Clinical Research Regulation For Canada and Mali

Last content review/update: November 2, 2026

Overview

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

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

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

Clinical Trial Review Process

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

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

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

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

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

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

As per the G-Dcntrl, HC requires information about decentralized elements in the clinical trial application to review whether these elements were designed to minimize risk to participants, support appropriate oversight and monitoring throughout the trial, and help achieve trial objectives. Additionally, sponsors must attest that the trial, including all decentralized elements, will be conducted according to good clinical practice (GCP). Depending on the decentralized elements and activities within the proposed trial known at the time of application, HC will review how participant visits and clinical trial activities will be conducted (e.g., in person, by telephone or telehealth platform, or through third parties or vendors). See G-Dcntrl for more details about clinical trials with decentralized elements.

As delineated in the CanadaFDA and the G-Inspections, HC is authorized to implement an inspection strategy and to ensure compliance with CanadaFDA. The G-Inspections states that HC’s Regulatory Operations and Enforcement Branch (ROEB) monitors compliance, which is assessed through inspections and other compliance and enforcement activities, such as compliance verifications. Compliance verifications of clinical trials may be initiated when there are reasonable grounds to believe that non-compliance may have occurred or is occurring and that enforcement measures may be necessary (e.g., complaints received regarding specific trials, reports of adverse drug reaction(s), or reports from other regulatory authorities). The Clinical Trial Compliance Program within ROEB is responsible for clinical trial site selection for inspections in collaboration with the PDD and the BRDD. A risk-based approach is applied in the site selection process to minimize the potential health risks inherent to clinical trials involving human participants. The selection of sites for inspection is based on a variety of criteria to select sites throughout all levels of the drug assessment and regulatory approvals process. For clinical trial sites with decentralized elements, G-Dcntrl states that the main location of the clinical trial site associated with the qualified investigator (QI) is the primary point of contact for an inspection. HC inspectors may request documentation from sponsors and QIs to demonstrate adequate coordination, oversight, and monitoring of delegated parties, as well as the measures in place to protect participant safety. See the Risk-Insp for a risk classification guide used by ROEB; this guide describes how inspectors classify risk-based observations and assign a rating, promotes consistency, and provides examples of inspection observations.

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

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

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

Expanded Access Clinical Trial

The Expd-CTs explains that in Canada, an expanded access clinical trial is a type of clinical trial that provides access to investigational products (IPs) that have the potential to treat people living with medical conditions who do not qualify for other clinical trials or are not able to participate in one. When appropriate, expanded access clinical trials can use more flexible protocols and a decentralized model to facilitate access for a larger, potentially more diverse population of participants, in more accessible settings. Since expanded access clinical trials are a type of clinical trial under the CanadaFDR, they require a CTA for review by HC. HC will review applications for the sponsor’s evidence from previous studies that the proposed use of the IP would not endanger the health and safety of participants. HC assesses all CTAs on a case-by-case basis. CTAs for expanded access clinical trials follow the same review processes and timelines as other clinical trials. HC scientists and physicians review expanded access CTAs to assess whether:

The risks in using the drug in the trial are considered and would not endanger health and safety
The best interests of those taking part in the trial have been considered, including that drugs are used in the right way for the participants being studied
The goals of the trial can be met

Per the Expd-CTs, group-level access to a drug in Canada is available only through an expanded access clinical trial and not through the individual-patient Special Access Program. Therefore, sponsors wishing to include a Canadian arm in an international expanded access program for multiple patients must do so through an expanded access clinical trial.

1.1-1.3 and 3.2

1.2, 2.1, 2.3-2.7, and Appendix 1

3 and 4

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

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

What is the Health Products and Food Branch?

Last content review/update: January 23, 2026

Overview

As indicated in DecreeNo2011-753 and MLI-2, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) is responsible for regulating clinical trials, examining applications to import investigational drugs, and reviewing clinical trial authorization records for drugs to be registered in Mali. In addition, as stated in LawNo09-059, prior to a trial’s commencement, the DPM must review the clinical trial application research data submitted by the sponsor or principal investigator, as well as the opinions of the ethics committees (ECs) consulted.

According to LawNo09-059 and the DPM-ClinTrialDocs, the DPM review and approval process takes place after the EC review and approval process. Per LawNo09-059, the EC must communicate its opinion on a research project to the DPM. LawNo09-059 also indicates that the EC’s opinions of the research data must be submitted along with the application to the DPM prior to the agency commencing its review. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review.

Per DecreeNo2017-0245, all clinical research conducted in Mali must benefit the country in general and its local populations.

Clinical Trial Review Process

According to MLI-1, upon receipt of the completed and signed application, the research and evaluation section of the DPM completes the reviewer section of the form (see MLI-1). This section requires the reviewer to provide the following information: date/time of application receipt; file number; reviewer name and signature; date/time, if additional information is requested; date of receipt of additional information requested; date/opinion of the Technical Committee; and any other information.

According to MLI-17, the DPM secretary provides the clinical trial application to the DPM director once it is received. The DPM director then initially assigns the application to either the Medicine Regulation Division or the Quality Assurance Division. The Quality Assurance Division conducts an evaluation once it receives the application. Additional information from the applicant may be requested. Once the division completes its evaluation, it sends the application and evaluation to the Minister of Health and Social Development for final approval and issuance of a certificate. The approval decision is then provided to the applicant as well as regional offices, health professional councils, health inspectors, and all MSDS departments.

In addition, per LawNo09-059, health inspectors, the DPM, and the members of the approved EC are authorized to ensure compliance with the provisions of this law and any regulations adopted for the law’s implementation.

Context

Part 2 - Eligibility and Receipt of the Application File (Section 1 - Checklist)

Title 3 (Articles 13 and 17)

Chapter 1 (Section 1, Articles 2-3 and Section 2)

Article 3

Regulatory Fees

Last content review/update: November 2, 2026

According to CAN-56, there are no fees to submit a clinical trial application in Canada.

Fees

Last content review/update: January 23, 2026

Directorate of Pharmacy and Medicine (DPM)

According to MLI-1, applicants are required to pay application fees to submit an application to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)). Applicants should contact the DPM for application fee information.

Payment Instructions

No information is available regarding payment instructions.

Part 2 - Eligibility and Receipt of the Application File (Section 1 - Checklist)

Ethics Committee

Last content review/update: November 2, 2026

Overview

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

Per CAN-35 and CAN-13, all proposed or ongoing research involving human participants carried out by, funded by, or otherwise under the auspices of Health Canada (HC) or the Public Health Agency of Canada (PHAC) must obtain approval from a joint EC representing those two (2) agencies—as well as complying with the CanadaFDR and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. This joint EC is known as the HC-PHAC REB. Further, if an institution is conducting an HC- or PHAC-funded project, the HC-PHAC REB must review and approve the research even if it has been previously reviewed and approved by another EC. See CAN-35 for details on the HC-PHAC REB’s development, responsibilities, and composition. HC’s operational policy (CAN-13) outlines policies and procedures that the joint HC-PHAC REB must follow when reviewing clinical trials.

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

Ethics Committee Composition

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

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

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

Also, see CAN-52 for additional guidance on EC composition, functions, and operations. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Terms of Reference, Review Procedures, and Meeting Schedule

According to G-TCPS2, institutions must have in place written procedures for the appointment, renewal, and removal of EC members, including Chairs. Further, institutions must have clear written policies describing the mandate of each EC. An institution may wish to use different models for the ethics review of research conducted under its auspices.

The G-TCPS2 states that an EC should have adequate expertise, experience, and training to understand the disciplines, methodologies, and approaches of the research that it considers for research ethics review. Institutions should ensure that all EC members receive appropriate education and training in ethics review of research involving humans, to enable them to fulfill their duties. This includes providing training opportunities for all members in core principles and understanding of the G-TCPS2, basic ethics standards, applicable institutional policies, and legal or regulatory requirements. It includes an understanding of the role and mandate of ECs and responsibilities of EC members. Training should be tailored to the types and complexities of the research that the EC reviews.

Per the G-TCPS2, when there is less than full attendance, decisions requiring full review should be made only when the members present have the specific expertise, relevant competence, and knowledge necessary to provide an adequate ethics review. Ad hoc advisors, observers, research ethics administration staff, and other attendees must not be counted toward quorum or permitted to vote; decisions made without quorum are not valid or binding. ECs must hold regular meetings and normally meet face to face to review research not assigned to delegated review. Where members are geographically dispersed or exceptional circumstances prevent attendance, participation by phone, videoconference, or other technology may be acceptable, provided quorum is maintained and the Chair ensures active participation. A schedule of EC meetings should be communicated to researchers, and ECs should establish a process for reaching decisions requiring full review, such as consensus or, where necessary, a vote.

G-TCPS2 indicates that proportionate review means the level of EC review is determined by the level of foreseeable risk to participants: the lower the risk, the lower the level of scrutiny through delegated review; the higher the risk, the higher the level of scrutiny through full-board review. Full EC review should be the default requirement for research involving humans. Where research is determined to involve minimal risk, an EC may authorize delegated review in accordance with its institutional policies and written procedures. Delegated reviewers may refer proposals to the full EC, and any proposed negative decision must be reviewed and endorsed by the full EC before it is communicated to the researcher. Delegated decisions must be well documented and formally reported to the full EC, which remains responsible for the ethics of all research involving humans within its jurisdiction. ECs must function impartially, provide researchers with a fair hearing, and provide reasoned and appropriately documented opinions and decisions. Approvals and refusals must be communicated in writing. Where members disagree, an effort should be made to reach consensus; if disagreement persists, the decision must be made in accordance with the EC’s agreed-upon and documented process. The EC makes the final determination regarding the nature and frequency of continuing research ethics review using a proportionate approach. At minimum, continuing review consists of an annual status report for multi-year projects and an end-of-study report for projects lasting less than one (1) year.

Regarding records, G-TCPS2 indicates that ECs must prepare and maintain comprehensive records, including all documentation related to the projects submitted to the EC for review, attendance at all EC meetings, and accurate minutes reflecting EC decisions. Where the EC denies ethics approval for a research proposal, the minutes must include the reasons for this decision. When deciding the retention period of their files, ECs should be guided by their institutional record-keeping policies and other relevant legal or regulatory requirements. Files, minutes, and other relevant documentation must be accessible to authorized representatives of the institution, researchers, sponsors, and funders when necessary to assist internal and external audits, or research monitoring, and to facilitate reconsideration or appeals. The minutes of EC meetings must clearly document the EC’s decisions, any dissents, and the reasons for them. EC decisions should be supported by clear references (e.g., date of decision, title of project), documentary basis for decision, the plan for continuing ethics review and timelines, reasons for decisions, and any conditions or limitations attached to the approval. Providing reasons for EC decisions is optional when ethics approval is granted. ECs should have written procedures for its management of record keeping and other submitted reports. EC must maintain reports and decisions on unanticipated issues or changes to approved research.

For examples of EC SOPs, see CAN-13 for the HC-PHAC REB operational policy.

1.2, 1.4, 2.1, and 2.7

Introduction and Chapter 6

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

2 and 3

About the REB and Policies, Guidelines, and Resources

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Overview

As stated in LawNo09-059, Mali requires investigators to obtain approval from a scientific committee and an approved ethics committee (EC) for each clinical trial. The scientific committee evaluates the technical validity of the research protocol. The EC provides its opinion on the validity of the research methods, particularly as they relate to participant protection and consent. Per DecreeNo2017-0245, all clinical research protocols must be submitted to the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)) or to an accredited institutional EC. The CNESS should also be informed of any research protocol approved by an accredited EC. Furthermore, the EC assumes the moral responsibility for the research on behalf of the state and is directed to continuously monitor the implementation of the adopted protocol, at its own expense.

According to MLI-17, Mali’s EC system consists of seven (7) committees:

CNESS
Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako) (USTTB))
National Institute of Public Health (Institut National de Santé Publique (INSP)) EC
Ethics Committee for the Center for Sickle Cell Disease Research and Control (le Comité d’Ethique de Centre de Recherche et Lutte Contre la Drépanocytose) (CRLD))
Bamako Dermatology Hospital (Hôpital de Dermatologie de Bamako (HDB)) EC
Alioune Blondin Beye Peacekeeping School (EMP-ABB) of Bamako (l’Ecole de Maintien de la Paix Alioune Blondin BEYE de Bamako) EC
Ethics Committee of the National Office for Reproductive Health (Comite D'Ethique De L'Office National De La Sante De La Reproduction (ONASR)) (D-No2024-0000992)

Note: The ClinRegs profile will focus on the CNESS, the CIESS/USTTB, and the INSP EC. Refer to DecreeNo2019-0246 and OrderNo2021-5895 for additional information on the HDB EC, and MLI-19 for additional information on the EMP-ABB EC.

Ethics Committee Composition

National Ethics Committee for Health and Life Sciences (CNESS)

As specified in DecreeNo02-200 and OrderNo2019-5050, the CNESS consists of 37 members, including a president, a vice-president, and a permanent secretary. The committee’s composition is specifically represented by the following:

Three (3) members nominated by the President of the Republic of Mali
Twenty-seven (27) members from the scientific community selected for their competence and interest in ethical issues
Seven (7) researchers from the research sector, including representatives from the CIESS/USTTB and CRLD

Please refer to DecreeNo02-200 for detailed information on member composition and responsibilities. See also DecreeNo2015-0864 and OrderNo2019-5050 for details on the appointment of the president and a list of CNESS board members.

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

Per D-No2021-0415 and D-No2021-0416, the CIESS/USTTB consists of 14 members appointed by the USTTB rector and chosen from the different departments within the USTTB and from civil society. As indicated in D-No2021-0416, the members specifically include: a forensic pharmacist, an anthropologist/ethicist, an evangelist, an immunologist/genomicist, a parasitologist/clinical research specialist, a pediatrician, a public health professional, an anesthesiologist, an entomologist, a pharmacist/biologist, a pulmonologist, a civil society representative, a jurist, and a chemist.

