be processed by a legal provision
The erasure hinders judicial or administrative proceedings related to tax obligations, the investigation and prosecution of crimes, or the updating of administrative sanctions
The data are necessary to protect the data owner’s legally protected interests
The data are necessary to carry out an action based on the public interest
The data are necessary to comply with a legal obligation acquired by the data owner
The data are processed for prevention or for medical diagnosis, or for the management of health services, provided that such treatment is carried out by a health professional subject to a duty of secrecy

Please refer to PDP-PrivateLaw and PDP-Public for detailed information on the principles guiding the protection and handling of personal data. See also MEX-95 for additional information on the protection of personal data held by private parties.

Additionally, per PDP-Trnspcy, obligated subjects and individuals must be responsible for the personal data in their possession, and may not disseminate, distribute, or commercialize the personal data contained in the information systems, developed in the exercise of their functions, unless there has been the express consent, in writing or by a similar means of authentication, of the persons to whom the information refers. See PDP-Trnspcy for detailed requirements.

Consent for Processing Personal Data

As explained in PDP-PrivateLaw and PDP-Public, the consent document or “privacy notice” is a physical, electronic, or any format document generated by the data controller or responsible party, that is made available to the data owner prior to processing that informs them of the purpose of collecting their data. Processing must be limited to the fulfillment of purposes delineated in the privacy notice. If the data controller or responsible party intends to process the data for another purpose, the data owner’s consent must be obtained again. PDP-Public specifies that the data controller or responsible party may process personal data for purposes other than those established in the privacy notice, provided that it has the authority granted by applicable law and the data owner has given their consent, unless the data owner has been reported missing, in accordance with the terms set forth in this law and other applicable provisions.

PDP-PrivateLaw and PDP-Public further explain that the consent may be given expressly or tacitly. Consent is understood to be expressed when the data owner’s will is expressed verbally, in writing, by electronic means, optically, with unequivocal signs, or by any other technology. Consent is tacit when the privacy notice has been made available to the owner, but the owner does not express their will to the contrary. As a general rule, tacit consent will be valid, unless the applicable legal provisions require that the data owner’s consent will be expressly stated. Per PDP-PrivateLaw, consent may be revoked at any time without retroactive effects being attributed to it. To revoke consent, the data controller must specify the mechanisms and procedures to be followed in the privacy notice.

PDP-PrivateLaw and PDP-Public state that in the case of sensitive data, the data owner or responsible party is required to obtain the data owner’s express written consent. PDP-PrivateLaw further indicates that the consent should be obtained through a written or electronic signature, or any authentication mechanism established for that purpose. Databases containing sensitive personal data may not be created without justifying their creation for legitimate, concrete purposes, and in accordance with the specified activities delineated and pursued by the data controller or responsible party. The data controller or the responsible party must also make reasonable efforts to limit the processing to the minimum time necessary.

As delineated in PDP-PrivateLaw and PDP-Public, the data controller or the responsible party will not be required to obtain consent when processing sensitive data in the following cases (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

When an applicable law authorizes such processing
There is a court order, resolution, or well-founded and reasoned mandate from a competent authority
When sensitive personal data transfers are made between those responsible, the transfers are compatible with the original purpose that motivated the processing of personal data
When there is a judicial order, resolution, or well-founded and motivated mandate of the competent authority
For the recognition or defense of the owner's rights before the competent authority
When personal data is required to exercise a right or fulfill obligations derived from a legal relationship between the owner and the person in charge
When there is an emergency that could potentially harm an individual or the individual’s property
When personal data is necessary to carry out a treatment for the prevention, diagnosis, or provision of health care
When the personal data is contained in publicly accessible sources
When personal data is subject to a prior dissociation procedure
When the owner of the personal data is a person reported missing under the terms of the law on the matter

Also, as outlined in PDP-PrivateLaw, when a data controller or responsible party intends to transfer personal data to national or foreign third parties, the privacy notice and the purposes to which the data owner subjected the processing must be communicated. National or international data transfers carried out with the data owner’s consent may be necessary when it is:

Provided for in a law or treaty to which Mexico is a party
Necessary for medical prevention or diagnosis, the provision of health care, medical treatment, or the management of health services
Made to holding companies, subsidiaries, or affiliates under the data controller’s common control, or to a parent company, or to any company of the same group that operates under the same internal processes and policies
Necessary by virtue of a contract entered into, or to be entered into, in the data owner’s interest, by the data controller and a third party
Necessary or legally required to safeguard a public interest, or to procure or administer justice
Necessary for the recognition, exercise, or defense of a right in a judicial proceeding
Necessary for the maintenance or fulfilment of a legal relationship between the data controller and the data owner

Please refer to PDP-PrivateLaw and PDP-Public for detailed consent and privacy notice requirements.

Consent for Processing Personal Data of Minors

Per PDP-Public, in processing the personal data of minors, the best interest of the children and adolescents must be prioritized in accordance with the applicable legal provisions.

MEX-4 further states legal guardians must always give consent when processing children’s personal data. This applies to any individual younger than 18 years of age.

(See the Children/Minors section for additional information on consent requirements for children/minors.)

6.1

Title One (Article 3) and Title Four (Article 64)

Chapters I (Articles 1-3), II-III, and V

Title One (Articles 2-3 and 7), Title Two (Articles 10-12, 15-17, 25, 37, and 40), and Title Three (Chapter I)

Documentation Requirements

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

Health Canada’s implementation of the ICH Harmonised Guideline for Good Clinical Practice E6(R3) will go into effect on April 1, 2026, and stakeholders are expected to be in full compliance by that date. See the Health Canada notice for more details.

Obtaining Consent

In all Canadian clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in the CanadaFDR, the G-TCPS2, CAN-35, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

As per the CanadaFDR, the G-TCPS2, and CAN-52, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Research Ethics Board (REB) in Canada) and provided to HC with the clinical trial application (CTA). (See the Required Elements section for details on what should be included in the form.)

The G-TCPS2 and CAN-52 state that the qualified investigator (QI) must provide detailed research study information to the participant or legal representative/guardian. As delineated in the G-TCPS2, CAN-35, and CAN-52, the ICF content should be in plain language (i.e., non-technical and easy to understand) and provided in a format that facilitates understanding. For example, written documentation may be supplemented with audio and/or visual aids. The participant and legal representative/guardian should also be given adequate time to consider whether to participate. CAN-35 notes that the person obtaining consent may also need to explain the consent form verbally to ensure that the participant fully understands the information. See CAN-35 for informed consent and assent templates and sample forms.

Re-Consent

According to CAN-52, any change in the ICF that is relevant to the participant’s consent should be approved by the institutional EC prior to implementing any changes. The participant or legal representative/guardian should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented.

Per the G-TCPS2, consent must be maintained throughout the research project. Researchers have a continuous duty to provide participants with all information relevant to their ongoing consent to participate in the research. Consent begins with the initial contact (e.g., recruitment) and carries through to the end of participation in the study. Throughout the clinical trial, researchers have a continuous responsibility to provide participants and ECs with all information relevant to participants’ ongoing consent to participate in the research. The researcher also must notify participants of any changes to the research project that may affect them. These changes may have ethical implications, may be relevant to their decision to continue in the study, or may be unique to the particular circumstances of individual participants. Specifically, researchers must disclose changes to the risks or potential benefits of the research. Change in participant capacity is an important element of ongoing consent. Rather than an age-based approach to consent, researchers should use an approach based on decision-making capacity in compliance with any laws governing research participation. This includes those whose decision-making capacity is in the process of development, those whose decision-making capacity is diminishing or fluctuating, and those whose decision-making capacity remains only partially developed. Mechanisms should be in place from the outset to identify and address any changes that could affect consent. Further, within the limits of consent provided by the participant, researchers should disclose to the participant any material incidental findings discovered in the course of research. Incidental findings are considered to be material incidental findings if they are reasonably determined to have significant welfare implications for the participant or prospective participant. Where material incidental findings are foreseeable, researchers should inform participants during the initial consent process. In addition, researchers should develop a management plan for review by the EC. For more information on how to address material incidental findings, see G-ConsentMatIncFindings.

Language Requirements

CAN-35 further specifies that consent forms should be provided in the language that participants are most comfortable with. The G-TCPS2 and CAN-52 require the ICF to be presented in plain language that the participant is able to understand. Per CAN-35, ICFs should be translated where it is relevant to particular communities. If there is a language barrier, the G-TCPS2 indicates that the qualified investigator should select an intermediary who has the necessary language skills to ensure effective communication. Further, per CAN-35, the level of language used should be appropriate to the age and comprehension/reading level of the participant population, generally at approximately a grade 6-8 reading level.

Documenting Consent

As per the G-TCPS2, CAN-52, and CAN-35, the participant or legal representative/guardian, as well as the qualified investigator (QI), must sign and date the ICF. CAN-52 and the G-FDR-0100 state that the QI should retain the signed ICF. CAN-35 indicates that information letters and ICFs must be presented on institutional/department letterhead.

According to CAN-52, where the participant is illiterate and/or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

The written ICF and any other written information to be provided to the participant is read and explained to the participant and legal representative/guardian
The participant and legal representative/guardian have orally consented to the participant’s involvement in the trial, and have signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or legal representative/guardian should receive a copy of the signed and dated ICF.

As per the G-TCPS2 and CAN-52, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or appear to waive the participant’s legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representative(s) from their liabilities for any negligence.

Per CAN-35, in some situations, written consent is not feasible or desirable, for example due to logistical issues or because of the preferences of the participants. In addition, some individuals may perceive written consent as an attempt to legalize the consent process, thereby creating mistrust. It is also important to recognize that in some cultures written consent is not consistent with community traditions. In these cases, it may be more appropriate to use a handshake, a verbal agreement, or oral consent. The G-TCPS2 further indicates that researchers can use a range of procedures to seek and document consent, including oral consent documented in field notes, and other forms of recording (e.g., a consent log, audio or video recordings, or other electronic means). Evidence of consent may also be documented via completed questionnaires (in person, by mail, or by email or other electronic means). ECs should consider the power relationship that might exist between researchers and participants, and whether a waiver of the requirement for signed written consent may affect the welfare of the participants. If researchers plan to obtain non-written consent, they must explain their strategy to the EC.

Waiver of Consent

As explained in the G-TCPS2, there are research situations that call for alterations of consent. The EC may approve research that involves an alteration to the consent requirements if the EC is satisfied, and documents that all of the following apply:

The research involves no more than minimal risk to the participants
The change to consent requirements is unlikely to adversely affect the welfare of participants
It is impossible or impracticable to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required
In the case of a proposed alteration, the exact nature and extent of any proposed alteration is defined
There is a plan to brief participants and offer the option of refusing consent and/or withdrawing data and/or human biological materials

4.8, 8.2, and 8.3

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Policies, Guidelines, and Resources; Consent Process (Key Considerations)

5.5, 5.6, 5.8, and 5.10

Chapters 3 and 10

Part C (Division 5 (C.05.005, C.05.006, C.05.008, and C.05.010))

Last content review/update: October 31, 2025

Obtaining Consent

In all Mexican clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in HlthResRegs, GenHlthLaw, NOM-004-SSA3-2012, and COFEPRIS-GCP. Per COFEPRIS-GCP, the principal investigator (PI) is required to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32) in obtaining and documenting informed consent, and per G-RECs-Op-2018, the PI must also comply with consent requirements as delineated in the Declaration of Helsinki (MEX-76). (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MEX-22)).

As per HlthResRegs and G-RECs-Op-2018, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by a Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) and provided to COEFPRIS with the request for research protocol authorization. (See the Required Elements section for details on what should be included in the form.)

