Clinical Research Regulation For Malawi and Mexico

Last content review/update: October 7, 2025

Overview

In accordance with the PMRAAct, the Pharmacy and Medicines Regulatory Authority (PMRA) is responsible for reviewing and approving clinical trial applications for new drugs, generic drugs, and imported drugs to be registered in Malawi.

The R-HlthResCoord indicates that before submitting a clinical trial application to the PMRA, the sponsor or principal investigator (PI) must obtain full ethical approval from either of the two (2) National Commission for Science and Technology (NCST)-approved ethics committees (ECs)—the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC). Parallel submissions of a clinical trial application to an EC and the PMRA are prohibited.

As per the SciTechOrder, an NCST-issued license is required for research activities involving humans; research involving clinical trials; and research activities of multicentered research. The SciTechOrder does not specify whether the process of obtaining an NCST-issued license is separate from the NHSRC and COMREC approvals. See the Scope of Review section for information on NHSRC and COMREC approvals of the aforementioned research activities.

Clinical Trial Review Process

According to MWI-50, the PMRA receives clinical trial applications through the office of the Director General, and the applicant must submit evidence of ethical clearance from either the NHSRC or COMREC.

Per MWI-34, the guidance in the G-CTARevVacBiol and the G-CTAProcsVacBiol also apply to clinical trials of drugs. The G-CTARevVacBiol and the G-CTAProcsVacBiol indicate that upon receipt of a clinical trial application, the PMRA initially screens the application for completeness and assigns a PMRA reference number to the application. According to the G-CTARevVacBiol, the result of the screening will be communicated, and the screening form will be forwarded by fax, to the applicant. The applicant will forward any outstanding documents to the PMRA. The PMRA’s technical staff then reviews the application or may forward it to an expert, or to an evaluator for scientific review.

The G-CTAProcsVacBiol specifies that the application is evaluated by three (3) PMRA-appointed expert clinical trial reviewers who will provide a written report to the designated registration office, also known as the “Focal Point” division. The Focal Point will then collate and present the expert reviews to the PMRA Clinical Trial Review Committee (CTRC). The CTRC then reviews all the available documentation and provides a recommendation for approval or rejection. The PMRA considers the CTRC’s recommendation and issues a written approval or rejection.

MWI-50 further specifies that the PMRA may grant full or conditional approval depending on the nature of the CTRC’s findings. Depending on the study’s risk profile, the PMRA may conduct post-authorization good clinical practice (GCP) inspections for select clinical trials. Per the G-CTARevVacBiol, if the application is neither approved nor rejected, the PMRA’s technical staff will communicate its recommendation to the applicant. The response from the applicant will be considered at the PMRA’s subsequent scheduled meeting, and the subsequent decision will be communicated to the applicant. If changes must be made to the protocol, investigator’s brochure, or any other document, the amended document should be submitted with the applicant’s response.

The G-CTAProcsVacBiol states that the applicant may appeal a rejection decision, providing additional information, or amending the application to meet the PMRA’s requirements. The appeal will be referred to the CTRC for a final recommendation to the PMRA.

Per MWI-61, the PMRA may conduct GCP inspections during ongoing clinical trials to provide real-time assessment of the investigator’s conduct of the trial and protection of participants. Clinical trial sites may be inspected before regulatory approval, while the trial is ongoing, when participants are being enrolled in a trial, on a routine basis, when triggered by a complaint, or if there is a suspicion of serious non-compliance integrity issues and/or scientific/ethical misconduct. See MWI-61 for more information.

(See the Submission Process and Timeline of Review sections for details on the administrative and technical processing and review timelines. See also the G-CTARevVacBiol and the G-CTAProcsVacBiol for more information on the PMRA’s review procedures.)

2 and 3

1-6

Part II (Sections 4-5) and Part XIII (Section 131)

2.0 and 8.0-8.3

Last content review/update: October 31, 2025

Overview

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

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

Clinical Trial Review Process

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

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

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

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

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

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

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

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

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

Reliance Reviews

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

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

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

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

UHAP Evaluations

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

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

Inspections

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

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

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

9.2

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

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

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

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

Preamble, 1.3, 1.7, and 2

Requirements (9) and Additional Information

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

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

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

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

Article 177

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

7

4.2, 5.2, 6.3, 9.2, and 10.3

1-2

2.1-2.2

Regulatory Fees

Last content review/update: October 7, 2025

Pharmacy and Medicines Regulatory Authority

According to the PMRAAct, a person who intends to conduct a clinical trial must apply to the Pharmacy and Medicines Regulatory Authority (PMRA) for a clinical trial certificate upon payment of the prescribed fee.

Per the PMRAFeesRegs, the following fees apply to clinical trials:

Application, review, and registration: 5% of total budget
Annual renewal: $2,200 USD
Amendments: $300 USD

As delineated in the PMRAFeesRegs, a fee equaling 6% of the total invoice value must also be paid for the importation of unregistered medicines or allied substances from authorized sources. The G-ImpExpMP further indicates that this fee is subject to change from time to time.

Payment Instructions

No information is available regarding payment instructions.

National Commission for Science and Technology

No information is available regarding fees for the National Commission for Science and Technology (NCST).

3.3

Part VII (Section 75)

10 and 11

Last content review/update: October 31, 2025

Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)

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

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

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

For health permit authorization, the fees are as follows:

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

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

Payment Instructions

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

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

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

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

Costs

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

Requirements (4) and Costs

Costs

Requirements (10) and Costs

Requirements (2) and Costs

Ethics Committee

Last content review/update: October 7, 2025

Overview

Malawi has a centralized registration process for ethics committees (ECs) and EC review. As mandated by the SciTechAct, the National Commission for Science and Technology (NCST) is the governmental body responsible for EC oversight, and for the promotion and coordination of research in Malawi.

As per the G-NHSRC, the G-COMREC, and MWI-50, the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC) are the two (2) NCST-approved ECs responsible for monitoring and evaluating health research studies involving humans. Per the R-HlthResCoord, each EC has members representing the other committee in order to facilitate the transfer of information between the ECs. The NHSRC and COMREC report to and are centrally monitored by the NCST.

National Health Sciences Research Committee

The G-HlthResConduct and the R-HlthResCoord indicate that the NHSRC has the sole jurisdiction to review studies with a national interest and multicenter studies, as well as studies from all other researchers and institutions. As described in MWI-63, the NHSRC’s mandate is to promote, support, coordinate, and regulate research and development in the fields of infectious diseases, health systems, reproductive health, environmental health, nutrition, non-communicable diseases, social and behavioral research, trauma and rehabilitation, mental health, and other health related areas. It is responsible for the following functions in clinical trial regulations and authorizing/overseeing clinical trials:

Develop and review procedures, guidelines, and standards for the conduct of health-related research in Malawi
Advise the Malawian Government, including the Ministry of Health (MOH), on all scientific and ethical aspects of health-related research
Review and clear all research protocols in health and biomedical sciences fields, except those under COMREC’s jurisdiction
Offer guidance, in relation to each protocol, on the balance between the use of laboratories and expertise outside the country, and the import of techniques and equipment (including personnel) into the country upholding that all research specimens and materials must not be exported without permission from the NHSRC
Review and clear on behalf of the Malawian Government all materials originating from health-related research which is intended for publication within and outside Malawi except where these have already been cleared by COMREC
Offer a platform for the dissemination of health-related research results and exchange of best practices and experiences in health-related research

College of Medicine Research and Ethics Committee

The G-HlthResConduct and the R-HlthResCoord indicate that COMREC, as a subsidiary of the NHSRC, only reviews and approves studies involving or originating from College of Medicine (COM) or Kamuzu College of Nursing (KCN) (now known collectively as the Kamuzu University of Health Sciences (KUHeS), per MWI-62) faculty members and students, and their collaborators/coinvestigators/affiliates. Per MWI-40, COMREC’s functions include protecting the safety of human research participants by determining that the proposed research is both scientifically and ethically sound. COMREC’s responsibilities include the following:

Review and approve the science and ethics of proposed research and amendments to previously approved protocols
Annual continuing reviews of approved studies running for more than one (1) year
Follow the progress of studies until the termination of the research
Monitor and report to institutional or regulatory authorities any serious or continuing non-compliance with ethical standards
Recommend suspension or termination of approval of research not conducted in accordance with guidelines or that has been associated with unexpected serious harm to participants

As indicated in MWI-41, KUHeS is in the process of establishing the Kamuzu University of Health Sciences Research Committee (KUREC) to continue COMREC functions. The KUREC establishment is yet to be approved by the NCST. According to MWI-25, the COMREC guidance and forms provided in the Malawi profile are still being used. For more information including support services, see MWI-41.

Ethics Committee Composition

National Health Sciences Research Committee

As per the G-NHSRC, NHSRC must consist of members with varying backgrounds, including the social sciences, to promote complete and adequate research proposal review. The committee should include one (1) lay person, as well as members from the following organizations:

National Research Council of Malawi (one (1) member)
MOH headquarters (two (2) members)
COMREC (two (2) members)
Community Health Sciences Unit (one (1) member)
National AIDS Commission (one (1) member)
Center for Social Research (one (1) member)
Queen Elizabeth Central Hospital (one (1) member)
Zomba Central Hospital (one (1) member)
Lilongwe Central Hospital (one (1) member)
Christian Health Association of Malawi (one (1) member)
Mzuzu University (one (1) member)
Mzuzu Central Hospital (one (1) member)
Nurses and Midwives Council of Malawi (one (1) member)
Ministry of Justice (one (1) member)

The members elect the chairperson and the vice-chairperson.

College of Medicine Research and Ethics Committee

The G-COMREC specifies that COMREC should be multidisciplinary, and its members must have the basic qualifications, experience, and expertise to conduct fair scientific and ethical proposal reviews. The committee must have a maximum membership of 15, and include representatives from the biomedical sciences, research methods, behavioral science, and research ethics areas. Additionally, there must also be representatives from the NCST, the NHSRC, the KCN, and the lay community.

Furthermore, the committee must be diverse, have balanced gender representation, and embody community interests and concerns. Members are also required to sign a confidentiality agreement and refuse projects in which they have a conflict of interest. Members from the COM staff serving on the committee must be a minimum grade of senior lecturer, and preferably have peer reviewed publications.

See the G-NHSRC and the G-COMREC for additional EC membership criteria and qualification requirements.

Terms of Reference, Review Procedures, and Meeting Schedule

National Health Sciences Research Committee

The G-NHSRC states that the MOH’s Research Unit serves as a secretariat for NHSRC, and is responsible for preparing materials and meeting logistics. Research proposals must be distributed to NHSRC members two (2) weeks before the scheduled meetings to allow members time to adequately review the submitted proposals. Half of the NHSRC’s membership constitutes a quorum of any meeting, and the meeting is rescheduled within the following two (2) weeks if a quorum is not reached. Half of the ordinary quorum forms a quorum for the rescheduled meeting if no ordinary quorum is reached. Otherwise, the meeting must be rescheduled.

As delineated by the G-NHSRC, NHSRC decisions are reached by consensus. If there is no consensus, a decision is made by simple majority of members present through an open ballot. In the event of a tie, the chairperson casts a vote.

According to the G-NHSRC, when new NHSRC members have been appointed, they may attend the first one (1) or two (2) meetings as an observer in order to learn about the workings of the NHSRC before being assigned reviewer responsibility. Such members will undergo NHSRC orientation sessions covering guidelines and standard operating procedures (SOPs) of the committee and any practical matters with the secretariat and chairperson. Continuing education for all members in matters of health research ethics and related disciplines in human research protections is also essential, and the chairperson is responsible for fostering local and international networks, links, and partnerships for the purposes of continuing the NHSRC’s education and development.

Per the G-NHSRC, NHSRC members must serve on the committee for three (3) years and are required to renew their appointments if requested by their organizations. The G-NHSRC and the G-HlthResConduct also indicate that the NHSRC meets once every two (2) months.