D-No2021-0415 states that the CIESS/USTTB is presided over by a scientific person appointed by the rector and selected from among the committee members for a period of three (3) years, which is renewable one (1) time. The president is seconded by a vice-president. The CIESS/USTTB may also call upon a competent person with specific expertise to assist the committee in its work.

National Institute of Public Health (INSP) Ethics Committee

OrderNo2019-011 and DecreeNo2019-0247 state that the INSP EC members are appointed by the Minister of Health and Social Development and the committee elects a president from among its members.

As delineated in D-No2020-001817 and OrderNo2019-011, the INSP EC consists of 12 members including a representative of the General Directorate of Health and Public Hygiene; a representative of the Institute of Human Sciences; four (4) representatives of the Minister in charge of Scientific Research; a representative of the High Islamic Council; a representative of the Catholic Church of Mali; a representative of the Association of Groups of Evangelical Protestant Churches and Missions of Mali; a representative of the Malian Human Rights Association; a representative of the National Order of Physicians of Mali; and a representative of communication professionals. Per OrderNo2019-011, the EC may call upon any resource person according to their skills.

Terms of Reference, Review Procedures, and Meeting Schedule

DecreeNo2017-0245 states that the institutions promoting the research and the EC must take necessary measures to minimize conflicts of interest.

National Ethics Committee for Health and Life Sciences (CNESS)

According to DecreeNo02-200, the CNESS is required to develop standard operating procedures (SOPs) specifying detailed rules for the operation of the committee, the technical committee(s), and the Permanent Secretariat. The Minister of Health and Social Development must approve the SOPs.

Per DecreeNo02-200, the CNESS must convene at the request of the president. The committee may also meet at the request of a simple majority of its members in sessions, in special sessions, or whenever circumstances require the members to do so. CNESS meetings are not open to the public, and the committee may deliberate only if at least half of its members are present. For additional CNESS procedures and information on other administrative processes, see DecreeNo02-200.

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

As explained in D-No2021-0415, the term of office for CIESS/USTTB members is three (3) years and is renewable one (1) time. Committee membership is free. The president leads the meetings and represents the CIESS/USTTB among various organizations and institutions. When the president is absent, the vice-president performs the president’s duties.

In addition, per D-No2021-0415, the CIESS/USTTB meets whenever necessary, when convened by its president. The president is required to convene the meeting at the written request of two thirds of its members. The committee cannot review proposals without the absolute majority of its members. If a quorum is not reached, the members are reconvened within a period of eight (8) days, and the committee’s deliberations are then valid regardless of the number of members present. In addition, per D-No2021-0415, the agenda and the necessary documents are made available to members at least one (1) week prior to the meeting.

D-No2021-0415 further states that consensus is the basic principle governing the functioning of the CIESS/USTTB. If consensus is not reached, the decision may be made by a relative majority vote. The president must have an additional vote if a majority does not emerge. The president may propose that the committee sessions be extended to observers in an advisory capacity.

Additionally, per MLI-17, all ECs in Mali are required to follow the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). The CIESS/USTTB members are also required to take an ICH Good Clinical Practice E6(R3) training course.

National Institute of Public Health (INSP) Ethics Committee

As per DecreeNo2019-0247, the INSP EC meets as needed, mainly for reviewing protocols submitted for its approval, when convened by its president, or at the request of two thirds of its members. The EC members are appointed by the Minister of Health and Social Development for a period of three (3) years and it is renewable.

Title 3 (Article 13)

Article 1

Chapter III (Articles 22-23)

Articles 4-11 and 16

Article 1

Chapter 2

Articles 5, 17, and 19

Articles 22-23

Scope of Review

Last content review/update: November 2, 2026

Overview

According to the CanadaFDR, the G-CanadaCTApps, and the G-TCPS2, the primary scope of information assessed by institutional ethics committees (ECs) (called Research Ethics Boards (REBs) in Canada) relates to maintaining and protecting the dignity and rights of human research participants and ensuring their safety throughout their participation in a clinical trial. ECs must also pay special attention to reviewing informed consent and protecting the welfare of certain classes of participants deemed vulnerable.

See the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which CAN-50 indicates that Health Canada (HC) has adopted, for additional EC responsibilities and requirements. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Role in Clinical Trial Approval Process

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

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

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

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

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

G-Dcntrl indicates that for clinical trials with decentralized elements a single EC can approve activities at a clinical trial site as well as decentralized trial elements. However, sponsors and qualified investigators may need to obtain their own additional provincial or institutional approvals or permissions, or meet community-specific requirements, to use institutional resources or gain access to specific locations or populations, such as Indigenous communities.

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

1.2, 1.4, 2.1, 2.5, and 2.7

Research ethics board approval

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

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

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Overview

According to LawNo09-059, the primary mission of Mali’s ethics committees (ECs) is to ensure the scientific quality and ethical conduct of health research in the country, specifically with regard to participant protection and consent. ECs 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 by verifying the adequacy of confidentiality and privacy safeguards. ECs must also confirm that the study’s goal is to increase scientific understanding of humans and to provide approaches likely to improve the health conditions under consideration. See LawNo09-059 for detailed ethical review guidelines. Per DecreeNo2017-0245, the rights of vulnerable persons, must be particularly protected when they are participating in a study. See also MLI-4 for additional information related to the protection of personal data in biomedical research.

Per MLI-17, all ECs in Mali are required to follow the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (MLI-5).

Per MLI-17, Mali’s ECs also require researchers to comply with MLI-5.

National Ethics Committee for Health and Life Sciences (CNESS)

According to DecreeNo02-200, the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)) was established by the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) as an advisory committee to address ethical issues arising from advances in knowledge in the fields of medicine, pharmacy, biology, health, and other life sciences, and to make recommendations in these areas.

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

As indicated in D-No2021-0415, the mission of the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) is to give opinions on the ethical problems resulting from research progress in the fields of health and life sciences and to make recommendations on these subjects. See the D-No2021-0415 for additional information on the CIESS/USTTB’s responsibilities.

Per the FMPOS-USTTB-ECProcs, the CIESS/USTTB complies with the World Health Organization (WHO)’s Good Clinical Research Practices (MLI-3), the Declaration of Helsinki (MLI-16), and any other requirements in force in Mali. (Note: Per MLI-17, the CIESS/USTTB is still using the FMPOS-USTTB-ECProcs.) Additionally, per MLI-17, the CIESS/USTTB also follows the MLI-5 guidelines.

Per the FMPOS-USTTB-ECProcs, the CIESS/USTTB must also establish a monitoring and evaluation procedure for all research protocols with a favorable decision. This follow-up monitoring should be in effect from the initial decision through the conclusion of the trial.

National Institute of Public Health (INSP) Ethics Committee

Per OrderNo2019-011, the National Institute of Public Health (Institut National de Santé Publique (INSP))’s mission is to set up a health watch system and epidemiological surveillance and to promote health policy and systems research. In accordance with LawNo2019-023, which ratifies OrderNo2019-011, the INSP established an EC as one (1) of its administrative and management bodies. Per OrderNo2019-011, taking into account the socio-cultural context, the INSP EC is charged with giving its opinions on response measures to health threats and crises, research projects and information programs, and education and communication. See also MLI-15 for additional information on the INSP.

Role in Clinical Trial Approval Process

As set forth in LawNo09-059 and the DPM-ClinTrialDocs, EC approval is required prior to obtaining the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM))’s approval. The EC must communicate its opinion on a research project to the DPM. Further, the sponsor or investigator must send the EC’s opinion with its application to the DPM prior to the agency commencing its review. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review.

Per DecreeNo2017-0245, the EC must notify the investigator of its decision in writing. The CNESS must be informed when an institutional EC, such as the CIESS/USTTB, approves a research protocol. If the protocol is rejected, then the EC must notify other ECs in Mali and the DPM. The investigator may request a re-evaluation of the protocol after integrating the EC’s feedback and requested changes. The EC is required to review and follow up on this request.

Per DecreeNo2017-0245, the EC must also review and approve any protocol amendments prior to those changes being implemented.

Additionally, per DecreeNo2017-0245, the investigator must comply with all decisions and recommendations from the EC. Investigators must also immediately inform the EC of any problems encountered during the course of the study, including deviations from the protocol and complaints from participants. DecreeNo2017-0245 mandates that clinical research must follow good clinical and laboratory practices.

There is no stated expiration date for an EC approval in LawNo09-059, DecreeNo2017-0245, or the FMPOS-USTTB-ECProcs.

In addition, per LawNo09-059, health inspectors, the DPM, and the members of the approved EC are authorized to ensure compliance with the provisions of this law and any regulations adopted for the law’s implementation.

National Ethics Committee for Health and Life Sciences (CNESS)

According to MLI-17, the CNESS’s EC only participates in the EC review process with the CIESS/USTTB when the research pertains to an emerging infectious disease, such as during the Ebola virus disease outbreak. MLI-17 also notes that the CNESS is responsible for reviewing and approving protocols submitted by the Malian Government or protocols of public health importance to the country.

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

MLI-17 indicates that the CIESS/USTTB is the primary EC responsible for reviewing and approving clinical research protocols. Per D-No2021-0415, the CIESS/USTTB is specifically responsible for analyzing and evaluating health research projects in compliance with scientific and ethical principles; deciding on the ethical validity of research protocols submitted for its assessment; and carrying out the mid-term review of approved research protocols and regularly monitoring them in the field to ensure the research is carried out in accordance with the ethical principles.

National Institute of Public Health (INSP) Ethics Committee

According to MLI-17, the INSP's EC only participates in the EC review process with the CIESS/USTTB when the research pertains to an emerging infectious disease, such as during the Ebola virus disease outbreak.

Title 2 (Article 3) and Title 3 (Articles 10, 12-15, and 17)

Articles 1 and 21

Articles 2-3

Chapter 1

Articles 3, 5-6, 14, 18-19, and 21

Chapters I and II, Annex, and Guide to Ethics Committee Protocol Review

Ethics Committee Fees

Last content review/update: November 2, 2026

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

REB Review Fees

Last content review/update: January 23, 2026

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

Per the FMPOS-USTTB-ECProcs, the cost to submit a protocol for review by the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) is 20,000 West African CFA francs.

However, according to MLI-17, CIESS/USTTB investigators are required to pay a fee of 300,000 West African CFA francs to submit a protocol for EC review and approval.

Payment Instructions

No information is available regarding payment instructions for the CIESS/USTTB.

National Ethics Committee for Health and Life Sciences (CNESS)

No information is available regarding fees or payment instructions for the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)).

National Institute of Public Health (INSP) Ethics Committee

No information is available regarding fees or payment instructions for the National Institute of Public Health (Institut National de Santé Publique (INSP)) EC.

Chapter I (Section I, Article 8)

Oversight of Ethics Committees

Last content review/update: November 2, 2026

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

Last content review/update: January 23, 2026

Overview

No information is available regarding ethics committee (EC) authorization in Mali. However, per DecreeNo2017-0245, the state, local authorities, development partners, and clinical research promoters provide financing and capacity building for ECs.

Registration, Auditing, and Accreditation

No information is available on registration, auditing, and accreditation.

Article 22

Submission Process

Last content review/update: November 2, 2026

Overview

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

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

Regulatory Submission

Per the G-CanadaCTApps, CTAs (CAN-4) should be sent directly to the appropriate HPFB Directorate for review—the Pharmaceutical Drugs Directorate (PDD) for pharmaceutical drugs or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) for biological drugs and radiopharmaceuticals.

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

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

Electronic Common Technical Document (eCTD) Electronic Submission

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

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

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

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

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

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

Media must be mailed to HC at the address below:

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

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

Non-eCTD Electronic Submission

For non-eCTD electronic submissions, G-Non-eCTD indicates that the CTA (CAN-4) must be provided in PDF format. Other files submitted should be in PDF format, unless otherwise specified in G-Non-eCTD. PDF documents should be generated from electronic source documents and not from scanned materials, except where access to an electronic source document is unavailable or where a signature is required. Documents that are more than 10 pages should be bookmarked. Sections, subsections, tables, figures, and appendices should be bookmarked, with no more than four (4) levels of bookmarks. Hyperlinks within the same PDF document are acceptable, but hyperlinks between different documents must not be used. Stakeholders are responsible for ensuring that hyperlinks function, and links must also include references to the applicable section or page. Documents that legally require signatures may be signed electronically, or the signature page may be printed, signed, scanned, and saved as a PDF. If only one (1) page of a multi-page document contains a signature, the scanned page should be included in the same location in the PDF. Each document should have only one (1) PDF file. The cover letter does not require a signature but should include the printed name, phone number, and email address of the contact person.

As explained in G-Non-eCTD, all regulatory transactions should be validated before being transmitted to HC. For the applicable requirements, including validation rules, see the Rules-Non-eCTD. Initial CTAs and CTA-As should be submitted on electronic media, accompanied by a paper copy of the cover letter, and sent directly to the Office of Clinical Trials within PDD for pharmaceuticals or the Office of Regulatory Affairs within BRDD for biologics and radiopharmaceuticals. The ElecSubms contains a zip file of the folder structure for clinical trial non-eCTD submissions. (Note: As per ElecSubms, G-Non-eCTD is only available upon request at no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure the text 'non eCTD Guidance Document' is in the subject line of the email.)

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

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

All media should be labelled and contain the following information:

Stakeholder Name
Brand Name

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

As per the G-Non-eCTD, G-MDSA, CAN-18, and CAN-17, non-eCTD CTAs involving pharmaceutical drugs should be sent to PDD, and CTAs involving biologics and/or radiopharmaceuticals should be sent to BRDD at the addresses listed below (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

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

Office of Regulatory Affairs
Biologic and Radiopharmaceutical Drugs Directorate
Health Products and Food Branch
Ground Floor, Health Canada Building 6
100 Eglantine Driveway
Tunney’s Pasture
Address Locator: 0601C
Ottawa, Ontario, Canada
K1A 0K9

Telephone: 613-957-1722
E-mail: brdd.ora@hc-sc.gc.ca

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

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

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

Ethics Review Submission

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

Guidance documents, notices, and supporting documents

1.2, 2.2, 2.3, and 2.7

2.3 and 9

3.1-3.4 and Appendix B

1.3 (Table 1), 3.2, and 5

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

Research Ethics Board (Apply for Ethics Review)

Submissions (Does ESG NextGen support Health Canada)

Last content review/update: January 23, 2026

Overview

In accordance with LawNo09-059 and DPM-ClinTrialDocs, Mali requires the sponsor (also referred to as the promoter in Mali) or the principal investigator (PI) to obtain clinical trial authorization from the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)). As delineated in LawNo09-059, the investigator is required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. According to MLI-17, the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d’Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) is the primary EC for reviewing clinical research protocols in Mali. As per LawNo09-059 and the DPM-ClinTrialDocs, the sponsor or the PI must send the EC’s opinion with its application to the DPM prior to the agency commencing its review. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review. (See the Submission Content section for detailed submission requirements).