HlthResRegs, COFEPRIS-GCP, and NOM-012-SSA3-2012 state that the PI must provide detailed research study information to the participant or legal representative/guardian. As delineated in HlthResRegs, G-RECs-Op-2018, NOM-012-SSA3-2012, MEX-32, and MEX-84, the ICF content should be presented with a clear explanation and provided in a format that facilitates understanding. Per NOM-012-SSA3-2012 and MEX-32, the participant or legal representative/guardian should also be given adequate time to consider whether to participate. GenHlthLaw and MEX-84 further note the ICF should be expressed in writing in an accessible, timely manner and in an understandable language, using accurate and complete information, including the possible benefits and expected risks, and the treatment alternatives, to ensure that services are provided on the basis of free and informed consent. Once comprehension of the information is guaranteed through the necessary means and supports, individuals have the right to accept or reject consent. G-DIGIPRiS-ResProts, MEX-84, and G-HumResProt indicate the ICF and/or assent form, as applicable, is a document through which the research participant agrees to voluntarily participate in a research study and to undergo experimental procedures when the information is presented in a sufficient, timely, clear, and truthful manner regarding the expected risk and benefits.

As per HlthResRegs, G-RECs-Op-2018, and MEX-32, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or appear to waive their legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

Re-Consent

According to G-RECs-Op-2018 and MEX-32, any change in the ICF that is relevant to the participant’s consent should be approved by the REC (CEI) prior to implementing any changes. Per G-RECs-Op-2018 and MEX-32, the participant or legal representative/guardian should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participating in the trial. MEX-32 further states the communication of this information should be documented.

Language Requirements

G-HumResProt states that the applicant must submit the request for protocol authorization application and all associated documentation (including the protocol and the ICF) in Spanish.

Documenting Consent

As delineated in HlthResRegs, G-RECs-Op-2018, and MEX-32, the participant or legal representative/guardian, as well as two (2) witnesses, must sign the ICF. MEX-32 specifies that the ICF should be dated, and any updates must also be signed, and a copy of the amendments provided to the participant or legal representative/guardian. If the participant does not know how to sign, the participant will provide a fingerprint and will also need to designate someone to sign the participant’s name on their behalf. A copy of the signed ICF will be provided to the participant or legal representative/guardian. Per G-DIGIPRiS-ResProts, which complies with MEX-22, the ICF version and date must coincide with what is recorded as approved in the opinions of the ethics committees (ECs). G-HumResProt further specifies the ICF should be signed by the PI, the participant and the participant’s family, or a legal representative and two (2) witnesses. The names of the witnesses, the addresses, and the relationships the witnesses have with the research participant must be indicated. MEX-84 also notes a section in the ICF should be provided for the participant or the legal representative to sign the document to indicate express acceptance. The section must include general data (full name, address, relationship with the participant) and signatures of two (2) witnesses.

Waiver of Consent

No information is currently available regarding waiver requirements.

3.3

25-32

1.28, 2.9, and 4.8

Search for the Status of Implementation of ICH Guidelines by ICH Members

XIII. Specific Sections of the Procedure on the Platform (V)

3.1 and 3.9

1.2, 3.3, 10, Annexes 5 and 6, and Glossary

Requirements (9) and Additional Information

Title III (Chapter IV, Article 51 Bis 2) and Title V (Chapter I, Article 100)

Title II (Chapter I, Articles 20-22)

0 (Introduction)

4.3 and 10.6

Required Elements

Last content review/update: July 18, 2025

Based on the G-TCPS2, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), and CAN-35, the informed consent form (ICF) should include the following statements or descriptions in plain language, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

The study involves research and an explanation of its purpose and duration
The trial treatment(s) and the probability for random assignment to each treatment
The procedures to be followed, including all invasive procedures
The participant’s responsibilities
Those aspects of the trial that are experimental
Any reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
Any reasonably expected benefits; if no benefit is expected, the participant should be made aware of this
The disclosure of specific alternative procedure(s) or therapies available to the participant, and their important potential benefits and risks
Compensation and/or treatment available to the participant in the event of a trial-related injury
The anticipated prorated payment, if any, to the participant for participating in the trial
Any expenses the participant needs to pay to participate in the trial
That participation is voluntary, and that the participant can refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled
Information concerning the possibility of commercialization of research findings, and the presence of any real, potential, or perceived conflicts of interest on the part of the researchers, their institutions, or the research sponsors
Confidentiality of records identifying the participant will be maintained, and permission given to monitors, the auditors, the ethics committee (EC), and Health Canada (HC) to access the participant’s medical records to verify the procedures and/or data, without violating the confidentiality of the participant, insofar as the applicable laws and regulations permit, and that, by signing a written ICF, the participant or legal representative/guardian is authorizing such access
That records identifying the participant will not be made publicly available, insofar as the applicable laws and/or regulations permit; if the results of the trial are published, the participant’s identity will remain confidential
The participant or legal representative/guardian will be notified in a timely manner if information becomes available that may affect the participant’s willingness to continue
The qualified investigator’s contact information for further information regarding the trial and the rights of participants, and whom to contact in the event of a trial-related injury
The identity and contact information of a qualified designated representative who can explain scientific or scholarly aspects of the research to participants
Information on stopping rules, foreseeable circumstances, and/or reasons under which the participant’s involvement in the trial may be terminated
The approximate number of participants in the trial

Per CAN-50, Canada has implemented CAN-52.

Per CAN-35, if blood is taken, indicate total volume (e.g., teaspoons and milliliter equivalent) and note the possibility of bruising or swelling while giving blood, or other possible discomforts at the site where blood is drawn. Further, state that there may be minimal chance of infection and that discomforts experienced will be brief and transient.

CAN-35 also indicates that participants should not be told if an EC has approved the study, since this may appear to offer a guarantee of safety. Further, no clause or language should be used to excuse or appear to excuse investigators or other persons or institutions involved from liability for their negligence or other faults. Sample consent forms can be found in CAN-35.

See the Vulnerable Populations and Consent for Specimen sections for further information.

4.8

Efficacy guidelines

Policies, Guidelines, and Resources, and Consent Process (Sample consent forms)

Chapter 3

Last content review/update: October 31, 2025

As delineated in G-RECs-Op-2018 and MEX-84, the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Identification data (title, protocol number, version, version date, research institution data, principal investigator (PI) name, medical emergency establishment data, and Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)), and this data must coincide with the opinions of the ethics committees)
The study rationale and objectives
Purpose and procedures, including all invasive procedures
Identification of experimental aspects of the study
Trial duration
Participant’s responsibilities
Investigator responsibilities
Approximate number of participants
Circumstances that may terminate the study
Duration of study
Any expected risks or discomforts to the participant
Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point (physical examination, laboratory tests and imaging should not be considered as benefits to the participant)
Alternative treatments that may be beneficial to the participant
Trial treatment(s) and the probability for random assignment to each treatment
Explains the blinding of the study (if applicable) and what it consists of
Allocation method
Compensation and/or treatment available for the participant by the health care institution in the case of trial-related injury
All drugs, products, and procedures are free
That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
Assurance that the participant will not be identified and that their confidential information relating to their privacy will be maintained
Confidentiality of records identifying the participant will be maintained (including sensitive personal data and data derived from the study), and permission given to monitors, auditors, the REC (CEI), and the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) to access the participant’s medical records to verify the procedures or trial data, without violating the participant’s confidentiality, insofar as the applicable laws and regulations permit
Contact information for the sponsor and PI in the event of participant problems or trial-related injuries
Communication channels and data to request clarification and to guarantee a response to questions and clarification of concerns about procedures, risks, benefits, and other matters related to the investigation and treatment of the participant
Foreseeable circumstances under which the PI(s) may remove the participant without their consent
Commitment to provide updated information throughout the study although this may affect the participant’s willingness to continue
Notification that any additional research study expenses will be absorbed by the research budget

The Guideline for Good Clinical Practice E6(R1) (MEX-32) also mentions the following required elements:

Any expected risks or discomforts, when applicable, to the embryo, fetus, or nursing infant
Any anticipated prorated payment to the participant for participating in the trial
Any expenses the participant needs to pay to participate in the trial

Additionally, per NOM-012-SSA3-2012, the investigator must ensure that the ICF explicitly states the compensation to which the research participant is entitled in the event of suffering damage to their health directly attributable to the research, and the availability of free medical treatment, even in the event the participant decides to withdraw from the study before it is concluded.

See HlthResRegs, NOM-012-SSA3-2012, G-RECs-Op-2018, and MEX-32 for additional details related to ICF requirements. (Note: Per MEX-2, COFEPRIS is in the process of implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MEX-22)).

Also, see the Vulnerable Populations and Consent for Specimen sections for further information.

3.3

4.8

Search for the Status of Implementation of ICH Guidelines by ICH Members

Annex 5

Title II (Chapter I, Article 21)

4.3, 4.6, 9.29, 10.6-10.7, 11.2-11.3

Participant Rights

Last content review/update: July 18, 2025

Overview

In accordance with the CanadaFDR, the G-TCPS2, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), Canada’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-TCPS2 and CAN-52, which Canada has implemented per CAN-50, state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

The informed consent template in CAN-35 provides that if a participant has any questions about their rights, they should contact:

Health Canada-PHAC Research Ethics Board Secretariat
70 Colombine Driveway, Room 941C, PL: 0909C
Brooke Claxton Building, Tunney's Pasture
Ottawa, ON K1A 0K9
Telephone: 613-941-5199
Fax: 613-941-9093
reb-cer@hc-sc.gc.ca

The Right to Participate, Abstain, or Withdraw

As stated in the G-TCPS2 and CAN-52, the participant or legal representative/guardian should be informed that participation is voluntary, that they may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

Per CAN-35, participants should be assured that their participation is completely voluntary, they are under no obligation to participate, and they are free to withdraw at any time without consequence. It should be made clear that their decision to withdraw will not influence their relationship with the researcher in any way. The researcher should explain what will happen to participant samples or data if they choose to withdraw. If applicable, clearly state the point in the study at which removal of samples or data becomes difficult or impossible.

The Right to Information

As per the G-TCPS2 and CAN-52, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

According to the G-TCPS2 and CAN-52, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

Per CAN-35, the ICF should explain what information will be collected about participants and for what purpose, including the type of information that will be collected (e.g., will it be coded or de-identified?) and how it will be stored. Further, the ICF should state who will have access to the collected information and describe the efforts that will be made to prevent the risk of participant re-identification. Limits to confidentiality and additional requirements for projects led by HC or the Public Health Agency of Canada (PHAC) are provided in CAN-35.

The Right of Inquiry/Appeal

The G-TCPS2 and CAN-52 state that the research participant or legal representative/guardian should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or the participant’s rights.

The Right to Safety and Welfare

CAN-52, which upholds the Declaration of Helsinki, clearly state that a research participant’s right to safety and the protection of their health and welfare must take precedence over the interests of science and society.

See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

1.27, 3.1, and 4.8

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Consent Process (Consent Form Template)

5.1 and 5.5

Chapter 1 (Article 1.1), Chapter 2, and Chapter 3 (Articles 3.1 and 3.2)

Part C (Division 5 (C.05.001 and C.05.005))

Last content review/update: October 31, 2025

Overview

In accordance with HlthResRegs, NOM-012-SSA3-2012, G-RECs-Op-2018, and the Guideline for Good Clinical Practice E6(R1) (MEX-32), Mexico’s ethical standards promote respect for all human beings and safeguard the rights of research participants. (COFEPRIS-GCP requires the principal investigator (PI) to comply with MEX-32). HlthResRegs and MEX-32 state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MEX-22)).

