Clinical Research Regulation For Mexico and Vietnam

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

Last content review/update: September 15, 2025

Overview

In accordance with the ClinDrugTrialGCP, PharmLaw-VNM, and ASTTReg, Vietnam’s Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process for registered and unregistered investigational products (IPs). The ASTT is responsible for reviewing all clinical study documents, and per the ClinDrugTrialGCP, PharmLaw-VNM, the ECReg, and the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research protocol. The ECReg further indicates that institutional level ECs, known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam, are responsible for reviewing clinical trial documents before submitting them to the NECBR. For institutions conducting research involving humans that do not have a CEBRGL, the review and evaluation of the research is performed by a CEBRGL appropriate to the research field.

According to the ClinDrugTrialGCP, the ASTT reviews a clinical trial registration dossier submitted by the sponsor, as well as a study approval dossier submitted by the institution. Evidence of institutional EC approval from a CEBRGL is a required element of the study approval dossier, so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the NECBR’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and PharmLaw-VNM, ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval. (Note: The ClinDrugTrialGCP and BioequivTrial also refer to the sponsor as “organizations and individuals with clinical trial drugs” or “donor”.)

As per the ClinDrugTrial and PharmLaw-VNM, the scope of the MOH’s assessment includes all clinical trials (Phases I-IV) for the following:

Drugs that contain a new active ingredient, or products with a new combination of marketed ingredients
Newly developed biologics or biologics with a new combination of marketed ingredients
Newly developed vaccines that are manufactured and used for the first time in Vietnam
Drugs, biologics, and vaccines which have been legally marketed for a period of less than five (5) years in the country of origin (or a country of reference if provided for under international treaties to which Vietnam is a signatory)
Drugs, biologics, and vaccines for which a clinical trial has been conducted, but have not met the MOH’s or internationally recognized good clinical practice (GCP) requirements

In addition, per the TradMedicine, the MOH also reviews and approves traditional medicines to be used in clinical trials (Phases I-IV) unless deemed exempt by the agency. The category of traditional medicine includes drugs developed from a provincial-level scientific research project or higher, drugs that were granted a certificate, or drugs used for treatment at health establishments at a provincial level or higher for 10 years or more and for 200 or more patients. The drugs must also have been approved by a Science and Technology Council or an EC specialized in traditional medicine as effective and safe to treat traditional medical diseases. Traditional medicines also include ancient methods.

For information on bioequivalence trials and testing, see the BioequivTrial and the BioTestReq.

Note: The ClinDrugTrial has been partially repealed by the ClinDrugTrialGCP, and Appendix I of the ClinDrugTrialGCP has been amended and replaced by the Appendix in the BioequivTrial.

Clinical Trial Review Process

Registration Dossier Review

According to the ClinDrugTrialGCP, the ASTT requires the sponsor to submit a clinical trial registration dossier. Upon receipt of the appropriate files, the ASTT will check the validity of the dossier. If the dossier is incomplete, the ASTT will provide a written notice and specific instructions for the sponsor to supplement the dossier. The sponsor is responsible for coordinating with the ASTT to complete the dossier within a maximum of 60 days from the date of receipt of the written notice. Past this time limit, the submitted application is no longer valid. Following the review of a complete and valid dossier, the ASTT Director will either issue a written approval (see Form 13 in Appendix III of the ClinDrugTrialGCP) or clearly state the reason for disapproval in writing.

See the Submission Process, Submission Content, and Timeline of Review sections for more information on registration dossiers.

Approval Dossier Review

Per the ClinDrugTrialGCP, research institutions must submit dossiers requesting clinical drug trial approval to the ASTT. The ASTT checks the validity of the dossier, and if it is incomplete, the ASTT will provide a written notice and specific instructions for the institution to supplement the dossier. The institution is responsible for coordinating with the ASTT to complete the dossier within a maximum of 60 days from the date of receipt of the written notice. Past this time limit, the research approval procedure must be repeated from the beginning.

The ClinDrugTrialGCP states that following receipt of a complete and valid dossier, the MOH will organize a meeting of the NECBR. After receiving the NECBR’s evaluation report of the research protocol, the ASTT will synthesize and complete the dossier, then submit it to the Minister of Health for approval if the protocol meets the requirements. If the protocol is not approved or needs correction, the ASTT will notify the institution in writing and clearly state the reason. If the protocol needs to be modified, the institution is responsible for coordinating with the ASTT to complete the dossier in up to 90 days from the date of receipt of the written notice. Past this time limit, the protocol approval procedure must be repeated from the beginning.

Procedures for the approval of research protocol amendments follow the same procedure described above for clinical drug trial approval. For more information, see the ClinDrugTrialGCP.

See Submission Process, Submission Content, and Timeline of Review sections for more information on the approval dossier.

Inspection

According to the ClinDrugTrialGCP, the ASTT conducts initial and ongoing periodic GCP assessments of facilities/establishments conducting clinical trials. An ASTT assessment team conducts a practical assessment of the implementation of GCP at the clinical trial facility and prepares a GCP Compliance Assessment Report (see Form 2 in Appendix III of the ClinDrugTrialGCP), which finds that the facility meets GCP, needs to make corrections/improvements, or does not comply with GCP. Based on the results of the report, the ASTT may issue a GCP certificate (see Form 3 in Appendix III of the ClinDrugTrialGCP), impose sanctions, and/or request that the Minister of Health revoke the facility’s GCP certificate. The ASTT publishes a list of GCP-compliant facilities, and the Minister of Health ensures that assessment team members meet specific conflict-of-interest and qualification standards. Additionally, the ASTT may conduct unscheduled assessments at the request of the MOH under certain conditions, based on the test drug’s level of risk for affecting participant health and the level of compliance with GCP.

See Appendix III of the ClinDrugTrialGCP for additional related forms. See the ClinDrugTrialGCP and the ASTT-GCPAssess for additional details on the ASTT’s GCP assessments.

The BioequivTrial indicates that the ASTT may also conduct inspections to ensure the rights and health of participants in the trial, ensure the quality and integrity of the research data, ensure that the responsibilities of stakeholders in the research are implemented in accordance with applicable regulations, and promptly detect violations of the research protocol. The MOH will determine the inspection scale and frequency based on the objective, purpose, design, complexity, blinding technique, scale, and end date of the research. The MOH must send an inspection notice to the sponsor and institution at least five (5) days before the inspection, and the inspection report must be completed and sent to the sponsor and institution within 20 days of the inspection.

Clinical Trial Exemptions

The DrugRgstrtn indicates that the Minister of Health may exempt new drugs and vaccines from certain phases of a clinical trial based on the opinion of the MOH’s Advisory Council in the following cases:

To meet urgent needs for national defense, security, epidemic prevention and control, and overcoming the consequences of natural calamities and catastrophes for which other drugs are not yet available on the market
To treat rare and serious diseases
The drug has been licensed for circulation by at least one (1) of the reference regulatory agencies specified in Article 2 of the DrugRgstrtn based on clinical records exempted according to the regulations of these agencies

The DrugRgstrtn adds that the new drugs and vaccines must simultaneously meet the following criteria:

The drug has been licensed for circulation in at least one (1) country in the world
There is clinical data that is not complete or there is complete clinical data, as prescribed in Article 18 of the DrugRgstrtn, but there is no full assessment of racial factors that may affect the safety and effectiveness of the drug

The DrugRgstrtn further indicates that certain generic drugs, new drugs (except vaccines), and herbal medicines that have been granted a circulation registration certificate before January 1, 2017 are exempt from clinical trials. See the DrugRgstrtn and the PharmLaw-VNM for more information on drugs that are exempted from a trial or certain phases of a trial.

Article 5

Articles 89 and 94

Appendix (Articles 1, 8, and 18 and Form 1)

Articles 2 and 18-20

Articles 1 and 7

Articles 8-17, 19, 21-23, and 29 and Appendix III (Forms No. 1-4 and 13)

Articles 4 and 6

Articles 1-3

Regulatory Fees

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

Last content review/update: September 15, 2025

No information is currently available regarding fees required to submit a clinical trial application for authorization to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT).

Ethics Committee

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

Last content review/update: September 15, 2025

Overview

As per the ECReg, the ClinDrugTrialGCP, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), and PharmLaw-VNM, Vietnam requires institutional and national level ethics committee (EC) approval for clinical trials. According to the ECReg, institutional level EC approval is provided by a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL). PharmLaw-VNM states that national level EC approval is conducted by the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR).

Ethics Committee Composition

The ECReg details general EC requirements applicable to both the CEBRGLs and the NECBR, as well as specific requirements for each type of EC.