College of Medicine Research and Ethics Committee

COMREC requires written SOPs to be maintained, and all relevant records (e.g., SOPs, reports, curriculum vitaes (CVs), meeting minutes, and correspondence) to be archived for three (3) years following the study’s completion, as delineated in the G-COMREC. The COMREC secretariat must compile all the relevant documents and materials required for review of a proposal and circulate them to the members at least 14 days before the date of the scheduled meeting. Quorum of any meeting is achieved when a majority of the members attend. The quorum should preferably include members of both genders, a member whose primary area of expertise is in a non-scientific area, and at least one (1) member who is independent of the COM. If the quorum cannot be achieved, the meeting must be rescheduled within two (2) weeks of the failed meeting. If the subsequent meeting does not achieve quorum, then the chairperson must make a decision based on the expertise and number of members present.

The G-COMREC further states that COMREC’s final decision will be reached through a consensus. If there is no consensus, a decision is made through a majority vote.

Per the G-COMREC, COMREC members must receive initial and continuing training regarding the ethics and science of research. The appointment of committee members is valid for three (3) years, and a member may be reappointed to serve another three (3) year term. According to the G-COMREC and the G-HlthResConduct, COMREC meets every month. To see the current list of members and the meeting schedule, see MWI-40.

Functions, COMREC Responsibilities, Submission Dates, and Support Services

Mandate and Terms of Reference

1.0, 2.0, 3.1-3.3, 4.0, 5.7-5.8, and 8.0

1 and 7

1.0, 3.1-3.3, and 4.0

Part IV

2.0 and 8.0

Last content review/update: October 31, 2025

Overview

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

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

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

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

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

Ethics Committee Composition

Research Ethics Committee Composition

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

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

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

Hospital Bioethics Committee Composition

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

Terms of Reference, Review Procedures, and Meeting Schedule

Research Ethics Committees

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

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

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

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

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

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

Hospital Bioethics Committees

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

9.2

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

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

2

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

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

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

Preamble, Fourth, Sixth-Tenth, and Twelfth

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

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

0-1 and 9

Scope of Review

Last content review/update: October 7, 2025

Overview

According to the G-NHSRC and the G-COMREC, the primary scope of information assessed by the two (2) National Commission for Science and Technology (NCST)-approved ethics committees (ECs)—the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC)—relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

The G-HlthResConduct states that scientific design; recruitment of research participants; care and protection of research participants; ethical consideration; and community consideration are essential elements that the NHSRC and COMREC must review in a clinical trial application. Per the G-NHSRC, the NHSRC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See the Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these populations).

The G-HlthResConduct and the R-HlthResCoord indicate that COMREC, as a subsidiary of NHSRC, only reviews and approves studies involving or originating from the College of Medicine (COM) or Kamuzu College of Nursing (KCN) (now known collectively as the Kamuzu University of Health Sciences (KUHeS), per MWI-62) faculty members and students, and their collaborators/coinvestigators/affiliates. The NHSRC has the sole jurisdiction to review studies with a national interest and multicenter studies, including those from COM and KCN, as well as studies from all other researchers and institutions.

Role in Clinical Trial Approval Process

The R-HlthResCoord indicates that before submitting a clinical trial application to the Pharmacy and Medicines Regulatory Authority (PMRA), the sponsor or principal investigator (PI) must obtain full ethical approval from either the NHSRC or COMREC. Parallel submissions of a clinical trial application to an EC and the PMRA are prohibited.

Moreover, as specified in the R-HlthResCoord, for all studies originating outside Malawi, the sponsor or the PI is required to obtain approval from an EC based in their country prior to submitting an application to the NHSRC or COMREC for ethical review and approval.

Per the G-NHSRC and the G-COMREC, the applicable EC will screen submitted applications for completeness, and help determine the type of review to be conducted.

Per the COMREC-Format, COMREC will send a written acknowledgement within two (2) weeks of receipt of the proposal. Following COMREC’s review, the results and comments from the Research Committee will be sent to the PI within two (2) weeks. This response will include how to proceed (e.g., resubmission or response for specific issues).

The G-NHSRC states that new studies submitted to the NHSRC are generally reviewed by a fully convened NHSRC meeting. The following studies will be reviewed by the full NHSRC:

All high-risk studies
Studies involving vulnerable populations (including pregnant women, prisoners, mentally incompetent patients, etc.)
Any clinical interventional study that randomly assigns human participants to alternative experimental or placebo groups
Studies involving sensitive information connected to personal identifiers
Studies previously reviewed that require major issues to be addressed

The G-NHSRC and the G-COMREC indicate that following the NHSRC’s or COMREC’s review, the EC will decide to approve the research, stipulate minor changes for approval, or not approve the research. A negative decision on an application must be supported by clearly stated reasons. In addition, the G-NHSRC states that if the NHSRC determines that substantive changes/clarifications must be made before approval may be granted, the study will be deferred for a full NHSRC meeting.

The G-COMREC specifies that the COMREC’s approval of a new application is valid for one (1) year. However, the R-HlthResCoord indicates that EC approval of a study is valid for the period of the study as described in the protocol, which is effective from the date of approval as indicated in the approval letter.

The R-HlthResCoord, the G-NHSRC, and the G-COMREC state that the EC must review and approve any protocol amendments prior to those changes being implemented. See MWI-52 and MWI-44 for the NHSRC and COMREC amendment request forms, respectively. Any changes cannot be implemented until approved by the EC.

The G-COMREC requires that COMREC follow the progress of studies for which a positive decision has been reached and establish a subcommittee responsible for monitoring ongoing studies. The follow-up review intervals are determined by the nature of the research project. However, each protocol should undergo a follow-up review at least once a year. As part of its monitoring process, COMREC conducts inspections of institutions and study sites.

Studies of National Interest

All studies of national interest, as defined in the G-NHSRC, the G-COMREC, and the R-HlthResCoord to include all vaccine trials and stem cell research, should be referred to the NHSRC, regardless of the origin of the protocol. The NHSRC may form a standing committee for that specific project, which will monitor the project through to its conclusion, composed of members to be drawn on the basis of their expertise.

Multicenter Studies

As delineated in the R-HlthResCoord, the NHSRC is designated and mandated to review and approve multicenter clinical trials, including those originating outside Malawi. The NHSRC will conduct a full initial review of the same protocols for a multicenter study submitted by different investigators provided that such protocols are submitted simultaneously. Protocols for the same multicenter trial to be implemented at different institutions may also be merged into one (1) protocol that the NHSRC will treat as a joint submission for review.

Continuing Review

According to the G-NHSRC and the G-COMREC, all approved studies running for more than one (1) year are subject to continuing annual review by the approving EC (the NHSRC or COMREC). If the materials for continuing EC review are not received within one (1) month following the expiration date of the previous approval, then the study will be classified as lapsed and inactive. If a study has lapsed, the EC will order that all study-related operations cease, except those necessary for the welfare of the participants. Per the G-NHSRC, if the PI wants to continue an NHSRC-reviewed study that has lapsed for two (2) months, the PI must submit a new application for NHSRC review and wait for approval before resuming research under the protocol. MWI-53 indicates that the NHSRC follows, at a minimum, the regulations set forth in the Declaration of Helsinki (MWI-42) and the Council for International Organizations of Medical Sciences (CIOMS) guidelines as the criteria for continuing review of a study. The PI is responsible for timely submission of a continuing review application to prevent any lapse in NHSRC approval. NHSRC regulations do not provide for exceptions to the requirement for continuing review. The NHSRC’s continuing review application form is available at MWI-53.

Expedited Review

Per the G-NHSRC and the G-COMREC, research studies that have previously been reviewed by a fully convened committee and require the PI to address minor issues, may be approved through the NHSRC’s or COMREC’s expedited processes. Studies by students may also be considered for expedited review. Expedited review can be considered for continuing review of research previously approved by the NHSRC or COMREC, where the research is permanently closed to the enrollment of new subjects, and all subjects have completed all research related interventions.

Per the G-COMREC, COMREC’s review period for such a resubmission must not exceed 14 days from the date of the resubmission. The G-NHSRC further indicates that the NHSRC will also consider expedited review for continuing review of research previously approved by NHSRC where no subjects have been enrolled and no additional risks have been identified, or where the remaining research activities are limited to data analysis and report writing.

For more information on each EC’s expedited review procedures, see the G-NHSRC and the G-COMREC.

Exemption from Review

As delineated in the G-NHSRC and the G-COMREC, certain types of human participants research may be exempted from NHSRC or COMREC review. Exemption may be considered for research involving the collection or study of existing data, documents, records, program evaluation, pathological specimens, or diagnostic specimens, if the sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

Suspension or Termination of Study/Approval

Per the G-NHSRC, the NHSRC chairperson or the convened NHSRC may suspend a study at any time if it is determined that the study requires further review or evaluation. This determination may be made in the event of an adverse event, non-compliance, or other danger to human participants. The study will be reviewed at the next convened meeting to determine if it requires changes. The NHSRC must notify the PI and the sponsor in writing specifying reasons for suspension or termination with a copy to the National Research Council of Malawi (NRCM). The NRCM must be informed of all the suspended or terminated studies with detailed reasons for the decision. In the event of documented serious adverse events and any unanticipated problems as documented by the researcher, the NHSRC must terminate the study and order the investigator to follow up with study participants. In the case of any officially or unofficially reported noncompliance, protocol violation, or deviation by the researcher, the NHSRC must suspend the study to ensure safety of the study participants and carry out an investigation. Upon investigation of the problem prompting the suspension of the study, the convened NHSRC must terminate the study if convinced beyond any reasonable doubt that there was noncompliance, deviation, or violation of the protocol.

The G-COMREC states that COMREC may recommend to COM management suspension or termination of approval of research that is not being conducted in accordance with the guidelines, or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval must include a statement of the reasons for COMREC's action and must be reported promptly to the investigator, appropriate institutional officials, Dean of Postgraduate Studies and Research, and the Principal of the COM. The Principal of the COM must then send a report of suspended or terminated studies with the reasons contained therein to the NCST and the PMRA, or any other government agency responsible for research policy matters.

4

1.0, 3.2, 3.3, 5.1, 5.4-5.9, 6.0, and 7.0

1, 7, and 9

1.0, 2.0, 3.1, 5.1-5.4, 5.7, 6.2, and 9.2

2.0, 6.0, 7.0, 7.2, 8.1-8.4, 8.6, and 9.0

Last content review/update: October 31, 2025

Overview

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

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

Role in Clinical Trial Approval Process

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

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

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

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

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

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

9.2

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

2

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

Requirements (9) and Additional Information

Title V (Chapter I, Article 100)

Article Four and Single Annex (Single Committee Form)

Preamble and Fifth

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

0, 6.3, 8.4, 9.2, and 10.3

Ethics Committee Fees

Last content review/update: October 7, 2025

National Health Sciences Research Committee

According to MWI-4 and MWI-15, non-Malawian researchers must pay $150 USD or its equivalent in Malawian Kwacha to the National Health Sciences Research Committee (NHSRC) upon submission of a research proposal. Malawian students (Masters and below) are required to pay 5000 Malawian Kwacha.

The G-NHSRC indicates that following the protocol’s approval, the principal investigator must also pay the Ministry of Health (MOH) a fee of 10% of the total budget indicated in the proposal to cover NHSRC institutional capacity strengthening and administrative operating expenses. MWI-15 further specifies that the fee, referred to as a 10% NHSRC Human Subject Protection (HSP) fee, must be paid by PhD students and above.