Regulatory Submission

As per DPM-ClinTrialDocs and MLI-1, applicants must submit an application for clinical trial authorization. DPM-ClinTrialDocs states that one (1) hard copy of the application should be submitted with a commitment signed by the sponsor along with one (1) hard copy of each of the clinical trial application documents. However, MLI-1 indicates that two (2) copies of the application file should be submitted in paper format along with one (1) copy in electronic format (specifying CD or USB drive). MLI-1 further explains that the application file consists of three (3) parts:

Letter of request addressed to the Minister of Health (template provided)
Admissibility and receipt of the application file (consisting of a Checklist to be completed by the applicant and the DPM, and a Receipt box to be completed by the DPM’s research and evaluation section)
Application form (to be completed by the applicant)

According to MLI-17, there are no guidelines on the format of the clinical trial application or proposed protocol amendments. There is no specified language requirement for all the documents to be submitted to the DPM. However, per DPM-ClinTrialDocs, the investigator’s brochure must be provided in French. Additionally, MLI-1 and DecreeNo2017-0245 indicate that the protocol must be written in French.

Ethics Review Submission

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

According to the FMPOS-USTTB-ECProcs, investigators are required to submit 15 hard copies of the application packet to the CIESS/USTTB. The protocol must be submitted in paper and electronic form and the documents must be in French.

National Ethics Committee for Health and Life Sciences (CNESS)

No information is available regarding submission procedures for the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)).

National Institute of Public Health (INSP) Ethics Committee

No information is available regarding submission procedures for the National Institute of Public Health (Institut National de Santé Publique (INSP)) EC.

Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22-23)

Article 3

Annex

Submission Content

Last content review/update: November 2, 2026

Regulatory Authority Requirements

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

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

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

Protocol
Summary of potential risks/benefits
Clinical trial attestation that includes drug information (chemistry, names, classifications, dosage, therapeutic purpose, human-sourced excipient, drug identification number or notice of compliance, manufacturing information); sponsor’s contact information; if the drug is to be imported, contact information for the sponsor’s representative in Canada who is responsible for the sale of the drug; and contact information for the qualified investigator at each site, if known at the time of submittal
Contact information for each institutional ethics committee (EC) (known as Research Ethics Board (REB) in Canada) that approved the protocol, if known at the time of submitting the application (provided in the required Clinical Trial Site Information (CTSI) form (CAN-6))
Contact information of any institutional EC that previously refused to approve the protocol, its reasons, and refusal date
Investigator’s Brochure (IB)
Informed consent form (ICF)
Information about use of a human-sourced excipient
Chemistry and manufacturing information
Proposed date for trial commencement at each site, if known

Per the Mdrn-CTFrmwrk, for multi-site trials operating within a streamlined multi-site ethics review process, sponsors sometimes identify the same EC for all clinical trial sites. When providing information on a new site through CAN-6, sponsors only need to include the contact information for an EC once, as long as:

The same EC has previously been identified as having approved other sites in that trial
The EC's contact information has already been provided to HC in the context of the clinical trial, and continues to be up to date

Accordingly, as indicated in the Mdrn-CTFrmwrk, the form's section on EC approval may only contain the name of the approving board and the date of its approval.

Refer to the CanadaFDR, the G-FDR-0100, the G-CanadaCTApps, the G-DrugApp, the G-QltyBioCTs, and the G-QCM-PharmCTAs for detailed submission information.

Ethics Committee Requirements

Each institutional EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies to be supplied and application format requirements.

The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, requires clinical trial researchers to submit their research proposals for EC review and approval of their ethical acceptability prior to the start of recruitment of participants, data collection, access to data or collection of human biological materials. Researchers must submit sufficient details to enable the EC to make an informed review of the ethical acceptability of the research. In addition, they should include a plan for monitoring safety, efficacy/effectiveness (where feasible), and validity in their proposal for EC review. This plan must describe:

How participant safety will be monitored and what actions will be taken in the event of a threat to participant safety
How intervention efficacy will be monitored (where feasible) and what actions will be taken if efficacy is found to be greater than expected
The criteria by which participants may be removed from a study for safety reasons
The study-wide stopping rules (if any) by which studies may be stopped or amended due to evidence of inferior safety, superior efficacy or futility
The reporting procedure that will be followed to ensure any information relevant to participant welfare or consent is reported clearly and in a timely fashion to the EC

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

Clinical Protocol

The CanadaFDR requires submission of a clinical trial protocol. Per G-FDR-0100, a protocol should describe the objectives, design, methodology, statistical considerations and organization of a clinical trial, and it should be consistent with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52). The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence. CAN-50 indicates that HC adopted CAN-52.

2.3 and 2.7

Introduction, Application and Authorization, and Appendix A (Glossary)

I Introduction, S Drug Substance, and P Drug Product

Chapter 6 (Article 6.11) Chapter 11 (Article 11.6)

1

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

Apply for Ethics Review

Efficacy guidelines

Last content review/update: January 23, 2026

Regulatory Authority Requirements

As specified in DPM-ClinTrialDocs and MLI-1, the following documentation must be submitted by the sponsor (also known as the promoter in Mali) to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Completed clinical trial authorization application signed by the sponsor
Copy of the ethics committee (EC) approval of clinical trial protocol
Copy of the clinical trial protocol signed by the sponsor in French
Copy of investigator’s brochure (IB) in French
Copy of insurance contract covering entire trial period
Updated and valid certificate of clinical trial insurance
Declaration forms completed and signed by the investigator(s)
Copy of informed consent form (ICF)
Participant information note/flyer
Statement of commitment signed by the sponsor
Copy of investigators’ curriculum vitaes (CVs)
Certificate(s) of Good Manufacturing Practices for Products issued by the pharmaceutical regulatory authority in the country of manufacture (clinical trial IP, placebo, comparator product, other products used in the clinical trial)
Copy of product stability certificate
Establishment opening certificates and/or authorization certificates of manufacturing laboratories issued by the pharmaceutical regulatory authority of the country of manufacture
Copies of import and/or export requests for investigational products (IPs)
Supporting documents for payment of application fees
Other documents provided (specify)

Per MLI-17, there are no guidelines on the format and content of the clinical trial application or proposed protocol amendments.

Ethics Committee Requirements

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

As per the FMPOS-USTTB-ECProcs, investigators must submit the following documentation to the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) in the clinical trial application packet:

Application letter
Application form (dated and signed)
Protocol (dated and in print and electronic form) with supporting documents/annexes
Protocol synopsis (non-technical language, if possible)
Description of research related ethical considerations
Summary of IP (e.g., tolerance, pharmacological, pharmaceutical, and toxicological data) (See Investigational Products topic for detailed coverage of this subject)
Summary of clinical experience acquired to date (e.g., IB, publication(s), and product characteristic summaries)
ICF and other related information for potential participants (See Informed Consent topic for additional information)
Participant compensation information (see Insurance & Compensation section for additional information)
Participant information (e.g., booklet of observations, patient diaries, and questionnaires)
Study insurance policy
Opinion of the Scientific Committee from the applicant institution, if available
Investigators’ CVs (dated and signed) and their percentage of time on the project
Recruitment procedures
Investigator declaration to comply with ethical principles
Decision of previous review by other ECs or regulatory authorities (if applicable)
Budget

See the FMPOS-USTTB-ECProcs for detailed CIESS/USTTB submission requirements.

National Ethics Committee for Health and Life Sciences (CNESS)

No information is available regarding submission content for the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)).

National Institute of Public Health (INSP) Ethics Committee

No information is available regarding submission content for the National Institute of Public Health (Institut National de Santé Publique (INSP)) EC.

Clinical Protocol

Per MLI-17, the clinical study protocol should include the following elements:

Protocol summary
Sponsor information
CVs of key personnel and their level of effort within the project
Budget
Trial schedule rationale
Recruitment and enrollment process
Informed consent process
Procedures
Compensation
Risks and benefits
Event grading and reporting

According to DecreeNo2017-0245, the protocol must be written in an easy-to-understand language and comply with international standards. It must also describe the conditions for obtaining the free and informed consent of research participants. Per MLI-17, Mali’s ECs also require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5).

Part 2 - Eligibility and Receipt of the Application File (Section 1 - Checklist)

Articles 3-5

Chapter I, Section II, Annex, and Guide to Ethics Committee Protocol Review

Timeline of Review

Last content review/update: November 2, 2026

Overview

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

Regulatory Authority Approval

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

As specified in the G-CanadaCTApps and the G-MDSA, during the review period, the Directorate may request additional information from the sponsor, who has two (2) calendar days to provide such information. The G-MDSA clarifies that, where warranted, HC can adjust the timelines to be longer or shorter based on the complexity of the request, communications with the sponsor, and/or circumstances of the review, including pausing the clock during the scientific review. The G-CanadaCTApps also states that HC will issue a Not Satisfactory Notice (NSN) if a timely response to requested information has not been provided. The G-MDSA indicates that the review of the submission will stop on the date the NSN is sent.

Ethics Committee Approval

The EC review and approval process timeline varies by institution. The G-TCPS2, which sets the ethical benchmark for all Canadian institutional ECs, recommends a proportionate approach to ethics review—the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review). In either case, pursuant to the G-TCPS2, the institutional EC should make its decisions in an efficient and timely manner.

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

2.1, 2.3.3, 2.5, and 2.7

4.1.3, 4.2 and 4.4

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

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

Apply for Ethics Review

Last content review/update: January 23, 2026

Overview

Per LawNo09-059 and the DPM-ClinTrialDocs, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM))’s review and approval of a clinical trial application is dependent upon obtaining written proof of ethics committee (EC) approvals. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review.

Regulatory Authority Approval

According to MLI-17, the DPM Quality Assurance Division has set the timeline for evaluating applications at 15 days, but there are no guidelines stipulating specific timelines for review. The DPM secretary provides the clinical trial application to the DPM director once it is received. The approval decision is provided to the applicant as well as regional offices, health professional councils, health inspectors, and all Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) departments.

Ethics Committee Approval

Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB)

As specified in the FMPOS-USTTB-ECProcs, the investigator must submit a request to the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d’Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) President at least 15 days before the date of the EC’s meeting to review the protocol. The CIESS/USTTB will then acknowledge receipt of the application and will inform the investigator if the application is complete. The CIESS/USTTB will complete its review of the protocol within a minimum period of 15 days. Only those members who attended the meeting or communicated their opinion at the meeting are permitted to be involved in the decision-making process. The decision will be one (1) of the following: approved, conditional approval (modifications/response to stipulations), or rejected.

The FMPOS-USTTB-ECProcs further states that in the event the president is requested to provide an urgent protocol review (referred to as a restricted review), then the evaluation is conducted according to the same review process used by the EC, but involves only six (6) committee members specifically selected for their expertise in a particular research area. In this case, the decision made by the restricted review committee is communicated to the rest of the EC during the next session. The investigator is notified in writing about the committee’s decision within seven (7) business days.

National Ethics Committee for Health and Life Sciences (CNESS)

No information is available regarding timeline of review for the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)).

National Institute of Public Health (INSP) Ethics Committee

No information is available regarding timeline of review for the National Institute of Public Health (Institut National de Santé Publique (INSP)) EC.

Title 3 (Article 13)

Section II and Annex

Initiation, Agreements & Registration

Last content review/update: November 2, 2026

Overview

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

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

Clinical Trial Agreement

Prior to initiating trial activities, as delineated in the G-FDR-0100, agreements made by the sponsor with the qualified investigator, institution, service providers, and any other parties (e.g., independent data monitoring committee or adjudication committee) involved with the clinical trial should be documented. The sponsor is also responsible for obtaining agreements from all involved parties to permit monitoring and auditing by sponsors, inspections by regulatory authorities (domestic and foreign) and review by ECs, including providing direct access to source records and facilities, including those of service providers. Any of the sponsor's trial-related activities that are transferred to and assumed by a service provider should be documented in an agreement. The sponsor's trial-related activities that are not specifically transferred to and assumed by a service provider are retained by the sponsor.

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

G-Dcntrl indicates that sponsors and QIs are responsible for ensuring that all agreements supporting decentralized trial activities clearly define roles, responsibilities, and oversight expectations. Trial-related activities delegated to service providers should be documented in written agreements that establish how tasks will be performed, supervised, and documented; investigational products and data will be managed; and compliance with regulations and good clinical practice will be maintained.

See CAN-6, CAN-8, and CAN-19 for additional clinical trial forms. Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Clinical Trial Registration

As per the CT-Rgstrn, sponsors should register their clinical trial before it has opened for enrollment in Canada but no later than 21 calendar days after the date of enrollment of the first participant. HC considers the registration date as the date when the clinical trial registration materials are first submitted to a registry. For a multi-national clinical trial with one (1) or more Canadian sites, sponsors should add the Canadian site(s) to their existing registry record. Ideally, this should be done before opening for enrollment, but no later than 21 calendar days after the date of enrollment of the first participant at the Canadian site(s). Sponsors should register their clinical trial with an international clinical trial registry that complies with World Health Organization (WHO) international standards, including the International Clinical Trials Registry Platform (ICTRP) (CAN-60). Two (2) widely used registries that are publicly accessible and part of the WHO network are ClinicalTrials.gov (CAN-45), and the International Standardized Randomized Controlled Trial Number (ISRCTN) Registry (CAN-46). Sponsors should include the protocol code/number in their registry record.