Per the ECReg, EC membership should have at least five (5) members, ensuring gender principles, and include the following:

Members with expertise in the health sector and independent from the organization/institution that established the EC
Members that are clinicians
Members with experience in reviewing legal documents
Members not in the health sector
Members under 50 years old and members aged 50 or older

The ECReg further indicates that the EC cannot include the head of the organization/institution that established the EC. The EC may include alternate members, which must meet the same standards and have the same responsibilities as the EC members. Members with expertise in the health sector and members with experience in reviewing legal documents must have a university degree or higher, and members who are not specialized in the health sector must have a college degree or higher. Members must also have an understanding of Good Clinical Practice (GCP) and the EC’s standard operating procedures (SOPs).

According to the ECReg, the EC’s professional and administrative secretaries must be honest and objective. Furthermore, professional secretaries must have a university degree or higher in the health sector, as well as an understanding of GCP principles and the EC’s SOPs. Administrative secretaries must have a college degree or higher and knowledge of the EC’s SOPs.

Council of Ethics in Biomedical Research at the Grass Root Level

The ECReg states that a CEBRGL consists of one (1) chair, at least one (1) vice chair, EC members, alternate members (if any), a standing body, and specialized subcommittees (when necessary). The number of vice chairs, EC members, alternate members (if any), professional secretaries, administrative secretaries, and professional subcommittees are specified in the CEBRGL's SOPs. The head of the organization/institution that establishes the CEBRGL assigns a unit to act as the standing member of the CEBRGL.

The CEBRGLReg further indicates that CEBRGLs may have at most 11 members. All members must be honest, objective, and have biomedical research ethics knowledge and expertise. The chair and vice chair should be prestigious scientists.

The ECReg requires that the chair and vice chair(s) have a university degree or higher in the health sector and at least 10 years of working experience related to the relevant research field as assessed by the EC. They must also have a good reputation, and the ability to manage, synthesize, and unify opinions to achieve consensus among EC members. The chair and vice chair(s) must have an understanding of GCP principles and the SOPs of the EC. An individual cannot be appointed as the chair of the EC for more than two (2) consecutive terms.

According to the CEBRGLReg, a secretariat based in the host institution’s Science Research Management Office should assist the CEBRGL with application processing and other administrative tasks.

See the ECReg and the CEBRGLReg for additional CEBRGL membership criteria.

National Ethics Committee in Biomedical Research

The ECReg requires the NECBR to have one (1) chair, at least three (3) vice chairs, members, alternate members (if any), specialized subcommittees, and the National Ethics Committee Office. The National Ethics Committee Office, a supporting agency of the NECBR, is located at the MOH’s Administration of Science, Technology and Training (ASTT). The National Ethics Committee Office consists of a chief of office, deputy chief(s) of office, a chief accountant working part-time, and officers.

The ECReg indicates that the number of NECBR vice chairs, members, alternate members, professional secretaries, administrative secretaries, and professional subcommittees, as well as the number of National Ethics Committee Office deputy chiefs of office and office staff, are specified in the NECBR’s SOPs. The ASTT is the standing body of the NECBR. However, NECBR membership must not include civil servants of the MOH.

The ECReg further requires that the chair and vice chair(s) have a doctorate degree or higher in the health sector and at least 15 years of working experience related to the relevant research field as assessed by the NECBR. They must also have a good reputation, and the ability to manage, synthesize, and unify opinions to achieve consensus among NECBR members. The chair and vice chair(s) must have an understanding of GCP principles and the SOPs of the NECBR. An individual cannot be appointed as the chair of the NECBR for more than two (2) consecutive terms.

See the ECReg for additional NECBR membership criteria and VNM-1 for the list of 2023-2028 NECBR term members. Additionally, see VNM-14 for a list of NECBR SOPs.

Terms of Reference, Review Procedures, and Meeting Schedule

According to the ECReg, both CEBRGLs and the NECBR have five (5) year terms. However, the CEBRGLReg indicates that CEBRGLs have three (3) to five (5) year terms, as specified in the EC’s establishment decision. The ECReg also stipulates that the EC for the next consecutive term must include at least 20% new members.

As stated in the ECReg, EC activities are non-profit. When reviewing research involving humans, the EC must fully apply the ethical principles prescribed in the ECReg, the EC’s operating regulations, the EC’s SOPs, and relevant legal regulations. In addition, ECs operate on the principles of collective, democratic, and independent conduct when evaluating research proposals and making decisions. If necessary, ECs may invite an independent consultant to review the application and attend the EC meeting.

According to the ECReg, a full procedural review requires at least five (5) EC members to attend the meeting and vote, including at least one (1) member with appropriate expertise in the health sector, one (1) member without expertise in the health sector, one (1) independent member, and members of both genders. For ECs with a professional subcommittee, the meeting must have at least two (2) members of the appropriate professional subcommittee attending the meeting and voting. The study is only approved when there are less than two (2) negative votes out of the total number of valid votes. In case it is difficult to reach consensus in the review meeting, the EC chair has the right to decide to proceed with the vote immediately or request the principal investigator to complete the research dossier for the EC to review and vote in the next EC meeting. In case the EC’s meeting to review research documents does not ensure the number and structure of members as prescribed, the EC’s leaders may invite alternate members to participate in reviewing research documents and vote as EC members. Additionally, EC members may not review research in which they or a relative/close associate has a conflict of interest. See the ECReg for more details.

In addition, the ECReg states that ECs must conduct periodic assessments of clinical trials at least once a year. The EC’s chair must promulgate operating regulations for the EC, which must specify the order and procedures for evaluating research according to the full process and the expedited/shortened process. The EC’s chair must also approve and publicly announce the EC’s SOPs to achieve consensus in their establishment, the training of EC members, and the performance of specific tasks and duties of the EC. Additionally, the EC must make public the ethical guidelines for biomedical research it uses and keep information related to research confidential.

As set forth in CEBRGLReg, the CEBRGLs should operate within written SOPs to conduct their reviews. The chair oversees the meetings, makes conclusions, and reports this information to the institutional head. Voting members must have no conflict of interest with the research. The CEBRGL members must review research documentation and prepare comments for the secretary prior to the meeting. Most CEBRGLs do not meet regularly but instead meet upon request for review and on the availability of the majority of its members. The CEBRGLs should also refer to the NECBR’s SOPs to develop their own SOPs. See CEBRGLReg for detailed CEBRGL review procedures.

Article 94

Appendix (Article 8)

Articles 19 and 22

Articles 3-4, 6, 8-13, and 15-16

Articles 3-4 and Chapters II-III

Scope of Review

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

Last content review/update: September 15, 2025

Overview

According to the ECReg, the CEBRGLReg, the ClinDrugTrialGCP, and the PharmLaw-VNM, the primary scope of information assessed by ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The ECs involved in clinical trial approval in Vietnam include institutional level ECs, called Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs), and the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR).

As per the ECReg, the CEBRGLReg, and the PharmLaw-VNM, ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable or those with limited or no legal capacity. The ECReg further indicates that when considering research involving vulnerable groups, representatives of the research participants or experts with knowledge and experience working with the groups must participate in the EC meeting. (See the Vulnerable Populations; Children/Minors; and Pregnant Women, Fetuses & Neonates sections for additional information about these populations.)

The ECReg and the CEBRGLReg state that CEBRGLs and the NECBR are responsible for reviewing the ethics and science of biomedical research involving humans. According to the CEBRGLReg, CEBRGLs must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. See the ECReg and the CEBRGLReg for detailed ethical review guidelines.

The ECReg indicates that when assessing research before implementation, ECs should evaluate the following:

Research design and data collection
Pre-clinical and clinical research results (if applicable)
Potential risks and benefits of the research or research product (if applicable)
Impact of the research on the community with research participants
Selection of research populations and advertising used in recruiting potential participants
Process of providing information and obtaining research information and volunteer forms
Financial benefits and financial costs related to research participants
Protection of the research participants’ privacy and confidentiality
Process of monitoring, evaluating, and handling adverse events (for research involving intervention on research participants)
Researcher qualifications and research site

See the ECReg and the Progress Reporting section for additional information on what ECs should consider when reviewing ongoing research and research result reports.

Role in Clinical Trial Approval Process

As delineated in the ClinDrugTrialGCP, the MOH’s Administration of Science, Technology and Training (ASTT) is responsible for reviewing the clinical trial registration and study approval dossiers for completeness. Evidence of institutional EC approval from a CEBRGL is a required element of the study approval dossier, so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the NECBR’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM, the ASTT’s review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval.

The ECReg indicates that CEBRGLs are responsible for reviewing clinical trial documents before submitting them to the NECBR. For institutions conducting research involving humans that do not have a CEBRGL, the review and evaluation of the research is performed by a CEBRGL appropriate to the research field.

