Mali
Mali

Quick facts

Clinical trial application language Unspecified
Regulatory authority & ethics committee review may be conducted at the same time No
Clinical trial registration required No
In-country sponsor presence/representation required No
Age of minors Up to 17
Specimens export allowed Unspecified

Regulatory Authority > Regulatory Authority

Last content review/update: September 15, 2022

Directorate of Pharmacy and Medicine (DPM)

Per DecreeNo2011-753, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) is the competent authority 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 clinical trial’s commencement, the DPM must review the clinical trial application research data submitted by the sponsor or principal investigator, as well as the opinion(s) of the ethics committee(s) consulted.

As set forth in DecreeNo2011-753 and MLI-8, the DPM is a regulatory body under the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)). An MSDS-appointed director is authorized to direct, coordinate, oversee, and control the directorate’s pharmaceutical activities. Law-MOHOrg also notes that the DPM’s mission is to define pharmaceutical regulations, examine and monitor drug marketing authorization dossiers, develop and implement national programs for essential drugs, and create support tools in the rational use of medicines.

DecreeNo2011-753 and OrderNo00-3476 further specify that the DPM consists of three (3) divisions including the Regulation and Monitoring Division of the Practice of the Pharmaceutical Profession (also known as the Medicine Regulation Division), the Quality Assurance and Economics of Medicines Division (also known as the Quality Assurance Division), and the Biomedical Analysis Laboratories Division.

Per DecreeNo2011-753, OrderNo00-3476, and MLI-8, the Regulation and Monitoring Division of the Practice of the Pharmaceutical Profession is responsible for regulating and defining the rules governing market authorization, supervising the procedure for importing, exporting, and placing pharmaceutical products on the market, and managing pharmaceutical product storage, distribution, and destruction.

DecreeNo2011-753 and MLI-8 also explain that the Quality Assurance and Economics of Medicines Division coordinates the DPM’s quality assurance procedures, handles the review of clinical trial authorization records, ensures the evaluation and follow-up of clinical trials, and manages the development of Mali’s pharmacovigilance program.

Per DecreeNo2017-0245, the DPM must:

  • Ensure strict compliance with ethical standards, and good clinical and laboratory practices by researchers
  • Arbitrate between the participants and/or researchers in case of occurrence of offense(s) and/or deviation(s)
  • Apply the law in force for any offense(s) and deviation(s) from the protocols by the researchers

Please note: Mali is party to the Nagoya Protocol on Access and Benefit-sharing (MLI-6), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see MLI-14.

Contact Information

Per MLI-10 and MLI-11, the DPM’s contact information is as follows:

Ministry of Health and Social Development
Directorate of Pharmacy and Medicine (DPM)
Street 569 (Darsalam limit shopping center) Commune II Bamako
BPE 5202
Mali

Phone: Int. (223) 222 65 70
Fax: Int. (223) 223 24 63
Email:
dpm@dirpharma.org

Chapter 1 ((Section 1, Articles 2 and 3) and (Section 2))
Article 18
2.1
Title 3 (Article 13)
Articles 1-8
Context
II (The Challenges of Mastering the Procedure) and III (1)
Clinical Trial Oversight

Regulatory Authority > Scope of Assessment

Last content review/update: September 15, 2022

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

Per MLI-9, the DPM secretary provides the clinical trial application to the DPM director once he or she has received it. 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 provided to the applicant as well as regional offices, health professional councils, health inspectors, and all MSDS departments.

MLI-9 also notes that DPM conducts fast-track processing of applications, such as in the case of the Ebola vaccine trial. However, regulations that cover these circumstances are not available.

Chapter 1 ((Section 1, Articles 2 and 3) and (Section 2))
Article 3
Title 3 (Article 13)
Context

Regulatory Authority > Regulatory Fees

Last content review/update: September 15, 2022

According to MLI-9, applicants do not pay fees for any Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) services.

Ethics Committee > Ethics Committee

Last content review/update: September 15, 2022

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 Committee of Ethics 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. Furthermore, the EC assumes the moral responsibility of the state and is directed to follow the investigator’s implementation of the protocol at its own expense.

According to MLI-17, Mali’s EC system consists of six (6) committees:

  • CNESS
  • Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS))
  • 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

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 Ethics Committee (INSP EC)

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 both 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 upon 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 his/her 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.

National Institute of Public Health (INSP EC)

As per DecreeNo2019-0247, the INSP EC meets each time as needed, mainly for reviewing protocols submitted for its approval, upon convocation 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.