Payment Instructions

Per MWI-15, the application fee and the 10% HSP fee may be paid at the MOH Headquarters Cash Office or through the following bank details:

Account Name: NHSRC NCST Review Fees
Account Number: 1010759176
Bank Name: National Bank of Malawi
Bank Address: Capital City Branch, Lilongwe 3, Malawi
Swift Code: NBMAMWMW008

College of Medicine Research and Ethics Committee

Per MWI-1 and MWI-40 researchers must provide evidence of payment of $150 USD to the College of Medicine Research and Ethics Committee (COMREC) upon the submission of a research proposal. MWI-1 states that COMREC is also mandated to charge a College of Medicine (COM) fee of 10% of the total budget indicated in the proposal. The COM’s Dean of Postgraduate Studies and Research can grant waivers for the 10% fee.

However, the G-COMREC states that the COM’s processing fee is $100 USD for each new protocol submission and resubmission for the fourth time, and that eligible investigators may apply to management for exemption from paying the fee. The COMREC-Format also states that the PI must submit a $100 processing fee or its equivalent.

Payment Instructions

As indicated in MWI-43, the processing fee for ethics application submissions should be made at the following account, and the deposit slip emailed to comrec@medcol.mw:

Account Name: COMREC / College of Medicine
Account Number: 9100003028906
Name of Bank: Standard Bank
Name of Branch: Ginnery Corner; Current account
Swift Code: SBICMWMX

Ethics Applications/Submissions

4

3.3.10

8.0

Last content review/update: October 31, 2025

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

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

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

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

No information is available on Hospital Bioethics Committee fees.

2.7

4.2

Seventh, Ninth, and Eleventh

Oversight of Ethics Committees

Last content review/update: October 7, 2025

Overview

The R-HlthResCoord indicates that the National Commission for Science and Technology (NCST) is the central statutory body responsible for coordinating and regulating all research, science, and technology related activities in Malawi, as mandated by the SciTechAct.

The R-HlthResCoord further specifies that the NCST provides oversight to the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC). The NCST’s core responsibilities in this capacity include:

Participating as an ex-officio member for the NHSRC and COMREC by having a voting representative from the NCST sit on both committees
Reviewing and approving the ethics committees’ (EC) guidelines and standard operating procedures
Monitoring the ECs’ performance and adherence to relevant national policies, laws, regulations, and guidelines

Registration, Auditing, and Accreditation

As stated in the SciTechOrder, an NCST-issued license is required for the accreditation of research institutions and the establishment of an institutional EC. Additional information regarding the NCST-issued license is not available at this time.

Part IV

2.0 and 2.2

Last content review/update: October 31, 2025

Overview

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

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

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

Registration, Auditing, and Accreditation

Research Ethics Committees

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

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

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

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

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

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

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

Hospital Bioethics Committees

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

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

Preamble, Articles One-Three and Seven

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

5.3, 11, and Annex 4

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

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

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

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

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

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

4.8 and 9.1.4

Submission Process

Last content review/update: October 7, 2025

Overview

According to the G-CTARevVacBiol, the R-HlthResCoord, and MWI-50, the Pharmacy and Medicines Regulatory Authority (PMRA) requires the applicant to obtain PMRA approval and ethics committee (EC) approval of a clinical trial application.

The R-HlthResCoord indicates that before submitting a clinical trial application to the PMRA, the sponsor or principal investigator (PI) must obtain full ethical approval from either of the two (2) National Commission for Science and Technology (NCST)-approved ECs—the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC). Parallel submissions of a clinical trial application to an EC and the PMRA are prohibited.

Regulatory Submission

According to MWI-60, an electronic or soft copy of the clinical trial application dossier must be sent to the PMRA at registration@pmra.mw and info@pmra.mw.

As per the G-CTARevVacBiol and MWI-9, applicants must submit three (3) copies of the clinical trial application to the PMRA. MWI-60 further requires that the three (3) dossier hard copies be submitted in a lever arch file to the Director General. Each section of the dossier must be well demarcated for ease of reference by PMRA reviewers. The application may be made by a sponsor or the sponsor’s agent, who must submit a power of attorney (MWI-33) attesting to be a duly appointed agent.

There is no specified language requirement for the clinical trial documents to be submitted to the PMRA.

Ethics Review Submission

National Health Sciences Research Committee

As stated in the G-HlthResConduct and MWI-15, the applicant is required to bind and submit application materials (plus an electronic copy, per MWI-15) to the NHSRC at least three (3) weeks before the date of the review meeting.

MWI-15 states that applications should be submitted to the NHSRC at the following address:

The Chairperson
National Health Sciences Research Committee
Ministry of Health Research Department Area 2/124
P.O. Box 30377
Lilongwe 3, Malawi
Tel: +265 1 789 400

The electronic copy should be submitted at the same time to research@health.gov.mw and mohdoccentre@gmail.com.

MWI-15 indicates that three (3) copies of each item indicated in the NHSRC Checklist (MWI-4) must be submitted in the research proposal package to the NHSRC (See the Submission Content section for a list of these items). Three (3) copies for Malawian student proposals (up to master’s level) must also be submitted to the NHSRC secretariat for expedited review. The submission must be bound in the order indicated by MWI-4 as one (1) PDF document. (See the Submission Content section for more details on the individual elements of the NHSRC research proposal submission.)

According to MWI-15 and MWI-4, the data collection tools and informed consent forms must be provided to the NHSRC in both English and Chichewa (or the appropriate local language).

The R-HlthResCoord indicates that for multicenter trials, sponsors and PIs may plan to hold a pre-clinical trial submission and authorization meeting with the NHSRC, at their own choice and cost. The sponsor or PI must write to the NHSRC secretariat of the review committee to request the meeting’s arrangement at least four (4) weeks in advance of the suggested meeting date. For more information, see the R-HlthResCoord.

College of Medicine Research and Ethics Committee

Per the R-HlthResCoord, COMREC may at its own discretion allow a pre-clinical trial application procedure, where applicable, at the request and cost of the sponsor. As stated in the G-HlthResConduct, the applicant is required to submit application materials to COMREC at least three (3) weeks before the date of the review meeting. However, the COMREC-Format states that the PI must send copies of the proposal to the COMREC Secretary 30 days before the date of the meeting. Further, a letter from the respective department head(s) indicating that the research has the approval of the department(s) must be sent to the Secretariat with the proposal. Research affiliations must submit a supporting letter from the department head. To see the COMREC meeting schedule, see MWI-40.

As noted in the COMREC-Format, COMREC recognizes that different funding agencies may have different guidelines/format requirements. Where this is the case, the PI should prepare the proposal in the required format, provided that the format used gives all or most of the details as contained in COMREC’s guidelines. The PI must provide supportive evidence for the format used to the Secretariat. Otherwise, the proposed guidelines and format should be followed.

Per the COMREC-Format, the PI must prepare four (4) copies of the proposal. According to MWI-10, protocol submissions to COMREC may be made through the Research Ethics Information Management System (REIMS) (MWI-19). Following submission, the protocol will be reviewed, and feedback will be given through the applicant’s registered email address. All file attachments should be in PDF format with clear, descriptive names. Per MWI-19, ECs in Tanzania, Rwanda, and Kenya also participate in REIMS. See MWI-10 for more information on the REIMS submission portal.

MWI-19 provides the following additional contact information for COMREC:

Tel: +265 888 118 993
Email: comrec@medcol.mw

However, MWI-1 indicates that all documents should be submitted to COMREC by email to comrec@medcol.mw in one (1) PDF file, if the file size does not exceed 5MB. If the file size is over 5MB, then the file should be sent as a compressed zipped file. The data collection tools and informed consent forms must be provided in both English and Chichewa (or the appropriate local language).

4

3.2

1 and 8

2.0, 7.1, and 8.0-8.3

Last content review/update: October 31, 2025

Overview

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

Regulatory Submission

Pre-submission Registrations

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

DIGIPRiS Submissions

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

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

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

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

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

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

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

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

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

Enabled Pre-Assessment Support Unit (UHAP) Evaluation Submissions

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

Ethics Review Submission

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

9.2

Contact Information

Access with Electronic Signature of the SAT

Introduction and General Application Information

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

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

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

Requirements (1-2) and Additional Information

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

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

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

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

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

5.2, 6.3, and 9.2

Submission Content

Last content review/update: October 7, 2025

Regulatory Authority Requirements

As per the G-CTAProcsVacBiol, the G-CTARevVacBiol, and MWI-60, the following documentation must be submitted to the Pharmacy and Medicines Regulatory Authority (PMRA) in an application to conduct a clinical trial (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Comprehensive table of contents for the entire application, including a complete list of all documents provided in the application. The location of each document should be identified by tab identifiers. In general, the name for the tab identifier should be the name of the document
Cover letter signed by the principal investigator (PI) or sponsor
Proof of payment of the application and registration fees
Signed and stamped Clinical Trial Application (Form CT 8) (MWI-9)
Current version of the study protocol signed and dated by the sponsor and investigator (in the format provided in the International Council for Harmonisation’s (ICH) good clinical practice (GCP) guidelines and/or in line with Attachment 1 of MWI-60)
Investigator’s Brochure (IB), where applicable (in the format provided in the ICH GCP guidelines)
Certificate of Good Manufacturing Practice (GMP) of the investigational product (IP) (also referred to as an investigational medicinal product (IMP) in Malawi) and/or placebo, or evidence of manufacture quality, safety, and consistency
Mock-up labels for the IP
Blank case report forms (CRFs) and serious adverse events (SAEs) reporting form to be used in the study
Investigational Medicinal Product Dossier (IMPD) or alternative as provided in Attachment 2 of MWI-60
Stability data of the IP and auxiliary medicine(s) for climatic zone IVa if not registered in Malawi by the PMRA
Evidence of registration of the IP or auxiliary medicines in a country with Stringent Regulatory Authority (SRA) and/or Certificate of Pharmaceutical Product (CoPP), i.e., if IP/auxiliary medicines are not registered by the PMRA
Summary of Product Characteristics (SmPC) for IP and auxiliary medicines
Pharmacy plan
Report summaries of prior clinical trials with the IP (part of IB if it is in the ICH format)
Capacity building plans including training and updating of staff involved in the trial
Informed consent form (ICF) (in ICH format)
Declaration of intent by the national PI or contact person (MWI-31)
Signed and completed declaration by investigators (MWI-32)
Investigator(s) Curriculum Vitae(s) (CVs), including that of pharmacist(s)
Financial declaration by sponsor and PI (MWI-59)
Ethical clearance certificate from an independent ethics committee (EC) recognized by the laws of Malawi
Certified copy of clinical trial insurance for study participants endorsed by the National Commission for Science and Technology (NCST)
Malpractice insurance for investigators and associated staff endorsed by the NCST
Evidence of accreditation or equivalent of the designated laboratories (see the World Health Organization (WHO)’s guidance on Good Clinical Laboratory Practice (MWI-30))
Completed PMRA Material Transfer Agreement Form on Shipping of Samples (MWI-14)
Description of the site facilities (pictorial presentations may be included)
Evidence of registration of investigators with appropriate bodies
Evidence of registration of pharmacists with the PMRA
Evidence of GCP training by investigators and pharmacists in the last three (3) years
Batch release certificate
Authorization of the clinical trial from the country of origin, if applicable
Full, legible copies of key, peer-reviewed published articles supporting the application
Any other requirement as may be determined by the PMRA

If any of the above items are not submitted, justification must be provided. The application may be made by a sponsor or the sponsor’s agent, who must submit a power of attorney (MWI-33) attesting to be a duly appointed agent. See MWI-60 for more details. According to MWI-34, the guidance in the G-CTARevVacBiol and the G-CTAProcsVacBiol also apply to clinical trials of drugs.