Also see HC’s Clinical Trial Search Portal (CAN-59), which is a search tool to find information about Canadian clinical trials. It is not a registry, but some of the information is collected directly from international registries.

Registration and Resources

1.2 and 2.7

Agreements

5.6

Part C (Division 5 (C.05.006))

Efficacy guidelines

Last content review/update: January 23, 2026

Overview

According to LawNo09-059 and DPM-ClinTrialDocs, a clinical trial can only commence after the sponsor (also known as the promoter in Mali) or the principal investigator (PI) receives authorization from the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)). According to LawNo09-059, the investigator is also required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval.

Per DecreeNo2017-0245, the research must also meet the following conditions:

Benefit the country in general and the people concerned
Be conducted by a person and/or a team qualified with regard to their scientific skills proven in the field
Meet the criteria of good clinical practice and internationally recognized laboratories
Respect locally recognized habits and customs
Respect national and international standards

In addition, per MLI-17, the applicant is required to obtain an import license from the DPM which approves the protocol and forwards the EC letter to the MSDS, also noting that all of the protocol requirements have been met and approved. The MSDS, in turn, signs the clinical trial approval letter and approves the import license for the shipment of an investigational product to be used in the trial (See the Manufacturing & Import section for additional information).

Clinical Trial Agreement

Per DecreeNo2017-0245, national sponsors are required to have a written undertaking of acceptance and collaboration of the team leader of each institution where the research activities take place.

The DPM-ClinTrialDocs also states that before the trial begins, the sponsor(s) should sign the protocol and a statement of commitment to comply with ethical principles. Per MLI-1, prior to initiating the trial, the sponsor should also sign the statement of commitment in the application form for clinical trial authorization (see MLI-1) certifying the accuracy of the information provided in the application; that the trial will comply with the protocol, Malian regulations, and good clinical practice (GCP) principles; and that unexpected serious adverse effects will be declared along with submitting safety reports and a final clinical trial report to the DPM.

In addition, according to MLI-17, Mali’s ethics committees (ECs) also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for additional clinical trial agreement requirements.

Clinical Trial Registration

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

Part 3 - Information (Section 8 - Promoter’s Commitment)

Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22-23)

Articles 3 and 15

Safety Reporting

Last content review/update: November 2, 2026

Safety Reporting Definitions

According to the CanadaFDR and G-CanadaCTApps, the following definitions provide a basis for a common understanding of Canada’s safety reporting requirements:

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

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

For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Safety Reporting Requirements

Investigator Responsibilities

Per the G-FDR-0100, the collection, assessment, and reporting of AEs is a critical component of the conduct of any clinical trial. The assessment of the site AEs should be done by the qualified investigator (QI) or the delegated sub-investigator(s) for seriousness, expectedness, and causality determination, when they become aware. All SAEs should be reported immediately (after the QI reasonably becomes aware of the event) to the sponsor. The QI should also include an assessment of causality. In accordance with applicable regulatory requirements, the protocol may identify SAEs not requiring immediate reporting; for example, deaths or other events that are endpoints. Subsequent information should be submitted as a follow-up report, as necessary.

Sponsor Responsibilities

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

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

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

Other Safety Reports

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

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

Form Completion & Delivery Requirements

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

Additionally, the G-DSUR indicates that HC recommends that DSURs in electronic Common Technical Document (eCTD) format be submitted via the Common Electronic Submissions Gateway (CESG) (CAN-25). For information on eCTD format, refer to the ElecSubms. For technical questions on eCTD filings, contact ereview@hc-sc.gc.ca as instructed in the G-DSUR.

2.1 and 2.8

Notice, 1.2, and 2.4

Serious unexpected adverse drug reaction reporting

Chapter 11 (Article 11.8)

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

Efficacy guidelines

Last content review/update: January 23, 2026

Safety Reporting Definitions

According to OrderNo2011-4201, the following safety reporting definitions provide a basis for a common understanding of Mali’s safety reporting requirements (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Adverse Drug Reaction (ADR) or Adverse Reaction (AR) – All harmful and unintended responses to a medicinal product related to any dose
Adverse Event (AE) – Any untoward medical occurrence in a patient or clinical investigation participant who was administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment
Serious Adverse Event (SAE)/Serious Adverse Effect or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Severe Adverse Effect – Effect requiring, in addition to discontinuation of the drug, additional care
Moderate Adverse Effect – Effect that is neither serious nor severe
Unexpected Adverse Drug Reaction or Unexpected Adverse Reaction – An adverse reaction, the nature or severity of which is not consistent with the applicable product information or summary of product characteristics concerned

In addition, per MLI-17, Mali’s ethics committees (ECs) also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional safety reporting information.

OrderNo2011-4201 established the procedures for implementing pharmacovigilance via Mali’s National Pharmacovigilance System. The system includes the National Pharmaceutical Regulatory Authority (ANRP), the National Pharmacovigilance Reference Center (CNRP), and several advisory bodies. The ANRP is represented by the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)), which is responsible for ensuring compliance with pharmacovigilance operating standards and procedures; transmitting to the manufacturing laboratory the information concerning the undesirable effects of health products, and more. The CNRP is responsible for carrying out technical pharmacovigilance activities and is concerned with the safety of using medicinal products in order to verify facts reported by the notifications received. (See OrderNo2011-4201 for additional details).

Safety Reporting Requirements

As specified in the FMPOS-USTTB-ECProcs, all SAEs/SADRs that occur during the study must be reported to the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d’Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) within 72 hours of the event. All AEs/ADRs and non-serious AEs/ADRs should be identified in the continuing review report.

OrderNo2011-4201 further delineates the following reporting obligations:

Any doctor, dental surgeon, midwife, or health agent with prescribing responsibility who has observed an AE likely to be due to a health product, whether or not the responsible party is the prescriber, must report it immediately to the CNRP
Any pharmacist who becomes aware of an undesirable effect likely to be due to a health product that has been delivered must declare it immediately to the Pharmacovigilance Committee of the district to which the pharmacist belongs
Any member of a healthcare profession having made the same observation must also inform the nearest Pharmacovigilance Committee
The pharmaceutical industry and any producer or distributor of a health product are required to declare any undesirable effect relating to the products they market
Anyone who has had an AE can report to the health worker and/or the nearest health structure

Sponsor Responsibilities

Per the DPM’s application form for clinical trial authorization in Mali (MLI-1), the sponsor (also known as the promoter in Mali) is required to declare unexpected SAEs and to submit safety reports in accordance with the regulations in force in Mali.

Form Completion & Delivery Requirements

No information is available regarding form completion and delivery requirements.

Part 3 - Information (Section 8 - Promoter’s Commitment)

Chapter 1 (Articles 1-2), Chapter 2 (Articles 4-8), and Chapter 3

Article 21

Progress Reporting

Last content review/update: November 2, 2026

Interim and Annual Progress Reports

Pursuant to the CanadaFDR and the G-CanadaCTApps, investigators and sponsors share responsibility for submitting interim and annual reports on the status of a clinical trial. The investigator is required to provide annual progress reports to the institutional ethics committee (EC) and submit interim progress reports to the EC and Health Canada (HC) if there are any significant changes affecting the trial or risk to participants. The sponsor is required to submit annual reports (in the form of an updated Investigator’s Brochure (IB)) to HC. Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

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

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

Final Report

While the CanadaFDR does not require submission of a final study report to HC, the CT-Rgstrn states that HC’s policy for reporting summary results aligns with international initiatives, including the Declaration of Helsinki (CAN-58). Sponsors should submit the summary results of their clinical trial within 12 months following primary study completion, which is the final study visit for collection of data on the primary outcome for the last participant in a global study, whether the clinical trial concluded according to the pre-specified protocol or stopped early. For clinical trials with more than one (1) primary outcome measure with different completion dates, the primary study completion is the date when data collection is completed for all primary outcome measures. In cases where submission of summary results within one (1) year of primary study completion will jeopardize the scientific integrity of the clinical trial, summary results may be submitted within one (1) year of study completion, which is the final study visit for collection of data on any remaining secondary outcome measures and adverse event information for the last participant in the global study, whether the clinical trial concluded according to the pre-specified protocol or stopped early. If a sponsor intends to apply for market authorization for the product studied or a new condition of use, the sponsor may defer submitting summary results until 30 calendar days after HC renders a decision on the application or the sponsor cancels or withdraws it, or up to 36 months following primary study completion, whichever is earlier. HC does not support deferral for products or new conditions of use that the sponsor does not intend to market or for which product development has stopped. Sponsors should submit the summary results of their clinical trial to the same registry where their trial is registered. (See Initiation, Agreements & Registration section for information on clinical trial registration.)

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

Reporting Results

2.8

Chapter 11 (Article 11.8)

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

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Interim and Annual Progress Reports

The Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) does not have country specific progress reporting requirements. However, DecreeNo2017-0245 notes that if the study lasts longer than one (1) year, an annual report must be provided to the ethics committee (EC). Additionally, according to MLI-17, Mali’s ECs follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional information.

The FMPOS-USTTB-ECProcs also states that the principal investigator (PI) must submit an annual progress report to the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d’Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)).

Final Report

Per MLI-1, the sponsor (promoter) is required to submit a final clinical trial report to the DPM no later than one (1) year after the end of the trial.

Per the FMPOS-USTTB-ECProcs, the PI must submit a final report to the CIESS/USTTB following the trial’s conclusion.

In addition, per DecreeNo2017-0245, researchers must provide the results of the research in the form of a workshop, final report, and/or a publication. In addition, a copy of the final report must be provided to the EC, which the committee must keep for at least 10 years. DecreeNo2017-0245 also states that Malian sponsors must inform the national authorities of the research results.

Part 3 - Application (Section 8 – Promoter’s Commitment)

Article 20

Section III (Articles 19 and 22)

Definition of Sponsor

Last content review/update: November 2, 2026

As per the CanadaFDR and the G-CanadaCTApps, a sponsor is defined as an individual, corporate body, institution, or organization that conducts a clinical trial. In accordance with the G-FDR-0100, a sponsor may transfer any or all of the sponsor's trial-related activities to a service provider in accordance with applicable regulatory requirements. However, the ultimate responsibility for the sponsor's trial-related activities, including protection of participants' rights, safety, and well-being and reliability of the trial data, resides with the sponsor.

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

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

2.1

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

Last content review/update: January 23, 2026

As per LawNo09-059, a sponsor (also referred to as a promoter in Mali) is defined as a natural or legal person, an institution, or an organization that supports research through the initiation or financing of a clinical trial.

Per DecreeNo2017-0245, a sponsor may be domestic or foreign. Per MLI-17, an in-country representative is not required.

In addition, per MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional sponsor guidelines.

Title 1 (Chapter 2, Article 2)

Articles 15-16

Site/Investigator Selection

Last content review/update: November 2, 2026

Overview

Per the CanadaFDR and the G-FDR-0100, every sponsor must ensure that a clinical trial is conducted in accordance with good clinical practice (GCP) and must also ensure that:

At each clinical trial site, there is no more than one (1) qualified investigator (QI)
At each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of the QI
Each individual involved in the conduct of the clinical trial is qualified by education, training, and experience to perform the tasks

The G-FDR-0100 explains that the sponsor’s selection and oversight of QIs and service providers are fundamental features of the oversight process. As stated in Mdrn-CTFrmwrk, a "qualified investigator" may be:

A physician or dentist who is authorized under CanadaFDR to act as a qualified investigator
An individual who has the education, training, and experience required to conduct the clinical trial in accordance with regulatory requirements, despite not meeting the regulatory requirement to be a physician or dentist in CanadaFDR

Mdrn-CTFrmwrk further specifies that in clinical trials where the investigator is not a physician or dentist, medical decisions with respect to the trial that are outside the licensed scope of practice of the investigator must be made by a qualified physician or dentist on the clinical trial team who is:

Licensed to practice in the province or territory where the site is located
Responsible for medical oversight and participant care, including medical decisions with respect to the trial

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

Per G-Dcntrl, for clinical trials with decentralized elements, sponsors and QIs should assess whether decentralized locations have sufficient funding, time, equipment, and staff to support trial conduct that complies with GCP. Considerations include local care and institutional practices, provincial or territorial requirements, training needs, and coordination and communication across locations. The main location and remote locations supervised by one (1) QI constitute a single clinical trial site. The main location must be identified on the Clinical Trial Site Information (CTSI) form (CAN-6) and receive EC approval before trial initiation.

For additional guidance on investigator selection, qualifications, and training, see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

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

Foreign Sponsor Responsibilities

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

Data and Safety Monitoring Board

The G-TCPS2 provides the following considerations to help researchers and ECs determine whether a Data and Safety Monitoring Board (DSMB) (known as an Independent Data-Monitoring Committee in Canada) is needed:

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

Also see CAN-52 for ICH guidance on DSMBs.

Multicenter Studies

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

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

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

2.1 and 2.7.2

Design considerations, Single and multi-site clinical trials, and Identifying clinical trial sites

Chapter 11 (Article 11.7)

2

Part C (Division 5 (C.05.005))

Canadian Clinical Trials Asset Map

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Overview

As set forth in LawNo09-059, the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical research study, taking into account the appropriateness and availability of the study site and facilities. When the research is to be conducted in one (1) or more public or private institutions, the sponsor or the principal investigator (PI) is required to inform the director(s) of these institutions prior to initiating the study.

Per DecreeNo2017-0245, all members of the research team must be properly trained on the needs of the research as well as in research ethics. The sponsoring institution must do the following:

Provide training for staff involved in conducting biomedical research
Require researchers to disclose their conflicts of interest in advance
Have the conflict-of-interest declarations reviewed by an ethics committee (EC) and, where appropriate, formulate an appropriate strategy

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to MLI-17, Mali’s ECs also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for additional information.