Articles 4-11 and 16
Article 1
Chapter 2
Articles 5, 17, and 19
Articles 22-23
Title 3 (Article 13)
Chapter III (Articles 22 and 23)
Article 1

Ethics Committee > Scope of Review

Last content review/update: September 15, 2022

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, such as pregnant or breastfeeding women, people deprived of liberty, persons unable to express themselves with full cognizance, as well as minors, must be particularly protected when they are participating in a study.

Per MLI-17, all six (6) ECs in Mali follow the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (MLI-7).

Per MLI-17, Mali’s ECs also require researchers to comply with MLI-7.

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 (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) is to give opinions on the ethical problems raised by the progress of research in the field 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 (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology (FMOS)).

Per the FMPOS-USTTB-ECProcs, in addition to complying with the MLI-7, 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 good clinical practice (GCP) guidelines prepared by the Collaborative Institutional Training Initiative (CITI) Program (MLI-13), and all new members are required to take the CITI training.

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 on ethical issues raised by advances in knowledge in the fields of medicine, pharmacy, biology, health, and other life sciences, and to make recommendations in these areas.

National Institute of Public Health (INSP)

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 reassessment after integrating the feedback and requested changes from the EC. The EC is obliged to consider 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.

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 Ethics Committee for Health and Life Sciences (CNESS)/ National Institute of Public Health (INSP)

According to MLI-17, the CNESS and INSP's ECs only participate 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 Mali government or protocols of public health importance to the country.

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
Title 2 (Article 3) and Title 3 (Articles 10 and 12-15)
Articles 1 and 21
1.25, 4, and 5.5

Ethics Committee > Ethics Committee Fees

Last content review/update: September 15, 2022

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

As stated in D-No2021-0415, the operating costs of the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) are covered by the costs of submitting research protocols to this committee. Per the FMPOS-USTTB-ECProcs, the cost to submit a protocol for review by the CIESS/USTTB is 20,000 West African CFA francs (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS)).

However, per 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 currently available regarding payment instructions for the CIESS/USTTB.

National Ethics Committee for Health and Life Sciences (CNESS)

No information is currently 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)

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

Article 18
Chapter I (Section I, Article 8)

Ethics Committee > Oversight of Ethics Committees

Last content review/update: September 15, 2022

Overview

No information is available regarding ethics committee (EC) authorization in Mali. However, per DecreeNo2017-0245, the state, the local authorities, the development partners, and the 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

Clinical Trial Lifecycle > Submission Process

Last content review/update: September 15, 2022

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 (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d’Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) is the primary EC for reviewing clinical research protocols in Mali (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS)). 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, applicants must submit one (1) hard copy of the application with a commitment signed by the sponsor and one (1) hard copy of each of the clinical trial application documents. Per MLI-9, 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. In addition, per DecreeNo2017-0245, 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 currently available on 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)

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

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

Clinical Trial Lifecycle > Submission Content

Last content review/update: September 15, 2022

Regulatory Authority Requirements

As specified in DPM-ClinTrialDocs, the following documentation must be submitted to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)):

  • Clinical trial application
  • Copy of the ethics committee (EC) approval
  • Copy of the clinical trial protocol signed by the sponsor
  • Copy of investigator’s brochure (IB) in French
  • Copy of insurance contract covering entire trial period
  • Copy of informed consent form (ICF)
  • Statement of commitment signed by the sponsor
  • Copy of investigators’ curriculum vitaes (CVs)
  • Copy of product manufacturing certificate
  • Copy of product stability certificate
  • Copy of marketing authorization from the country of origin

Per MLI-9, 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 (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) in the clinical trial application packet (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS)):

  • 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 investigational product (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 currently available on 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)

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

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 require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MLI-7).

Articles 3-5
Chapter I, Section II, Annex, and Guide to Ethics Committee Protocol Review
6

Clinical Trial Lifecycle > Timeline of Review

Last content review/update: September 15, 2022

Overview

Per LawNo09-059, 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 the ethics committee (EC) approvals. Therefore, the DPM review and approval process may not be conducted in parallel with the EC review.

Regulatory Authority Approval

Per MLI-9, 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 he/she receives it. 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.

MLI-9 also notes that the DPM conducts fast-track processing of applications, such as in the case of the Ebola vaccine trial. However, regulations that cover these circumstances are not available.

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 (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) 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 their decision within seven (7) business days (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS)).

National Ethics Committee for Health and Life Sciences (CNESS)

No information is currently available on 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)

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

Section II and Annex
Title 3 (Article 13)

Clinical Trial Lifecycle > Initiation, Agreements & Registration

Last content review/update: September 15, 2022

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 team qualified with reference to their scientific skills proven in the field
  • Meet the criteria of good clinical practice and internationally recognized laboratories
  • Respect the habits and customs recognized locally
  • 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.