Ethics Committee Requirements

National Health Sciences Research Committee

According to the G-NHSRC, MWI-4, and MWI-15, any proposals submitted to the National Health Sciences Research Committee (NHSRC) must be accompanied by the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

The NHSRC checklist (MWI-4)
Cover letter from the PI
The NHSRC application form (MWI-15)
Research proposal summary, maximum four (4) pages
Full/main research proposal (see the G-NHSRC, MWI-4, and MWI-15 for details)
Data collection instruments in both English and Chichewa (or other appropriate local language)
Informed consent in both English and Chichewa (or other appropriate local language)
Letter of approval from foreign EC, where applicable (for all students studying in foreign universities)
Support letters from affiliating institutions (e.g., universities, hospitals, research institutions, or companies where the study is going to take place)
A copy of the receipt for the paid application fee
CVs for all the investigators
Proof of funding from the sponsor/funder (where applicable)

MWI-4 requires that if any of the above items are not included in the submission to the NHSRC, an explanation must be provided.

College of Medicine Research and Ethics Committee

The COMREC-Format, MWI-1, and MWI-40 indicate that for submissions to the College of Medicine Research and Ethics Committee (COMREC), a single PDF file should include the following information (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Completed copy of the COMREC checklist (MWI-1)
Cover letter from the PI
Protocol according to COMREC’s format (COMREC-Format)
ICFs in both English and Chichewa for adult participants ages 18 and above, parental consent forms for all minors, and assent forms (in addition to the parental consent forms) for all minors between the ages of 7 and 17 (template provided at MWI-56)
Data collection tools (those that will involve obtaining information from research participants should be translated into Chichewa)
Material transfer agreement forms and documents
Proof of payment of the processing fee
Waiver letter for the 10% College of Medicine (COM) overhead fee, if applicable
Information regarding whether the research proposal has been submitted to another EC
Letter of support from COM head of the principal department hosting the research
Letter(s) of support from heads of all other departments and institutions in which any research work will be done
Evidence of current active registration with the Medical Council of Malawi for the PI and other investigators
A copy of a brief CV of each of the investigators (one (1) copy of each), except those which have been submitted within the same academic year
Certificate of GCP/human participant protection

For re-submissions, MWI-40 indicates that all the documents listed above plus the following additional documents should be submitted:

Introduction letter explaining how queries were resolved
Revised protocol with tracked/highlighted changes
Revised protocol with accepted changes/clean version

For amendments, MWI-40 provides that the following documents should be submitted to COMREC:

Cover Letter
Amendment form (MWI-44)
Revised protocol with tracked/highlighted changes
Revised protocol with accepted changes/clean version

MWI-1 further indicates that the proposal should not be submitted unless every item on the checklist is included, or unless a reason can be provided for the absence of any item. The completed checklist must be attached to the front of the submission. See the G-COMREC and MWI-1 for more information.

Clinical Protocol

As delineated in the G-CTAProcsVacBiol, the clinical protocol should comply with the format provided in the ICH's GCP guidelines. Per MWI-25, clinical trials in Malawi are required to follow the ICH's Guideline for Good Clinical Practice E6(R2) (MWI-22). In addition, MWI-60 provides recommended items to address in a clinical trial protocol and related documents, based on SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidance.

In addition, per the G-HlthResConduct, MWI-60, and MWI-22, the following elements should be included in the protocol (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Cover page
General information (protocol title, identifying number, and date; registry name; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study, along with role responsibilities)
Protocol summary/abstract
Background and justification
Investigator(s) CV(s) and contact information
IP description (See the Investigational Products topic for detailed coverage of this subject)
Form, dosage, route, method, and frequency of administration and treatment period
Summary of potential risks and known benefits to research participants
Hypothesis
Trial objectives and purpose
Study setting
Trial design, random selection method, and blinding level
Work plan/Gantt chart
Participant selection/withdrawal, timeline, and sample size
Participant treatment
Safety and efficacy assessments
Literature review
Adverse event reporting requirements (See the Safety Reporting section for additional information)
Statistics and methods to track trial data
Sponsor specifications for direct access to source data/documents
Quality control/quality assurance procedures and practices
Data monitoring, including composition of a data monitoring committee, and auditing
Ethical considerations, including confidentiality, and plans for seeking EC approval
Plans for communicating important protocol modifications to relevant parties
Data management and recordkeeping
Dissemination of findings
Financing and insurance details
Publication policy
Consent form, and information on who will obtain consent
Plans for collection, laboratory evaluation, and storage of biological specimens

For more detailed protocol requirements and recommendations, refer to MWI-60, MWI-22, and the G-HlthResConduct.

Per the COMREC-Format and MWI-1, COMREC recommends that a proposal (i.e., the protocol) involving COMREC staff 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):

Title
Full names, qualifications, and academic titles of all investigators and their trainees; the PI should be listed first, co-investigators should be indicated, and brief up-to-date CVs of each investigator should be provided
Institution(s) under whose umbrella the research project will be conducted
Executive summary, not to exceed one (1) and half pages
Background information and introduction
Rationale/justification for the research project
Objectives of the study
A detailed methodology, including the type of study, study place, study population, study period, sample size, data collection, data management and analysis, results presentation, and dissemination of the results
Ethical considerations
Possible constraints and how these will be addressed, by whom and when
Requirements for conducting the research, such as personnel, sites, material, equipment, and transportation
Budgetary estimates with each line item quantified in monetary terms
Training provided for study staff
References

See the COMREC-Format and MWI-1 for more details on each of these proposal components.

6

3

5.0

1, 2, 3.2, and Screening Form

7 (Checklist of Required Documents)

5 and 7

5.1

Last content review/update: October 31, 2025

Regulatory Authority Requirements

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

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

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

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

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

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

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

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

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

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

Ethics Committee Requirements

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

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

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

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

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

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

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

See Agrmnt_ResProtProcs for detailed requirements.

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

Clinical Protocol

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

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

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

2-10

6. Clinical Trial Protocol and Protocol Amendment(s)

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

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

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

Requirements

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

6.1-6.3

Timeline of Review

Last content review/update: October 7, 2025

Overview

As stated in the R-HlthResCoord, one (1) of the two (2) government approved ethics committees (ECs), the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC), must review and approve a clinical trial application prior to the Pharmacy and Medicines Regulatory Authority (PMRA) initiating its review and approval process. Parallel submissions of a clinical trial application to an EC and the PMRA are prohibited.

Regulatory Authority Approval

According to the G-CTARevVacBiol, the PMRA review process takes approximately six (6) weeks.

As per the G-CTARevVacBiol and the G-CTAProcsVacBiol, once the dossier is submitted to the PMRA, the application is screened for completeness. According to the G-CTARevVacBiol, the result of the screening will be communicated to the applicant within 10 working days after receipt of the application, and the screening form will be forwarded by fax. The applicant will have 10 working days to forward any outstanding documents to the PMRA. The PMRA’s technical staff then reviews the application or may forward it to an expert or evaluator for scientific review, with an allocated review period of three (3) weeks.

However, the G-CTAProcsVacBiol specifies that the application is evaluated by three (3) PMRA-appointed expert clinical trial reviewers who will provide a written report within 14 days to the designated registration office, also known as the “Focal Point” division. The Focal Point will then collate and present the expert reviews to the PMRA Clinical Trial Review Committee (CTRC). The CTRC then reviews all the available documentation and provides a recommendation for approval or rejection. The PMRA considers the CTRC’s recommendation and issues a written approval or rejection. (Per MWI-34, the guidance in the G-CTARevVacBiol and the G-CTAProcsVacBiol also apply to clinical trials of drugs.)

As stated in the G-ImpExpMP, the PMRA’s processing time for an import permit application is 10 working days.

Ethics Committee Approval

National Health Sciences Research Committee

The G-NHSRC indicates that in the case of an approval with no changes, the chairperson must inform the investigator in writing within seven (7) days. The NHSRC’s timeline for review of research proposals is not otherwise specified in the requirements.

College of Medicine Research and Ethics Committee

According to the G-COMREC, COMREC must ensure that submitted complete proposals are reviewed in a timely manner, i.e., within the month of submission. Per the G-COMREC and the COMREC-Format, a written decision is provided to the applicant within two (2) weeks of the meeting at which the decision was made.

4

5.1 and 5.9

3.5

1-3

2-6

5.4

7.0, 7.2, 8.0-8.2

Last content review/update: October 31, 2025

Overview

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

Regulatory Authority Approval

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

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

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

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

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

Enabled Pre-Assessment Support Unit (UHAP) Evaluations

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

Ethics Committee Approval

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

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

9.2

10

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

Term

3.3, 6.2, 8.1, and 8.2

Requirements (9), Term, and Additional Information

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

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

Title VI (Chapter IV, Article 196)

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

5.2, 6.3, 9.2, and 10.3

Initiation, Agreements & Registration

Last content review/update: October 7, 2025

Overview

According to the G-CTARevVacBiol, the R-HlthResCoord, and MWI-50, the Pharmacy and Medicines Regulatory Authority (PMRA) requires the applicant to obtain PMRA approval and ethics committee (EC) approval before initiating a clinical trial.

The R-HlthResCoord indicates that before submitting a clinical trial application to the PMRA, the sponsor or principal investigator (PI) must obtain full ethical approval from either of the two (2) National Commission for Science and Technology (NCST)-approved ECs—the National Health Sciences Research Committee (NHSRC) or the College of Medicine Research and Ethics Committee (COMREC).

In addition, as per the D-ImprtRelIMPs, the sponsor should not supply the investigational product (IP) to be used in the clinical trial until the sponsor obtains all required documentation. As stated in the G-ImpExpMP, IP import permit applications should be made by the pharmacist of record for the trial. (See the Manufacturing & Import section for additional information.)

Clinical Trial Agreement

The G-CTAProcsVacBiol requires the sponsor to sign a letter of agreement with the participating institution(s) before the trial begins. In addition, the investigators and the sponsor or the contract research organization must sign an agreement specific to the clinical trial.

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 indicates that the sponsor should obtain the investigator’s/institution’s agreement to:

Conduct the trial in compliance with good clinical practice (GCP), with the applicable regulatory requirement(s), and with the approved protocol
Comply with procedures for data recording/reporting
Permit monitoring, auditing, and inspection
Retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

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

Clinical Trial Registration

No clinical trials registry exists at this time and there is no stated requirement to register in an international registry.

Governance

For proposals subject to COMREC review, the COMREC-Format states that all research proposals, including resubmissions, must be submitted through and endorsed by the respective department head(s), with supporting letters from the department and affiliated institutions where applicable. The department head acts as the formal channel for submissions, ensuring departmental approval before proposals reach the Secretariat.

5.6

4

3

3.7

1, 3.2, and Screening Form

7 (Checklist of Required Documents (Appendices 1, 8, and 10) and CTA Sections 4 and 8)

8.0-8.2

Last content review/update: October 31, 2025

Overview

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

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

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

Clinical Trial Agreement

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

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

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

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

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

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

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

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

Clinical Trial Registration

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

Governance

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

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

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

2, 4.1, 4.5, and 9.2

4.9, 5.6, and 5.9

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

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

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

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

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

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

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

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

7.4

5.2, 6.3, 7.4, and 9.1-9.2

Safety Reporting

Last content review/update: October 7, 2025

Safety Reporting Definitions

In accordance with the G-SAEs-PMRA, the following definitions provide a basis for a common understanding of Malawi’s safety reporting requirements:

Adverse Event (AE) – Any AE associated with the use of a medicine in humans, and which does not necessarily bear a causal relationship to the treatment. This may include an AE occurring in the following circumstances: during use in professional practice; from an overdose, whether accidental or intentional; from drug abuse; from drug withdrawal; and as a result of any failure of expected pharmacological action.
Adverse Drug Reaction (ADR) – A reaction characterized by the suspicion of a causal relationship between the drug and the occurrence.
Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – An adverse experience occurring at any dose that results in death, is life-threatening, requires or extends patient hospitalization, results in persistent or significant disability, is a birth defect or congenital anomaly; or is an important medical event that, based upon appropriate medical judgment, may jeopardize the participant, and may require intervention to prevent one (1) of the listed outcomes.