Foreign Sponsor Responsibilities

DecreeNo2017-0245 further states that international sponsors are required to:

Oversee the scientific and ethical evaluation of biomedical research protocols
Ensure that the proposed biomedical research is compatible with the national ethical, regulatory, and legal requirements
Provide financial, documentary, and other assistance to promote the strengthening of ethical evaluation capacity
Develop reasonable and appropriate activities so that the results can be made available to participants
Assist in defining policies and procedures to encourage the integrity of biomedical research and to provide guidance in case of allegations or evidence of scientific misconduct

In addition, per MLI-17, a foreign sponsor is not required to use a local representative or contract research organization.

Data and Safety Monitoring Board

Mali does not have country specific requirements pertaining to data and safety monitoring boards. See MLI-5 for additional information.

Multicenter Studies

LawNo09-059 notes that a research coordinator should also be appointed to coordinate activities of investigators working on the same project in different centers.

Title 3 (Articles 2 and 13) and Title 4 (Article 20)

Articles 3, 14, and 16-18

Insurance & Compensation

Last content review/update: November 2, 2026

Insurance

The CanadaFDR does not require the sponsor to provide insurance coverage to investigators, institutions, or trial participants. However, the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50, guides sponsors on providing insurance. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Compensation

Injury or Death

The Canadian regulations do not require compensation for trial participants in the event of trial-related injuries or death. However, the G-TCPS2, which sets the ethical benchmark for all Canadian institutional ethics committees (ECs) (known as Research Ethics Boards in Canada), provides that, during informed consent, participants should be given information about any payments, including compensation for injury.

Trial Participation

The Canadian regulations do not require compensation for trial participation. However, as per the G-TCPS2, the informed consent form (ICF) should contain a statement with a description of the anticipated prorated payment to the participant(s) that is reasonably expected for participation in the trial. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants or cause them to overlook important facts and risks.

Also see CAN-52, which guides sponsors on providing compensation.

Chapter 3 (Article 3.2)

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Insurance

According to LawNo09-059, DecreeNo2017-0245, and DPM-ClinTrialDocs, the sponsor is required to carry a valid insurance policy for the expected duration of the study for any unforeseen injury to research participants. LawNo09-059 specifically states that in the case of biomedical research on human beings, the sponsor (also referred to as a promoter in Mali) must obtain an insurance policy guaranteeing the civil liability of the sponsor and all involved parties, regardless of the nature of the relationship between the parties and the sponsor. Furthermore, a sponsor whose civil liability is not guaranteed by an insurance policy is at risk of being imprisoned for one (1) to six (6) months and/or fined 300,000 to 1,000,000 West African CFA francs.

In addition, MLI-1 indicates that an updated and valid certificate of clinical trial insurance should be included in the application submission package (see MLI-1 for the application form).

Compensation

Injury or Death

As specified in LawNo09-059 and the FMPOS-USTTB-ECProcs, the sponsor is responsible for providing compensation to participants in the event of trial-related injuries or death.

Per LawNo09-059, in the case of biomedical research without direct benefit to the participant, the sponsor must provide compensation to the injured participant and indemnify liable parties for any harmful consequences as a result of the research, regardless of whether the sponsor is at fault. In the case of biomedical research with direct benefit to the participant, the sponsor must provide compensation to the injured participant and indemnify liable parties, unless proof is provided verifying that the trial-related injuries are not attributable to the sponsor or that of any intervening party. In either scenario, the sponsor is not permitted to oppose the legal claims of a third party (including the trial participant) or the voluntary withdrawal of the participant who had initially consented to the research.

In addition, according to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for additional compensation requirements.

Trial Participation

Per LawNo09-059 and the FMPOS-USTTB-ECProcs, the participant may also be reimbursed for expenses incurred in connection with participating in the study. However, per LawNo09-059, in the case of commercial benefit from a research study, the sponsor must negotiate benefits or discounts for the community that is the subject in the study.

Post-Trial Access

DecreeNo2017-0245 requires the researcher to ensure that the local community has access to post-study benefits after the trial’s conclusion.

Part 2 - Eligibility and Receipt of the Application File (Section 1 - Checklist)

Title 2 (Articles 8-9), Title 3 (Article 16), and Title 4 (Article 23)

Articles 7 and 14-15

Annex

Risk & Quality Management

Last content review/update: November 2, 2026

Quality Assurance/Quality Control

As stated in the CanadaFDR, the sponsor must ensure that a clinical trial is conducted in accordance with good clinical practice and must ensure, among other things, that the trial is scientifically sound and clearly described in a protocol; the trial and use of the drug comply with the protocol and the CanadaFDR; and systems and procedures that assure the quality of every aspect of the trial are implemented. Regarding quality, the G-FDR-0100 explains that the sponsor is responsible for the establishment of a quality management system consisting of documented procedures (standard operating procedures (SOPs), protocol procedures, etc.) to assure the quality of every aspect of a clinical trial. The range and extent of oversight measures should fit the purpose and be tailored to the complexity of and risks associated with the trial. Quality management includes the design and implementation of efficient clinical trial protocols, including tools and procedures for trial conduct (including data collection and management), to ensure the protection of participants' rights, safety, and well-being, and the reliability of trial results. The sponsor should adopt a proportionate and risk-based approach to quality management, which involves incorporating quality into the design of the clinical trial (i.e., quality by design) and identifying those factors that are likely to have a meaningful impact on participants' rights, safety, and well-being, and the reliability of the results. The sponsor should describe the quality management approach in the clinical trial report.

In addition, G-FDR-0100 states that risks to critical-to-quality factors should be managed proactively and adjusted when new or unanticipated issues arise once the trial has begun. Risk review is a key component to risk-based quality management systems, and Health Canada (HC) expects that sponsors will be able to demonstrate that risk control measures are periodically reviewed and remain effective and relevant, considering emerging knowledge and experience throughout the trial.

Per G-Dcntrl, for trials with decentralized elements, sponsors and qualified investigators (QIs) should collaborate with trial sites and service providers to implement a quality management system covering decentralized activities and supporting compliance with HC regulations and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. Processes should identify, evaluate, control, communicate, and review risks affecting participant safety or the reliability of results, including risks arising from decentralized elements. Additional training, continuing quality checks, and competency assessments may be needed beyond SOPs. See G-Dcntrl for additional details.

Further, CAN-50, Canada implements the ICH Guidance E8(R1): General Considerations for Clinical Studies (CAN-49), which provides guidance on conduct during the clinical trial. Other relevant ICH guidance adopted per CAN-50 are the guidance on statistical principles for clinical trials (CAN-53) and the addendum on estimands and sensitivity analysis (CAN-39). The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Monitoring Requirements

As indicated in the G-FDR-0100, the sponsor should determine the appropriate extent and nature of monitoring based on identified risks. Factors to consider include the objective, purpose, design, complexity, blinding, number of trial participants, investigational product, current knowledge of the safety profile, and endpoints of the trial. Monitoring may include site monitoring (performed onsite and/or remotely) and centralized monitoring. The frequency of monitoring activities should also be determined based on identified risks. Monitoring activities and their frequency should be modified as appropriate using knowledge gained. Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of site monitoring or be used on its own. Use of centralized data analytics can help identify systemic or site-specific issues, including protocol noncompliance and potential unreliable data. In addition to monitoring, a sponsor should perform audits in a manner that is proportionate to the risk associated with the conduct of the trial. See CAN-52 for additional guidance on sponsor responsibilities involving monitoring and auditing.

Further, per the G-FDR-0100, it is critical to include processes that will be followed to address situations of non-compliance, as well as to identify events that would require either a review or revision of the monitoring plan. HC expects these components to be clearly documented in risk-based monitoring plans. The sponsor should describe the requirements of monitoring reports (including their content and frequency) in the standard procedures. Reports of site and/or centralized monitoring should be provided to the sponsor in a timely manner for review and follow up. When needed, the report should describe findings requiring escalation for action and resolution. The sponsor should decide on the appropriate action to be taken, and these decisions and the resolution of the actions involved, where needed, should be recorded. For additional information on monitoring reports, refer to the U.S. Food & Drug Administration (FDA)’s Guidance for Industry: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers.

Next, per the G-FDR-0100, if it is discovered that noncompliance significantly affects or has the potential to significantly affect human participant protection or reliability of trial results, the sponsor should perform a root cause analysis, implement appropriate corrective and preventive actions, and confirm their adequacy, unless otherwise justified. Where the sponsor identifies issues that are likely to significantly impact the rights, safety, or well-being of the trial participant(s) or the reliability of trial results (i.e., serious noncompliance), the sponsor should notify the HC and the institutional ethics committee (known as Research Ethics Boards in Canada).

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

Per G-Inspections, regulated parties (sponsors, qualified investigators, contract research organizations, and any other party involved in the conduct of clinical trials) have mandatory responsibilities under the CanadaFDA and can be inspected. Foreign entities that conduct regulated activities in Canada, or in relation to a product imported in Canada, are also subject to Canadian law. During an inspection or a compliance verification, a regulated party is required to provide all reasonable assistance and information necessary for the HC inspector to perform their duties, including providing evidence that its facility, equipment, and practices and procedures meet the applicable requirements. As indicated in G-Dcntrl, sponsors should oversee decentralized elements in clinical trials across all locations, including remote locations, with monitoring directed toward potential safety concerns, data quality, and reliable results. See the Risk-Insp for HC’s risk classification guide for observations related to inspections of clinical trials of human drugs.

Premature Study Termination/Suspension

The CanadaFDR and the G-CanadaCTApps state that if a trial is prematurely terminated or suspended, the sponsor should inform HC no later than 15 days after the termination or suspension. In addition, the sponsor should provide HC with the reason(s) for the termination or suspension and its impact on the proposed or ongoing clinical trials related to the drug in Canada by the sponsor. The sponsor should also promptly notify the qualified investigators of the termination or suspension and advise them in writing of any potential risks to the participants’ health. Further, the G-CanadaCTApps states that the sponsor’s notification to HC should include confirmation that the sale or importation of the drug to the discontinued sites has been stopped and that reasonable measures to ensure the return of all unused quantities of the drug will be taken. This notification must also be submitted for premature discontinuation of a clinical trial or clinical trial site outside Canada where there are ongoing trials with the drug in Canada. See G-FDR-0100 for additional information and interpretation of discontinuation, suspension, and cancellation. CAN-52 also provides guidance on premature termination or suspension.

2.8.1

Managing risk and Quality management systems

Discontinuation, Suspension and Cancellation, and Good Clinical Practices

2 and 4

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

Purpose and Scope, and Glossary

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Quality Assurance/Quality Control

Mali does not have country specific requirements pertaining to risk and quality management. According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5), which provides details on quality, data, and records management. Refer to MLI-5 for additional quality assurance and quality control requirements.

Monitoring Requirements

Mali does not have country specific monitoring requirements. See MLI-5 for additional information.

Premature Study Termination/Suspension

LawNo09-059 states the sponsor must inform the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) of any premature termination of the investigation and explain the reason for this decision. The FMPOS-USTTB-ECProcs also specifies that in the case of suspension or termination of the study, the investigator must inform the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) within 72 hours and provide reasons for this decision.

Title 3 (Article 13)

Section III (Article 21)

Data & Records Management

Last content review/update: November 2, 2026

Electronic Data Processing System

The G-FDR-0100 states that systems and processes that aid in data capture, management, and analyses, as well as those that help ensure the quality of the information generated from the clinical trial, should fit the purpose of the trial, capture the data required by the protocol, and be implemented in a way that is proportionate to the risks to participants and the importance of acquired data. Quality should be addressed in the design or adaptation of electronic systems for clinical trial purposes to ensure the integrity of relevant trial data. Any electronic system used to capture, process, manage, and/or archive clinical trial information should be adequately validated, and evidence of validation should be retained and readily available for inspection by Health Canada (HC) inspectors. The approach for validation should be based on a risk assessment that considers the intended use of the system; the purpose and importance of the data/record that are collected/generated, maintained, and retained in the system; and the potential of the system to affect the well-being, rights, and safety of trial participants and reliability of trial results. The responsibilities of the sponsor, qualified investigator (QI), and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use. The sponsor should periodically review the risk control measures to ascertain whether the implemented systems remain effective and relevant, considering experience and emerging knowledge.

Per the G-FDR-0100, any modifications or additions made to the electronic system (for example software upgrades or migration of data) can impact its intended functions by altering the quality of validated applications and the system itself. This may affect the integrity of electronic information and the reliability of the system. Therefore, adequate documented assessment and approval of changes to hardware or software during the clinical trial are required. The impact of such a change should be evaluated and documented, and partial validation of some components of the electronic system may be required.

G-Dcntrl states that computerized systems and digital health technologies used in decentralized activities should be suitable for their intended use and validated through a risk-based approach consistent with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. Sponsors should address data transfer integrity, security, interoperability, audit trails, and cybersecurity, with documented procedures and training supporting system development, maintenance, and use. See G-Dcntrl for additional details.

For additional information on computerized system validation and electronic records, see CAN-52. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Records Management

As set forth in the CanadaFDR and the CanadaFDR1024, the sponsor must record, handle, and store all trial-related information to allow complete and accurate reporting, interpretation, and verification. The CanadaFDR requires the sponsor to maintain all trial-related records for a period of 15 years. Per the G-FDR-0100, the electronic system should allow for the retrieval of records and the generation of complete and accurate paper copies of the electronic source data. The system should provide audit trails for the entire 15-year record retention period. Records created, maintained, and processed by outsourced systems are subject to the same requirements as the data/records generated by company-owned systems.

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

G-Dcntrl states that records of agreements and contracts (paper or electronic) must be available or accessible from the main location of the clinical trial site. Per the Mdrn-CTFrmwrk, the sponsor is responsible for obtaining and retaining records for all EC approvals that may be required for participating sites, in accordance with applicable local requirements. The sponsor must retain records of all approvals for verification during clinical trial inspections. To meet this requirement, the sponsor must maintain complete and accurate records demonstrating EC approval for research undertaken at a clinical trial site.

Also see CAN-52 for additional guidance.