The ECReg indicates that ECs may review a research dossier or application under an expedited/shortened process if:

The research involves minimal risk
The research documents were completed according to a previous review’s results
The research documents have been reviewed and approved by another institutional EC
It is a periodic or ad hoc report for research that has already been approved
It is an application for amendment and supplementation of a research protocol that has already been approved
It is reporting adverse events occurring in research that has already been approved
It is reporting violations of an approved research protocol

According to the ECReg, research dossiers are reviewed under the EC’s full process if they do not qualify for expedited/shortened review as stipulated above, or if the EC chair requests that the dossier be examined according to the full process. See the Ethics Committee and Timeline of Review sections for more information on the expedited and full review processes.

The ECReg indicates that within five (5) working days of the results of its assessment, the EC must send a written notification of its evaluation to the leading research institution and principal investigator (PI). The EC may approve, conditionally approve, or decide not to approve a research dossier, and the written notifications must be issued accordingly (see Appendices I, IV, and V of the ECReg). See the ECReg for more information on the EC’s review of amendments or supplements to the research outline.

Per the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), for administrative changes to the clinical trial protocol, the research institution must report in writing to the ECs at all levels and the ASTT. Changes that do not affect the health and interests of trial participants, or the research designs, processes, and procedures, must be approved by the CEBRGL and the NECBR. The application and evaluation process are carried out in accordance with the provisions of the ECReg. Changes affecting the health and interests of trial participants, or the research designs, processes, and procedures, must be approved by competent regulatory agencies. The application for approval of changes and procedures must comply with the ClinDrugTrialGCP. See the ECReg and the ClinDrugTrialGCP for more information.

For internal NECBR forms and documents, see VNM-3.

According to the BioequivTrial, ECs may also conduct periodic or unscheduled inspections. The sponsor and EC should determine the scale and frequency of the inspections based on the objectives and design of the research. The purpose of the inspection should be to evaluate trial conduct and PI/study team compliance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and other applicable regulatory requirements. The sponsor or the EC must send an inspection notice to the institution and PI at least five (5) days before the inspection, and the inspection report must be completed and sent to the institution and PI within 20 days of the inspection.

The ECReg indicates that the EC must conduct periodic reviews, at least once a year, of ongoing clinical trials. The EC monitors and supervises research through direct supervision at the research site or through reviewing progress reports, reviewing research results, conducting periodic reviews, and conducting ad hoc reviews of the research. The EC’s monitoring and supervision content includes reviewing: compliance with procedures and standards for recruiting research participants; the protection of rights, safety, and health of research participants; and the collection of biological samples, information, and research data from research participants.

The ECReg further states that the NECBR and CEBRGLs are responsible for assessing the recording, reporting, and handling of adverse events occurring during the study.

Articles 90 and 94

Appendix (Articles 8 and 18)

Articles 2, 19, and 22-23

Articles 4-6, 8, 16, and 18-20 and Appendices I, IV, and V

Articles 5 and 8-9

Ethics Committee 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

Last content review/update: September 15, 2025

As stated in the ECReg, ethics committees (ECs) should issue guidelines indicating the research application appraisal fee (if any).

According to VNM-12, the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR) and institutional level ECs (known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)) charge a fee to review clinical trial documentation. The current NECBR and CEBRGL fees are $1,000-$2,000 USD.

Article 17

Oversight of Ethics Committees

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

Last content review/update: September 15, 2025

Overview

The ECReg requires that institutional level ethics committees (ECs), known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam, notify the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) regarding their establishment and consolidation according to the form in Appendix VI of the ECReg. The EC must also update the information on the institution’s website within 15 days from the date of the decision to establish or consolidate the EC.

Registration, Auditing, and Accreditation

The ECReg indicates that the ASTT is responsible for maintaining a list of ECs on the ASTT website. The ASTT must update the list within 15 days from the date of receiving a notice of establishment from the EC. ECs are periodically inspected by the ASTT to ensure that they comply with the requirements specified in the ECReg. If the EC is found to be noncompliant, the ASTT will withdraw the EC’s name from the updated list on the website. The ASTT may suspend, or propose suspension to a competent authority, of an EC’s operation in case it is found that the EC violates the provisions of the ECReg, affecting the protection of rights, safety, and health of research participants.

Article 23 and Appendix VI

Submission Process

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

Last content review/update: September 15, 2025

Overview

In accordance with the ClinDrugTrialGCP, PharmLaw-VNM, and ASTTReg, Vietnam requires the applicant to obtain clinical trial authorization from the Ministry of Health (MOH). The Administration of Science, Technology and Training (ASTT) is the department within the MOH that manages the clinical trial review process. As delineated in the ClinDrugTrialGCP, the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), must also approve the research protocol.

As per the ClinDrugTrialGCP, evidence of institutional EC approval from a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) is a required element of the study approval dossier submitted to the ASTT, so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the NECBR’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM, ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval.

Regulatory Submission

According to VNM-12, the registration dossier and the study approval dossier should be submitted to the MOH’s ASTT at the address found in VNM-11:

Ministry of Health
Administration of Science, Technology and Training
No. 138B Giang Vo
Ba Dinh District
Hanoi City, Vietnam

As per the ClinDrugTrialGCP, the sponsor must submit, directly or via post, one (1) copy of the clinical trial registration dossier signed by the sponsor’s representative(s) to the ASTT. Separately, research institution(s) must submit one (1) copy of the study approval dossier, signed by the principal investigator (PI) and the head of the testing facility, directly or via post to the ASTT. See Appendix III of the ClinDrugTrialGCP for the registration form and the forms that comprise the study approval dossier. (Note: The ClinDrugTrialGCP also refers to the sponsor as “organizations and individuals with clinical trial drugs” or “donor” throughout the document.)

As delineated in the ClinDrugTrialGCP, the clinical trial application and accompanying material must be provided in Vietnamese or English. If the document is not available in Vietnamese or English, a notarized translation of the document must be provided in Vietnamese or English. The ClinDrugTrialGCP also indicates that the Investigator’s Brochure (IB) summary (also referred to as the research product profile in Vietnam) submitted to the MOH with the registration application should be in Vietnamese or in English with a supplementary summary in Vietnamese. See the Submission Content section for detailed information on documentation to be submitted.

Ethics Review Submission

As per VNM-12, the application for NECBR approval should also be submitted at the address found in VNM-11:

Ministry of Health
Administration of Science, Technology and Training
No. 138B Giang Vo
Ba Dinh District
Hanoi City, Vietnam

VNM-12 indicates that for NECBR review, the applicant must submit four (4) copies of the relevant documents directly or via post to the ASTT. Except for the IB, the Certificate of Analysis, and the good manufacturing practices (GMP) certificate, which may be in English, all relevant documents must be submitted in Vietnamese.

According to the ECReg, ECs issue their own guidelines on the requirements for submitting research applications for review. See the Submission Content section for the minimum requirements of the EC evaluation guidelines.

Article 94

Articles 19-22 and Appendix III (Forms No. 6 and 7)

Article 17

Articles 1-3

Submission Content

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

Last content review/update: September 15, 2025

Regulatory Authority Requirements

As per the ClinDrugTrialGCP, the following documentation must be submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) for clinical trial registration dossiers:

Clinical trial registration application form signed by a representative of the sponsor (See Form No. 6 in Appendix III of the ClinDrugTrialGCP)
Summary of the Investigator’s Brochure (IB) (also referred to as the research product profile in Vietnam) including general information about the clinical reagent (name, ingredients, indications, physical properties, chemistry, preparation, and other relevant information), pre-clinical research materials, and clinical trial study documents from previous phases

For clinical trial study approval dossiers, the ClinDrugTrialGCP indicates that the following documentation must be submitted to the MOH’s ASTT:

Clinical trial approval application form signed by the principal investigator (PI) and the head of the research institution (See Form No. 7 in Appendix III of the ClinDrugTrialGCP)
Full IB, including proof of compliance with Good Laboratory Practice (GLP) for research institutions or proof of compliance with Good Manufacturing Practice (GMP) for drug manufacturers, and proof of compliance with quality testing requirements from national inspection agencies or ex-warehousing certificates for vaccine or biological batches (Refer to the Quality Requirements section for detailed IB requirements)
A copy of the written approval for clinical trial registration from the MOH’s ASTT
For phase IV clinical trials, a certified or notarized copy of the written request for phase IV clinical drug testing from the respective regulatory authorities
A certified or notarized copy of the research institution’s certificate of eligibility for pharmaceutical business
Certification of participation by all study sites for multicenter research studies in Vietnam
A certified or notarized copy of the approval from the People’s Provincial Committee (for community-based studies)
Contract/agreement between the sponsor and the host institution; and contract/agreement between sponsor and the contract research organization (CRO), if applicable
Explanation of study protocol (See Form No. 8 in Appendix III of the ClinDrugTrialGCP)
Case report form (CRF)
PI’s Curriculum Vitae (CV) and a copy of the Good Clinical Practice (GCP) certificate issued by the MOH or an institution recognized by the MOH
Informed Consent Form (ICF) (See Form No. 9 in Appendix III of the ClinDrugTrialGCP) (See also the Required Elements section for additional information)
Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) evaluation report
Investigational product (IP) labeling

See the ClinDrugTrialGCP for detailed requirements.