The Right to Participate, Abstain, or Withdraw

As stated in HlthResRegs, NOM-012-SSA3-2012, G-RECs-Op-2018, MEX-32, and MEX-84, the participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As per HlthResRegs, NOM-012-SSA3-2012, G-RECs-Op-2018, MEX-32, and MEX-84, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

According to G-RECs-Op-2018, MEX-32, and MEX-84, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. In addition, per NOM-004-SSA3-2012, although clinical records are the property of the institution or the medical services provider that generates them, the participant has ultimate ownership rights over this information to protect their health and the confidentiality of their data.

The Right of Inquiry/Appeal

MEX-32 states that the research participant or legal representative/guardian should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or their rights. G-RECs-Op-2018 further specifies that the names and contact information of the PI and the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI))’s president, including a 24-hour telephone number in case of emergency, should be provided.

The Right to Safety and Welfare

HlthResRegs, NOM-012-SSA3-2012, G-RECs-Op-2018, COFEPRIS-GCP, and MEX-32, which upholds the Declaration of Helsinki (MEX-76), clearly state that a research participant’s right to safety and the protection of their health and welfare must take precedence over the interests of science and society.

See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

3.3

Introduction and 4.8

Search for the Status of Implementation of ICH Guidelines by ICH Members

Preamble and 3.1

1.1, 1.2, 3.2, and Annex 5

Title II (Chapter I, Articles 13 and 21)

5.4

0, 5.3, and 11.3

Emergencies

Last content review/update: July 18, 2025

The G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. As per CAN-52, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or, if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee (EC) (known as Research Ethics Board (REB) in Canada) must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Per G-TCPS2, research involving medical emergencies must be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the EC. The EC may allow research that involves medical emergencies to be carried out without the consent of participants, or legal representatives/guardians, if all of the following apply:

A serious threat to the prospective participant requires immediate intervention
Either no standard efficacious care exists, or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care
Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant
The prospective participant is unconscious or lacks capacity to understand the risks, methods, and purposes of the research project
Authorization from the legal representative/guardian cannot be secured in sufficient time, despite diligent and documented efforts to do so
No relevant prior directive by the participant is known to exist

4.8

Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines

Chapter 3 (Articles 3.7-3.9)

Last content review/update: October 31, 2025

The HlthResRegs and the Guideline for Good Clinical Practice E6(R1) (MEX-32) make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies (COFEPRIS-GCP requires the principal investigator (PI) to comply with MEX-32). (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MEX-22)).

According to HlthResRegs, in an emergency, when it is deemed necessary to use an investigational drug, or a known drug with indications, doses, or routes of administration other than the established uses, the treating physician must obtain the favorable opinion of the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) and the Research Committee, and an informed consent form (ICF) signed by the research participant or legal representative/guardian. The terms under which this documentation is obtained must meet the following requirements:

The REC (CEI) and Research Committee will be informed of the use of the investigational drug in advance if the researcher can anticipate the need for use in emergency situations. If this is not possible, an opinion must be obtained after the situation occurs. In both cases, the committees will issue an opinion in favor of or against approving the planned or recurring unintended use of the drug.
A signed ICF must be obtained from the participant or legal representative/guardian unless the participant’s condition prevents them from signing the form, the legal representative/guardian are not available to sign the form, or stopping use of the drug constitutes an almost absolute risk of death to the participant.

Per MEX-32, in emergency situations, when prior consent of the participant is not possible, the consent of the legal representative/guardian, if present, should be requested. When prior consent of the participant or legal representative/guardian cannot be obtained, the ethics committee must provide documented approval in order to protect the participant’s rights, safety, and well-being, pursuant to the applicable regulations. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

In addition, per GenHlthLaw, in cases of medical emergency, and when the terminally ill patient is unable to express their consent, and in the absence of family members, a legal representative, guardian or trusted person, the specialist doctor, and/or the institution’s Bioethics Committee will make the decision to apply a necessary surgical medical procedure or treatment.

4.8

Search for the Status of Implementation of ICH Guidelines by ICH Members

3.1

Title V (Chapter I, Article 100) and Title VI (Chapter II, Article 166 Bis 8)

Title III (Chapter II, Article 71)

Vulnerable Populations

Last content review/update: July 18, 2025

Overview

As per the G-TCPS2, in all Canadian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52) characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from not participating. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students; subordinate hospital and laboratory personnel; employees of the pharmaceutical industry; members of the armed forces; and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

CAN-52, which Canada has implemented per CAN-50, specifies that ethics committees (ECs) (known as Research Ethics Boards in Canada) must pay special attention to protecting participants who are from vulnerable populations. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

See the Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these vulnerable populations.

1.61, 3.1, and 4.8

Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines

Chapter 3 (Article 3.9) and Chapter 4 (Article 4.7)

Last content review/update: October 31, 2025

Overview

As delineated in G-RECs-Op-2018, in all Mexican clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. G-RECs-Op-2018 characterizes vulnerable populations as individuals or groups experiencing diminished autonomy due to imposing social, political, and/or economic situations that prevent them from having control over their quality of life. Populations traditionally viewed as vulnerable include minors, women, persons with disabilities, the elderly, those suffering from mental illness, immigrants, those who are illiterate, those belonging to ethnic or racial minorities, the unemployed, the homeless, and reclusive individuals.

As per COFEPRIS-GCP, the principal investigator (PI) is required to comply with the Guideline for Good Clinical Practice E6(R1) (MEX-32), which similarly characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from not participating. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students; subordinate hospital and laboratory personnel; employees of the pharmaceutical industry; members of the armed forces; and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MEX-22)).

G-RECs-Op-2018 specifies that Research Ethics Committees (RECs) (Comités de Ética en Investigación (CEIs)) should ensure that additional security mechanisms are implemented to minimize the specific risks for each group. MEX-32 similarly states that ethics committees must pay special attention to protecting participants who are from vulnerable populations.

See the Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired sections for additional information about these vulnerable populations. Information on the other vulnerable populations specified in HlthResRegs is provided below.

Persons in Dependent Groups

As indicated in HlthResRegs, for clinical trials involving participants who are involved in subordinate or dependent relationships, the REC (CEI) must ensure the following:

Participation or refusal of individuals to participate or withdrawal of consent during the study, will not affect their school, work, military status, or that which is related to the judicial process and any conditions of compliance with a sentence, if applicable
Research results are not used to the detriment of the individuals involved
The health institution and sponsors take responsibility for dangers associated with medical treatment, and where appropriate, provide legally required compensation for the harmful consequences of the investigation

Per G-RECs-Op-2018, the following criteria must also be met to conduct a study with a subordinate population:

The PI must clearly define the reasons for planning to recruit a subordinate population
Protocol approval must also be obtained in which a written statement from the immediate boss or corresponding authority of the subordinate participant(s) verifying that no coercion existed
If resident doctors or partners are recruited for the study, the program director must provide the REC (CEI) with a letter of support issued by a person without ties to the study
Confidentiality of research data for the group of subordinate and student participants is important to consider to avoid negatively impacting the participants’ employment possibilities, professional development, study plans, or social relationships. The REC (CEI) will also need to pay special attention to the PI’s plans to safeguard data security

The HlthResRegs and G-RECs-Op-2018 further specify that these relationships include participants who are in junior or subordinate positions in hierarchically structured groups, such as students, employees, workers in laboratories and hospitals, members of the armed forces, prisoners, social rehabilitation centers, and other members of special population groups in which informed consent can be influenced by some authority.

Persons in Local Communities

As per HlthResRegs, clinical trials involving participants in local communities must meet the following requirements:

Research will be permitted when the expected benefit is reasonably assured, and when previous studies carried out on a small scale have not produced conclusive results
The PI must obtain the approval of the health authorities and other civil authorities of the community to be studied, in addition to obtaining informed consent from individuals who are included in the trial
In the case of vulnerable communities due to their economic or social conditions, such as indigenous communities, the REC (CEI) is also required to issue a favorable opinion
Experimental investigations in communities may only be carried out by establishments that have the Ministry of Health (Secretaría de Salud)’s prior authorization
The experimental design should offer practical measures of protection for research participants, and ensure that valid results will be obtained, involving the minimum number of participants
The most pertinent ethical considerations applicable to research on participants must be extrapolated to the communal context

Terminally Ill Persons

As stated in GenHlthLaw, if a terminally ill person is a minor, or is incapable of expressing their consent, consent should be provided by the parent(s)/guardian(s), and in their absence, by their legal representative(s).

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Search for the Status of Implementation of ICH Guidelines by ICH Members

3.1

Annex 5

Title VIII Bis (Chapter II (Article 166 Bis 8))

Title II (Chapters II and V)

Children/Minors

Last content review/update: July 18, 2025

Per CAN-35, because the G-TCPS2 does not specify an age of consent for children, the decision on whether to seek consent from children is based on whether they have the capacity to understand the research and the risks and benefits of their participation. Youth who have not reached the age of majority (either 18 or 19 depending on the province or territory) may still be old enough to provide their own consent. For children who are not sufficiently mature to provide consent but are able to understand the nature of study participation, researchers must obtain the child’s assent in addition to the consent of an authorized third party. The decision of a child not to assent must be respected regardless of whether third-party consent was obtained.

CAN-35 provides the following criteria for determining whether participants can provide their own consent, or whether an authorized third party should be involved:

The risk level associated with the research project
The legal requirements for age of consent in that jurisdiction
The characteristics of the research participant (e.g., maturity level)
In certain cases, the topic of the research itself

CAN-35 states that it is generally accepted that youth can consent to minimal risk studies at 16 years of age, and that assent should be sought from children beginning at approximately seven (7) years of age. However, it is ultimately up to the researcher to determine whether to obtain assent or consent from children, and to provide the rationale for this decision to the ethics committee (EC) (known as a Research Ethics Board in Canada). Researchers should also consider that within a single research project, some minors may be capable of consenting while others may not. See CAN-35 for additional details regarding obtaining consent from minors.

As per the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. All pediatric participants, however, should be informed to the extent compatible with the child’s understanding, and if capable, the pediatric participant should sign and personally date the ICF. Per CAN-50, Canada has implemented CAN-52. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

As stated in G-TCPS2, children should only participate in clinical studies when the research objective cannot be achieved with adult participants only. When considering the inclusion of children in research, the investigators and ECs must consider a child’s stage of physical, physiological, psychological, and social development to ensure adequate protections for the child’s welfare.

Assent Requirements

Per G-TCPS2 and TCPS2-InterpCnsnt, where a child has some ability to understand the significance of the research, the researcher must ascertain the wishes of that individual with respect to participation. Children—whose decision-making capacity is in the process of development—may be capable of verbally or physically assenting to, or dissenting from, participation in research. While their assent would not be sufficient to permit them to participate in the absence of consent by the child’s parent/legal guardian, their expression of dissent must be respected.

Further, according to CAN-12, which offers best practices and guidance to researchers and ECs in pediatric research and complements the G-TCPS2, provincial laws in Canada vary as to when a child is presumed to be legally competent to provide informed consent. Some provinces use age while others use a competence-based evaluation.

As per CAN-12, if the pediatric participant has the capacity for assent, then affirmative assent is required to participate in a study according to the participant’s level of development and capacities. When the child develops the legal capacity to provide informed consent or attains the legal age of majority (which depends on the province), researchers should obtain an informed consent. Regarding dissent, CAN-12 states that the researchers must respect the dissent of a child who is capable of understanding.

CAN-35 provides sample assent forms and templates. For more detail and guidance about best practices for research involving pediatric participants, see CAN-12.

Guidelines III and IV

4.8

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Consent Process (Key Considerations)

Chapter 3 (Article 3.10) and Chapter 4 (Article 4.4)

1

Last content review/update: October 31, 2025

Per GenChldRtsLaw, a child is defined as under 12 years of age, and adolescents are those between 12 and 18 years of age. For the purposes of the age of majority, children are those under 18 years of age. When there is doubt as to whether the person is over 18 years of age, it should be presumed that the person is an adolescent. When there is doubt as to whether the person is over or under 12 years of age, it should be presumed that the person is a child.