Requirements and oversight for digital systems and Agreements

Labeling and Records

1

Part C (Division 5 (C.05.012))

Regulatory Impact Analysis Statement

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Electronic Data Processing System

Mali does not have country specific data processing requirements. According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for additional information.

Records Management

As set forth in LawNo09-059, the sponsor and the investigator must record, process, and maintain research information in such a manner as to permit the presentation of complete and accurate research reports and to facilitate their interpretation and verification.

Title 3 (Article 18)

Personal Data Protection

Last content review/update: November 2, 2026

Responsible Parties

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

Data Protection

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

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

G-Dcntrl states that for decentralized data collection through wearables, digital platforms, or remote monitoring, sponsors should consider where data is stored, who may access it, and how to prevent unauthorized sharing or reuse.

Consent for Processing Personal Data

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

The G-TCPS2 states that to seek broad consent for the storage and future unspecified use of data, researchers must provide prospective participants, or authorized third parties, with applicable information as set out in the informed consent requirements. See the Informed Consent topic, as well as the following details:

The type, identifiability, and amount of data being collected and stored for re-use, and for what potential purpose
The voluntariness of the participant’s consent, including any limitations on the feasibility of withdrawal
A general description of the nature and types of future research that may be conducted, including whether the research might be conducted outside of Canada (if known)
The risks and potential benefits of data storage and use in future unspecified research, including areas of uncertainty where risks cannot be estimated
Access to a general description of the repository and its governance
A statement regarding participants’ preference to being contacted for additional future research
Whether the data could be shared with researchers who are not subject to the G-TCPS2
Whether the research will (if known) or might include whole genome sequencing or similar technologies that may pose a substantial risk of re-identification of the participant or identification of material incidental findings (when appropriate)
Whether linkage of data gathered in the research with other data about participants – either contained in public or personal records – is anticipated
Separate options for consenting to participate in a specific research project and for consenting to the storage of data for future unspecified research

See Brd-Cnst for additional clarifications on broad consent for the storage and future unspecified use of data.

Per G-Dcntrl, when using digital tools for decentralized activities, there may be concerns about data storage, access, and reuse or sharing without consent. Sponsors and qualified investigators can work collaboratively with participants to ensure informed consent is maintained.

Data management plans and Equitable and participant-centred use of technology

Chapter 2 (Article 2.1), Chapter 3 (Article 3.13), and Chapter 5 (A. Key Concepts and 5.1)

Part I (2, 6.1, and 7)

3, 7, and 8

Last content review/update: January 23, 2026

Responsible Parties

For the purposes of data protection regulation in Mali, the Mali-DPL delineates responsibilities for the “data controller.” The data controller is defined as any person who, alone or jointly with others, makes the decision to collect and process data of a personal character and determines its purposes. A “subcontractor,” in turn, is defined as any natural or legal person, public or private, or any other body or association that processes data on behalf of the data controller.

Additionally, Mali-DPL establishes the Personal Data Protection Authority (Autorité de Protection des données à Caractère Personnel) (APDP)), which is responsible for ensuring the protection of personal data and participating in the regulation of the sector. See Mali-DPL for more information on the APDP.

Data Protection

Per the Mali-DPL, the law provides conditions under which personal information may be gathered and processed. The data controller must ensure that all of the necessary precautions are taken to preserve the security of the personal data being collected. In particular, the data controller must prevent the data from being distorted, damaged, or accessed by unauthorized third parties. The authorities who are legally empowered within the framework of a particular investigative mission, such as the judicial authority, the judicial or control police, may ask the controller to communicate personal data to them. The data controller’s subcontractor must also present sufficient guarantees to ensure the implementation of security and confidentiality measures. This requirement does not exempt the data controller from the obligation to ensure compliance with these measures.

The Mali-DPL further explains that the collection and processing of personal data must comply with the following principles:

Be collected and processed in a fair, lawful, and non-fraudulent manner for specific, explicit, and legitimate purposes
Not be used for other purposes
Be adequate, proportionate, and relevant to the purposes for which they are collected or used
Be accurate, complete, and, if necessary, updated
Be kept in a form identifying the persons concerned only for the period needed to serve the purposes for which they are collected or used

These provisions do not preclude the conservation and use of data processed for archival management purposes or for historical, statistical, or scientific purposes in accordance with the procedures defined by law.

See also MLI-4 for additional information related to the processing of personal data in biomedical research.

For additional information about consent, see the Documentation Requirements and Required Elements sections.

Consent for Processing Personal Data

As delineated in the Mali-DPL, a data participant’s consent is defined as any expression of explicit, unequivocal, free, specific, and informed will by which the person concerned or the person’s legal, judicial, or contractual representative, accepts that their personal data be processed.

Mali-DPL also provides a definition for sensitive personal data that encompasses health-related considerations. Sensitive data is defined as any personal data relating to religious, philosophical, political, union, sexual, or racial opinions or activities, as well as health, social measures, prosecutions, criminal, or administrative sanctions. Processing related to sensitive data is prohibited because of the risk of discrimination and infringement of individual rights and freedoms.

However, per Mali-DPL, sensitive data may be processed with the appropriate guarantees as defined by the authority in charge of personal data protection, if the processing is necessary or is implemented to safeguard the life of the data participant or of a third party, when the data participant cannot give consent, due to legal incapacity or material impossibility.

Mali-DPL further explains that when personal data is collected directly from a data participant, during the collection and regardless of the means and media used, the data controller must provide the data participant with the following information:

The data controller’s identity, and where applicable, the representative’s identity
The determined purpose(s) of the processing for which the data is intended
The categories of data concerned
The recipient(s) or categories of recipient(s) to whom the data is likely to be communicated
Whether the answer is compulsory or optional as well as the possible consequences of a lack of response
Whether the data participant can ask to no longer be included in the file
The existence of a right of access to the data concerning the data participant and the rectification of this data
The data retention period
The planned transfers of personal data to foreign countries, where applicable

Chapters 2 (Article 3), 4 (Article 9), 5 (Article 15), and 6 (Articles 20 and 31)

Documentation Requirements

Last content review/update: November 2, 2026

Obtaining Consent

In all Canadian clinical trials, a freely given informed consent is required from each participant in accordance with the requirements set forth in the CanadaFDR and the G-TCPS2. Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

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

The G-TCPS2 states that the qualified investigator (QI) must provide detailed research study information to the participant or legal representative/guardian. The ICF content should be in plain language (i.e., non-technical and easy to understand) and provided in a format that facilitates understanding. For example, written documentation may be supplemented with audio and/or visual aids. The participant and legal representative/guardian should also be given adequate time to consider whether to participate.

As stated in Mdrn-CTFrmwrk, HC is moving from “written” to “documented” informed consent to allow new approaches for obtaining consent (e.g., remote or electronic platforms, electronic signatures, and documentation of consent where it is provided orally). Informed consent requirements will be considered met by HC where processes:

Are appropriately documented
Comply with good clinical practice and CAN-52 principles
Ensure that consent is informed and given in accordance with the applicable laws governing consent

Per G-Dcntrl, sponsors must inform participants of the potential risks and anticipated benefits of any decentralized elements in a clinical trial. In designing and implementing consent processes across locations, sponsors should consider whether the approach may introduce additional cognitive or emotional demands for participants. Reasonable steps should be taken to minimize unnecessary burden while supporting informed and voluntary decision-making. Virtual meeting platforms and electronic signatures may make the informed consent process more efficient for those who live in remote areas. However, participants may face additional challenges in providing informed consent remotely. Sponsors and QIs should be careful not to create a disadvantage for those who face barriers such as reliable private internet access, digital literacy, or comfort with virtual tools, or prefer not to use virtual platforms. Trial-related documentation should support any proposed delegation of duties related to the informed consent process to trial personnel or other third party, any proposed virtual meeting to obtain informed consent, and the proposed medium of the documented record of participants providing their consent (for example, written, video, audio). The following should also be considered:

Providing different methods of informed consent to those who request them, including in-person consent meetings and physical copies of the ICF
Using virtual meeting platforms that include both audio and video features so that QIs (or delegated persons) and participants can take part in the informed consent process and discussion in real time, and interact virtually with a real person

Further, the G-FDR-0100 indicates that a clinical trial participant cannot be involved in any aspect of a clinical trial until they have gone through the informed consent process, with a trial staff member (doctor, study nurse, clinical trial coordinator, etc.) and signed the document indicating that they understand the information and have agreed to participate in the trial. Neither the QI, nor the QI site staff, should coerce or unduly influence a participant to participate or to continue their participation in a trial. A qualified physician should be available to answer any medical questions that the participant may have regarding their participation in the trial. Information should be as clear and concise as possible, use simple language, and avoid unnecessary volume and complexity. See CAN-52 for additional information.

For guidance from Canadian researchers on the core elements for obtaining consent to ensure transparency and improve participants’ understanding of their involvement in research studies, see CAN-57.

Re-Consent

Per the G-TCPS2, consent must be maintained throughout the research project. Researchers have a continuous duty to provide participants with all information relevant to their ongoing consent to participate in the research. Consent begins with the initial contact (e.g., recruitment) and carries through to the end of participation in the study. Throughout the clinical trial, researchers have a continuous responsibility to provide participants and ECs with all information relevant to participants’ ongoing consent to participate in the research. The researcher must also notify participants of any changes to the research project that may affect them. These changes may have ethical implications, may be relevant to their decision to continue in the study, or may be unique to the particular circumstances of individual participants. Specifically, researchers must disclose changes to the risks or potential benefits of the research.

The G-TCPS2 indicates that rather than an age-based approach to consent, researchers should use an approach based on decision-making capacity in compliance with any laws governing research participation. This includes those whose decision-making capacity is in the process of development, those whose decision-making capacity is diminishing or fluctuating, and those whose decision-making capacity remains only partially developed. Mechanisms should be in place from the outset to identify and address any changes that could affect consent. A change in participant capacity is an important element of ongoing consent.

Further, the G-TCPS2 states that within the limits of consent provided by the participant, researchers should disclose to the participant any material incidental findings discovered in the course of research. Incidental findings are considered to be material incidental findings if they are reasonably determined to have significant welfare implications for the participant or prospective participant. Where material incidental findings are foreseeable, researchers should inform participants during the initial consent process. In addition, researchers should develop a management plan for review by the EC. For more information on how to address material incidental findings, see G-ConsentMatIncFindings.

See CAN-52 for additional information.

Language Requirements

Per the G-FDR-0100, the ICF must be made available for each participant in either official language (French or English) or other language as appropriate. The G-TCPS2 requires the ICF to be presented in plain language that the participant is able to understand. If there is a language barrier, the QI should select an intermediary who has the necessary language skills to ensure effective communication.

Documenting Consent

As per the G-TCPS2, the participant or legal representative/guardian, as well as the QI, must sign and date the ICF. The G-FDR-0100 states that the QI should retain the signed ICF.

The G-TCPS2 further indicates that researchers can use a range of procedures to seek and document consent, including oral consent documented in field notes, and other forms of recording (e.g., a consent log, audio or video recordings, or other electronic means). Evidence of consent may also be documented via completed questionnaires (in person, by mail, by email, or other electronic means). ECs should consider the power relationship that might exist between researchers and participants, and whether a waiver of the requirement for signed written consent may affect the welfare of the participants. If researchers plan to obtain non-written consent, they must explain their strategy to the EC.

See CAN-52 for additional information.

Waiver of Consent

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

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

Informed consent process

Good Clinical Practices

Chapters 3 and 10

3

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

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Obtaining Consent

In all Malian clinical trials, a freely given, written informed consent is required to be obtained from each participant in accordance with the principles set forth in LawNo09-059 and DecreeNo2017-0245. In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5).

As per the FMPOS-USTTB-ECProcs and DecreeNo2017-0245, the informed consent form (ICF) and patient information sheet(s) are essential documents that must be reviewed and approved by the EC and provided to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) for approval with the clinical trial application. (See the Required Elements section for details on what should be included in the form.)

LawNo09-059 and DecreeNo2017-0245 state that the investigator or the physician who represents the participant must provide detailed research study information to the participant or the legal representative/guardian. Per DecreeNo2017-0245, in order to provide consent, the participant must have previously received and understood all necessary information on the proposed research and have reached a decision without coercion, influence, undue inducement, or intimidation.

In addition, per DecreeNo2017-0245, the participant's involvement in clinical research must be strictly voluntary. The refusal to participate in clinical research, or the desire to withdraw from the study at any time, must not cause any harm to the participant or the loss of expected benefits.

See also MLI-5 for additional consent requirements.

Re-Consent

No information is available regarding re-consent requirements.

Language Requirements

The FMPOS-USTTB-ECProcs requires the ICF to be presented in written form in a language that the potential participant is able to understand. Per DecreeNo2017-0245, the ICF must also be translated into the language of the person whose consent is required, under the responsibility of the investigator or the legal representative/guardian.

Documenting Consent

LawNo09-059 and DecreeNo2017-0245, state that the participant must sign the ICF. However, per LawNo09-059, if it is not possible for the participant to do so, the participant’s consent may be recorded or filmed. A participant’s consent must be obtained in the presence of a third party who is completely independent of both the investigator(s) and the sponsor. In addition, where biomedical research is carried out on minors or prohibited adults with either direct individual benefit or without direct individual benefit, and the research does not present a serious foreseeable risk, consent must be provided by the legal representative/guardian of these participants. See also MLI-5 for additional consent documentation requirements.

Waiver of Consent

No information is available regarding waiver of consent requirements.