Ethics Committee Requirements

The ECReg indicates that both the institutional level ethics committees (ECs) (CEBRGLs) and the national EC (National Ethics Committee in Biomedical Research (NECBR)) issue their own guidelines on the requirements for the review of research application submissions. The guidelines include information on the following:

Name and address of the secretary, staff, or member of the EC receiving the application file, or address of the website receiving the online application (if any)
List of all written material in the file
Specifications of the documents
Language of the documents in the file
Number of copies to be submitted
Application deadline compared to review date
Notification method for invalid documents
Time limit for submitting additional documents (if necessary)
Expected time to announce the review results
The required format of the forms to be submitted as prescribed by the EC (if any)
Research appraisal fee (if any)

See the ECReg and the Scope of Review section for information on what ECs should consider when reviewing research before implementation, ongoing research, and research result reports.

Clinical Protocol

As per the ClinDrugTrialGCP, the MOH requires the following elements to be included in a protocol submission:

Title
Protocol code
Duration
Management level (state/ministry/institution/province)
PI/co-investigator(s) names and contact information
Funding
Phase requested
Institution to conduct research
Sponsor and contact information
Situation of domestic and foreign research
Objectives
Methodology (including trial design, random selection method, and standard operating procedures (SOPs) for each research technique)
Participant selection/withdrawal
Participant treatment
AE reporting requirements (See the Safety Reporting section for additional information)
Laboratory test methods
Ethical considerations
Inspection and monitoring
Post study medical care
Study team training
International cooperation
Implementation progress
Format of the expected results
Activities of coordinating organizations

See Appendix III in the ClinDrugTrialGCP for a copy of the full form.

Article 19 and Appendix III (Forms No. 6, 7, 8, and 9)

Article 17

Timeline of Review

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

Last content review/update: September 15, 2025

Overview

As per the ClinDrugTrialGCP, evidence of institutional ethics committee (EC) approval from a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) is a required element of the study approval dossier submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), so CEBRGL and ASTT approval cannot be conducted in parallel. Additionally, the National Ethics Committee in Biomedical Research (NECBR)’s review of the protocol is initiated by the MOH as part of the ASTT’s study approval dossier review procedures. Per the ClinDrugTrialGCP and the PharmLaw-VNM, ASTT review is finalized once NECBR approval is obtained and the entire study approval dossier is sent to the Minister of Health for final approval.

Regulatory Authority Approval

Registration Dossier Review

As delineated in the ClinDrugTrialGCP, the ASTT initially checks the validity of the sponsor-submitted registration dossier (which includes the registration application form and Investigator’s Brochure (IB) summary) within five (5) working days from the date of receipt of the application. If any issues are identified, the ASTT will issue a written notice to the sponsor, who must coordinate with the ASTT to complete the dossier within 60 days of receipt. Past this time limit, the submitted application is no longer valid. The ASTT Director will issue a written decision within five (5) working days of receiving a complete and valid dossier.

Approval Dossier Review

The ClinDrugTrialGCP indicates that research institutions must submit dossiers requesting clinical drug trial approval to the ASTT. The ASTT checks the validity of the study approval dossier within five (5) working days from the date of receipt of the application. If any issues are identified, the ASTT will issue a written notice to the institution, which must coordinate with the ASTT to complete the dossier within 60 days of receipt. Past this time limit, the research approval procedure must be repeated from the beginning.

The ClinDrugTrialGCP states that within 25 days of receiving a complete and valid study approval dossier, the MOH will organize a meeting of the NECBR. Within five (5) working days after receiving the NECBR’s evaluation report, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

If the research protocol is not approved or needs to be corrected, the ASTT must notify the institution and state the reason, as per the ClinDrugTrialGCP. The institution must coordinate with the ASTT to complete the dossier within 90 days from the date of the notice. Past this time limit, the protocol approval procedure must be repeated from the beginning. Within five (5) working days after receiving the completed research protocol in accordance with the written notice, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

Ethics Committee Approval

According to the ECReg, ECs issue their own guidelines on the requirements for submitting research applications for review. See the Submission Content section for detailed information on minimum requirements for the EC guidelines.

According to VNM-12, the review and approval process for CEBRGLs takes 30 days. Meetings are scheduled upon request and are based on the availability of the majority of its members.

The ECReg indicates that within five (5) working days from the date that the research dossier evaluation results are available, the EC must send a written notification to the leading research institution and principal investigator.

See Scope of Review section for details on the EC’s role in the clinical trial approval process.

Article 94

Articles 19 and 21-22

Articles 17 and 19

Initiation, Agreements & Registration

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

Last content review/update: September 15, 2025

Overview

As delineated in the ClinDrugTrialGCP, the PharmLaw-VNM, and the ASTTReg, a clinical trial can only commence in Vietnam after authorization from the Ministry of Health (MOH) has been received. The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. The ClinDrugTrialGCP indicates that the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers. The MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research protocol. Once the ASTT has completed its review and the NECBR has reviewed and approved the research protocol, the Minister of Health must give final approval to the entire study approval dossier. The ECReg further indicates that institutional level ECs, known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) in Vietnam, are responsible for reviewing clinical trial documents before submitting them to the NECBR. For institutions conducting research involving humans that do not have a CEBRGL, the review and evaluation of the research is performed by a CEBRGL appropriate to the research field.

As per the ExprtImprtMeds, an import license must be obtained for the shipment of an investigational product (IP) to be used in the trial from the MOH’s Drug Administration of Vietnam (DAV). See the Manufacturing & Import section for additional information.

Clinical Trial Agreement

As per the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the sponsor is required to enter an agreement with the participating principal investigator (PI)/host institution(s) before the trial begins to demonstrate the financial agreement between the parties. The PharmLaw-VNM also states that the sponsor is required to sign a clinical trial contract with the investigator(s).

Clinical Trial Registration

According to VNM-12, the ASTT encourages the sponsor and the PI to register their study with the United States National Institutes of Health’s ClinicalTrials.gov (VNM-13).

Article 3

Articles 92 and 94

Appendix (Article 8 and Form 1)

Articles 19 and 21-22

Articles 4-6

Articles 1-3

Safety Reporting

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

Last content review/update: September 15, 2025

Safety Reporting Definitions

As delineated in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) and the AERprtingD62, the following definitions provide a basis for a common understanding of Vietnam’s safety reporting requirements:

Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence (including any signs, symptoms, illnesses, or test results) in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
Serious Adverse Event (SAE) – Any untoward medical occurrence that may lead to death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or permanent incapacity, creates a congenital anomaly/birth defect, or requires appropriate medical intervention to prevent the aforementioned situations or medically important event
Unexpected AE – AEs in which the essence, severity, specificity, or consequences are different or have not been recorded or considered in the study protocol or relevant study documents

Also, according to VNM-12, the Ministry of Health (MOH) uses the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (VNM-5) to define its safety reporting terminology.

Safety Reporting Requirements

Investigator Responsibilities

As per the BioequivTrial and the AERprtingD62, the principal investigator (PI) is responsible for detecting and settling SAEs and updating AE/SAE information to ensure the timeliness of reporting and the safety of the research participants. The PI is required to report to the sponsor, the institutional ethics committee (EC), also known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), the MOH’s National Ethics Committee in Biomedical Research (NECBR), the MOH’s Administration of Science, Technology and Training (ASTT), and the National Centre for Drug Information and Adverse Drug Reaction Monitoring (National DI and ADR Centre).

The BioequivTrial indicates that depending on the type of AE/SAE, the PI must comply with the following reporting requirements:

Fatal or life-threatening SAEs in Vietnam: A report, in accordance with Form 4 in the Appendix of the BioequivTrial, must be submitted to the NECBR, the ASTT, and the National DI and ADR Centre within seven (7) working days from the date of receiving information about the SAE. Updates on the SAE must be provided in additional reports until the participant recovers or stabilizes.
SAEs that are not fatal or life-threatening in Vietnam: A report, in accordance with Form 4 in the Appendix of the BioequivTrial, must be submitted to the NECBR, the ASTT, and the National DI and ADR Centre within 15 working days from the date of receiving information about the SAE.
Non-serious AEs occurring in Vietnam: The AEs must be recorded and summarized in a periodical report, and reported in the full results of the trial research results to the NECBR and the ASTT.

The BioequivTrial indicates that in the event of fatal or life-threatening AEs/SAEs, the PI and the host institution are required to suspend the trial immediately, provide care and treatment to the participant(s), overcome and resolve the consequences, and document the events. According to the AERprtingD62, the PI must also document any deaths. The BioequivTrial and the AERprtingD62 further indicate that the PI and the host institution must report these events to the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR.