In addition, according to the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) MLI-7, the sponsor should obtain the investigator's/institution's agreement to:

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

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

Clinical Trial Registration

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

Articles 3 and 15
Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22 and 23)
5.6

Clinical Trial Lifecycle > Safety Reporting

Last content review/update: September 15, 2022

Safety Reporting Definitions

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(R2) (MLI-7), which provides the following safety reporting definitions:

  • Adverse Drug Reaction (ADR): All noxious 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) 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
  • Unexpected Adverse Drug Reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable product information

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 (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) within 72 hours of the event. All AEs/ADRs and non-serious AEs/ADRs should be identified in the continuing review report.

Form Completion & Delivery Requirements

No information is currently available regarding form completion and delivery requirements.

Article 21
1, 4.11, and 5.16

Clinical Trial Lifecycle > Progress Reporting

Last content review/update: September 15, 2022

Interim and Annual Progress Reports

As delineated in the FMPOS-USTTB-ECProcs, the principal investigator (PI) must submit an annual progress report to the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS)).

DecreeNo2017-0245 also notes that if the study lasts longer than one (1) year, an annual report must be provided to the ethics committee (EC).

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(R2) (MLI-7), which also explains that the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial and/or increasing the risk to participants.

Final Report

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 it must keep for at least 10 years. DecreeNo2017-0245 also states that Malian sponsors must inform the national authorities of the research results.

Article 20
Section III (Articles 19 and 22)
4.10 and 4.13

Sponsorship > Definition of Sponsor

Last content review/update: September 15, 2022

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.

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(R2) (MLI-7), which also specifies that a sponsor-investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

MLI-7 also notes that a sponsor may transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

Per DecreeNo2017-0245, a sponsor may be domestic or foreign.

Articles 15-16
Title 1 (Chapter 2, Article 2)
1.53, 1.54, 5.1, and 5.2

Sponsorship > Site/Investigator Selection

Last content review/update: September 15, 2022

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:

  • Ensure the training of staff who participate in the conduct of 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, make adjustments

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices (GCPs). 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(R2) (MLI-7), which provides guidance to sponsors on investigator and site selection. According to MLI-7:

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

Foreign Sponsor Responsibilities

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

  • Take charge of the scientific and ethical evaluation of biomedical research protocols
  • Ensure that the proposed biomedical research is compatible with the ethical, regulatory, and national legal systems
  • Provide financial, documentary, and other assistance with a view to promoting the strengthening of ethical evaluation capacity
  • Develop reasonable and appropriate activities so that the results can be made available to participants
  • Help to define specific policies and procedures to encourage the integrity of biomedical research and to serve as a guide 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

MLI-7 notes that a Data Safety Monitoring Board (DSMB) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Multicenter Studies

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

As delineated in MLI-7, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and the EC approval provided
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication among investigators is facilitated
Articles 3, 14, and 16-18
Title 3 (Articles 2 and 13) and Title 4 (Article 20)
1.25, 5.5, 5.6, and 5.23

Sponsorship > Insurance & Compensation

Last content review/update: September 15, 2022

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. The 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 take out an insurance policy guaranteeing his/her civil liability, and that of 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.

Compensation

Injury or Death

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(R2) (MLI-7), which provides guidance for sponsors on how to compensate research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

As specified in LawNo09-059 and the FMPOS-USTTB-ECProcs, the sponsor is responsible for providing compensation to injured 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.

Trial Participation

Per LawNo09-059 and the FMPOS-USTTB-ECProcs, the participant may also be reimbursed for expenses incurred in connection with his/her participation in the study. However, per LawNo09-059, in the case of commercial benefit of a research study, the sponsor must negotiate patronage dividends for the community being studied.

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

Articles 7, 14, and 15
Title 2 (Articles 8-9), Title 3 (Article 16), and Title 4 (Article 23)
Annex
4.8 and 5.8

Sponsorship > Risk & Quality Management

Last content review/update: September 15, 2022

Quality Assurance/Quality Control

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(R2) (MLI-7), which provides details on quality, data, and records management. Per MLI-7, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

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

Audit Requirements

Per MLI-7, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Per the FMPOS-USTTB-ECProcs, the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (Comité Institutionnel d'Éthique de la Recherche en Santé et en Sciences de la Vie/Université des Sciences, des Techniques et des Technologies de Bamako) must 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 (Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS)).

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 CIESS/USTTB within 72 hours and provide reasons for this decision.