Safety Reporting Requirements

As stated in the G-SAEs-PMRA, the sponsor or the investigator(s) is required to report all SAEs that meet the Pharmacy and Medicines Regulatory Authority (PMRA)’s reporting requirements as soon as possible (within 24-72 hours) following site awareness using the SAE Form (MWI-12). All deaths that are assessed as definitely, probably, or possibly related must be reported to the PMRA within 24 hours of site awareness, and the SAE Form (MWI-12) must be submitted within three (3) working days of site awareness. See the G-SAEs-PMRA for additional details on reporting timelines for different reportable SAE situations.

The G-NHSRC indicates that the National Health Sciences Research Committee (NHSRC) requires the investigator to submit a written report for any occurrence of an AE. In the event of documented SAEs and any unanticipated problems as documented by the researcher, the NHSRC must terminate the study and order the investigator to follow up with study participants. Per the G-COMREC, AE and SAE reports must also be submitted to the College of Medicine Research and Ethics Committee (COMREC).

Form Completion & Delivery Requirements

As per the G-SAEs-PMRA, all SAEs that meet reporting requirements must be reported to the PMRA on an SAE Form (MWI-12). The G-SAEs-PMRA indicates that the form must be submitted to the PMRA office by email or hand delivered to the offices at the following address:

The Director General
Pharmacy and Medicines Regulatory Authority
P.O. Box 30241
Lilongwe 3, Malawi
Tel: 265-1755166/165
Email: info@pmra.mw, registration@pmra.mw

According to the G-NHSRC, AE reports submitted to the NHSRC must provide the following details:

Title of protocol
NHSRC assigned reference number
Name of investigator
Local affiliating institution for studies originating from outside Malawi
Subject identifier
Date and site/place of event
Description of event (i.e., nature of injury or other adverse occurrence, assessment of severity, and assessment of relationship of the event to the study)
Action taken by the researcher
Signature of the principal investigator (PI)

See MWI-2 for the NHSRC SAE Reporting Form.

6.0

1 and 2

5.7-5.8

Last content review/update: October 31, 2025

Safety Reporting Definitions

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

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

Safety Reporting Requirements

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

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

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

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

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

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

Investigator Responsibilities

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

Other Safety Reports

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

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

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

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

Form Completion & Delivery Requirements

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

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

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

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

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

3.6

2-6

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

1-5

Title III (Chapter I (Article 64))

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

8.1.2, 8.1.11, and 8.2.1-8.2.10

4.5, 8.7-8.10, and 10.9

Progress Reporting

Last content review/update: October 7, 2025

Interim and Annual Progress Reports

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 notes that the investigator should promptly provide written reports to the sponsor and the institutional ethics committee (EC) on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

According to the G-NHSRC, the National Health Sciences Research Committee (NHSRC) requires an initial submission of a progress report within three (3) months of approval of the study, and an annual report for medium to long-term studies.

The G-COMREC requires that the College of Medicine Research and Ethics Committee (COMREC) follow the progress of studies for which a positive decision has been reached and establish a subcommittee responsible for monitoring ongoing studies. As part of the monitoring process, every approved study must submit annual reports by November 30, regardless of the date of its approval.

As required in MWI-58, the principal investigator (PI) must submit an annual progress report to the Pharmacy and Medicines Regulatory Authority (PMRA). All sections of the Clinical Trial Annual Progress Reporting Form for Investigators (MWI-58) must be completed in typescript and submitted together with accompanying documents to the PMRA Director General at info@pmra.mw. Both hard and soft (electronic) copies must be submitted.

The G-NHSRC and the G-COMREC further state that all approved studies continuing for more than one (1) year are subject to continuing review by the approving EC. As part of this review, applicant(s) are required to submit a progress report describing the number of participants enrolled, any problems that occurred during the prior approval period, any new knowledge regarding the study, and any procedural changes.

See MWI-54 and MWI-8 for the NHSRC and COMREC report forms, respectively.

Final Report

As required by the G-NHSRC and the G-COMREC, the applicant is required to submit a final report to the approving EC when a study is completed.

According to the G-NHSRC, the investigator must submit three (3) copies of the final technical report when submitting written notice of the completion of the study to NHSRC.

Other Considerations

The G-NHSRC states that all data originating from a research study conducted in Malawi are the property of the Malawi Government irrespective of the source of funds for carrying out the study. Therefore, investigators are required to submit copies of their reports to NHSRC for review prior to submitting for publication within or outside of Malawi. Investigators are expected to have plans for disseminating research findings in Malawi.

4.10 and 4.13

5.5 and 6.0

5.1, 5.6, and 11

Last content review/update: October 31, 2025

Interim and Annual Progress Reports

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

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

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

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

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

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

Final Report

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

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

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

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

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

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

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

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

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

Definition of Sponsor

Last content review/update: October 7, 2025

As per the D-ImprtRelIMPs and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22), a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. Per MWI-25, clinical trials in Malawi are required to follow MWI-22. MWI-22 goes on to specify that a sponsor-investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

In accordance with MWI-22, a sponsor may transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

A sponsor may be domestic or foreign. As specified in the R-HlthResCoord, a sponsor that is a foreign company, organization, or individual(s), must first be affiliated with a local Malawian institution that is recognized by the National Commission for Science and Technology (NCST) prior to commencing any operations in the country.

1.53, 1.54, 5.1, and 5.2

7

10.0

Last content review/update: October 31, 2025

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

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

4.1

1.53 and 5.2

1.5-1.6, 4.1-4.2, and 4.15

4.18

Site/Investigator Selection

Last content review/update: October 7, 2025

Overview

The G-CTAProcsVacBiol specifies that the investigator(s) must be qualified, experienced, and have specific good clinical practice (GCP) training. The principal investigator (PI) should have acted as a sub-investigator in at least one (1) prior clinical study. The investigator must also commit to complying with the clinical trial protocol, have no conflicts of interest, and have no history of GCP noncompliance.

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 provides the following guidance to sponsors on investigator and site selection:

The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected. If the organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicenter trials, their organization and/or selection are the sponsor’s responsibility.
Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator’s Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.

As stated in the G-CTAProcsVacBiol, all clinical trials must also be conducted in a laboratory that can provide evidence of accreditation with a recognized control authority to conduct the specified test. In the absence of an accreditation authority, proof of Good Laboratory Practice compliance and validation of assay methods should be provided.

Foreign Sponsor Responsibilities

According to the G-NHSRC, foreign researchers must be affiliated with a local institution and provide a supporting letter from the institution as evidence. Additionally, they must have a local collaborator. The R-HlthResCoord further indicates that any foreign-based institution or organization must first be affiliated with a local Malawian institution that is recognized by the National Commission for Science and Technology (NCST) prior to commencing any operations in the country.

Data and Safety Monitoring Board

Although not specified as a sponsor requirement, the G-CTAProcsVacBiol states that a Data Safety Monitoring Board (DSMB) or a similar body must be established and empowered to regularly assess the trial and to recommend a pause or termination of the trial for safety reasons. MWI-22 notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Multicenter Studies

As delineated in MWI-22, in the event of a multicenter clinical trial, the sponsor must ensure that:

All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and given ethics committee (EC) 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 among investigators is facilitated

1.25, 5.5, 5.6, and 5.23

7 (Checklist of Required Documents (Appendices 8 and 10) and CTA Sections 4 and 8)

5.1

10

Last content review/update: October 31, 2025

Overview

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

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

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

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

Foreign Sponsor Responsibilities

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

Data Safety Monitoring Board

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

Multicenter Studies

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

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

4.6, 7.2-7.3, and 8.2

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

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

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

Requirements (5-6), and Additional Information

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

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

10.1

0-2

Insurance & Compensation

Last content review/update: October 7, 2025

Insurance

As set forth in the G-CTInsurance-MWI, the G-CTAProcsVacBiol, the G-CTARevVacBiol, and the G-COMREC, the sponsor or the investigator(s) are responsible for providing insurance coverage for any unforeseen injury to research participants. Before a clinical trial begins, the sponsor should also provide insurance or indemnify the investigator and the institution against claims arising from malpractice or negligence. See the G-CTInsurance-MWI, the G-CTAProcsVacBiol, the G-CTARevVacBiol, and the G-COMREC for detailed information on when insurance is required.

As per the G-CTInsurance-MWI, the sponsor or the investigator(s) must provide the participants with a no-fault insurance policy and certificate for the duration of the trial, and for five (5) years following the trial’s completion. “No-fault” is defined as insurance for which proof of negligence or other wrongful conduct need not be established. However, the causal connection between the trial and harm, bodily injury, or death must be proven to trigger the obligation to make a compensation payment. The National Health Sciences Research Committee (NHSRC), the College of Medicine Research and Ethics Committee (COMREC), or the Pharmacy and Medicines Regulatory Authority (PMRA)'s Clinical Trial Review Committee are responsible for determining which clinical trials fall within the scope of this requirement.

Per the G-CTInsurance-MWI, obtaining and submitting insurance is a requirement and a prerequisite to obtaining clinical trial ethics and regulatory approval. The insurance documentation must be included as part of the application package submitted to either the NHSRC or COMREC, and the PMRA. As specified in the G-CTAProcsVacBiol, the sponsor or the investigator(s) must also comply with the insurance and compensation requirements delineated in the Association of the British Pharmaceutical Industry’s guidelines (MWI-21 and MWI-20).

The PMRA’s Indemnity Form for Conducting Clinical Trials (Form CT 10) is available at MWI-18.

Compensation

Injury or Death

As specified in the G-CTInsurance-MWI, the G-CTAProcsVacBiol, and the G-COMREC, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

As per the G-CTAProcsVacBiol, the sponsor must follow the principles set forth in the Association of the British Pharmaceutical Industry’s guidelines (MWI-21 and MWI-20) to comply with Malawi’s participant compensation and treatment requirements due to trial-related injuries. The guidelines state that the sponsor should furnish written assurance to the investigator that the sponsor will agree to pay compensation to participants and/or the legal heirs in the event of trial-related injuries or death. The investigator, in turn, communicates this information to the relevant ethics committees (ECs).

MWI-21 provides several basic principles to guide sponsors in fulfilling their compensation obligations. Compensation should be paid as follows:

When it can be demonstrated that a causal relationship exists between a participant’s injury and participation in a trial
When a child is injured in utero through participation by the child’s mother in a clinical trial
When the injury results in permanent injury or disability to the participant
When there is an adverse reaction to a medicinal product under trial, and injury is caused by a procedure adopted to deal with that adverse reaction

MWI-21 states that the likelihood of an adverse reaction, or the fact that the participant has freely consented (whether in writing or otherwise) to participate in the trial should not exclude the participant from being eligible for compensation. The amount of compensation paid to the participant should be appropriate to the nature, severity, and persistence of the injury. The compensation should also be generally consistent with the amount of damages commonly awarded for similar injuries.

According to MWI-21, the amount paid in compensation should be abated, or in certain circumstances excluded, in light of the following factors (which will depend on the risk level the participant can reasonably be expected to accept):

The seriousness of the disease being treated
The degree of probability that adverse reactions will occur and any warning given
The risks and benefits of the established treatments relative to those known or suspected of the trial medicines

Per MWI-21, in any case where the sponsor agrees to pay the participant, but the two (2) parties differ on what is the appropriate level of compensation, it is recommended that the sponsor agree to seek the opinion of a mutually acceptable independent expert at the sponsor’s own cost. This opinion should then be made available to the participant(s), and the expert’s opinion should be given substantial weight by the sponsor in reaching a decision on the payment amount.

Additionally, any participant claims pursuant to MWI-21, should be made to the sponsor, preferably via the investigator. The participant should include details on the nature and background of the claim, which the sponsor should review expeditiously. The review process may be delayed if the participant requests an authority to examine any medical records relevant to the claim.