For AEs that cause harm to the participant’s health, the BioequivTrial and the AERprtingD62 indicate that the PI is responsible for treating and following up on the participant’s health until the person is stable.

According to the BioequivTrial, the PI should provide periodic updates regarding AEs/SAEs to the sponsor, the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR. If the extent and frequency of AEs/SAEs exceeds the allowable limit, investigators may propose to the sponsor, EC, and competent regulatory authority that the clinical trial be suspended.

The BioequivTrial and the AERprtingD62 indicate that all of the following must be reported:

SAEs occurring at study sites in Vietnam
SAEs occurring at study sites outside of Vietnam in a multicenter Vietnamese study that lead to cessation/suspension of the study or a change in the protocol
All other AEs occurring in clinical drug trials at study sites in Vietnam

Sponsor Responsibilities

Per the BioequivTrial and the AERprtingD62, the sponsor must coordinate with the PI to report AEs/SAEs occurring at study sites in Vietnam to the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR. The sponsor must collect AE/SAE data.

For SAEs occurring at study sites outside of Vietnam in a multicenter Vietnamese study, the BioequivTrial states that the sponsor must report to the NECBR, the ASTT, and the National Center of DI and ADR within 10 working days from the date of a decision to stop/suspend the study, withdraw participants from the study, or change the research protocol.

In addition, the AERprtingD62 requires that the sponsor report findings from clinical trials, epidemiology studies, in vitro studies, information in the medical literature, and other sources of information, if the findings suggest an important risk related to the investigational product.

Form Completion & Delivery Requirements

Per the BioequivTrial, SAEs in Vietnam should be reported using a Reporting Form for SAEs in Clinical Trials (Appendix, Form 4).

1, 5.16-5.17, and 7

1-3

Appendix (Articles 1 and 19-20, and Form 4)

Progress Reporting

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

Last content review/update: September 15, 2025

Interim and Annual Progress Reports

According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), investigators are responsible for providing periodic and unscheduled reports.

The ECReg states that ethics committees (EC) should evaluate the following content when reviewing ongoing research:

Compliance with the approved research protocol
Protection of rights, health, and safety of research participants
Recording, handling, and reporting of adverse events (AEs) and serious adverse events (SAEs) occurring during the study (if any)
Violation of the research protocol and remediation and prevention of violations (if any)
Amendments and/or supplements to the research protocol and related documents (if any)

Final Report

The BioequivTrial and the ClinDrugTrialGCP indicate that the principal investigator (PI), the sponsor, and the host institution are responsible for submitting a final report to the Ministry of Health (MOH) when a study is completed. The final report, which must include an analysis of the data and information on AEs/ SAEs, must be submitted in accordance with Form No. 12 in Appendix III of the ClinDrugTrialGCP. The BioequivTrial further states that the clinical trial results must be made public within three (3) years from the date of issuance of the competent authorities' decision approving the results, and should comply with applicable copyright regulations.

The ECReg states that the EC should evaluate the following content when reviewing reports of the research results:

Compliance with the research protocol during implementation
Integrity, accuracy, and reliability of research data
Scientific and accurate nature of research results report

As per the ECReg, the EC may approve, conditionally approve, or decide not to approve a research result report. See Appendices III-V of the ECReg for each form, respectively.

Appendix (Articles 5, 20, and 23 and Form 3)

Appendix III (Form No. 12)

Articles 18-19 and Appendices III-V

Definition of Sponsor

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

Last content review/update: September 15, 2025

As per the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the sponsor is defined as an organization or individual that owns research drugs, has a need to conduct clinical drug trials, and has a commitment to provide funding for clinical drug trials. (Note: The ClinDrugTrialGCP and the BioequivTrial also refer to the sponsor as “organizations and individuals with clinical trial drugs” or “donor”.)

In addition, per the PharmLaw-VNM, the sponsor may select a qualified contract research organization (CRO) (also known as a research support organization in Vietnam) to run the clinical trial. The ClinTrialSup defines a CRO as an organization with the legal status to operate in the field of clinical trial research support and that is staffed with appropriately qualified personnel.

According to the ClinTrialSup, CROs may perform clinical research support activities such as implementing sponsors’ clinical research responsibilities, carrying out administrative support activities, and conducting clinical research monitoring. The ClinDrugTrialGCP indicates that a cooperative contract should exist between the sponsor and a CRO, if applicable. According to the PharmLaw-VNM, a sponsor and the CRO may be domestic or foreign.

In addition, as per the ClinTrialSup, CROs are also responsible for registering their organizations with the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT). Before implementing any activities in support of a clinical trial, a CRO must submit a registration dossier and the applicable forms for approval. The CRO is also required to report annually on its clinical research activities to the MOH’s ASTT. (See the ClinTrialSup for detailed information on clinical trial research support activities and the related registration forms.)

Articles 1 and 92

Articles 3, 9-11, 15, and 17, and Appendix I (Forms No. 1-2)

Appendix (Article 1)

Article 19

Site/Investigator Selection

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

Last content review/update: September 15, 2025

Overview

As set forth in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) and PharmLaw-VNM, the sponsor is responsible for selecting the investigator(s), the principal investigator (PI), the consultant experts, and the research institutions, taking into account the appropriateness and availability of the study site and facilities.

As stated in the BioequivTrial, all investigators must possess appropriate qualifications, training, and experience. All investigators involved in the trial must obtain completion certificates for a good clinical practice (GCP) course and a safety reporting course, each to be updated every three (3) years, from the Ministry of Health (MOH) or an authorized training facility.

See the BioequivTrial for information on PI and investigator rights and responsibilities.

Foreign Sponsor Responsibilities

No information is currently available on foreign sponsor requirements.

Data and Safety Monitoring Board

According to VNM-12, there are no requirements for establishing a Data and Safety Monitoring Board (DSMB). However, the MOH’s National Ethics Committee in Biomedical Research (NECBR) may recommend the establishment of a DSMB.

Multicenter Studies

The BioequivTrial states that for multicenter studies, in addition to analyzing general research results, it is necessary to conduct a separate analysis of key safety and efficacy variables on Asian or Vietnamese research populations using drugs for which racial factors are considered to have an effect on efficiency and safety. Furthermore, per the ClinDrugTrialGCP, the clinical trial study approval dossier must include documentation certifying the participation of research institutions in multicenter studies in Vietnam.

Article 92

Appendix (Articles 3, 5-6, 16, and 23)

Article 19

Insurance & Compensation

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

Last content review/update: September 15, 2025

Insurance

According to VNM-12, there is no specific Vietnamese guidance that addresses indemnity agreements between the sponsor and the contract research organization (CRO), investigator(s), or institution(s). However, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) lists an insurance contract as an essential document to be obtained by the principal investigator (PI), institution, and sponsor before conducting a clinical trial. The purpose of the insurance contract is to ensure that research participants will be compensated in the event of a trial-related injury.

Compensation

Injury or Death

As specified in the PharmLaw-VNM, the sponsor is responsible for providing compensation to research participants in the event of trial-related injuries. The BioequivTrial also states investigators are responsible for compensating participants when an adverse event that seriously impacts the participant’s health was caused by the investigator’s violation of the research protocol.

Trial Participation

According to the BioequivTrial, payment and compensation, if any, to clinical trial participants must be clearly indicated in the research protocol.

Article 92

Appendix (Articles 5-6 and 21, and Form 1)

Risk & Quality Management

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

Last content review/update: September 15, 2025

Quality Assurance/Quality Control

As stated in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the sponsor is responsible for assigning a monitor to assist in maintaining a quality assurance (QA) system with written standard operating procedures (SOPs) that ensure trials are conducted and data are generated, recorded, and reported in compliance with the protocol. In addition, the quality management system applied in clinical trials must meet International Organization for Standardization (ISO) 9001-equivalent standards or higher.

Per the BioequivTrial, the principal investigator (PI) is responsible for ensuring the accuracy, truthfulness, confidentiality, integrity, and verifiability of the research data. Correction of data must be in accordance with applicable regulations, which indicate that the original data should not be deleted, and the assigned researcher must record their name, sign for confirmation, and specify the date of correction. The lead investigator must submit an encrypted list of trial participants to the regulatory agency after the clinical trial ends. The retention and submission of the list of participants after decryption must be kept secret.

The trials should be conducted in compliance with good clinical practice (GCP) principles and standards outlined in the ClinDrugTrialGCP and the BioequivTrial Appendix, which are based on the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (VNM-5) and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (Please refer to Annex 3 of The Use of Essential Drugs: Sixth Report of the WHO Expert Committee for these guidelines (VNM-10)).