Additionally, per HlthResRegs, in all cases, a written informed consent must be obtained from those exercising parental authority, or the legal guardian(s) of the minor, except in the case of emancipated minors over 16 years of age. Moreover, when the mental capacity or psychological state of the minor or incapacitated person permits, their acceptance must also be obtained after the investigator(s) have explained what they intend to do in the study. However, the Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) may waive compliance with these requirements for justified reasons.

As set forth in G-RECs-Op-2018 and HlthResRegs, a research study involving minors must ensure that similar studies have been previously done in older people and in immature animals, except when it comes to studying conditions that are specific to the neonatal stage or specific conditions associated with certain ages.

Per G-RECs-Op-2018, research studies classified as risky and likely to benefit the minor directly, will be admissible when the following requirements are met:

The risk is justified by the importance of the benefit that the minor will receive
The benefit is equal to or greater than other alternatives already established for its diagnosis and treatment
When the mental capacity and psychological state of the minor allow, the informed assent must also be obtained, after explaining what is intended to be done. The REC (CEI) may waive compliance with these requirements for justified reasons
The informed consent information provided is appropriate for the understanding of minors

Per G-RECs-Op-2018 and HlthResRegs, when two (2) persons exercise the parental authority of a minor, only the consent of one (1) of them must be permitted if there is irrefutable or manifest proof that the other is unable to provide it, proof of the parental authority’s negligence, or imminent risk to the minor’s health or life.

HlthResRegs indicates that investigations classified as risky, and with a probability of direct benefit for the minor, will be permitted in the following circumstances:

The risk is justified by the importance of the benefit that the minor will receive, and
The benefit is equal to or greater than other alternatives already established for diagnosis and treatment

Per HlthResRegs, investigations classified as risky and without direct benefit to the minor, will be allowed in the following circumstances:

When the risk is minimal: The intervention or procedure must represent a reasonable experience for minors, and comparable with those characteristics of their current or expected medical, psychological, social, or educational situation. Also, the intervention or procedure should have high probability of obtaining generalizable knowledge about the condition or illness of the minor to benefit others with this disorder as well
When the risk is greater than the minimum: The research should offer a good chance of understanding, preventing, or alleviating a serious problem affecting the health and well-being of children. Also, the head of the health institution should establish strict supervision to evaluate the magnitude of the risks anticipated or others that may arise, and immediately suspend the investigation when the risk could affect the biological, psychological, or social welfare of the minor

Assent Requirements

The applicable regulatory requirements do not specify the age of assent required for minors.

Per G-RECs-Op-2018, assent must also be obtained from a minor who is deemed capable of providing assent, and the minor must be informed about the study in a manner tailored to their emotional and intellectual maturity level, considering at all times the seriousness of the decision.

Annex 5

Title One (Article 5)

Title II (Chapter III)

Pregnant Women, Fetuses & Neonates

Last content review/update: July 18, 2025

As per the G-TCPS2, studies involving women of childbearing age, or who are pregnant, require additional safeguards to ensure that the research assesses the risks to the women and the fetuses. The following guidance applies to research involving materials related to human reproduction:

Research using materials related to human reproduction in the context of an anticipated or ongoing pregnancy must not be undertaken if the information can reasonably be obtained by alternative methods
Materials related to human reproduction for research use must not be obtained through commercial transaction, including exchange for services

Per the G-TCPS2, research on in vitro embryos already created and intended for implantation to achieve pregnancy is acceptable if:

The research is intended to benefit the embryo
Research interventions will not compromise the care of the woman, or the subsequent fetus
Researchers closely monitor the safety and comfort of the woman and the safety of the embryo
Consent was provided by the gamete donors

According to the G-TCPS2, research involving embryos that have been created for reproductive or other purposes permitted by law, but are no longer required for these purposes, may be ethically acceptable if:

The ova and sperm from which they are formed were obtained in accordance with the G-TCPS2
Consent was provided by the gamete donors
Embryos exposed to manipulations not directed specifically to their ongoing normal development will not be transferred for continuing pregnancy
Research involving embryos will take place only during the first 14 days after their formation by combination of the gametes, excluding any time during which embryonic development has been suspended

Per the G-TCPS2, research involving a fetus or fetal tissue:

Requires the consent of the woman
Must not compromise the woman’s ability to make decisions regarding continuation of her pregnancy

In accordance with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

4.8

Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines

Chapter 4 (Article 4.3) and Chapter 12 (Articles 12.6-12.9)

Last content review/update: October 31, 2025

As per HlthResRegs, studies involving women of childbearing age; women who are in any stage of pregnancy or are postpartum; or studies involving treatments or procedures using embryos, fetuses, or newborns, are required to obtain an informed consent form (ICF) from the woman and her spouse or partner. In addition, HlthResRegs and G-RECs-Op-2018 note that consent from the spouse or partner may only be waived in the case of their incapacity (or irrefutable or manifest inability) to provide it, or when there is imminent risk to the health or life of the woman, embryo, fetus, or newborn. All studies must also comply with the general ethics requirements that must be fulfilled prior to research involving humans as delineated in HlthResRegs.

HlthResRegs and G-RECs-Op-2018 further state that research in pregnant women will only be permitted if it is for therapeutic benefit, and represents an opportunity to understand, prevent, or alleviate any serious pathology. HlthResRegs and G-RECs-Op-2018 indicate that these studies are allowed when they are aimed at improving a pregnant woman’s health with minimal risk to the embryo or fetus, or per HlthResRegs, seek to increase the fetus’s viability, with minimal risk to a pregnant woman. G-RECs-Op-2018 adds that the ICF should mention the possible risk to the fetus.

According to HlthResRegs, investigations to be carried out on pregnant women should be preceded by studies carried out on non-pregnant woman to demonstrate the study’s safety, with the exception of studies requiring the specific condition. Those investigations classified as higher than minimum risk and will be conducted using women of childbearing age should implement the following measures:

Certify the women are not pregnant prior to their acceptance as research participants, and
Decrease the chances of pregnancy as much as possible during the development of the investigation

Per HlthResRegs and G-RECs-Op-2018, during studies conducted with pregnant women, the following requirements must be met:

The investigators will not have the authority to decide on the time, method, or procedure used to terminate the pregnancy, nor will they participate in decisions regarding the viability of the fetus
The Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI))’s authorization is required prior to any modification of the method used to terminate the pregnancy. These modifications mean that there will be minimal risk to the mother’s health and do not represent any risk to the survival of the fetus, and
In any case, it is strictly forbidden to grant monetary or other incentives to interrupt the pregnancy, for the interest of the investigation or for other reasons

As set forth in HlthResRegs and G-RECs-Op-2018, investigators must comply with the following additional criteria when conducting studies with women who are in any stage of pregnancy or are postpartum:

Research without therapeutic benefit in pregnant women, whose objective is to obtain general knowledge about pregnancy, should not represent a risk greater than the minimum for the woman, the embryo, or the fetus
Investigations in pregnant women that imply an intervention or experimental procedure not related to pregnancy, but with therapeutic benefit for women (e.g., cases of toxemia gravidarum, diabetes, hypertension, and neoplasms, etc.) should not expose the embryo or the fetus to a greater than minimum risk, except when the use of the intervention or procedure is justified to save the life of the woman
For investigations during labor, the informed consent must be obtained prior to initiating the study and must expressly state that consent may be withdrawn at any time during labor
Investigations in women during the puerperium will be allowed when they do not interfere with the health of the mother and the newborn
Research on women during lactation will be authorized when there is no risk for the infant, or when the mother decides not to breastfeed, she ensures her feeding by another method and provides informed consent

Per HlthResRegs, studies involving treatments or procedures using embryos, fetuses, or newborns must meet the following requirements:

Fetuses will be permitted to be subjects of investigation only if the techniques and means used provide maximum security for them and the pregnant woman
Newborns will not be used as subjects of investigation until it has been established with certainty whether or not they are live births, except when the research is aimed at increasing their probability of survival until the viability phase, the study procedures do not cause the cessation of their vital functions or when, without adding any risk, they seek to obtain important generalizable knowledge that cannot be obtained in any other way
Live births may be used as subjects of investigation if the investigator(s) obtain consent from the woman and her spouse or partner

In addition, HlthResRegs indicates that investigations involving embryos, deaths, fetuses, still births, macerated fetal matter, cells, tissues, and the use of biological materials extracted from them, must comply with GenHlthLaw. GenHlthLaw specifically prohibits the use, for any purpose, of embryonic or fetal tissues caused by induced abortions. G-RECs-Op-2018, by comparison, states that for investigators to use biological materials derived from abortions, the informed consent must be independent from the consent granted for an abortion and will not include financial compensation.

Annex 5

Title XIV (Chapter I, Article 318 and Chapter III, Article 330)

Title II (Chapter IV, Articles 41-55)

Prisoners

Last content review/update: July 18, 2025

According to the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

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Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Chapter 3 (Article 3.1) and Chapter 4 (Article 4.7)

Last content review/update: October 31, 2025

No applicable requirements

Mentally Impaired

Last content review/update: July 18, 2025

According to the G-TCPS2 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), the ethics committee (EC) (known as Research Ethics Board in Canada) must approve the participation of research participants who are mentally or physically incapable of giving consent. Per CAN-50, Canada has implemented CAN-52.

Per CAN-35, adults with diminished decision-making capacity include:

Individuals whose decision-making capacity remains only partially developed, such as those living with permanent cognitive impairment, and
Individuals who once were capable of making an autonomous decision regarding consent but whose decision-making capacity is diminishing or fluctuating (e.g., due to cognitive impairment resulting from an injury or disease).

Per CAN-35, as is the case for any vulnerable population, care must be taken to ensure that adults with diminished decision-making capacity are not inappropriately included in research because of their situation, and neither should they be excluded from participating in research that may benefit them.

The G-TCPS2 indicates that for research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the EC must ensure that, at a minimum, the following conditions are met:

The researcher involves participants who lack the capacity to decide on their own behalf to the greatest extent possible in the decision-making process
The researcher seeks and maintains consent from the participant’s legal representative/guardian in accordance with the best interests of the persons concerned
The legal representative/guardian is not the researcher or any other member of the research team
The researcher demonstrates that the research is being carried out for the participant’s direct benefit, or for the benefit of other persons in the same category; if the research does not have the potential for direct benefit to the participant but only for the benefit of the other persons in the same category, the researcher shall demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate how the participant’s welfare will be protected throughout the participation in research
When authorization for participation was granted by a legal representative/guardian, and a participant acquires or regains decision-making capacity during the course of the research, the researcher must promptly seek the participant’s consent as a condition of continuing participation

Per CAN-35 and the G-TCPS2, the participant’s legal representative/guardian can provide consent for adults who lack the capacity to decide on their own behalf in accordance with the best interests of the persons concerned. In such cases, participants should still be involved to the greatest extent possible in the decision-making process, and their assent to participate must be obtained if they are capable of expressing their wishes in a meaningful way (whether verbally or physically). Importantly, when authorization for participation was granted by the participant’s legal representative/guardian and a participant acquires or regains decision-making capacity during the course of the research, the researcher must promptly seek the participant’s consent as a condition of continuing participation.

Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

1.61 and 3.1

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Consent Process (Key Considerations)

Chapter 3 (Article 3.7-3.10)

Last content review/update: October 31, 2025

The Mexican government has updated the GenHlthLaw to prioritize mental health with the development of health policies required to be in accordance with the provisions of the MexConstitution and international treaties on human rights. For the purposes of this law, mental health is understood as a state of physical, mental, emotional, and social well-being determined by the individual's interaction with society and linked to the full exercise of human rights. Refer to GenHlthLaw for details on consent requirements for the treatment of the mental health services user population.