Section III (Articles 18 and 21)
Title 3 (Article 13)
5.1, 5.15, 5.19, 5.21, and 6.10

Sponsorship > Data & Records Management

Last content review/update: September 15, 2022

Electronic Data Processing System

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(R2) (MLI-7). Per MLI-7, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base his/her approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to MLI-7 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.

Per MLI-7, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, MLI-7 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Title 3 (Article 18)
1.65, 5.5, and 8

Sponsorship > Personal Data Protection

Last content review/update: September 15, 2022

Responsible Parties

In addition, for the purposes of data protection regulation in Mali, the Mali-DPL delineates responsibilities for the “data controller.” According to the Mali-DPL, 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.

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 he/she takes all of the necessary precautions 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 his/her 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 allowing the identification of the persons concerned for a period which does not exceed that necessary for 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.

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

Consent for Processing Personal Data

Mali-DPL 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 subject or of a third party, when the data subject cannot give his consent, due to legal incapacity or material impossibility.

Chapter 2 (Article 3) and Chapter 4 (Article 9)

Informed Consent > Documentation Requirements

Last content review/update: September 15, 2022

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(R2) (MLI-7).

As per the FMPOS-USTTB-ECProcs, DecreeNo2017-0245, and MLI-7, 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, DecreeNo2017-0245, and MLI-7 state that the investigator or the physician who represents the participant must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). 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.

Per MLI-7, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

Re-Consent

No information is currently available regarding re-consent requirements.

Language Requirements

The FMPOS-USTTB-ECProcs requires the ICF to be presented in written form in the 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 his/her legal representative.

Documenting Consent

LawNo09-059, DecreeNo2017-0245, and MLI-7 state that the participant must sign the ICF.

Per LawNo09-059, if it is not possible for the participant to do so, his/her 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(s) of these participants.

MLI-7 states that where the participant is illiterate and/or his/her legal representative(s) and/or guardian(s) is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

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

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

Waiver of Consent

No information is currently available regarding waiver of consent requirements.

Articles 8-10 and 13-14
Annex and Guide to Ethics Committee Protocol Review
Title 3 (Articles 10 and 12)
2, 4.4, 4.8, 8.2, and 8.3

Informed Consent > Required Elements

Last content review/update: September 15, 2022

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(R2) (MLI-7). Based on LawNo09-059, DecreeNo2017-0245, and MLI-7, the informed consent form (ICF) should include the following statements or descriptions, as applicable (note that specific items might not be included in each source):

  • The study purpose, the procedures, the duration of the trial, and the enrollment conditions
  • The trial treatment(s) and the probability for random assignment to each treatment
  • The participant’s responsibilities and the expected duration of his/her participation
  • Experimental aspects of the study
  • Any expected risks to the participant, including if the study is prematurely concluded. Risks should not be minimized. If applicable, risks to the embryo, fetus, or nursing infant should be described.
  • Explanation of the compensation and/or medical treatment available in case of adverse events that occurred during the study
  • Any expected benefits to the participant; benefits should not be exaggerated; it should be made clear when there is no intended clinical benefit
  • A description of other possible benefits for the participant and/or community, whether or not related to participation
  • That participation is voluntary, and that the participant can withdraw from the study at any time without liability and without detriment to the overall scientific quality of the results
  • In the case of withdrawal, the participant may request the withdrawal
  • Any compensation provided for time spent participating in the study
  • Any anticipated expenses for participating in the study
  • The contact information for the EC, the principal investigator, and any organization or person to be contacted regarding the clinical research and the participant's rights
  • That the monitor(s), the auditor(s), the EC, and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or the participant's legally acceptable representative is authorizing such access
  • The extent to which confidentiality of records identifying the participant will be maintained
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study that may affect the participant's willingness to continue
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • Approximate number of participants involved in the study
Article 12
Title 3 (Article 10)
4.4 and 4.8

Informed Consent > Participant Rights

Last content review/update: September 15, 2022

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 follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MLI-7), which addresses participant rights.

(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, DecreeNo2017-0245, and MLI-7, the participant should be informed that participation is voluntary, that he/she 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, DecreeNo2017-0245, and MLI-7, 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 and MLI-7, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. It is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal

Per DecreeNo2017-0245 and MLI-7, the research participant and/or his/her legal representative(s) or guardian(s) 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 his/her rights. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Safety and Welfare

DecreeNo2017-0245 and MLI-7 principles state that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

Articles 9 and 11-14
Title 3 (Article 10)
2, 3.1, and 4.8

Informed Consent > Emergencies

Last content review/update: September 15, 2022

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) follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MLI-7), which addresses consent in the case of medical emergencies.