Monitoring Requirements

As part of its QA system, the BioequivTrial states that the sponsor should assign a monitor to inspect the trial. The sponsor should appoint individuals who are independent from the trial and are qualified by training and experience to conduct inspections, in accordance with the ClinTrialSup. The ClinDrugTrialGCP further indicates that SOPs, the monitoring/inspection plan, and procedures must also be submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT).

According to the ClinDrugTrialGCP, clinical trial facilities/establishments must apply and comply with GCP. Facilities providing clinical drug trial services and facilities with non-commercial clinical drug trial activities must submit a dossier to the ASTT requesting initial assessment of compliance with GCP together with the appraisal fee as prescribed by the Minister of Finance. As part of the GCP assessment, the clinical trial facility briefly presents its organization, personnel, implementation activities, GCP application, or other items according to the content of the ASTT assessment team’s plan. The assessment team conducts a practical assessment of the implementation of GCP at the facility and prepares a GCP Compliance Assessment Report (see Form 2 in Appendix III of the ClinDrugTrialGCP), which finds that the facility meets GCP, needs to make corrections/improvements, or does not comply with GCP. In response to the GCP Compliance Assessment Report, the facility may send a written explanation disagreeing with the assessment, make corrections or repairs, and/or request a copy of an issued GCP certificate. The ASTT also conducts periodic assessments of a facility’s GCP compliance, which follow a similar format. See the ClinDrugTrialGCP and the ASTT-GCPAssess for additional details on the ASTT’s GCP assessments.

For information on ASTT and ethics committee (EC) monitoring responsibilities, see the Scope of Assessment and Scope of Review sections.

Premature Study Termination/Suspension

According to the BioequivTrial, the sponsor may terminate a trial early if serious protocol violations are discovered during an inspection that affect the safety of trial participants, or, the accuracy and truthfulness of the data. The sponsor should send notices to the Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), the MOH’s National Ethics Committee in Biomedical Research (NECBR), and the relevant authority, in addition to notifying the institution and PI.

Annex 3 (Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products)

Article 3

Appendix (Articles 15, 17, and 18 and Forms 1-2)

Articles 4-5 and 8-13 and Appendix III (Forms No. 1-4 and 8)

Data & Records Management

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

Last content review/update: September 15, 2025

Electronic Data Processing System

According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), when using electronic trial data processing systems, the sponsor should use appropriate data handling programs and have adequate standard operating procedures (SOPs) for these systems. In addition, per the ClinDrugTrialGCP, the research institution’s general documentation must include a brief description of any electronic document system in its technical and professional standards, if applicable.

Records Management

As per the BioequivTrial, all information on clinical trials must be recorded, handled, managed, and kept in accordance with applicable regulations in order to accurately report, interpret, monitor, and check the accuracy and reliability of clinical trial information and data. Research institution facilities for storing clinical trial records and documents must ensure confidentiality; restricted access; fire and explosion prevention and control; and avoidance of adverse effects of light, temperature, humidity, and penetration of insects and other animals. In addition, research dossiers and documents should be archived and preserved according to the contract between the sponsor and the institution. For research and development of new products, documentation needs to be kept for at least 10 years.

Appendix (Articles 2, 14, 15, and 22)

Appendix II

Personal Data Protection

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)

Last content review/update: September 15, 2025

Responsible Parties

Per Decree13, the personal data controller is an organization or individual that decides the purposes and means of processing personal data. The personal data processor is an organization or individual that performs data processing on behalf of the data controller, through a contract or agreement with the data controller. An organization or individual that both decides the purposes and means for, and directly processes, personal data is referred to as a personal data controller and processor.

Decree13 states that the personal data controller must:

Implement organizational and technical measures, as well as appropriate safety and security measures, to prove that data processing activities have been carried out in accordance with Decree13, reviewing and updating these measures as necessary
Record and store a system log of personal data processing
Notify the Ministry of Public Security (MPS) of violations of regulations on protection of personal data as prescribed in Decree13
Select a personal data processor in accordance with a clear mandate and work only with a personal data processor that has appropriate safeguards in place
Ensure the rights of data subjects as prescribed in Decree13

Additionally, Decree13 indicates that the personal data processor must:

Only receive personal data after having a contract or agreement on data processing with the personal data controller, and process personal data in accordance with the contract or agreement
Fully implement measures to protect personal data specified in Decree13 and other relevant legal documents
Delete and/or return all personal data to the personal data controller after finishing data processing

According to Decree13, both the personal data controller and processor are also responsible to the data subject for damages caused by the processing of personal data. In addition, they must cooperate with the MPS and competent state agencies in protecting personal data by providing information for investigation and handling of violations of Decree13.

Per VNM-8, the MPS is responsible for protecting the rights of data subjects against violations of Decree13, and for maintaining the National Information Portal on Personal Data Protection (VNM-7). See VNM-7 for additional personal data protection resources.

According to the DataLaw-VNM, the Prime Minister of Vietnam decides on the sharing of private data managed by ministries, ministerial-level agencies, government agencies, and provincial People's Committees in urgent and unexpected cases of natural disaster prevention and control, epidemics, fires, explosions, or other necessary cases to resolve practical issues.

See the DataLaw-VNM for more information on general data law in Vietnam.

Data Protection

Per Decree13, organizations and individuals involved in personal data processing must apply personal data protection measures to prevent unauthorized collection of personal data from translation systems and equipment. It is illegal to set up software systems, enact technical measures, or organize activities of collecting, transferring, buying, and selling personal data without the consent of data subjects.

According to Decree13, personal data protection measures must be applied from the beginning and throughout the processing of personal data, including management, technical, investigational, and procedural measures. Network security for the data processing system, as well as the means and equipment, must be checked before processing data, irrecoverably deleting data, or destroying devices containing personal data.

Decree13 states that in the case of sensitive personal data, a department with the function of protecting personal data must be designated, personnel in charge of personal data protection must be appointed, and information about the department and individual in charge of personal data protection must be exchanged with the agency specializing in personal data protection (e.g., MPS). Additionally, data subjects must be notified that their sensitive personal data is being processed.

Decree13 states that if a violation of Decree13 has been detected, the personal data controller/personal data controller and processor must notify the MPS’s Department of Cybersecurity and Prevention within 72 hours after the violation occurs using Form No. 03 (see Appendix of Decree13 or VNM-9). If the notification is submitted after 72 hours, the reason for the late notice must be attached. Additionally, the personal data processor must notify the personal data controller of the violation as quickly as possible. See Decree13 and VNM-9 for more information on notification requirements for violations of personal data protection regulations.

As per the DataLaw-VNM, any cross-border transfer and processing of data must ensure national defense, security, and protection of national interests, public interests, rights, and legitimate interests of data subjects and data owners in accordance with the provisions of Vietnamese law and international treaties to which Vietnam is a member.

Consent for Processing Personal Data

Decree13 delineates that a data subject’s consent is only valid when the data subject voluntarily and clearly knows the type of personal data to be processed; the purpose of processing personal data; that organizations and individuals are allowed to process the personal data; and the rights and obligations of data subjects. The data subject’s consent must be expressed clearly, specifically in writing, by voice, by ticking the consent box, in the syntax of consent via text message, by selecting consent technical settings, or through another action that demonstrates consent. When there are multiple purposes for the data collection, the personal data controller/personal data controller and processor must list the purposes for the data subject to agree to one (1) or more of the stated purposes, and consent must be given for each purpose. The data subject’s consent must be expressed in a format that can be printed or reproduced in writing, including in electronic or verifiable formats. Silence or non-response of the data subject is not considered as consent, and the data subject may give partial or conditional consent. The data subject’s consent is valid until the data subject decides otherwise or when the competent state agency requests in writing.

Per Decree13, data subjects also have a right to: be aware of data processing activities; access their data; delete data; restrict data processing; provision of data; object to data processing; complain, denounce, and initiate lawsuits; claim damages; and self-defense. For the processing of sensitive personal data, the data subject must be informed that the data to be processed is sensitive personal data.

Decree13 states that in certain cases, the data subject’s consent is not required for the processing of personal data. This includes urgent cases where it is necessary to immediately process relevant personal data to protect the life and health of the data subject or others, and in the event of a state of emergency on national defense, security, social order and safety, major disasters, or dangerous epidemics.

See Decree13 for more details on obtaining consent from data subjects; the rights of data subjects; and situations where consent is not required for the processing of personal data.

Withdrawal of Consent

According to Decree13, withdrawal of consent must be in a format that can be printed or reproduced in writing, including in electronic or verifiable format. Upon receiving a request from a data subject to withdraw consent, the personal data controller/personal data controller and processor must notify the data subject of possible consequences and damages that may occur when consent is withdrawn. The personal data controller, personal data processor, personal data controller and processor, and any third parties must stop, and request any relevant organizations and individuals to stop, processing the data of the data subject that has withdrawn consent. Withdrawal of consent does not affect the legality of the data processing that was agreed to prior to the withdrawal.