Per HlthResRegs, when the mental capacity and psychological state of the participant permits, their acceptance must also be obtained after the investigator(s) explain what they intend to do during a clinical study. The Research Ethics Committee (REC) (Comité de Ética en Investigación (CEI)) may waive compliance with these requirements for justified reasons. All studies must also comply with the general ethics requirements that must be fulfilled prior to research involving humans as delineated in HlthResRegs.

As indicated in HlthResRegs, investigations classified as risky, but with a probability of direct benefit for the mentally incompetent participant, will be allowed when:

The risk is justified by the importance of the benefit that the incompetent participant will receive, and
The benefit is equal to or greater than other alternatives already established for diagnosis and treatment

In addition, per HlthResRegs, investigations classified as risky and without direct benefit to the mentally incompetent, will be allowed in the following circumstances:

When the risk is minimal: The intervention or procedure must represent a reasonable experience for the incompetent participant and be comparable with those characteristics of their current or expected medical, psychological, social, or educational situation. The intervention or procedure should also have a high probability of obtaining generalizable knowledge about the condition or illness of the mentally incompetent participant to benefit others with this disorder
When the risk is greater than the minimum: The research should offer a good chance of understanding, preventing, or alleviating a serious problem affecting the health and well-being of the mentally incapacitated. In addition, the head of the health institution should establish strict supervision to evaluate the magnitude of the risks anticipated or others that may arise, and immediately suspend the investigation when the risk could affect the biological, psychological, or social welfare of the mentally incompetent participant.

Title III (Chapter VII, Articles 72 and 75)

Title I (Chapter I, Article 1)

Title II (Chapter I, Article 14 and Chapter III, Articles 34 and 36-39)

Definition of Investigational Product

Last content review/update: July 18, 2025

New Info (Not Yet in Profile)

Health Canada’s implementation of the ICH Harmonised Guideline for Good Clinical Practice E6(R3) will go into effect on April 1, 2026, and stakeholders are expected to be in full compliance by that date. See the Health Canada notice for more details.

As delineated in the CanadaFDR, the G-GMP-Annex13, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form. Per CAN-50, Canada has implemented CAN-52. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent.

For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

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Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

3.0

5.1

Part C (Division 5 (C.05.001))

Last content review/update: October 31, 2025

As delineated in COFEPRIS-GCP and the Guideline for Good Clinical Practice E6(R1) (MEX-32), an investigational product (IP) is defined as any pharmaceutical form containing an active ingredient or placebo, or a product of biological or biotechnological origin that is used or tested in a clinical trial, including a registered product when used or packaged in a way different from which it was authorized, or when it is tested for indications that have not been authorized, or when it is used to obtain more information about its authorized use. COFEPRIS-GCP also notes this definition also applies to new chemical and biological entities, generics, new formulations, combination products, and biosimilars, and medical devices with or without the release of some active ingredient.

NOM-012-SSA3-2012 similarly states that investigational medicines or devices are used or applied to humans for scientific research purposes, for which there is insufficient scientific evidence to demonstrate its preventative, therapeutic, or rehabilitative effectiveness, or is intended to modify the therapeutic indications of already known products.

NOM-059-SSA1-2015 further defines an IP as a drug or biological product for which there is no previous experience in the country, has not been registered by the Ministry of Health (Secretaría de Salud), and therefore, has not been distributed commercially. This definition also encompasses medicines registered and approved for sale, when they are being investigated for an unapproved indication, dose, or route of administration, including their use in combination with other products that are different from the approved use.

(Note: In Mexico, IPs are also referred to as “drugs/products in research”).

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1.7

1 and 4.16

3.77

Manufacturing & Import

Last content review/update: July 18, 2025

Manufacturing

As specified in the CanadaFDR, the G-CanadaCTApps, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), Health Canada (HC) authorizes the manufacture of investigational products (IPs) in Canada. HC approves the manufacture of IPs as part of the clinical trial application (CTA) approval. Per CAN-50, Canada has implemented CAN-52. Note that per CAN-50, HC-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. The G-QCM-PharmCTAs provides guidance and templates to assist sponsors in completing the quality portion of the CTA, which in turn, enables HC to assess IP characteristics adequately. The G-GMP-Annex13 requires the sponsor to ensure that IPs for clinical trials are manufactured and imported in accordance with its provisions and with CanadaFDR requirements. Per the G-CanadaCTApps, sponsors must file amendments or notifications to a previously authorized CTA when manufacturing changes are proposed that may affect the quality or safety of the clinical trial drug or biologic supplies.

Import

Per the CanadaFDR and the G-FDR-0100, HC authorizes the sponsor to import an IP. A sponsor who is not based in Canada must have a Canadian representative who is responsible for the import of the IP and demonstrates compliance with the applicable regulatory requirements. This representative should be the sponsor’s senior medical or scientific officer residing in Canada and is responsible for providing an attestation with respect to the CTA at the time of filing. Per the G-CanadaCTApps, the G-DrugApp, and CAN-4, if clinical trial drugs are to be imported into Canada, the authorization template (Appendix 1) in CAN-4 should be completed and submitted for each importer in Canada. The G-DrugApp states that Canadian importer(s) must be located within Canada. As additional importers are identified, additional copies of the authorization template in CAN-4 should be provided to HC. The G-FDR-0100, provides additional guidance on requirements if a sponsor plans to send the clinical trial IP(s) directly to each trial site:

Each party, including individual Canadian clinical trial sites, importing drugs directly (i.e., receiving drug shipments directly from outside of Canada) is identified on Appendix 1 of the Drug Submission Application Form (HC/SC 3011 form) (CAN-4) for Phase I-III trials (submitted with the application if known at the time or prior to importation at the site). Appendix 1 may be replicated as many times as necessary to capture all importing parties.
Clinical Trial Site Information (CTSI) forms (CAN-6) for each Canadian site conducting the clinical trial are submitted to HC for Phase I-III trials, prior to the start of the study.
Systems are in place, when appropriate, to monitor the transportation and storage conditions from the foreign source to the various clinical trial sites across Canada.
There is documented accountability of the imported drugs used in clinical trials and distributed to various clinical trial sites located in Canada, including the disposition of drugs returned from the clinical trial sites.
A written agreement is in place between the sponsor and the qualified investigator describing their specific responsibilities, and this agreement is available at the clinical trial site.
There is evidence that the drugs used in clinical trials conducted in Canada meet Good Manufacturing Practice (GMP) requirements (e.g., certificates of manufacture, certificates of analysis, and/or evidence of approved lot release by a qualified individual).

The G-CanadaCTApps, the G-HlthProdImprtExptReqs, the G-FDR-0100, and CAN-32 state that if a sponsor wants to import a drug into Canada for a clinical trial, a copy of HC’s authorization (i.e., the No Objection Letter (NOL)) issued by either the Pharmaceutical Drugs Directorate (PDD) or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) must be included for the applicable trial with the shipment. A copy of this authorization must be provided at the port of entry. The G-HlthProdImprtExptReqs states that drugs without a Drug Identification Number may be imported where authorized for a Canadian clinical trial and a NOL was issued. The G-FDR-0100 further states that if 30 days have passed and the NOL was not issued, specific requests to import IPs should be directed to the Health Product Border Compliance Program at the following email account: hc.hpbcp-pcpsf.sc@canada.ca. Note that a sponsor does not have to submit a CTA for authorization to import an IP used in a Phase IV clinical trial.

Per CanadaFDR, the sponsor can make the following changes to the authorized use or importation of drugs if the sponsor notifies HC in writing within 15 days after the date of the change:

A change to the chemistry and manufacturing information that does not affect the quality or safety of the drug
A change to the protocol that does not alter the risk to the health of a clinical trial subject

Other changes must follow the amendment requirements delineated in the CanadaFDR. See the G-FDR-0100 for additional HC interpretations of the relevant provisions of the CanadaFDR.

Appendix 1

2.12 and 5.13

Drug Importation

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

1.0

2.3 and 2.7

5.2-5.3 and 5.6

I Introduction, S Drug Substance, and P Drug Product

Section # Block D and Appendix 1 Guidance

Importer’s Role, Table 1, and Human Drugs

Part C (Divisions 2-5)

Last content review/update: October 31, 2025

Manufacturing

According to GenHlthLaw, Reg-COFEPRIS, and Reg-HlthProd, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is responsible for authorizing the manufacture of all drug products for human use, including investigational products (IPs), in Mexico. Pursuant to GenHlthLaw, COFEPRIS, acting on behalf of the Ministry of Health (Secretaría de Salud), also issued NOM-059-SSA1-2015 and NOM-164-SSA1-2015 to provide standards delineating the minimum requirements necessary for the manufacture of drugs or active ingredients to be marketed in the country or used in clinical research. See NOM-059-SSA1-2015-Annexes to access the annexes to NOM-059-SSA1-2015.

As indicated in GenHlthLaw and Reg-HlthProd, drug manufacturers must submit a request to COFEPRIS to obtain a health registration prior to initiating any drug manufacturing activities. Reg-HlthProd states that COFEPRIS must complete its review in 60 days, or the application will be deemed approved. Per GenHlthLaw, the health registration is valid for five (5) years. The health registration may be extended for an additional five (5) years if the extension is requested prior to the expiration of the current authorization, or the registration will be cancelled or revoked. See also GenHlthLaw and Reg-HlthProd, for detailed drug manufacturer registration submission requirements. In addition, per MEX-110, COFEPRIS is recognized as a National Regulatory Authority of Regional Reference of Medicines and Biological Products by the Pan American Health Organization (PAHO)/World Health Organization (WHO), and per MEX-111, is also a member of Pharmaceutical Inspection Co-operation Scheme (PIC/S). Per MEX-2, COFEPRIS has also implemented the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) (MEX-81).

Import

As delineated in GenHlthLaw, Reg-COFEPRIS, Reg-HlthProd, and G-UnregDrugImprts, COFEPRIS is also responsible for authorizing the import of IPs. According to Reg-HlthProd and G-UnregDrugImprts, an applicant or the legal representative may submit a request to import an IP after COFEPRIS has approved the health authorization request for those drugs that are neither narcotic nor psychotropic, that do not have health registrations, and that are intended to be used for human research. As per GenHlthLaw, the applicant must be a resident of Mexico or have a legal representative submit an import request on the applicant’s behalf.

Per Reg-HlthProd, Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts, foreign manufacturers must submit a license, a good manufacturing practices (GMP) certificate, or a document issued by the competent authority in the country of origin that proves the company has permission to manufacture drugs. See MEX-36 for additional information on obtaining a GMP certificate.

Additionally, as provided in Agrmnt_GMPCert, COFEPRIS has issued an agreement establishing the use of a regulatory “reliance” model for GMP certification. Under this agreement, COFEPRIS will recognize the GMP certificates or equivalent documents for drugs and medicines issued by Recognized Regulatory Authorities (RRA). RRAs include:

National Regulatory Authorities that are PIC/S members
National Regulatory Authorities included in the WHO List of Authorities (WLAs)
Regional Reference National Regulatory Authorities (RRNs)
National Regulatory Authorities of the country of origin, exclusively for foreign-manufactured drugs

Per Agrmnt_GMPCert, COFEPRIS will also consider Certificates of Pharmaceutical Product (CPP) that demonstrate GMP compliance when the issuing authority does not provide a GMP certificate. See Agrmnt_GMPCert for detailed requirements governing the reliance model for GMP certificates.