Trial Participation

Per G-BioSampCompense, participants may also be reimbursed for trial-related expenses, if allowed by the EC. However, payments to participants that are construed to affect their voluntary participation are not allowed. Furthermore, lump sum payments for research participation are not allowed. Participants who incur direct costs from trial participation must be reimbursed if required by the EC. Such reimbursable expenses include travel and communications costs associated with routine clinical trial evaluations. During review of the protocol, the EC will make a case-by-case determination if the study should provide any form of acceptable recompense.

3 and 4

4.8 and 5.8

(b)(ii) and (b)(iii)

9.0

1, 2, 3.2, and Screening Form

7 (Checklist of Required Documents (Appendix 9), CTA Section 5, CTA Section 9, and Check of Appended Documents (Appendix 9))

1.0-3.0 and 7.0

Last content review/update: October 31, 2025

Insurance

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

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

Compensation

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

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

Injury or Death

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

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

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

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

Trial Participation

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

4.3

3.1 and 5.8

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

Preamble, 4.1, 4.8, and 4.13-4.14

Title V (Chapter I, Article 100)

Article Five

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

5.14 and 7.2

Risk & Quality Management

Last content review/update: October 7, 2025

Quality Assurance/Quality Control

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 guides sponsors on quality, data, and records management.

Per MWI-22, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

During protocol development, identification of processes and data that are critical to ensure participant protection and the reliability of trial results
Identification of risks to critical trial processes and data
Evaluation of the identified risks against existing risk controls
Decisions on which risks to reduce and/or which risks to accept
Documentation of quality management activities and communication to those involved in or affected by these activities
Periodic review of risk control measures to ascertain whether the implemented quality management activities are effective and relevant
In the clinical study report, a description of the quality management approach implemented in the trial and a summary of important deviations from the predefined quality tolerance limits and remedial actions taken

Monitoring Requirements

As part of its quality assurance system, the G-CTAProcsVacBiol notes that the sponsor should perform a clinical trial audit. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, standard operating procedures (SOPs), and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with the sponsor’s own SOPs, the auditor observations are documented, and data are available as needed for the Pharmacy and Medicines Regulatory Authority (PMRA) to review. No specific timeframe is provided for the audit process.

Per MWI-22, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Per MWI-61, the PMRA may conduct good clinical practice (GCP) inspections of clinical trial sites before regulatory approval, while the trial is ongoing, when participants are being enrolled in a trial, on a routine basis, when triggered by a complaint, or if there is a suspicion of serious non-compliance integrity issues and/or scientific/ethical misconduct. In general, the inspectee will be notified one (1) to four (4) weeks prior to the proposed announced inspection date and asked to confirm availability. The notification will identify the study and the proposed sites to be inspected. In relation to triggered inspections, the PMRA may provide a shorter notice period. The inspection dates will be confirmed with the inspectee, who may be required to submit information to the PMRA within 14 days of the receipt of the notice of GCP inspection. The inspection plan is finalized by the PMRA before the inspection. See MWI-61 for more information on PMRA GCP inspections.

Premature Study Termination/Suspension

According to MWI-22, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the ethics committee (EC) should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor. Refer to MWI-17 for the National Health Sciences Research Committee (NHSRC)’s protocol termination form.

The G-COMREC states that if a study is prematurely suspended/terminated, the applicant should notify the College of Medicine Research and Ethics Committee (COMREC) of the reasons for suspension/termination, and a summary of the results obtained should be communicated to the committee.

4.0 and 6.2-6.3

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

6.0

7 (CTA Section 8)

Last content review/update: October 31, 2025

Quality Assurance/Quality Control

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

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

Monitoring Requirements

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

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

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

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

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

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

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

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

Premature Study Termination/Suspension

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

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

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

4.2 and 7

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

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

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

Title V (Chapter I, Article 100)

Article Two and Single Annex (Single Sponsor Form)

Title III (Chapter I, Article 64)

7.5

7.2, 8.7-8.8, 9.2, and 10.5

Data & Records Management

Last content review/update: October 7, 2025

Electronic Data Processing System

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). As per MWI-22, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to MWI-22 for additional information.

Records Management

As set forth in MWI-22, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, MWI-22 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

According to MWI-15, consent forms must be kept for three (3) years after the completion of the investigation, unless otherwise stipulated by the National Health Sciences Research Committee (NHSRC).

1.65, 5.5, and 8

Last content review/update: October 31, 2025

Electronic Data Processing System

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

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

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

See MEX-32 for additional data processing requirements.

Records Management

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

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

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

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

4.9, 5.5, and 8

3.7 and 4.1

4.1, 5.1, and 5.2

5.4

Personal Data Protection

Last content review/update: October 7, 2025

Responsible Parties

For the purposes of data protection requirements, as stated in the G-DataPrtct-MWI, the data controller means a natural or legal person who, alone or jointly with another natural or legal person, determines the purpose and means of processing personal data. The data processor means a natural or legal person who processes personal data on behalf of a data controller. The Malawi Communications Regulatory Authority (MACRA) regulates the processing of personal data and is responsible for the enforcement of the G-DataPrtct-MWI.

Data Protection

A data controller and data processor must process personal data lawfully, fairly, and in a transparent manner, as described in the G-DataPrtct-MWI. Additionally, a data controller and data processor must collect personal data for a specific and legitimate purpose and must not process the data in a manner that is incompatible with the purpose for which it was collected. They also must not store personal data for a period that is longer than necessary to achieve the purpose for which the data is processed, except where the data is stored for the purpose of archiving for public interest or for research or statistical purposes. The appropriate technical or organizational security measures must be implemented to guarantee the security of personal data, including protection against unauthorized or unlawful processing and accidental loss, destruction, or damage of the data.

See the G-DataPrtct-MWI and MWI-64 for more details on the duties of a data controller and data processor.

Consent for Processing Personal Data

The G-DataPrtct-MWI indicates that a data controller must obtain the consent of a data subject before processing the personal data of the data subject. Where a data controller seeks consent from a data subject on several matters in the form of a written declaration, each matter on which consent is sought must be presented in a clearly distinguishable manner. A data subject may, at any time, withdraw consent given to a data controller and the withdrawal of the consent shall, where practicable, be in the same manner the consent was provided. The withdrawal must not affect the legality of the data processing that occurred before the withdrawal of the consent. Where a question arises on whether consent was freely provided, consideration must be taken of whether the performance of a contract between the data controller and the data subject, or the delivery of a good or a service by the data controller to the data subject, is conditional on provision of the consent.

According to the G-DataPrtct-MWI, a data controller must, at the time of collecting personal data from a data subject, provide the following information to the data subject:

The identity and contact details of the data controller or representative of the data controller
The legal basis for processing the personal data
The purpose for processing the personal data
Where possible, the storage period for the personal data
The existence of automated decision-making, including profiling
The rights of the data subject provided in the G-DataPrtct-MWI (described below)
The right to lodge a complaint with the MACRA
Whether the data controller intends to transfer the personal data to a place outside Malawi

As per the G-DataPrtct-MWI, a data subject has the right to obtain confirmation of whether personal data concerning the data subject is being processed by the data controller or data processor. Where the data controller or data processor confirms the processing of the personal data of the data subject, the data controller or data processor must provide the data subject with a copy of the personal data being processed (i) in a commonly used electronic format; (ii) within 30 days of receipt of the request; and (iii) where practicable, at no expense to the data subject. The data subject also has a right to data portability, rectification of personal data, erasure of personal data, restriction of processing personal data, object to the processing of personal data, and not to be subject to a decision based solely on automated processing. See the G-DataPrtct-MWI for more information on these rights.

Children and Incapacitated Persons

The G-DataPrtct-MWI delineates that where a data subject is a child or any other natural person lacking the legal capacity to exercise the rights of the data subject, a parent or legal representative/guardian of the data subject must exercise the rights of the data subject on behalf of the data subject. A data controller or data processor who intends to process personal data of a data subject who is a child or any other natural person lacking legal capacity to provide consent must obtain the consent from a parent or legal representative/guardian of the data subject. Additionally, the data controller or data processor who obtains such consent must put in place appropriate mechanisms to verify the age of the child or the mental capacity of the other natural person, as well as the identity of the parent or legal representative/guardian providing the consent.

Parts I (2), II (4-5), III (8-17), IV, and V

Last content review/update: October 31, 2025

Responsible Parties

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

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

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

Data Protection

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

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

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

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

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

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

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

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

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

Consent for Processing Personal Data

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

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

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

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

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

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

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

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

Consent for Processing Personal Data of Minors

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

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

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

6.1

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

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

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

Documentation Requirements

Last content review/update: October 7, 2025

Obtaining Consent

In all Malawian clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the G-NHSRC, the G-COMREC, and MWI-40. The G-BioSampCompense also confirms that a participant’s voluntary informed consent is required. Also, per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22).

As per the G-NHSRC, the G-CTAProcsVacBiol, the G-CTARevVacBiol, the G-COMREC, and MWI-22, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by one (1) of the two (2) National Commission for Science and Technology (NCST)-approved ethics committees (ECs)—the National Health Sciences Research Committee (NHSRC) and the College of Medicine Research and Ethics Committee (COMREC)—and provided to the Pharmacy and Medicines Regulatory Authority (PMRA) with the clinical trial application. (See the Required Elements section for details on the contents to be included in the form.)

The G-NHSRC and MWI-22 state that the participant or legal representative/guardian must be provided with detailed research study information. Per the G-NHSRC, the ICF content should be presented orally and in writing, in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion. When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education.

As per the G-NHSRC and MWI-22, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or the legal representative/guardian to waive or appear to waive the participant’s legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence. The G-BioSampCompense also confirms that researchers must not duly induce participants to participate in any proposed research. Rather, they must design and implement their studies in a manner that calls for the participants’ informed voluntary consent to participate.

Re-Consent

According to MWI-22, the written ICF and any other written information to be provided to participants should be revised whenever important new information becomes available that may be relevant to the participant’s consent. Any revised written ICF and written information should receive the EC's approval/favorable opinion in advance of use. The participant or legal representative/guardian should be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented, and the participant or legal representative/guardian should receive a copy of the signed and dated ICF updates, including a copy of any amendments to the written information provided to the participants.

Language Requirements

As stated in the G-NHSRC and the G-COMREC, the ICF should be written in English and any other relevant local languages that the participant is able to understand.

Documenting Consent

The G-NHSRC and MWI-22 specify that the participant or legal representative/guardian must sign the ICF. The G-NHSRC indicates that where the participant is illiterate, the NHSRC will permit the participant to provide a thumbprint in the presence of a witness, who must also sign the ICF. NHSRC also permits the participant to provide verbal consent in cases where the participant is illiterate. However, the script or information sheet to be read to the potential participant must be approved by NHSRC and signed for by the participant’s legal representative/guardian.

MWI-22 states that where the participant is illiterate or legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

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

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

According to MWI-15, consent forms must be kept for three (3) years after the completion of the investigation, unless otherwise stipulated by the NHSRC.

Waiver of Consent

Per the G-NHSRC, the NHSRC may waive the requirement for the investigator to obtain a signed ICF in cases where circumstances warrant such a waiver. The following conditions may be considered for a waiver:

The research presents no more than a minimal risk of harm to the participants and involves no procedures for which written consent is normally required outside of the research context
The research could not practically be carried out without the consent waiver and obtaining informed consent is not practicable
The consent document is the only link between the participant and the research and the principal risk of harm would come from a breach of confidentiality
The waiver is consistent with the individual’s rights

The G-NHSRC indicates that in lieu of a signed ICF, the NHSRC may require the investigator to provide participants with a written statement regarding the research in the form of an information or fact sheet. This statement should contain, at a minimum:

A statement verifying that the project involves research
A description of the level of involvement and amount of time expected from participants
A description of the study
A description of the risks and benefits to the participants
A statement describing the participant’s rights
A description of the compensation to be provided to participants
Contact information for both the investigator and NHSRC chairperson

2, 4.4, 4.8, 8.2, and 8.3

(b)(i)

5.0

Screening Form

7 (Checklist of Required Documents (Appendix 4), CTA Section 10, and Check of Appended Documents (Appendix 4))

5.1, 6.2, 7.0, and 7.4

Last content review/update: October 31, 2025

Obtaining Consent

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

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

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

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

Re-Consent

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

Language Requirements

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

Documenting Consent

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

Waiver of Consent

No information is currently available regarding waiver requirements.