Children

Per Decree13, children’s personal data must be processed in accordance with the principle of protecting the rights and ensuring the best interests of the children. The processing of children’s personal data must have the consent of the child if the child is seven (7) years of age or older, as well as the consent of the parent(s) or legal guardian(s). The personal data controller, personal data processor, personal data controller and processor, and any third parties must verify the age of the children before processing the children's personal data. The relevant parties must stop processing the children’s personal data and/or irreversibly delete or destroy the children’s personal data in the following cases:

The data was processed for improper purposes, or the purpose of processing personal data with the consent of the data subject has been fulfilled, unless otherwise provided for by law
The child’s parent(s) or legal guardian(s) withdraws consent for the processing of the child’s personal data, unless otherwise provided for by law
At the request of a competent authority when there are sufficient grounds to prove that the processing of personal data affects the children’s legitimate rights and interests, unless otherwise provided for by law

Articles 17 and 23

Articles 2, 9, 11-12, 17, 20, 22-23, 26-28, and 38-39 and Appendix (Form No. 03)

Documentation Requirements

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

Last content review/update: September 15, 2025

Obtaining Consent

In all Vietnamese clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the ClinDrugTrialGCP, the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), and the PharmLaw-VNM. As per the ClinDrugTrialGCP and the BioequivTrial, the informed consent form (ICF) is viewed as an essential document that must be sent to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) as part of the clinical trial study approval dossier, for which the Minister must issue final approval.

The ECReg indicates that a research proposal involving humans, including the ICF, must undergo ethical and scientific review by the MOH’s National Ethics Committee in Biomedical Research (NECBR) and an institutional level ethics committee (EC) (known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)).

The BioequivTrial states that the principal investigator (PI) or the clinical testing facility is responsible for obtaining written consent from trial participants before carrying out any study procedures.

According to the BioequivTrial, the informed consent information provided to participants should also be presented without coercion or unduly influencing enrollment in the clinical trial. The ClinDrugTrialGCP further states that the participant or legal representative/guardian should also be given the opportunity to ask questions about the research, and given adequate time to consider whether to participate.

Re-Consent

No information is currently available on re-consent.

Language Requirements

As delineated in the ClinDrugTrialGCP, the clinical trial application and accompanying material must be provided in Vietnamese or English. If the document is not available in Vietnamese or English, a notarized translation of the document must be provided in Vietnamese or English.

VNM-12 indicates that the ICF content should be presented in Vietnamese and English for global clinical studies, but for studies with domestic sponsors, only Vietnamese is required. The English copy serves as a reference to the NECBR. The study information sheet should be in Vietnamese.

Documenting Consent

As per the ClinDrugTrialGCP, the BioequivTrial, and the PharmLaw-VNM, the participant or the legal representative/guardian must sign and date the ICF. No information is provided in these sources concerning copies to be issued to the participant or legal representative/guardian.

Waiver of Consent

The ECReg indicates an EC may waive the requirement for voluntary consent from research participants if the study requires absolute confidentiality, or if consent cannot be obtained from the participant or legal representative/guardian. The EC’s decision to waive the voluntary consent requirement must consider the benefits and risks of the study to participants, as well as measures to protect the rights and safety of participants.

Articles 90 and 91

Appendix (Forms 1-2)

Articles 19-20 and 22 and Appendix III (Form No. 9)

Articles 5-7

Required Elements

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

Last content review/update: September 15, 2025

Based on the ClinDrugTrialGCP, the informed consent form (ICF) should include the following statements or descriptions, as applicable:

Description of research with an explanation of its purpose and objectives
Expected duration of study
Research methods to be followed
Inclusion and exclusion criteria for research participants
Identification of investigator(s) who will be responsible for assessing confidential medical information to select study participants
Number of participants involved in the study
Description of any foreseeable risks to the participant
Any expected benefits to the participant and/or the community, and any study-related payment to the participant
Alternative procedures or treatment that may be available to the participant
The extent to which confidentiality of records identifying the participant will be maintained
Selection of those parties who will be able to access, inspect, supervise, and monitor the participant’s records
Compensation and/or medical treatment available in the event of a trial-related injury
Person(s) to contact for further information regarding the trial and the rights of trial participants and whom to contact in the event of trial-related injury
Statement that participation is voluntary and the participant may withdraw at any time for any reason

See Form No. 9 in Appendix III of the ClinDrugTrialGCP for a copy of the ICF.

Articles 19 and 22 and Appendix III (Form No. 9)

Participant Rights

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

Last content review/update: September 15, 2025

Overview

In accordance with the ClinDrugTrialGCP, Vietnam’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As stated in the ClinDrugTrialGCP and the PharmLaw-VNM, the participant or the legal representative/guardian should be informed that participation is voluntary and that the participant may withdraw from the research study at any time for any reason without being held liable.

Additionally, the PharmLaw-VNM states that participants have the responsibility to comply with investigators’ instructions according to approved clinical trial documents.

The Right to Information

As per the ClinDrugTrialGCP and the PharmLaw-VNM, 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, and any compensation or treatment in the case of injury.

The Right to Privacy and Confidentiality

According to the ClinDrugTrialGCP and the PharmLaw-VNM, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The ClinDrugTrialGCP states that the research participant or legal representative/guardian should be provided with contact information for a person to contact regarding trial-related inquiries.

Furthermore, the PharmLaw-VNM states that the participant has the right to file a complaint or lawsuit against any illegal acts committed by the sponsor or investigator.

The Right to Safety and Welfare

As set forth in the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the benefits and risks or inconveniences to participants, society, or the community must be fully and carefully considered before starting a clinical trial on the basis of ensuring the safety, health, and interests of participants.

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

Articles 90 and 91

Appendix (Article 2)

Appendix III (Form No. 9)

Emergencies

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)

Last content review/update: September 15, 2025

The ECReg indicates an ethics committee (EC) may waive the requirement for voluntary consent from research participants if consent cannot be obtained from the participant or legal representative/guardian. The EC’s decision to waive the voluntary consent requirement must consider the benefits and risks of the study to participants, as well as measures to protect the rights and safety of participants.

Article 7

Vulnerable Populations

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).

1.61

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)

Last content review/update: September 15, 2025

Overview

As per VNM-4, in all Vietnamese clinical trials, research participants selected from vulnerable populations must be provided additional protections by the ethics committee and the investigator(s) to safeguard their health and welfare during the informed consent process. VNM-4 characterizes vulnerable populations as those incapable of giving consent, which may include children, pregnant women, people with mental disabilities, people living with HIV/AIDS, people who are illiterate, prisoners, detainees, sex workers, and other special populations.

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

Approval of Protocol, Monitoring and Evaluation, Final Review, and Dissemination of Research and Ethical Aspects of Biomedical Research

Children/Minors

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)

Last content review/update: September 15, 2025

According to ChildLaw, a child is someone under 16 years of age.

As set forth in the PharmLaw-VNM, when the participant is a minor, informed consent must be obtained from the legal representative/guardian.

Assent Requirements

No information is currently available regarding assent requirements.

Article 90

Chapter I (Article 1)

Pregnant Women, Fetuses & Neonates

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)

Last content review/update: September 15, 2025

The PharmLaw-VNM states that for studies involving women who are pregnant or breastfeeding, the rationale for participant selection and appropriate protection measures for these participants must be clearly stated in the study approval dossier.

Article 90

Prisoners

Last content review/update: October 31, 2025

No applicable requirements

Last content review/update: September 15, 2025

No information is currently available.

Mentally Impaired

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)

Last content review/update: September 15, 2025

No information is currently available.

Definition of Investigational Product

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”).

1.33

1.7

1 and 4.16

3.77

Last content review/update: September 15, 2025

The ClinDrugTrial defines an investigational product (IP) as a pharmaceutical product, biomedical product, vaccine, traditional medicine, or herbal medicine that contains a new active ingredient or substance, or a product with a new combination of already marketed pharmaceutical substances.

Chapter II (Article 5)

Manufacturing & Import

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

Last content review/update: September 15, 2025

Manufacturing

As set forth in the PharmLaw-VNM, Decree54, and the ClinDrugTrialGCP, the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) has overall responsibility for authorizing the manufacture of all drug products. According to VNM-4, once the ASTT reviews and the Minister of Health approves the study approval dossier, the Drug Administration of Vietnam (DAV) coordinates with the ASTT to review and approve the investigational product (IP) for manufacture or import.

In addition, the ClinDrugTrialGCP states that IPs which are under review for phase IV clinical trials require a certified or notarized copy of the written request for phase IV clinical drug testing from the respective regulatory authorities.

Import

As delineated in the ExprtImprtMeds, the MOH’s DAV is responsible for authorizing the import and export of drugs in Vietnam. According to ExprtImprtMeds, IPs for use in clinical trials are categorized as finished drugs without registration numbers. Once the MOH approves the study approval dossier, an import permit application must be submitted to the MOH’s DAV for approval of the IP. The import permit is valid for one (1) year.