Title 3 (Articles 10 and 12)

Articles 8-10 and 13-14

Annex and Guide to Ethics Committee Protocol Review

Required Elements

Last content review/update: November 2, 2026

Based on the CanadaFDR and the G-TCPS2, the informed consent form (ICF) should generally include the following statements or descriptions in plain language, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

Information that the individual is being invited to participate in a research project
The study involves research and an explanation of its purpose and duration
The identity of the researcher and the funder/sponsor
The procedures to be followed
The participant’s responsibilities
Any reasonably foreseeable risks or anticipated benefits to the participant and in general
Information about any payments, including incentives for participants, reimbursement for participation-related expenses, and compensation for injury
An assurance that prospective participants are under no obligation to participate and are free to withdraw at any time without prejudice to pre-existing entitlements
An assurance that prospective participants will be given, in a timely manner throughout the course of the research project, information that is relevant to their decision to continue or withdraw from participation
An assurance that prospective participants will be given information on their right to request the withdrawal of data or human biological materials, including any limitations on the feasibility of that withdrawal
Information concerning the possibility of commercialization of research findings, and the presence of any real, potential, or perceived conflicts of interest on the part of the researchers, their institutions, or the research sponsors
The measures to be undertaken for dissemination of research results and whether participants will be identified directly or indirectly
The identity and contact information of a qualified designated representative who can explain scientific or scholarly aspects of the research to participants
The identity and contact information of the appropriate individual(s) outside the research team whom participants may contact regarding possible ethical issues in the research
An indication of what information will be collected about participants and for what purposes
An indication of who will have access to information collected about the identity of participants
A description of how confidentiality will be protected
A description of the anticipated uses of data
Information indicating who may have a duty to disclose information collected, and to whom such disclosures could be made
A statement to the effect that, by consenting, participants have not waived any rights to legal recourse in the event of research-related harm
Information on stopping rules and when researchers may remove participants from trial
All other aspects of the clinical trial that are necessary for a person to make the decision to participate in the clinical trial

Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Chapter 3

Part C (Division 5 (C.05.010))

Efficacy guidelines

Last content review/update: January 23, 2026

Based on LawNo09-059 and DecreeNo2017-0245, 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 each source, which provide overlapping and unique elements):

The research objective, the methodology, the trial duration, and the enrollment conditions
The opinion of an approved ethics committee (EC)
Description of any expected risks to the participant, including if the study is prematurely concluded. Risks should not be minimized.
Description of any expected benefits to the participant; benefits should not be exaggerated
Description of other possible benefits for the participant and/or community, whether or not related to participation
Explanation that participation is voluntary, and that the participant can withdraw from the study at any time without liability and without harming the overall scientific quality of the results
Explanation of the principle of compensation provided for time spent participating in the study
Explanation of the management of adverse events that may occur during the study
Explanation of the principle of confidentiality and its preservation

In addition, according to MLI-17, Mali’s ethics committees (ECs) also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional ICF requirements.

Title 3 (Article 10)

Article 12

Participant Rights

Last content review/update: November 2, 2026

Overview

In accordance with the CanadaFDR and the G-TCPS2, Canada’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-TCPS2 states that a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

The Right to Participate, Abstain, or Withdraw

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

The Right to Information

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

The Right to Privacy and Confidentiality

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

The Right of Inquiry/Appeal

The G-TCPS2 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 the participant’s rights.

The Right to Safety and Welfare

The G-FDR-0100 upholds the Declaration of Helsinki (CAN-58), which states 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.

Good Clinical Practices

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

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

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Overview

As delineated in LawNo09-059 and DecreeNo2017-0245, a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. According to MLI-17, Mali’s ethics committees also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional guidance.

(See the Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Prisoners sections for additional information regarding requirements for participant rights.)

The Right to Participate, Abstain, or Withdraw

As set forth in LawNo09-059 and DecreeNo2017-0245, the participant should be informed that participation is voluntary, that the participant may withdraw from the research study at any time without liability and without detriment to the overall scientific quality of the results.

The Right to Information

As delineated in LawNo09-059 and DecreeNo2017-0245, a potential research participant has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, and any potential compensation, benefits, risks, or constraints. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality

Per DecreeNo2017-0245, 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.

See also MLI-4 for additional information related to the protection of personal data in biomedical research.

The Right of Inquiry/Appeal

Per DecreeNo2017-0245, the research participant or the 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

DecreeNo2017-0245 states 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.

Title 3 (Article 10)

Articles 9 and 11-14

Emergencies

Last content review/update: November 2, 2026

G-FDR-0100 states that in emergency situations, when prior consent of the participant is not possible, the consent of the participant's legal representative/guardian (as defined by provincial requirements), if present, should be requested. When prior consent of the participant is not possible, and the participant's legal representative/guardian is not available, enrollment of the participant should require measures described in the protocol and/or elsewhere, with documented approval by the ethics committee (EC) (known as a research ethics board in Canada), to protect the participant's rights, safety, and well-being, and to ensure compliance with applicable regulatory requirements. The participant or the participant's legal representative/guardian should be informed about the trial as soon as possible, and consent should be requested as appropriate.

Also see the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which Canada has implemented per CAN-50. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

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

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

The G-TCPS2 states that consent will not apply to public health activities undertaken by federal, provincial, and territorial public health officials operating under statutory powers during publicly declared health emergencies. The Ethcs-Emrgcy is an educational resource that provides ethical considerations, including for consent, to help institutions, ECs, and researchers protect participants and uphold public trust in the ethics review and conduct of research during publicly declared emergencies. It includes examples of practical applications from various publicly declared emergency contexts.

Good Clinical Practices

Chapter 3 (Articles 3.7-3.9) and Chapter 6 (D)

Information on ICH guidelines implemented by Health Canada and Efficacy Guidelines

Last content review/update: January 23, 2026

LawNo09-059 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by medical emergencies. According to MLI-17, Mali’s ethics committees (ECs) also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional guidance on consent requirements during emergencies.

As per LawNo09-059, the EC may approve emergency medical research when informed consent cannot be obtained from the participant. The investigator must submit a protocol for the EC’s approval that requires only the consent of the participant’s legal representative/guardian, if they are present. The participant should be informed about the research as soon as possible, at which time consent will be requested.

Title 3 (Article 11)

Vulnerable Populations

Last content review/update: November 2, 2026

Overview

Per the G-FDR-0100, the responsibility of an institutional ethics committee (EC) (known as a research ethics board in Canada) is to protect the rights, safety, and well-being of all human participants. An EC should pay special attention to trials that may include vulnerable human participants (elderly, children, mentally ill, prisoners, etc.). The G-TCPS2 states that in all Canadian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process.

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

Good Clinical Practices

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

Last content review/update: January 23, 2026

Overview

In all Malian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. LawNo09-059 states that biomedical research may only be carried out on persons incapable of giving consent or those who are unable to give consent due to restricted freedom, if consent is provided by their legal representative/guardian, and they will benefit individually or collectively from participating in the study.

According to LawNo09-059, these participants may include minors and adults incapable of giving their consent and under guardianship, pregnant women or women of childbearing age, persons deprived of their freedom, persons staying in a health or social institution, and patients in emergency situations.

DecreeNo2017-0245 mentions the following as vulnerable persons: pregnant or breastfeeding women, persons deprived of liberty, persons unable to express themselves with full cognizance, and minors. According to MLI-17, Mali’s ethics committees also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for additional guidance.

Per LawNo09-059, if a study is to be conducted without direct benefit to the participant(s), the research must comply with the following conditions:

Present no serious and foreseeable health risks
Be useful to people with the same age, illness, or disability characteristics
Provide results that cannot be achieved otherwise

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

Title 2 (Articles 4-7) and Title 3 (Article 12)

Article 6

Children/Minors

Last content review/update: November 2, 2026

Per CAN-35, because the G-TCPS2 does not specify an age of consent for children, the decision on whether to seek consent from children is based on whether they have the capacity to understand the research and the risks and benefits of their participation. Youth who have not reached the age of majority (either 18 or 19 depending on the province or territory) may still be old enough to provide their own consent. For children who are not sufficiently mature to provide consent but are able to understand the nature of study participation, researchers must obtain the child’s assent in addition to the consent of an authorized third party. The decision of a child not to assent must be respected regardless of whether third-party consent was obtained. (Note: CAN-35 offers practical guidance that is consistent with the G-TCPS2, but it is only required for research reviewed by the joint Health Canada (HC)-Public Health Agency of Canada (PHAC) Research Ethics Board (REB).)

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

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

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

As per the G-TCPS2, when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. All pediatric participants, however, should be informed to the extent compatible with the child’s understanding, and if capable, the pediatric participant should sign and personally date the ICF.

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

Assent Requirements

G-FDR-0100 states that if minors are to be included in a trial, the EC should review the assent information considering the age, maturity, and psychological state of the minor population intended to be enrolled, as well as applicable regulatory requirements. Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of the consent process, and assent from the minor to enroll in the trial should be obtained as appropriate. A process for consent should be considered if, during the trial, the minor reaches the age of legal consent, in accordance with applicable regulatory requirements.

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

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

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

For more details and guidance about best practices for research involving pediatric participants, see CAN-12.

Good Clinical Practices

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

1

Guidelines III and IV

Consent Process (Key Considerations)

Last content review/update: January 23, 2026

DecreeNo2017-0245 states that the rights of participants who are minors must be particularly protected. According to MLI-17, Mali’s definition of a child/minor and the age of consent is individuals below 18 years of age.

Per LawNo09-059, minors may be solicited for biomedical research only if they can benefit individually or collectively.

In accordance with LawNo09-059, when the research participant is a minor with either direct or indirect individual benefit, their parent/legal guardian must provide consent. In addition, the research must not present a serious foreseeable risk to participants who are minors.

In addition, per LawNo09-059, if a study is to be conducted without direct benefit to participant(s) who are minors, the research must comply with the following conditions:

Present no serious and foreseeable health risks
Be useful to people with the same age, illness, or disability characteristics
Provide results that cannot be achieved otherwise

Additionally, according to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional guidance.

Assent Requirements

No information is available regarding assent requirements.

Title 2 (Article 7) and Title 3 (Article 12)

Article 6

Pregnant Women, Fetuses & Neonates

Last content review/update: November 2, 2026

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

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

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

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

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

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

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

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

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

Last content review/update: January 23, 2026

DecreeNo2017-0245 states that the rights of participants who are pregnant or breastfeeding must be particularly protected.

As per LawNo09-059, biomedical research involving a woman of childbearing age or one who is pregnant may only be conducted if the benefits of the research outweigh the risks to the woman and her embryo, her fetus, or her child.

According to MLI-17, Mali’s ethics committees also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional guidance.

Title 2 (Article 5)

Article 6

Prisoners

Last content review/update: November 2, 2026

According to the G-TCPS2, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority.

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

Last content review/update: January 23, 2026

While no information is available specifically regarding prisoner consent requirements, DecreeNo2017-0245 states that the rights of participants deprived of liberty must be particularly protected.

According to LawNo09-059, persons deprived of liberty may only be solicited for biomedical research if they are expected to receive a direct and major benefit for their health.

Title 2 (Article 6)

Article 6

Mentally Impaired

Last content review/update: November 2, 2026

According to the G-TCPS2, the ethics committee (EC) (known as Research Ethics Board in Canada) must approve the participation of research participants who are mentally or physically incapable of giving consent.

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

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

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

Chapter 3 (Article 3.7-3.10)

Last content review/update: January 23, 2026

DecreeNo2017-0245 states that the rights of participants unable to express themselves with full cognizance must be particularly protected.

According to MLI-17, Mali’s ethics committees also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional guidance.

Article 6

Definition of Investigational Product

Last content review/update: November 2, 2026

As delineated in the CanadaFDR and the G-GMP-Annex13, an investigational product is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form.

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

5.1

Appendix A

Part C (Division 5 (C.05.001))

Last content review/update: January 23, 2026

According to MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for detailed investigational product guidelines and definitions.

Manufacturing & Import

Last content review/update: November 2, 2026

Manufacturing

As specified in the CanadaFDR and the G-CanadaCTApps, Health Canada (HC) authorizes the manufacture of investigational products (IPs) in Canada. HC approves the manufacture of IPs as part of the clinical trial application (CTA) approval. The G-QCM-PharmCTAs provides guidance and templates to assist sponsors in completing the quality portion of the CTA, which in turn, enables HC to assess IP characteristics adequately. The G-GMP-Annex13 requires the sponsor to ensure that IPs for clinical trials are manufactured and imported in accordance with its provisions and with CanadaFDR requirements. Per the G-CanadaCTApps, sponsors must file amendments or notifications to a previously authorized CTA when manufacturing changes are proposed that may affect the quality or safety of the clinical trial drug or biologic supplies.

Per G-GMP-Annex13, during development, critical parameters and in-process controls should be identified, adapted based on production experience, and justified by the knowledge available at the time. Although the manufacturing process need not be validated to the extent necessary for routine production, premises and equipment are expected to be validated in accordance with applicable good manufacturing practice (GMP) principles. Manufacturers must identify process steps that ensure participant safety and the reliability and robustness of clinical trial data and maintain written cleaning procedures and analytical methods to prevent cross-contamination. For sterile products, controls and processes related to sterility should meet the same standards as those for marketed products; where required, virus inactivation/removal and removal of other biological impurities should be demonstrated, with enhanced attention to aseptic-process validation and operator training. If a drug is modified, data such as stability, comparative dissolution, or bioavailability should demonstrate that the changes do not significantly alter its original quality characteristics; the sponsor should justify an appropriate retest date, and a reference sample of the comparator product should be retained following repackaging or over-encapsulation. For blinded products, systems should maintain the blind while permitting rapid product identification when necessary; where the manufacturer generates randomization codes, unblinding information should be available to the person in charge of quality control before the drugs are supplied, and the expiry assigned to all products should correspond to that of the shortest-dated product. See the G-GMP-Annex13 for additional details.

Per CAN-55, HC is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and meets international GMP standards.