Per NOM-059-SSA1-2015-Mod, COFEPRIS uses the reliance model to recognize GMP certificates from National Regulatory Authorities (e.g., PIC/S members, WLAs, or those with equivalence agreements) to ensure access to new, safe, effective, and high-quality therapeutic options for the treatment of diseases requiring advanced therapies (mainly biotechnological drugs), such as cancer, diabetes and mellitus. See NOM-059-SSA1-2015-Mod for additional information.

Reg-HlthProd further states that COFEPRIS may grant permission to import raw materials or finished products without health registration only in the following cases:

When a contingency arises
When required by health policy
For purposes of scientific research, registration, or personal use, or
For laboratory tests

In addition, Reg-HlthProd indicates that three (3) types of sanitary import permits may be issued:

Definitive import – authorizes the entry of products to remain in the national territory for an unlimited time
Temporary import – authorizes the entry of products for a limited time and with a specific purpose, with the understanding that they must return to the country of origin in a period not exceeding one (1) year
Import in transit – authorizes the entry of products for their transfer from one (1) national office to another, for their departure to leave the country, within a period not exceeding 30 days, and for sale or temporary distribution. The sale or distribution is authorized exclusively for medicines to be used for strategic purposes

Reg-HlthProd, MEX-84, G-DIGIPRiS-ResProts, and G-UnregDrugImprts state that an import request may be submitted to COFEPRIS once the agency has authorized the protocol for research to be conducted on human beings. The following documentation should be included (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Authorizations, Certificates and Visits Form (see MEX-25) (original)
Proof of payment of fees (original and two (2) copies)
Health License
Notice of Operation (original and one (1) copy)
Approval from the research protocol office authorized by COFEPRIS and its amendments, (only in the case of research on human beings) (original and one (1) copy)
Power of attorney
Technical and scientific information demonstrating the identity and purity of its components in accordance with Pharmacopoeia of the United Mexican States (Farmacopea de los Estados Unidos Mexicanos (FEUM)) and its supplements; the stability of the finished product in accordance with the corresponding standards; and therapeutic efficacy and safety according to the corresponding scientific information
Prescribing information (broad and reduced versions)
Sample label
Free sale certificate issued by the health authority of the country of origin
Certificate that the company has permission to manufacture medicines and proof of GMP issued by the corresponding authority of the country of origin
Letter of representation, when the laboratory that manufactures the import product abroad is not a subsidiary or parent company of the laboratory requesting the registration
Letter of delegation of responsibility to the importer signed by the sponsor
Letter of acceptance of responsibility from the importer signed by the importer’s legal representative

In addition, Reg-HlthProd requires documents originating from a foreign country to be presented in Spanish, or if in another language, with a Spanish translation made by an expert translator.

Per Reg-HlthProd and G-UnregDrugImprts, COFEPRIS has 10 days to approve the request. If COFEPRIS does not respond within this timeframe, the request is deemed approved. G-UnregDrugImprts also notes that COFEPRIS has eight (8) business days to send the applicant a prevention notification requesting missing or additional information required. The applicant, in turn, has five (5) business days to respond. Reg-HlthProd and G-UnregDrugImprts further states that the maximum validity of import authorizations is 180 days, which may be extended for an equal period, provided the conditions in which they have been granted have not changed.

In addition, as set forth in Agrmnt_RegHlthSup, COFEPRIS issued an agreement adopting the WHO’s Good Reliance Practices for evaluating health registration applications. Under this framework, COFEPRIS may consider and rely upon the decisions of other RRAs to determine whether their requirements, tests, and evaluation procedures are equivalent to those conducted in Mexico for ensuring the quality, safety, efficacy, and performance of health supplies. In reviewing these applications, COFEPRIS will also consider the regulatory decisions of other RRAs, as well as the evaluations carried out by the WHO’s Prequalification Programme.

Per Agrmnt_RegHlthSup, for the treatment of emerging diseases, neglected tropical diseases, or in cases of national emergency, the Ministry must determine the medicines, vaccines, and medical devices that may be acquired through the Pan American Health Organization (PAHO)’s Strategic Fund or Revolving Fund (regional pooled procurement mechanisms), or through other procurement mechanisms, which will be imported for the prevention and control of diseases and health emergencies. Vaccines, medicines, and medical devices that have been acquired by the Ministry through these procurement mechanisms are exempt from health registration in Mexico. When the products are of biological origin, they are also exempt from obtaining a distribution or sale authorization. In the case of vaccines, medicines, and medical devices that have been acquired at the Ministry’s request, more than one (1) import permit may be requested under this Agreement, in accordance with the request made in an official letter submitted to COFEPRIS. See Agrmnt_RegHlthSup for additional information on COFEPRIS’s reliance model for health registration and on the import mechanisms for public health emergencies.

Mexico also has rules that govern how pharmaceutical products are transported and imported. D-CargoTransprt bars exclusive cargo shipments to the Mexico City International Airport (AICM). See D-CargoTransprt and D-ModCargoTransprt for more details regarding the relocation of cargo shipments to other airports in Mexico.

Please note: Mexico is party to the Nagoya Protocol on Access and Benefit-sharing (MEX-5), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see MEX-35.

4.4, 5.1, and 10.1

Introduction (Box 1)

XIII. Specific Sections of the Procedure on the Platform (VI and XIV)

Requirements, Term, Form, and Additional Information

Requirements (8)

Title V (Chapter I, Article 102), Title XII ((Chapter I, Articles 194, 194 Bi., 195, 197, 198, and 200-204), (Chapter IV, Articles 221-222), (Chapter VII, Articles 257-258), and (Chapter XIII, Articles 285 and 295)), and Title XVI ((Chapter I, Articles 368-376, 376 Bis, and 378) and (Chapter III, Article 391 Bis))

Article Two

Chapters I (Articles 1-2) and IV

Chapter I (Article 3)

Preamble, Chapters I (Articles 1 and 3), II (Articles 4-5), and V

Title IV ((Chapter I, Articles 99-100) and (Chapter II, Article 113)), Title V (Chapter I, Article 132), Title VI ((Chapter I, Articles 160-161), (Chapter II, Articles 162-163), (Chapter III, 167-171, 185-186, 190-bis 1, 190-bis 2, 190-bis 5, 190-bis 6), and (Chapter IV, Articles 193-194 and 196)), and Title VII

1 and 16

1 and 10.9

Quality Requirements

Last content review/update: July 18, 2025

Investigator’s Brochure

In accordance with the CanadaFDR and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB). The CanadaFDR and CAN-52 specify that the IB must contain all of the relevant information on the investigational product(s) (IPs), including significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information. The sponsor must ensure that an up-to-date IB is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee. Note that per CAN-50, Health Canada (HC)-implemented ICH guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

The CanadaFDR and CAN-52 require the IB to provide coverage of the following areas:

Physical, chemical, and pharmaceutical properties and formulation parameters
Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
Summary of data and guidance for the investigator(s)

See Section 7.3 of CAN-52 for detailed content guidelines.

In accordance with the G-CanadaCTApps and CAN-22, the sponsor must submit annually to HC an updated IB, which serves as the annual report, including all safety information and global status. Revisions that are more frequent may be appropriate depending on the stage of development and the generation of relevant new information.

Quality Management

Pursuant to CAN-52, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial. As specified in CAN-52, G-GMP-CAN, and G-GMP-Annex13, the sponsor must ensure that the products are manufactured in accordance with Good Manufacturing Practice (GMP). The G-GMP-CAN requires a quality management system, incorporating GMP, to ensure that IPs are of the quality required for their intended use. Per the G-GMP-Annex13, the manufacturer’s quality system should be described in written procedures and available to the sponsor, taking into account GMP principles and guidelines.

2.12, 5.13, 7.3, and 8.2

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

4

2.8

5.1, 5.5, and 5.12

Part C (Division 5 (C.05.001, C.05.005, and C.05.012))

Last content review/update: October 31, 2025

Investigator’s Brochure

As indicated in MEX-2, Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the ICH Guideline for Good Clinical Practice E6(R2) (MEX-22). Agrmnt_ResProtProcs, G-HumResProt, MEX-84, and G-DIGIPRiS-ResProts are in compliance with MEX-22 regarding investigational product (IP) quality/manufacturing and investigator’s brochure (IB) requirements (also known as researcher’s manual in Mexico), while COFEPRIS-GCP complies with the Guideline for Good Clinical Practice E6(R1) (MEX-32).

As set forth in GenHlthLaw, and G-HumResProt, Agrmnt_ResProtProcs, MEX-84, and G-DIGIPRiS-ResProts, which are in compliance with MEX-22, the applicant or sponsor is responsible for providing the investigators with an IB. MEX-22 specifies that the sponsor is generally responsible for ensuring that an updated IB is made available to the investigator(s), and the investigators are responsible for providing the updated IB to the responsible ethics committees (ECs). The sponsor should also update the IB as relevant new information becomes available. According to MEX-84, G-DIGIPRiS-ResProts, and MEX-22, the IB should include the following elements (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Title
Confidentiality statement
Table of contents
Summary
Introduction
IP identification data (IP number, generic name of the drug or device, international nonproprietary name, trade name, if applicable)
Collection of clinical and preclinical IP data relevant to the study of IP(s) in human participants
Preclinical information (includes non-clinical pharmacology, pharmacokinetics, and metabolism in animals, toxicology)
Clinical information (includes pharmacokinetics and metabolism in humans, safety and efficacy, experience during commercialization)
Data summary and guide for the investigator
Document version and version date (coinciding with the approving opinions of the ECs)
For drug authorization requests: (include IP physicochemical and pharmaceutical properties, formulation, presentation, manufacturing, labeling, storage, packaging and stability, when applicable, etc.)
For COFEPRIS-04-010-D modality (risk-free research (observational studies)) authorization requests: include prescribing information

MEX-84 further notes the purpose of the IB is to provide researchers and others involved in the trial with information to facilitate their understanding of the rationale for and compliance with key protocol features such as: dose, dose frequency/interval, administration methods, and safety monitoring. The IB also provides information to support the design of the clinical phase of the study participants over the course of the clinical trial. The information in this document must be presented in a concise, objective, and balanced manner which allows the principal investigator, as well as the other parties involved in the trial, to assess the suitability of the proposed trial, emphasizing the relevant and updated scientific information on the IP to monitor participant safety.

See MEX-84, G-DIGIPRiS-ResProts, and MEX-22 for detailed IB guidelines.

Quality Management

As specified in COFEPRIS-GCP, GenHlthLaw, Reg-HlthProd, NOM-059-SSA1-2015, NOM-164-SSA1-2015, NOM-176-SSA1-1998, NOM-073-SSA1-2015, G-HumResProt, MEX-84, G-DIGIPRiS-ResProts, and MEX-22, the sponsor must verify that the products are manufactured in accordance with the current codes of Good Manufacturing Practice (GMP). See NOM-059-SSA1-2015-Annexes to access the annexes to NOM-059-SSA1-2015.