The PharmLaw-VNM further indicates that a drug/medicinal ingredient that does not have a certificate of free sale must be licensed for import with a quantity not exceeding that which is written on the import license when it is to be used in a clinical trial, a bioequivalence study, a bioavailability assessment, or as a sample for registration, testing, scientific research, or display at a fair or exhibition.

The ExprtImprtMeds and Decree54 require the following documents to be included in an import permit dossier (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Import order form (three (3) copies)
Copy of study protocol approved by the MOH
A Certificate of Pharmaceutical Product (CPP) (may be substituted with a Free Sale Certificate (FSC) or Good Manufacturing Practice (GMP) certificate)
The importer’s document bearing the importer’s seal, specifying the purposes and quantity of imported drugs and commitment to use the drugs for its intended purposes
Quality standards and testing methods
Drug label(s) and instruction manual(s) with importer seal (See the Labeling section for detailed labeling requirements)
Preclinical and clinical records for drug(s) containing new pharmaceutical substances, or drug(s) with new combinations of circulating pharmaceutical substances, and an information sheet on placebo’s composition, if applicable

According to the ExprtImprtMeds, dossiers and documents attached to the order form must be prepared on size A4 paper and bound into a solid set. The records must be arranged in the order of the table of contents, with separation between the sections. The separators must be numbered for easy reference and must be affixed for certification by the importing enterprise on the first page of each section of the entire dossier and must have a cover page clearly stating: the name of the importer, order number, date of order, and type of order. The application for foreign drug import must be written in Vietnamese or English. If the application is written in English, the information in the package insert must be written in Vietnamese, except for the following information that may be written in other languages with Latin origin:

Brand name, generic name, or international generic name of the drug
International generic or scientific name of ingredient or ingredient quantity of the drug in case it cannot be translated into Vietnamese
Name and address of the foreign enterprise that manufactures or franchises the drug

The MOH’s DAV will review and approve the import permit application within 15 working days from the date of receipt. According to VNM-12, however, the DAV review and approval process may take two (2) to eight (8) weeks if the DAV requires further clarification on the application. See the ExprtImprtMeds for applicable forms.

Please note: Vietnam is party to the Nagoya Protocol on Access and Benefit-sharing (VNM-2), 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 VNM-6.

Approval of Protocol, Monitoring and Evaluation, Final Review; Procedures for Manufacture and Import of Medicinal Drugs for Clinical Research

Chapter I (Articles 4-5), Chapter III (Articles 11 and 17), and Annex I (Form 11a)

Chapter II (Article 10) and Chapter V Section 2 (Article 60)

Article 19

Articles 1 and 73

Quality Requirements

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

Last content review/update: September 15, 2025

Investigator's Brochure

According to the BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP), the Investigator’s Brochure (IB) is considered an essential document to submit before a clinical trial may be conducted. Vietnam requires the sponsor to submit a summary of the IB to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) in the clinical trial registration dossier. Research institutions are required to submit the full IB to the ASTT in the study approval dossier. (Note: The ClinDrugTrialGCP and the BioequivTrial also refer to the sponsor as “organizations and individuals with clinical trial drugs” or “donor”.)

As per the ClinDrugTrialGCP and the BioequivTrial, the IB contains information and data about preclinical research and clinical trials on the investigational product(s) (IPs). The IB also demonstrates that clinical information related to the IP has been provided to the principal investigator (PI).

As specified in the ClinDrugTrialGCP, the IB must provide coverage of the following areas:

Information about the IP, including the ingredients, production processes, and quality standards
For pharmaco-chemical drugs, pharmaceutical drugs, traditional medicines: proof of compliance with Good Laboratory Practice (GLP) for research institutions or proof of compliance with Good Manufacturing Practice (GMP) for drug manufacturers
For vaccines: proof of compliance with quality testing requirements from national inspection agencies or ex-warehousing certificates for vaccine or biological batches
Preclinical research documents for the IP: research reports on pharmacological effects, toxicity, safety, recommendations on dosage, route of administration, and usage
Clinical research papers from the previous phases (if clinical trials are recommended in the next phase and the IP is not subject to exemption from previous phases)

Quality Management

The ClinDrugTrialGCP specifies that the IPs must be manufactured in a GMP-certified facility. The research institutions must also include a copy of the GMP certificate in the study approval dossier that is submitted to the ASTT.

(See the Product Management section for additional information on IP supply, storage, and handling requirements).

Appendix (Form 1)

Articles 3, 19, and 22

Labeling

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

Last content review/update: September 15, 2025

Investigational product (IP) labeling in Vietnam must comply with the requirements set forth in PharmLaw-VNM. Per VNM-12, the requirements in Articles 7 and 8 of the MedLabel should also be applied to IP labeling.

According to the MedLabel, the outer packaging label of the drug must show the following:

Drug name
Dosage form
Ingredients, content, and volume or concentration of pharmaceutical ingredients and medicinal materials in the drug formula
Packaging specifications
Indications, usage, and contraindications of the drug
Circulation registration number or import license number (if any)
Production batch number, date of manufacture, expiry date of the drug, quality standards, and drug storage conditions
Signs to note and recommendations when using the drug
Name and address of the drug manufacturing facility
Name and address of the import facility (for imported drugs)
Origin of the drug

Additionally, as stated in the MedLabel, the intermediate packaging label of the drug must contain at least the following information:

Drug name
Production batch number
Expiry date

As set forth in PharmLaw-VNM, the IP must also be clearly labeled with the wording: “Products used for clinical trials. Use for other purposes is prohibited.” According to VNM-12, this wording should be in Vietnamese. A sample IP with the label in the smallest packed unit must also be included in the study approval dossier.

(See the Product Management section for additional information on IP supply, storage, and handling requirements).

Article 88

Articles 7-8

Product Management

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

Last content review/update: September 15, 2025

Supply, Storage, and Handling Requirements

The BioequivTrial (which amends Appendix I of the ClinDrugTrialGCP) indicates that at the end of a clinical trial, the principal investigator (PI) must inventory the investigational product (IP). The sponsor is responsible for storing the IP and for working with the host institution to withdraw and destroy the unused or remaining products, in accordance with applicable regulations.

Record Requirements

As stated in the BioequivTrial, the sponsor and the PI are responsible for filing the following essential documents before the trial begins and during the conduct of the trial:

Sample(s) labels attached to IP container(s) (only the sponsor is required to file this information)
Instructions for handling IPs and trial-related materials (if not included in protocol or Investigator’s Brochure (IB))
Shipping records for IP- and trial-related materials

In addition, the sponsor and the PI are responsible for maintaining records of handling instructions and shipping records for IPs and trial-related materials.

Appendix (Article 22 and Forms 1-2)

Definition of Specimen

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)

Last content review/update: September 15, 2025

In Vietnam, as per Decree89 and the MgmtInfctSpcmn, specimens are defined as human blood, serum, plasma, urine, feces, human body fluids, and other specimens that contain infectious substances and microorganisms pathogenic to humans. In addition, as per the MgmtInfctSpcmn, infectious substances are those that are known or expected to contain pathogens affecting humans, and are classified as Category A and B. Category A specimens are those capable of causing life-threatening diseases, death, or permanent disability to humans when they are exposed (see Appendix I of the MgmtInfctSpcmn). Category B specimens are those not listed in Category A. Specimens are also referred to as “medical microbiological samples” in Decree89.

Chapter I (Article 2) and Appendix I

Article 2

Specimen Import & Export

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)

Last content review/update: September 15, 2025

Import

As set forth in the MgmtInfctSpcmn, the Ministry of Health (MOH)’s General Department of Preventive Medicine (DPM) is responsible for regulating the transportation of infectious specimens.

According to Decree89, samples of medical microorganisms, biological products, tissues, and organs transported across the Vietnamese border must be medically declared (See Form No. 13 in the Decree89).

VNM-12 further states that an import license from the DPM is required only if the specimens are infectious. Decree155Amend requires that application dossiers for the import of infectious specimens include:

A written request for the grant of an import license
A copy of the competent agency’s approval permitting the implementation of a valid research project, a copy of the approved project proposal or project document, or a copy of the valid written agreement between domestic and foreign establishments regarding the import of specimens
A declaration regarding compliance with applicable biosafety standards

As delineated in Decree155Amend, establishments applying for import permits must submit their dossiers directly or by post to the MOH. If there is no request to amend or supplement the dossier, the MOH must grant the import license within 15 days from the date of receipt of the application. See Decree155Amend for additional information on import licensing procedures.

Export

Per VNM-12, no license is required for the export of specimens.

Chapter III (Article 11) and Appendix II

Article 15

Article 34 and Appendix (Form No. 13)

Consent for Specimen