3.3

25-32

1.28, 2.9, and 4.8

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

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

3.1 and 3.9

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

Requirements (9) and Additional Information

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

Title II (Chapter I, Articles 20-22)

0 (Introduction)

4.3 and 10.6

Required Elements

Last content review/update: October 7, 2025

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 provides guidance on the elements to include in the informed consent form (ICF). The G-NHSRC and MWI-22 state that information about the research study should be clearly presented in both written and oral form.

Based on the G-NHSRC, the G-NHSRC-ICF, MWI-22, MWI-13, and MWI-56, the ICF should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

The study title, purpose, type, procedures, and duration—in lay terms
Experimental aspects of the study
The responsibilities and expected duration of the participant's participation
The trial treatment(s) and the probability for random assignment to each treatment
A statement about why the participant was selected to participate
Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
Any expected benefits to the participant, others, or to the country as a whole that may reasonably be expected from the research
Description of procedures, including data collection and any audio-recording of interviews or discussions, with an explanation of how recordings will be stored and kept confidential
Identification of any experimental procedures
Disclosure of alternate procedures or treatments available to participants that might be advantageous to the participant
Compensation and/or treatment available for the participant in the case of trial-related injury
The anticipated prorated payment, if any, to the participant for participating in the trial
The anticipated expenses, if any, to the participant for participating in the trial
That participation is voluntary, and that the participant can refuse to participate or withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
That the monitor(s), the auditor(s), the ethics committee (EC), and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or the participant's legally acceptable representative is authorizing such access
The extent to which confidentiality of records identifying the participant will be maintained, including that the participant’s name will not appear in any reports or publications
Name and contact details of institutions that have approved the study
Contact information for the sponsor and investigator in the event of participant problems or trial-related injuries
EC contact information
Foreseeable circumstances under which the investigator(s) may remove the participant without the participant’s consent
The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
That the participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue
Any additional costs to the participant that may result from participation in the research
The site of the study
Consent and signature or thumb print, including a statement that the participant has read (or been read) the information, has had the opportunity to ask questions, has received satisfactory answers, understands the study, and voluntarily agrees to participate, with the last sentence explicitly stating “I voluntarily agree”
Statement from the witness and researcher, with signatures, confirming the consent form was read accurately to the participant, that the participant had the opportunity to ask questions, received satisfactory answers, was not coerced, consented freely and voluntarily, and received a copy of the ICF

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

4.4 and 4.8

5.1, 6.2, 7.0, and 7.1

Last content review/update: October 31, 2025

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

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

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

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

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

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

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

3.3

4.8

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

Annex 5

Title II (Chapter I, Article 21)

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

Participant Rights

Last content review/update: October 7, 2025

Overview

Per the G-NHSRC, Malawi’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. Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), which addresses participant rights.

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

The Right to Participate, Abstain, or Withdraw

As set forth in the G-NHSRC and MWI-22, 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 delineated in the G-NHSRC and MWI-22, 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 for participation or injury/treatment, and any significant new information regarding the research study. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality

As per the G-NHSRC and MWI-22, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. It is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal

The G-NHSRC and MWI-22 state that the research participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of the participant’s rights. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Safety and Welfare

The Malawi government complies with MWI-22 principles that state a research participant’s right to safety and the protection of the participant’s health and welfare must take precedence over the interests of science and society.

2, 3.1, and 4.8

2, 6.2, and 7.1

Last content review/update: October 31, 2025

Overview

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

The Right to Participate, Abstain, or Withdraw

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

The Right to Information

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

The Right to Privacy and Confidentiality

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

The Right of Inquiry/Appeal

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

The Right to Safety and Welfare

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

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

3.3

Introduction and 4.8

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

Preamble and 3.1

1.1, 1.2, 3.2, and Annex 5

Title II (Chapter I, Articles 13 and 21)

5.4

0, 5.3, and 11.3

Emergencies

Last content review/update: October 7, 2025

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies.

Per MWI-22, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee (EC) must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

As per the G-NHSRC, a waiver of consent may be justified if the research being conducted could not practically be carried out without the consent waiver, and obtaining informed consent is not practicable. See the Documentation Requirements section for more information on waiver of consent.

4.8

7.4

Last content review/update: October 31, 2025

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

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

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

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

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

4.8

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

3.1

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

Title III (Chapter II, Article 71)

Vulnerable Populations

Last content review/update: October 7, 2025

Overview

As per the G-NHSRC, in all Malawian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The G-NHSRC characterizes vulnerable populations as those who are relatively or absolutely incapable of protecting their own interests due to illiteracy, a lack of education, autonomy, resources, or other necessary attributes. These participants may include children, pregnant women, prisoners, refugees, orphans, sex workers, people living with HIV and AIDS, persons with mental disabilities, and persons in dependent relationships (e.g., some women who culturally must ask their husbands before consenting to participate in a research study).

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 includes the following as vulnerable populations: 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 populations include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

The G-NHSRC specifies that National Health Sciences Research Committee (NHSRC) members must pay special attention to protecting participants who are from vulnerable populations. Consent for those who are not legally, mentally, and physically able should be sought from their legal representative/guardian in the form of a signature or thumbprint.

As per the G-NHSRC, trials involving vulnerable persons require the research to be directly related to the specific conditions of the vulnerable population involved, and that the participants should personally benefit from the research. In addition, the following elements must be considered when studies are conducted using vulnerable populations:

The methods of recruitment, selection, and inclusion/exclusion criteria, as well as informed consent, data confidentiality, and the participant’s willingness to volunteer
Group characteristics such as economic, social, physical, environmental, and cultural conditions
Applicable local laws that bear on the decision-making abilities of potentially vulnerable participants
Research studies involving potentially vulnerable population groups should have adequate procedures in place for assessing and ensuring participants’ capacity, understanding, and informed consent or assent
Safeguards may include NHSRC monitoring of the consent process where possible

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

1.61 and 4.8

5.2, 7.0, and 9.2

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)

Children/Minors

Last content review/update: October 7, 2025

The G-NHSRC states that a minor is a person less than 18 years of age. When the research participant is a minor, assent must be obtained in tandem with permission from the parent/legal guardian.

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 states that when a clinical trial includes minors, the minors should be informed about the trial to the extent compatible with their understanding and, if capable, they should sign and personally date the written informed consent.

Assent Requirements

As per the G-NHSRC, assent must be obtained from a minor who is deemed capable of providing assent. The National Health Sciences Research Committee (NHSRC) bases its assessment of a minor’s ability to assent on the minor’s age, maturity, and psychological state. In certain cases, the NHSRC may regard assent by minors to represent informed consent without requiring the permission of a parent/legal guardian. A typical case is when the minors are emancipated, and may include those that are legally married or are university students under the age of 18.

4.8

7.0 and 9.2

Last content review/update: October 31, 2025

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

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

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

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

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

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

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

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

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

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

Assent Requirements

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

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

Annex 5

Title One (Article 5)

Title II (Chapter III)

Pregnant Women, Fetuses & Neonates

Last content review/update: October 7, 2025

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 states that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

4.8

Last content review/update: October 31, 2025

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

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

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

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

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

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

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

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

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

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

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

Annex 5

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

Title II (Chapter IV, Articles 41-55)

Prisoners

Last content review/update: October 7, 2025

No information available regarding consent requirements for prisoners.

Last content review/update: October 31, 2025

No applicable requirements

Mentally Impaired

Last content review/update: October 7, 2025

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participants should be informed about the trial to the extent compatible with their understanding and, if capable, they should sign and personally date the written informed consent.

The G-NHSRC states that consent for those who are not mentally able should be sought from their legal representative/guardian in the form of a signature or thumbprint.

1.61, 3.1, and 4.8

7.0

Last content review/update: October 31, 2025

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

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

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

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

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

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

Title III (Chapter VII, Articles 72 and 75)

Title I (Chapter I, Article 1)

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

Definition of Investigational Product

Last content review/update: October 7, 2025

As delineated in the D-ImprtRelIMPs and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22), an investigational product (IP) (also referred to as an investigational medicinal product (IMP) in Malawi) is defined as a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unauthorized indication, or when used to gain further information about an approved use. Per MWI-25, clinical trials in Malawi are required to follow MWI-22.

1.33

7

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

Manufacturing & Import

Last content review/update: October 7, 2025

Manufacturing

According to the PMRAAct, the D-ImprtRelIMPs, and the G-CTARevVacBiol, the Pharmacy and Medicines Regulatory Authority (PMRA) is responsible for authorizing the manufacture of investigational products (IPs) (also referred to as an investigational medicinal products (IMPs)) in Malawi.

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 requires IPs to be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP) and used in accordance with the approved protocol. See MWI-11 for the PMRA’s GMP inspection application form.

Import

As stated in the PMRAAct, the D-ImprtRelIMPs, and the G-ImpExpMP, the PMRA is also responsible for authorizing the import of IPs. Per the PMRAAct and the G-ImpExpMP, the PMRA’s authorization is issued as an import permit. The G-ImpExpMP designates the principal investigator of a registered clinical trial as an authorized importer. IP import permit applications should be made by the pharmacist of record for the trial.

As per the G-CTAProcsVacBiol and the G-CTARevVacBiol, the applicant may apply for an import permit at the same time that the clinical trial application is submitted to the PMRA. (Per MWI-34, the guidance in the G-CTAProcsVacBiol and the G-CTARevVacBiol also apply to clinical trials of drugs.)

The G-ImpExpMP further states that upon receipt of an import application, the PMRA will conduct an assessment to verify whether the requirements, as described in the G-ImpExpMP, have been fulfilled. If the application meets the prescribed requirements, the applicant will be required to pay applicable import permit fees (See the Regulatory Fees section) and the PMRA will issue an import permit. In the case that an application has been rejected, the applicant will be issued a rejection letter (see Annex 2 of the G-ImpExpMP) that clearly states the reason(s) for rejection. The regulatory processing time for an import permit application is 10 working days. The import permit will be valid for six (6) months, not transferable to any other person, and may be extended for a period not exceeding three (3) months upon successful application to the PMRA. For additional information on general import application requirements, see the G-ImpExpMP.

Per the D-ImprtRelIMPs, shipping of IPs should be conducted according to instructions given by or on behalf of the sponsor in the shipping order. A pre-clearance inspection should be carried out at the port of entry by the PMRA. The sponsor must complete the cover sheet contained in Annex 1 of the D-ImprtRelIMPs for the importation and release of IPs. Please note: Malawi is party to the Nagoya Protocol on Access and Benefit-sharing (MWI-3), 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 MWI-35.

2.12 and 5.13

1, 3, 5, and Annex 1

1, 3.1, 3.3-3.5, 3.7, and Annex 2

2.1 and 3.2

3, 5, and 7 (Checklist of Required Documents (Fees), and Check of Appended Documents (Fees))

Part II (Section 4), Part V (Section 58), and Part X (Section 96)

Last content review/update: October 31, 2025

Manufacturing

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

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

Import

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4.4, 5.1, and 10.1

Introduction (Box 1)

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

Requirements, Term, Form, and Additional Information

Requirements (8)

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

Article Two

Chapters I (Articles 1-2) and IV

Chapter I (Article 3)

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

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

1 and 16

1 and 10.9

Quality Requirements

Last content review/update: October 7, 2025

Investigator's Brochure

In accordance with the G-CTAProcsVacBiol and the G-CTARevVacBiol, the Malawi government requires the sponsor to provide investigators with an Investigator’s Brochure (IB). Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). MWI-22 specifies that the IB must contain all of the relevant information on the investigational product(s) (IPs) (also referred to as investigational medicinal products (IMPs) in Malawi) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data. The sponsor should also update the IB as significant new information becomes available.