In accordance with the GenHlthLaw, Reg-HlthProd, NOM-059-SSA1-2015, NOM-164-SSA1-2015, NOM-176-SSA1-1998, Agrmnt_ResProtProcs, G-HumResProt, G-DIGIPRiS-ResProts, and MEX-22, COFEPRIS requires that drug manufacturers ensure IPs meet the required safety, efficacy, and quality characteristics and are manufactured, handled, and stored in accordance with applicable GMP and provide the following additional information (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Issue the corresponding certificate of analysis signed by the health officer to verify the drugs comply with the quality specifications indicated in the current edition of the Pharmacopoeia of the United Mexican States (Farmacopea de los Estados Unidos Mexicanos (FEUM)) and its supplements, or those specified in the pharmacopeias from other countries, if applicable (per NOM-176-SSA1-1998)
In case of foreign manufacture, the manufacturer must have a GMP certification, license, or document proving that the manufacturer has permission to manufacture medicines, issued by the competent authority in the country of origin (per Reg-HlthProd)

MEX-84 further specifies that the following IP documentation is required to demonstrate compliance with GMP:

Letter under oath, declaring that the IP and placebo are manufactured under standards that ensure a product is safe for use and that it has the ingredients and potency it claims to have in accordance with established quality requirements, or
Certificate of good practices for the IP, or
Certificate of pharmaceutical product

Additionally, per GenHlthLaw, verification of GMP compliance must be conducted by the Ministry of Health (Secretaría de Salud) or the Ministry’s authorized third parties, or if necessary, recognition of the respective certificate issued by the competent authority of the country of origin, provided there are recognition agreements in place between the competent authorities from both countries. See MEX-36 for additional information on obtaining a GMP certificate.

NOM-059-SSA1-2015 also notes that the manufacture of IPs for use in clinical studies presents greater complexity than marketed drug products due to the lack of systematic procedures resulting from the variety of clinical trial designs. In addition to applying basic GMP principles, drugs for research use in Mexico must also be released in accordance with good clinical practices, and the personnel involved in IP production and control must be experienced in handling drugs in the clinical research phase and be familiar with GMP.

Per NOM-059-SSA1-2015-Mod, COFEPRIS also uses the reliance model to recognize a GMP certificate and quality control laboratory analyses from National Regulatory Authorities (e.g., Pharmaceutical Inspection Co-operation Scheme (PIC/S) members, World Health Organization (WHO) List of Authorities (WLAs), or those with equivalence agreements) to ensure access to new, safe, effective, and high-quality therapeutic options for the treatment of diseases requiring advanced therapies (mainly biotechnological drugs), such as cancer, diabetes and mellitus. See NOM-059-SSA1-2015-Mod for additional information.

In addition, per MEX-110, COFEPRIS is recognized as a National Regulatory Authority of Regional Reference of Medicines and Biological Products by the Pan American Health Organization (PAHO)/WHO, and per MEX-111, is also a PIC/S member.

3.2 and 10.1

2.12, 5.6, 7, and 8.2-8.3

Search for the Status of Implementation of ICH Guidelines by ICH Members

XIII. Specific Sections of the Procedure on the Platform (V-VI)

4.3

Requirements (7-8)

Title V (Chapter I, Article 102) and Title XII (Chapter IV, Article 222)

Article Two and Single Annex (Single Committee Form)

Title II (Chapter I, Articles 7-9), Title IV (Chapter II, Article 113), Title V (Chapter II, Article 168 and 170), and Title VII

0, 1.2, 3.14, and 16

1

4.1

1-3, 6.1, and 9

Labeling

Last content review/update: July 18, 2025

Investigational product (IP) labeling in Canada must comply with the requirements set forth in the CanadaFDR, the G-CanadaCTApps, the G-GMP-Annex13, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52). The CanadaFDR and the G-CanadaCTApps state that for an IP to be used in a clinical trial, it must be properly labeled in both official languages: English and French. The CanadaFDR requires that IPs be packaged and labelled under the supervision of personnel who have had satisfactory technical, academic, and other training. The packager and/or labeler must have written procedures and ensure that the IP is packaged, labelled, and tested in compliance with those procedures. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. Per CAN-50, Canada has implemented CAN-52.

As delineated in the CanadaFDR and the G-GMP-Annex13, the following information must be included on the IP label:

A statement indicating that the drug is an investigational drug to be used only by a qualified investigator
Name, number, or identifying mark
Expiration date
Recommended storage conditions
Lot number
Sponsor’s name and address
Protocol code or identification
Radiopharmaceutical information, if applicable

With regard to the expiration date, the G-GMP-Annex13 further states that if it becomes necessary to change the expiration date, an additional label should be affixed to the IP. This additional label should state the new expiration date and repeat the batch number. It may be superimposed on the previous expiration date, but for quality control reasons, not on the original batch number. This operation should be performed at an appropriately authorized manufacturing site. However, when justified, it may be performed at the investigational site by or under the supervision of the clinical trial site pharmacist, or other health care professional in accordance with national regulations and with the sponsor’s requirements. Where this is not possible, it may be performed by the clinical trial monitor(s) who should be appropriately trained. The operation should be performed in accordance with good manufacturing practice (GMP) principles, specific and standard operating procedures and under contract, if applicable, and should be checked by a second person. This additional labelling should be properly documented in both the trial documentation and in the packaging records.

In addition, CAN-52 state that the IP must be coded and labeled in a manner that protects the blinding, if applicable.

5.13

Efficacy guidelines

8.7

2.8.7

5.11

Part C (Divisions 2 (C.02.006, C.02.011, C.02.015-016) and 5 (C.05.011))

Last content review/update: October 31, 2025

Investigational product (IP) labeling in Mexico must comply with the requirements set forth in COFEPRIS-GCP, NOM-164-SSA1-2015, NOM-059-SSA1-2015, and the Guideline for Good Clinical Practice E6(R1) (MEX-32). (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MEX-22)).

As delineated in COFEPRIS-GCP and NOM-059-SSA1-2015, the IP label must be written in Spanish and contain, at a minimum, the following information (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Name, address, and telephone number of the sponsor or main contact
Protocol identification number
Pharmaceutical form and route of administration
Manufacturer name and address
Lot number, identification code, and dosage form
Statements: “For clinical studies only” or "Permitted use only investigation, " "Forbidden marketing," and "Keep away from the reach of children"
Symbol or pictograms warning, if applicable
Expiration date
Storage conditions

NOM-164-SSA1-2015 also states that the IP label must indicate it is material under investigation.

In addition, MEX-22 indicates the sponsor should verify the IPs are coded and labeled in a manner that protects the blinding, if appropriate. In blinded trials, the IP coding system should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding. A sample of the attached IP container label(s) should also be provided to document compliance with applicable labelling regulations and appropriateness of instructions provided to the study participants.

Per NOM-164-SSA1-2015 and NOM-059-SSA1-2015, IPs for use in clinical trials should be packaged in a way that protects the products from alteration, contamination, and damage during storage and shipment. Additionally, procedures or instructions for the control of packaging, labeling, and distribution operations should be prepared.

Per NOM-059-SSA1-2015, in the case of products packaged for blinded clinical studies, manufacturers must ensure that the unused products and supplies are completely (100%) retrieved.

5.13, 8.2.13, and 8.2.17

Search for the Status of Implementation of ICH Guidelines by ICH Members

4.4

5.2

10.9.8

Product Management

Last content review/update: July 18, 2025

Supply, Storage, and Handling Requirements

Per CanadaFDR, drugs must be manufactured, handled, and stored in accordance with good manufacturing practice (GMP). As defined in the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CAN-52), which Canada has implemented per CAN-50, the sponsor must supply the investigator(s) with the investigational products (IP(s)), including the comparator and placebo, if applicable. The sponsor should not supply the IP(s) until approvals from Health Canada (HC) and the institutional ethics committee (EC) are obtained. CAN-52 specifies that the sponsor must ensure the following:

Timely delivery of the IP(s)
Records maintained for IP document shipment, receipt, disposition, return, and destruction
Written procedures including instructions for IP handling and storage, adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
IP product quality and stability over the period of use
IP manufactured according to any application of GMP
Proper coding, packaging, and labeling of the IP(s)
Acceptable IP handling and storage conditions and shelf-life

For IP packaging, the G-GMP-Annex13 provides the following guidance:

The risk of product mix up must be minimized by using appropriate procedures, specialized equipment, and relevant staff training.
To prevent errors, particularly when IPs are blinded, use heightened precautions, such as label reconciliation, line clearance, and in-process control checks by appropriately trained staff.
The packaging must ensure that the IP remains in good condition during transport and storage at intermediate destinations; any opening or tampering of the outer packaging during transport should be readily discernible.

The G-Storage provides principles and interpretations on the environmental control of clinical trial drugs during storage and transportation, including packaging. See G-Storage for information regarding compliance with the CanadaFDA and the CanadaFDR, as it relates to packaging clinical trial drugs for human use, such as the role of environmental controls, quality risk management, and special considerations for active pharmaceutical ingredients. In addition, CAN-52 state that the IP must be packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. Refer to CAN-52 for detailed sponsor-related IP requirements.

Record Requirements

As set forth in the CanadaFDR, the G-FDR-0100, and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. The CanadaFDR states that the sponsor should maintain all trial-related records for a period of 15 years. Pursuant to CanadaFDR1024, the sponsor must submit requested records to HC within 48 hours if safety concerns arise. Additionally, to facilitate inspection of a site, the sponsor must submit information to HC within seven (7) days of a request.

The G-Storage provides that when contracted parties, such as warehouses or commercial carriers, store or transport drugs, there should be a written agreement that outlines all relevant conditions.

5.5, 5.12, 5.13, 5.14, and 7

Efficacy guidelines

8.6

5.1, 5.5, 5.10, and 5.12

Regulatory Impact Analysis Statement

Part C (Division 5 (C.05.001, C.05.005, C.05.010, and C.05.012))

Last content review/update: October 31, 2025

Supply, Storage, and Handling Requirements

COFEPRIS-GCP and the Guideline for Good Clinical Practice E6(R2) (MEX-22) state the sponsor is responsible for supplying investigators with the investigational products (IP(s)) while ensuring that only the quantity of products necessary to carry out the study is provided, and that none of the products will be marketed or used for purposes unrelated to the investigation. (Note: Per MEX-2, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is in the process of implementing MEX-22).

MEX-22 further specifies that the sponsor is responsible for supplying the investigator(s)/institution(s) with the IP(s) and for ensuring the timely delivery of the IPs. However, the sponsor should not supply an investigator/institution with the IP(s)) until all the required documentation is obtained, such as the favorable opinion of the ethics committee (EC) and approval from COFEPRIS.

The sponsor should ensure written procedures include instructions that the investigator/institution should follow for the handling and storage of IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).

Additionally, MEX-22 indicates the IP should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). The sponsor should determine acceptable storage temperatures, storage conditions (e.g., protection from light), storage times, reconstitution fluids and procedures, and devices for product infusion, if any, for the IPs, and inform all involved parties (e.g., monitors, investigators, pharmacists, storage managers) of these determinations. Additionally, the sponsor should:

Take steps to ensure that the IP(s) are stable over the period of use
Maintain sufficient quantities of the IP(s) used in the trials to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period

Refer to MEX-22 for detailed sponsor-related IP requirements and MEX-36 for additional information on obtaining a GMP certificate.

COFEPRIS-GCP also delineates the sponsor is responsible for ensuring that IP manufacturing complies with NOM-073-SSA1-2015, which states that during the clinical trial, the manufacturer must validate the stability of the IP until the date of the last administration. The sponsor and the contract research organization (CRO) are responsible for ensuring that the research institution has a restricted storage area to protect the IPs and other products required for the investigation, including adequate temperature controls, humidity, and other conditions according to the manufacturer’s provisions. Additionally, the principal investigator is required to keep track of the receipt, storage, distribution, administration, destruction, or retrieval of the IP and other products required for the clinical study, in accordance with the research protocol provisions.

In addition, NOM-164-SSA1-2015 and NOM-059-SSA1-2015 indicate that there must be a procedure for the retrieval of IPs for clinical use that describes the responsibilities of all the members of the supply chain using the drug to include the manufacturer, the sponsor, the investigator, the clinical monitor, and the head of the research unit. NOM-164-SSA1-2015 further states that a system must be in place for the release of each lot of manufactured IPs and that a qualified person must approve the release. See NOM-059-SSA1-2015-Annexes to access the annexes to NOM-059-SSA1-2015.