Per CAN-50, Canada has implemented the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which provides additional guidelines on manufacturing IPs. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Import

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

The G-FDR-0100 provides additional guidance on requirements if a sponsor plans to send the clinical trial IP(s) directly to each trial site:

A No Objection Letter (NOL) has been issued by HC authorizing the importation of the clinical trial material in Phase I-III trials; no clinical trial drugs should be imported prior to the NOL issuance and the NOL should accompany the package at the time of the importation
Each party, including individual Canadian clinical trial sites, importing drugs directly (i.e., receiving drug shipments directly from outside of Canada) is identified on Appendix 1 of the Drug Submission Application Form (HC/SC 3011 form) (CAN-4)
Clinical Trial Site Information (CTSI) forms (CAN-6) for each Canadian site conducting the clinical trial are submitted to HC for Phase I-III trials, prior to the start of the study
Systems are in place, when appropriate, to monitor the transportation and storage conditions from the foreign source to the various clinical trial sites across Canada
There is documented accountability of the imported drugs used in clinical trials and distributed to various clinical trial sites located in Canada, including the disposition of drugs returned from the clinical trial sites
A written agreement is in place between the sponsor and the qualified investigator (QI) describing their specific responsibilities, and this agreement is available at the clinical trial site
There is evidence that the drugs used in clinical trials conducted in Canada meet GMP requirements (e.g., certificates of manufacture, certificates of analysis, and/or evidence of approved lot release by a QI)

The G-CanadaCTApps, the G-HlthProdImprtExptReqs, the G-FDR-0100, and CAN-32 state that if a sponsor wants to import a drug into Canada for a clinical trial, a copy of HC’s authorization (i.e., the NOL) issued by either the Pharmaceutical Drugs Directorate (PDD) or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) must be included for the applicable trial with the shipment. A copy of this authorization must be provided at the port of entry. The G-HlthProdImprtExptReqs states that drugs without a Drug Identification Number may be imported where authorized for a Canadian clinical trial and a NOL was issued. The G-FDR-0100 further states that if 30 days have passed and the NOL was not issued, specific requests to import IPs should be directed to the Health Product Border Compliance Program at the following email account: hpbcp-pcpsf@hc-sc.gc.ca. Note that a sponsor does not have to submit a CTA for authorization to import an IP used in a Phase IV clinical trial.

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

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

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

2.3 and 2.7

Section # Block D and Appendix 1 Guidance

Application and Authorization and Good Clinical Practices

1.0 and 8.2-8.4

Importer’s Role, Table 1, and Human Drugs

I Introduction, S Drug Substance, and P Drug Product

Part C (Divisions 2-5)

Appendix 1

Drug Importation

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Manufacturing

According to DPM-ClinTrialDocs, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) is responsible for authorizing the manufacture of investigational products (IPs) in Mali. The DPM reviews the manufacture of an IP as part of its review and approval of the clinical trial application. (See the Submission Process section for detailed application requirements).

According to MLI-17, Mali’s ethics committees (ECs) also follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional IP manufacturing requirements.

DecreeNo2017-0245 further mandates that clinical research must follow good clinical practices. In addition, as specified in MLI-1, the sponsor (also known as the promoter in Mali) must provide the following documentation to the DPM in the clinical trial application submission package:

Certificate(s) of good manufacturing practice (GMP) for products issued by the pharmaceutical regulatory authority in the country of manufacture (Clinical trial IP, placebo, comparator product, and other products used in the clinical trial)
Establishment opening certificates and/or manufacturing authorizations for manufacturing laboratories issued by the pharmaceutical regulatory authority of the country of manufacture (see MLI-1 for application)

Import

According to MLI-17, the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) is responsible for authorizing the import of IPs in Mali. Once the DPM receives the EC approval letter, it reviews and forwards the letter to the MSDS, noting that the protocol has met all of the requirements and is approved. The MSDS, in turn, signs the clinical trial approval letter and approves the import license prior to product shipment. Per DPM-ClinTrialDocs, the import license is valid for six (6) months. (See the Scope of Assessment section for more details on the clinical trial application review process). Per MLI-1, the sponsor must also provide copies of import and/or export requests for IPs to the DPM in the clinical trial application submission package (see MLI-1 for application).

Please note: Mali is party to the Nagoya Protocol on Access and Benefit-sharing (MLI-6), 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 MLI-14.

Part 2 – Eligibility and Receipt of the Application File (Section 1 - Checklist)

Articles 3 and 18

Quality Requirements

Last content review/update: November 2, 2026

Investigator’s Brochure

In accordance with the CanadaFDR, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all the relevant information on the investigational product(s) (IPs), including significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information. The sponsor must ensure that an up-to-date IB is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee. Per CAN-50, Canada has implemented the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which provides additional guidance on IB development and contents. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.

The CanadaFDR requires the IB to provide coverage of the following areas:

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

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

Quality Management

As specified in the G-GMP-CAN and G-GMP-Annex13, the sponsor must ensure that the products are manufactured in accordance with good manufacturing practice (GMP). The G-GMP-CAN requires a quality management system, incorporating GMP, to ensure that IPs are of the quality required for their intended use.

Per the G-GMP-Annex13, the manufacturer’s quality system should be described in written procedures and available to the sponsor, taking into account GMP principles and guidelines. The manufacturer should establish and maintain a quality control system placed under the authority of a person who has the requisite qualifications and is independent of production. Quality control of the clinical trial drug, including that of the comparator product or placebo, should be performed in accordance with the information submitted in the application for the clinical trial, as authorized by the relevant country. Verification of the effectiveness of blinding should be performed and recorded.

Per the G-FDR-0100, if a sponsor plans to send the clinical trial IP(s) directly to each trial site, there should be evidence that the drugs used in clinical trials conducted in Canada meet GMP requirements (e.g., certificates of manufacture, certificates of analysis, and/or evidence of approved lot release by a qualified individual).

2.8

4, 8.2, and 9.0

4

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

Information on ICH guidelines implemented by Health Canada and Efficacy guidelines

Last content review/update: January 23, 2026

Investigator’s Brochure

Mali does not have country specific Investigator’s Brochure (IB) requirements. However, according to MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). Refer to MLI-5 for detailed investigational product (IP) quality guidelines.

Quality Management

In accordance with the FMPOS-USTTB-ECProcs, an applicant must also provide the Institutional Ethics Committee for Health and Life Sciences Research (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie (CIESS))/University of Sciences, Techniques and Technologies of Bamako (Université des Sciences, des Techniques et des Technologies de Bamako (USTTB)) with the following IP information in the clinical trial application submission:

An adequate summary of all tolerance, pharmacological, toxicological, and pharmaceutical data available on the IP to be evaluated
A summary of the clinical experience to date with this IP (e.g., recent IB, publication(s), and summarized product characteristics)

See also MLI-5 for additional IP quality management requirements.

Annex

Labeling

Last content review/update: November 2, 2026

Investigational product (IP) labeling in Canada must comply with the requirements set forth in the CanadaFDR, the G-CanadaCTApps, and the G-GMP-Annex13. The CanadaFDR and the G-CanadaCTApps state that for an IP to be used in a clinical trial, it must be properly labeled in both official languages: English and French. The CanadaFDR requires that IPs be packaged and labelled under the supervision of personnel who have had satisfactory technical, academic, and other training. The packager and/or labeler must have written procedures and ensure that the IP is packaged, labelled, and tested in compliance with those procedures. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100. Per CAN-50, Canada has implemented the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which provides additional guidelines on labeling IPs. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

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

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

Per the G-FDR-0100, a label includes any legend, word, or mark attached to, included in, belonging to, or accompanying any drug or package. The sponsor is responsible for ensuring that the labeling of a clinical trial drug meets the requirements of the CanadaFDR, and that the system in place is validated, traceable, and does not compromise participant safety or product quality. The required information must be attached to, included with, or accompany each container of the drug product. If a label provides all the required information in both official languages (English and French), it is considered to have met the requirements of the CanadaFDR. However, traceability to the manufacturing lot should be maintained on the label immediately attached to the IP (i.e., primary container) such that its identity can be determined, and, if necessary, which unit was dispensed to each participant. For blinded clinical trials the sponsor must ensure that labeling information does not compromise the blinding. Labeling of a clinical trial drug with a manufacturer's lot number may compromise a blinded clinical trial. Identifiers other than a "lot" or "(L)" number (for example a batch number, a kit number, or a bar code) may be considered compliant, provided traceability is maintained. Where a bar code is included as the identifier on the label, the code on the drug label should readily link to information (for example, lot number and expiration date) through a validated computerized system. During an inspection, HC may verify that there is a system of traceability in place to ensure participant safety and that the computerized system, if applicable, is fully validated. It is acceptable for a marketed drug used in a clinical trial as a comparator, to be labelled in accordance with its marketing authorization, provided that the label on the marketed drug is appropriate for the trial. However, a marketed comparator drug used off-label must comply with the IP labeling requirements.

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

As indicated in the G-FDR-0100, HC may verify that a clinical trial drug has a valid expiration date during an inspection. If stability studies to support the expiration date for an IP are still ongoing at the time of labeling, the following may be considered acceptable in lieu of an expiration date:

A re-test date on the label if the sponsor has data to support the extended shelf-life of the drug, and
A manufacturing date is listed on the label, as long as the clinical trial site where the drug is dispensed has a document from the sponsor documenting the shelf-life of the drug

The above process should be documented, and procedures and quality control systems should be in place and in accordance with the approved clinical trial application. This additional labeling information should be properly documented in both the trial documentation and in the packaging records.

2.8.7

Labelling and Records

8.6

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

Efficacy guidelines

Last content review/update: January 23, 2026

Mali does not have country specific investigational product (IP) labeling requirements. However, per MLI-17, Mali’s ethics committees follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for additional IP labeling requirements.

Product Management

Last content review/update: November 2, 2026

Supply, Storage, and Handling Requirements

Per CanadaFDR, drugs must be manufactured, handled, and stored in accordance with good manufacturing practice (GMP). For investigational product (IP) packaging, the G-GMP-Annex13 provides the following guidance:

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

The G-Storage provides principles and interpretations on the environmental control of clinical trial drugs during storage and transportation, including packaging. See G-Storage for information regarding compliance with the CanadaFDA and the CanadaFDR, as it relates to packaging clinical trial drugs for human use, such as the role of environmental controls, quality risk management, and special considerations for active pharmaceutical ingredients.

G-Dcntrl states that for decentralized activities, sponsors and qualified investigators (QIs) must ensure GMP- and protocol-compliant transport, storage, and handling of IPs. Sponsors are responsible for preserving product integrity during transport and storage and addressing controlled-substance diversion risks. QI oversight may include maintaining accountability for the IP at decentralized locations. Sponsors should ensure that direct-to-home shipment and dispensing comply with applicable provincial and territorial requirements.

Per CAN-50, Canada has implemented the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R3) (CAN-52), which provides additional guidance on IP management. The G-FDR-0100 explains the relationship between the CanadaFDR and CAN-52, including additional guidance where needed or where CAN-52 does not apply. At all times, where the CanadaFDR exceeds the guidance set out in CAN-52, the CanadaFDR takes precedence.

Record Requirements

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

Per the G-FDR-0100, drug accountability records should include the following information:

Date of arrival on site
Quantity received
Identification (batch/lot number)
Expiration date
Quantity and date dispensed and to whom
Quantity and date returned by participants
Quantity and date of destruction or return to sponsor

As explained in the G-FDR-0100, to ensure that participants receive the IP according to their randomization, qualified investigators (QIs) should maintain records. The QI and/or a pharmacist or other appropriate individual should maintain records of the product's delivery, the inventory, the use by each participant (including documenting that the participants were provided the doses specified by the protocol), and the return to the sponsor and destruction or alternative disposition of unused product(s). Drug accountability records are required for:

Drugs that are the subject of the clinical trial, and do not have market authorization
Drugs that are the subject of the clinical trial, have market authorization, but are used off-label
Comparator drug, if it does not have market authorization
Comparator drug, if it has market authorization, but its labeling was changed (for example for blinding purposes)
Comparator drug, if it has market authorization, but is used off-label (unless it was not considered to be investigational in the context of the particular clinical trial, based on the assessment of the application)

Further, per in the G-FDR-0100, drug accountability records are not required for:

Drugs that are the subject of a Phase IV clinical trial
Comparator drug, if it has market authorization, is used on-label, and has not been altered in any manner
Rescue or concomitant medications, authorized for sale in Canada, that may be used on or off-label but are not the subject of the clinical trial (for example, they are used as supportive medications for known clinical applications)

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

See CAN-52 for additional guidance on IP record keeping.

Designing the trial, Quality management systems, and Roles and responsibilities

Labelling and Records

8.6

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

Regulatory Impact Analysis Statement

Efficacy guidelines

Last content review/update: January 23, 2026

Supply, Storage, and Handling Requirements

Mali does not have country specific investigational product (IP) management requirements. However, per MLI-17, Mali’s ethics committees (ECs) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R3) (MLI-5). See MLI-5 for IP supply, storage, and handling requirements.

Record Requirements

Mali does not have country specific IP record requirements. Refer to MLI-5 for IP record requirements.

Definition of Specimen

Last content review/update: November 2, 2026

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

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

Chapter 12 and Glossary

Glossary

Last content review/update: January 23, 2026

No applicable requirements

Specimen Import & Export

Last content review/update: November 2, 2026

Import/Export

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

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

Other Considerations

Per the G-TCPS2, institutions and researchers that maintain biobanks must ensure that they have or use appropriate facilities, equipment, policies, and procedures to store human biological materials safely, and in accordance with applicable standards. They must also establish appropriate physical, administrative, and technical safeguards to protect human biological materials and any information about participants from unauthorized handling. Procedures for storage and record keeping must include effective measures to ensure that participants’ identities are protected, including the security of facilities and effective procedures for data handling, record keeping, and regulating access to human biological materials and information. Appropriate governance of biobanks is also important for managing access to and use of stored biological materials. The appropriate governance structure and management of a biobank will vary depending on its size and usage. Organizations that maintain biobanks may have their own policies on privacy of, confidentiality of, and access to materials. Researchers should be aware of requirements for compliance with such policies. Identifiable data derived from human biological materials may be linked to other research or public databases. Researchers who propose to engage in data linkage must obtain ethics committee (EC) approval prior to carrying out the data linkage. Where data linkage involves or is likely to produce identifiable information, researchers must show that the data linkage is essential to the research, and appropriate security measures will be implemented to safeguard information.

Blood and blood components for transfusion

Chapter 5 (5.7) and Chapter 12 (12.5)

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

Licenses

Chapters 1 and 2

Last content review/update: January 23, 2026

No applicable requirements

Consent for Specimen