As specified in MWI-22, the IB must include the following sections:

Table of Contents
Summary
Introduction
Physical, Chemical, and Pharmaceutical Properties and Formulation
Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
Summary of Data and Guidance for the Investigator(s)

See MWI-22 for detailed content guidelines.

Quality Management

MWI-60 requires that an Investigational Medicinal Product Dossier (IMPD) or alternative be submitted in the clinical trial application to the Pharmacy and Medicines Regulatory Authority (PMRA). The IMPD must include information on the quality of any IP, the manufacture and control of the IP, and data from non-clinical studies and from its clinical use.

As per the G-CTAProcsVacBiol, the G-CTARevVacBiol, and the D-ImprtRelIMPs, the PMRA requires the following documents to accompany the IP (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

Evidence of manufacture under conditions compliant with current good manufacturing practice (GMP)
A release of specifications and tests, including a Certificate of Analysis (CoA) for each batch of IPs, as well as comparator(s), if applicable
A copy of the PMRA’s letter of approval of the clinical trial
Batch release certificate
A copy of a valid Certificate of Manufacture issued by the competent authority in the country of origin
A copy of a valid World Health Organization certificate of a pharmaceutical product issued by the competent authority in the country of origin

The D-ImprtRelIMPs states that the CoA should identify the product name or code; the sponsor/company name; batch numbers; expiration dates; date of issue; signature, qualification, and title of responsible person; and the results of physical and analytical tests. Per MWI-22, the sponsor must maintain a CoA to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

The sponsor should complete the cover sheet in Annex 1 of the D-ImprtRelIMPs, include it with each IP shipment, and use the checklist in Annex 2 to ensure the required documentation is attached. As delineated in the D-ImprtRelIMPs, the sponsor should also prepare IP shipping instructions, including information about the shipment’s overall physical condition, for PMRA review and approval. The sponsor should provide information on the acceptable storage temperatures and storage conditions.

5.13, 5.14, 7, and 8.2

5, 6, Annex 1, and Annex 2

3.2 and Screening Form

7 (Checklist of Required Documents (Appendices 2 and 10) and CTA Section 3)

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

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

4.3

Requirements (7-8)

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

Article Two and Single Annex (Single Committee Form)

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

0, 1.2, 3.14, and 16

1

4.1

1-3, 6.1, and 9

Labeling

Last content review/update: October 7, 2025

Investigational product (IP) labeling in Malawi must comply with the requirements set forth in the D-ImprtRelIMPs. The D-ImprtRelIMPs states that for an IP to be used in a clinical trial, it must be properly labeled in the official language of the country where the trial is being conducted.

As set forth in the D-ImprtRelIMPs, the following labeling information must be included on the outer packaging or on the immediate packaging when there is no outer packaging:

Wording that clearly indicates the IP is clinical trial material
Product name or unique code
Storage temperature and conditions
Expiration date
Sponsor contact details

Additionally, the G-ImpExpMP provides the following minimum labeling requirements for all imported medicines and/or active pharmaceutical ingredient (API):

The information printed on labels must be indelible, engraved, or embossed on a primary and secondary container
The immediate outer packaging of the medicine or API should be clearly labeled in English
The trade or brand name where applicable should be stated
The International Non-Proprietary Name (INN, generic name) should be clearly stated
Quantities of each API in the given formulation or quantities of the raw material stated
Date of manufacture and expiry or retest date in case of active raw materials
Batch or lot number
Storage conditions
Name and address of manufacturer
Registration number of the product issued by the Pharmacy and Medicines Regulatory Authority (PMRA) in both outer and inner package of the product(s) where applicable
Enclosed and accompanying literature must be in English
The specification of the API is given according to officially recognized pharmacopoeia, where applicable

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (MWI-22). The D-ImprtRelIMPs and MWI-22 state that the IP must be coded and labeled in a manner that protects the blinding, if applicable.

5.13

4

3.3

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

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4.4

5.2

10.9.8

Product Management

Last content review/update: October 7, 2025

Supply, Storage, and Handling Requirements

Per MWI-25, clinical trials in Malawi are required to follow the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MWI-22). As defined in the D-ImprtRelIMPs and MWI-22, the sponsor must also supply the investigator(s)/institution(s) with the investigational product(s) (IP(s)), including the comparator(s) and placebo, if applicable. The sponsor should not supply either party with the IP(s) until after obtaining Pharmacy and Medicines Regulatory Authority (PMRA) and ethics committee approvals.

The D-ImprtRelIMPs and MWI-22 indicate that IPs must be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. Additionally, the sponsor must ensure the following (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

IP product quality and stability over the period of use
IP is manufactured according to any applicable good manufacturing practice (GMP)
Proper coding, packaging, and labeling of the IP(s)
Records are maintained for document shipment, receipt, disposition, return, and destruction of the IP(s)
Acceptable storage temperatures, conditions, and times for the IP

Timely delivery of the IP(s)
Written procedures are established, including instructions for handling and storage of the 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
Sufficient quantities of the IP(s) are maintained to reconfirm specifications, should this become necessary

Refer to the D-ImprtRelIMPs for detailed sponsor-related IP requirements.

In addition, the PharmG-InvestDrugs states that the pharmacist at each clinical trial site, designated as the Pharmacist of Record, is the primary individual who is expected to develop and maintain an IP control system, which includes the technical procedures for product ordering, control, dispensing, and accountability. In addition, the Pharmacist of Record is responsible for the establishment of internal policies and procedures for the safe and proper use of IPs. The Pharmacist of Record will perform the day-to-day dispensing and accountability activities. A pharmacy plan must be created by the Pharmacist of Record for each clinical research site, addressing the control and use of IPs. See the PharmG-InvestDrugs for more information.

Record Requirements

In accordance with the D-ImprtRelIMPs, the sponsor is required to maintain a system for retrieving IP(s) and document this retrieval process (e.g., for deficient product recall, reclaim after trial completion, expired product reclaim). The sponsor must also maintain a system for the disposition of unused IP(s) and for the documentation of this disposition. Finally, the sponsor should maintain sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and maintain records of batch sample analyses and characteristics. Moreover, 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.

G-GMP-MWI requires that for IPs, the batch documentation must be retained for at least five (5) years after the completion or formal discontinuation of the last clinical trial in which the batch was used. Additionally, the G-ImpExpMP indicates that upon issuance of import authorization by the PMRA, the importer is expected to retain such records for five (5) years from the date of importation, either as hard or electronic copies. Stored import records should be easily accessible and availed for review to the PMRA’s inspector/officers for any post-import audit or investigations.

2.12, 5.5, 5.12-5.14, and 7

1, 3, 4, and 5

3.3

Pharmacy Plan

2.2.4

Last content review/update: October 31, 2025

Supply, Storage, and Handling Requirements

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

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

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

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

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

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

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

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

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

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

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

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

Record Requirements

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

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

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

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

4.7 and 10.1-10.2

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

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

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

3.4, 4.3, 4.5, and 4.12

3.24, 10.2, and 16.10

10.9

10.27

Definition of Specimen

Last content review/update: October 7, 2025

In Malawi, as per the G-StorExptSpecimens, specimens are defined as human or animal materials, collected directly from humans or animals, including, but not limited to excreta, secreta, blood and its components; tissue and tissue fluid swabs; and body parts being transported for purposes such as research and investigational activities.

Specimens are also referred to as human materials or biological products. The G-StorExptSpecimens defines human material as all biological material of human origin, including organs, tissues, bodily fluids, teeth, hair, nails, and substances extracted from such material as DNA or RNA.

Please refer to G-StorExptSpecimens for more specific definitions for selected terms including genetically modified micro-organisms and infectious substances.

5.4-5.6

Last content review/update: October 31, 2025

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

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

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

14

Title XIV (Chapter I, Article 314)

Chapter I (Article 6)

Specimen Import & Export

Last content review/update: October 7, 2025

Import/Export

As delineated in the G-CTAProcsVacBiol, MWI-14, and MWI-7, the applicant must obtain approval from the Pharmacy and Medicines Regulatory Authority (PMRA) to import and export human biological specimens into and out of Malawi. The G-CTAProcsVacBiol notes that the applicant may apply to the PMRA for permission to import and/or export materials at the same time that the applicant submits the clinical trial application.

The G-StorExptSpecimens specifies that the sponsor is responsible for shipping specimens, for preparing the required documentation (e.g., nationally authorized import/export permits and dispatch/shipping documents), and for ensuring that the samples collected from research participants are sent through the appropriate carrier to their destination. The sponsor may delegate these functions to the principal investigator (PI). Refer to Annex 1 of the G-StorExptSpecimens for a checklist to be completed by the PI for the proper storage and export of clinical trial samples. As per the G-StorExptSpecimens, the transport of specimens is subject to regulation by the International Air Transport Association.

In cases where investigators are unable to complete all required research tests in Malawi, MWI-14 and MWI-7 state that justification must be provided for the importation and exportation of samples.

Per the G-GenResReqs, the National Health Sciences Research Committee (NHSRC) requires investigators who wish to export biological/genetic materials to apply for a transfer under a material transfer agreement (MTA) that must be reviewed, approved, and signed for by NHSRC. The investigator must provide a satisfactory description of how the privacy and confidentiality of the individuals and communities and the safety of such materials will be maintained. Furthermore, an investigator is not permitted to transfer biological/genetic material to another research group locally and internationally unless NHSRC has approved a collaborative study between the two (2) parties and the material and information provided protects the participants. Additionally, as stated in the SciTechOrder, an NCST-issued license is required for the collection, storage, and use of human samples for research. The SciTechOrder does not specify whether the process of obtaining an NCST-issued license is separate from the NHSRC requirements described above.

Material Transfer Agreement

MWI-14, MWI-16, and MWI-7 indicate that the PMRA, the NHSRC, and the College of Medicine Research and Ethics Committee (COMREC) must ensure a MTA is in place that includes the following:

Intention of the importation and exportation of samples
Duration and location of storage
Appropriate informed consent authorizing the exportation and importation of samples
Person(s) who will have access to the samples
The controlling officer of the samples
Ownership of the samples
Capacity building (only applicable for MWI-7)

See MWI-14, MWI-16, and MWI-7 for the PMRA, NHSRC, and COMREC MTA forms, respectively.

The G-BioSampCompense also confirms that MTAs remain an instrument to be used by a researcher in requesting the approval of an ethics committee (EC) for the transfer of samples for analysis outside of Malawi.

Other Considerations

According to the G-GenResReqs and MWI-6, COMREC and NHSRC-approved samples can be stored for a maximum of five (5) years during which time all tests/analyses approved for that particular study should be concluded. MWI-6 further states that if the sample is to be used beyond five (5) years, an updated authorization must be provided, which will last another five (5) years before it can be renewed. Per G-BioSampCompense, while samples are primarily allowed to be stored as long as they are needed for the initial study, leftover samples are also permitted to be stored as long as needed for a research endeavor. See G-BioSampCompense for additional details regarding EC approval requirements.

(a)(iv) to (ix)

4.12

3, 5, and 7 (Checklist of Required Documents (Fees))

3, 6.4, and Annex 1

Last content review/update: October 31, 2025

Import

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

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

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

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

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

Export

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

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

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

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

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

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

Import/Export Permit Submission Procedures

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

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

Requirements, Form, Term, Validity, and Steps

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

Chapter I (Article 3)

Chapter VI (Articles 89 and 100)

Consent for Specimen