According to MEX-84, the following IP documentation is also required to be submitted to COFEPRIS:

Letter under oath guaranteeing the shelf life (stability) of the IP from the date of manufacture to the date of the last administration that will be carried out as part of the investigational protocol, or a protocol and report of results of the accelerated and long-term stability study of the IP and placebo, guaranteeing its stability from the date of manufacture to the date of the last administration in the research protocol
Letter under oath, declaring that the IP and placebo are manufactured under standards that ensure a product is safe for use and that it has the ingredients and potency it claims to have in accordance with established quality requirements; a certificate of good practices for the IP; or a certificate of pharmaceutical product
Letter of description of import inputs that expresses the approximate quantity of the IP

MEX-84 further notes that compliance with GMP and product stability are not equivalent. In the case of a letter under oath, it is valid to declare together compliance with GMP and that the shelf life of the IP is guaranteed at least until the date of the last administration of the IP and/or placebo.

In addition, per G-DIGIPRiS-ResProts, a letter of import supplies should be provided to COFEPRIS that clearly establishes the quantity and description of supplies that will be imported during each stage of the study. The letter should include the IP or placebo (when applicable), pharmaceutical form, presentation, concentration, and number of participants to be enrolled in Mexico. A letter of the stability studies should also be provided to support the IP and the placebo comply with the physical, chemical, and biological parameters which must be complied with throughout its useful life, and to maintain established quality specifications during storage and use.

Record Requirements

As indicated in the MEX-22, the sponsor should:

Maintain records that document shipment, receipt, disposition, return, and destruction of the IP(s)
Maintain a system for retrieving IPs and documenting this retrieval (e.g., for deficient product recall, reclaim after trial completion, expired product reclaim)
Maintain a system for the disposition of unused IP(s) and for the documentation of this disposition

MEX-22 further states the investigator/institution and/or a pharmacist, or other appropriate individual who is designated by the investigator/institution, should maintain records of the IP's delivery to the trial site, the inventory at the site, the use by each participant, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the IP(s) and trial participants. Investigators should maintain records that document adequately that the participants were provided the doses specified by the protocol and reconcile all IP(s) received from the sponsor.

Per NOM-059-SSA1-2015, the sponsor is also responsible for storing files related to the manufacture and control of the IP for at least five (5) years after product registration has been granted. Additionally, the sponsor must ensure that this documentation is safeguarded, and that the files are stored at the sponsor’s facilities or in specific facilities contracted for this purpose.

4.7 and 10.1-10.2

2.12, 4.6, 5.13-5.14, and 8.2.14-8.2.15

Search for the Status of Implementation of ICH Guidelines by ICH Members

XIII. Specific Sections of the Procedure on the Platform (VI)

3.4, 4.3, 4.5, and 4.12

3.24, 10.2, and 16.10

10.9

10.27

Definition of Specimen

Last content review/update: July 18, 2025

In Canada, a specimen is referred to as “human biological material” or “biological material.” According to the G-TCPS2, human biological materials include tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva, and other body fluids. The term also comprises materials related to human reproduction, including embryos, fetuses, fetal tissues, and human reproductive materials. The G-TCPS2 breaks down human biological material further into the following categories: anonymized, anonymous, coded, and identified human biological materials. Refer to the G-TCPS2 for more detailed information on these categories.

In addition, CAN-2 defines biological material as pathogenic and non-pathogenic microorganisms, proteins, and nucleic acids, as well as any biological matter that may contain microorganisms, proteins, nucleic acids, or parts thereof. Examples include, but are not limited to, bacteria, viruses, fungi, prions, toxins, genetically modified organisms, nucleic acids, tissue samples, diagnostic specimens, live vaccines, and isolates of a pathogen (e.g., pure culture, suspension, purified spores).

Glossary

Chapter 12 and Glossary

Last content review/update: October 31, 2025

In Mexico, a specimen is referred to as a “product of human beings.” According to GenHlthLaw and Reg-HumSpecDisp, products of human beings include any tissues or substances, excreted or expelled by the human body as a result of normal physiological processes.

GenHlthLaw and Reg-HumSpecDisp also provide more specific definitions for specimens including germ cells, stem cells, blood and derivatives, plasma, tissue, cellular concentrates, and organs. Please refer to these sources for more detailed information.

Additionally, G-RECs-Op-2018 states that human biological material includes organs, tissues, tissue components, cells, and products and cadavers of human beings.

14

Title XIV (Chapter I, Article 314)

Chapter I (Article 6)

Specimen Import & Export

Last content review/update: July 18, 2025

Import/Export

According to the G-HlthProdImprtExptReqs, Health Canada (HC) does not have jurisdiction over human biological materials to be imported for testing or research purposes. The G-HlthProdImprtExptReqs further states that all blood samples as well as cultures, diagnostic specimens, or research tissue are considered to be potential carriers of human or animal pathogens, and are regulated by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA). Per CAN-24, and CAN-2, the PHAC’s Centre for Biosecurity oversees the licensing process under the authority of the HPTA and the HPTR. The HPTA states that a license must be issued by the Minister that authorizes the import or export of human pathogens or toxins.

As specified in the HPTA, the HPTR, and CAN-2, individuals planning to conduct controlled activities (including producing, possessing, handling, using, storing, providing access to, transferring, disposing of, releasing, abandoning, or importing/exporting) with a human pathogen or toxin, whether imported or domestically acquired, must obtain a license. Per CAN-2, because all human biological materials are potential carriers of human pathogens, the PHAC has categorized these materials by risk group based on risk to the individual/animal and risk to the community. Risk Group 1 consists of microorganisms, nucleic acids, or proteins that are unable or unlikely to cause human or animal disease so they are generally not considered to be pathogens, and are therefore exempt from the HPTA and the HPTR licensing requirements. Risk groups 2 through 4 are considered to be pathogens or toxins with moderate to high individual risk and low to high community risk, and are subject to the HPTA and the HPTR licensing requirements. See CAN-2 for detailed information and instructions on how to obtain a license for activities associated with Risk Groups 2 through 4.

Chapters 1 and 2

Blood and blood components for transfusion

Purpose of the Act, Interpretation and Application, Obligation, Prohibitions, and Licenses

Licenses

Last content review/update: October 31, 2025

Import

As delineated in GenHlthLaw, Reg-COFEPRIS, and Reg-HumSpecDisp, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)) is responsible for authorizing the import of specimens (referred to as “products of human beings” in Mexico).

According to G-ImprtPermit, institutions that import products of human beings including tissues, cells, blood and its components or derivatives intended for research, diagnosis, teaching, or treatment for therapeutic purposes, must comply with specific COFEPRIS documentation submission requirements to apply for an import permit. The documentation required to obtain an import permit specifically for research purposes is as follows:

Import or Export of Products of Human Beings form (original) (see MEX-24)
Proof of payment of fees (one (1) original; G-ImprtPermit also specifies that in terms of the Federal Rights Law, proof of payment of fees is applicable only to the application for a permit for the hospitalization of blood units, their components, and hematopoietic progenitor cells)
Document certifying the operation of the foreign establishment issued by the health authority of the country of origin (original)
Health license for the corresponding line of business (original)
Notice of operation for the corresponding line of business (original)
Authorization document issued by COFEPRIS for the protocol when it is intended for humans, or a summary of the study when in vitro is being carried out, where appropriate (original)
Letter of acceptance in which the establishment that will receive the samples, justifying the reason and use of the samples (original)
Letter of transmission justifying the use and purpose of sending the samples (original)
Report on the date and procedure of destruction, if applicable (original)
Document certifying the operation of the establishment that supplies human blood, its components and derivatives, issued by the health authority of the country of origin (original)
Health license with the corresponding line of business (related to blood, its components or derivatives) (original)
Power of attorney (accreditation of the legal representative)

G-ImprtPermit further notes that COFEPRIS has 45 business days to respond to the import request, and 15 business day to notify the applicant of missing or additional information required in a prevention letter. The applicant, in turn, has five (5) business days to respond to COFEPRIS’s prevention letter. The import permit approval is valid for 180 business days. Refer to G-ImprtPermit for detailed information necessary to obtain import permits for teaching, diagnosis, and therapeutic purposes including the use of human blood (i.e., umbilical cord blood or hematopoietic progenitor cells) and corneas.

D-CargoTransprt bars exclusive cargo shipments to the Mexico City International Airport (AICM). See D-CargoTransprt and D-ModCargoTransprt for more details regarding the relocation of cargo shipments to other airports in Mexico.

Export

According to G-ExprtPermit, institutions that dispose of or export products of human beings including tissues, cells, blood and its components or derivatives that are intended for diagnosis, treatment, research, or teaching purposes must also submit documentation to COFEPRIS to apply for an export permit.

G-ExprtPermit indicates the following general documentation must be provided to export cells, tissues, and products of human beings and their components:

Import or Export of Products of Human Beings form (see MEX-24)
Proof of payment of fees (original and two (2) legible copies) (applicable only to requests for an export permit for units of blood, its components, and hematopoietic progenitor cells)
Document issued by the health authority of the destination country that certifies the operation of the establishment (original)
Letter of acceptance of the establishment abroad (original)
Authorization letter issued by COFEPRIS for the protocol when it is intended for humans, or a summary of the study when in vitro is being carried out, if applicable (original)
Notice of operation of health establishment (original)
Health license (original) (for cells, tissues, human products, and their components)
Power of attorney (original)

G-ExprtPermit further notes that COFEPRIS has 45 business days to respond to the export request, and 15 business days to notify the applicant of missing or additional information required in a prevention letter. The applicant, in turn, has five (5) business days to respond to COFEPRIS’s prevention letter. The permit approval is valid for 180 business days.

In addition, G-ExprtPermit outlines the following required documentation to be submitted to COFEPRIS to export umbilical cord blood or hematopoietic progenitor cells, for cryopreservation, research, or therapeutic purposes:

Import or Export of Products of Human Beings form (original) (see MEX-24)
Proof of payment of fees (one (1) original and two (2) legible copies; G-ExprtPermit also specifies that in terms of the Federal Rights Law, proof of payment of fees is applicable only to the application for a permit for the hospitalization of blood units, their components and hematopoietic progenitor cells)
Letter of acceptance of the establishment abroad (original)
Health license (original)
Document issued by the health authority of the destination country that certifies the operation of the establishment (original)
Power of attorney (original)

Import/Export Permit Submission Procedures

MEX-24 indicates that an applicant may submit a request to obtain a permit to import or export specimens in print, in person via COFEPRIS’s Comprehensive Service Center (Centro Integral de Servicios (CIS)) (MEX-37), or electronically via the Mexican Digital Window for Foreign Trade (Ventanilla Única de Comercio Exterior Mexicano (VUCEM)) (MEX-114). Per G-ImprtPermit and G-ExprtPermit, the application should be submitted electronically via MEX-114 (Refer to MEX-114 for submission instructions). G-ImprtPermit and G-ExprtPermit state that to submit an application online, it is necessary to obtain an e.signature (also known as e.firma). An e.signature can be obtained from the Tax Administration Service (Servicio de Administración Tributaria (SAT)) as described in MEX-83.

See MEX-116 for instructions on completing MEX-24. See also G-ImprtPermitMod for the required documentation and submission procedures to modify an import/export permit for products of human beings including tissues, cells, and blood and its components or derivatives.

Requirements, Form, Term, Validity, and Steps

Title I (Chapter I, Article 3), Title II (Chapter II, Articles 17 Bis), Title XII (Chapter XIII, Articles 283-286 Bis), and Title XVI (Chapter I, Article 375)

Chapter I (Article 3)

Chapter VI (Articles 89 and 100)

Consent for Specimen