As per LawNo09-059 and MLI-7, 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(s) or guardian(s), if they are present. The participant should be informed about the research as soon as possible, at which time his/her consent will be requested.

Title 3 (Article 11)
4.8

Informed Consent > Vulnerable Populations

Last content review/update: September 15, 2022

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(s) and/or guardian(s), 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 follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MLI-7), which includes the following as vulnerable populations: members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable populations include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

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.

Article 6
Title 2 (Articles 4-7) and Title 3 (Article 12)
1.61 and 4.8

Informed Consent > Children/Minors

Last content review/update: September 15, 2022

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 refers to individuals up to 17 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 individual benefit or without direct individual benefit, their legal representative(s) and/or guardian(s) most 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

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(R2) (MLI-7), which states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

Assent Requirements

No information is currently available regarding assent requirements.

Article 6
Title 2 (Article 7) and Title 3 (Article 12)
4.8

Informed Consent > Pregnant Women, Fetuses & Neonates

Last content review/update: September 15, 2022

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

As per LawNo09-059, any Malian clinical studies 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 follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MLI-7), which states that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

Article 6
Title 2 (Article 5)
4.8

Informed Consent > Prisoners

Last content review/update: September 15, 2022

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. The definition of a prisoner is not currently available in the regulatory resources.

Article 6
Title 2 (Article 6)

Informed Consent > Mentally Impaired

Last content review/update: September 15, 2022

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 follow and require researchers to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (MLI-7), which states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participant should be informed about the trial to the extent compatible with his/her understanding and, if capable, he/she should sign and personally date the written informed consent.

Article 6
1.61, 3.1, and 4.8

Investigational Products > Definition of Investigational Product

Last content review/update: September 15, 2022

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(R2) (MLI-7), which defines an investigational product as a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unauthorized indication, or when used to gain further information about an approved use.

1.33

Investigational Products > Manufacturing & Import

Last content review/update: September 15, 2022

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).

Per MLI-9, Mali does not have any legal requirements that IPs be produced in compliance with Good Manufacturing Practices (GMP). However, 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(R2) (MLI-7), which requires IPs to be manufactured, handled, and stored in accordance with applicable GMPs and used in accordance with the approved protocol.

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 ethics committee (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).

Please note: Mali is party to the Nagoya Protocol on Access and Benefit-sharing (MLI-6), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see MLI-14.

Articles 3 and 18
2.12 and 5.13

Investigational Products > Quality Requirements

Last content review/update: September 15, 2022

Investigator’s Brochure

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(R2) (MLI-7), which provides detailed IB requirements. MLI-7 specifies that the Investigator’s Brochure (IB) must contain all of the relevant information on the investigational products (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse event data. The sponsor should also update the IB as significant new information becomes available.

As specified in MLI-7, the IB must include the following sections:

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

See MLI-7 for detailed content guidelines.

Quality Documentation

MLI-7 requires IPs to be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practices (GMPs).

Per MLI-7, the sponsor must also maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

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

(Note: The CIESS recently changed its name from the Faculty of Medicine and Odontostomatology) (FMOS))

Annex
5.13, 5.14, 7, and 8.2

Investigational Products > Labeling

Last content review/update: September 15, 2022

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(R2) (MLI-7), which states that the investigational product (IP) be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.

5.13

Investigational Products > Product Management

Last content review/update: September 15, 2022

Supply, Storage, and Handling 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(R2) (MLI-7), which provides guidance on investigational product (IP) management. Per MLI-7, the sponsor must supply the investigator(s)/institution(s) with the IP(s), but not until he/she obtains approvals from the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)) and an EC.

The sponsor must ensure the following:

  • IP product quality and stability over the period of use
  • IP manufactured according to any applicable Good Manufacturing Practices (GMPs)
  • Proper coding, packaging and labeling of the IP(s)
  • Records maintained for document shipment, receipt, disposition, return, and destruction of the IP(s)
  • Acceptable storage temperatures, conditions, and times for the IP
  • Timely delivery of the IP(s)
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary

Record Requirements

Per MLI-7, the sponsor should comply with the following records requirements:

  • Maintain records that document shipment, receipt, disposition, return, and destruction of the IP(s)
  • Maintain a system for retrieving IPs and documenting this retrieval (e.g., for deficient product recall, reclaim after trial completion, and expired product recovery)
  • Maintain a system for the disposition of unused IP(s) and for the documentation of this disposition
2.12, 5.5, 5.12, 5.13, 5.14, and 7

Specimens > Definition of Specimen

Last content review/update: September 15, 2022
No relevant provisions.

Specimens > Specimen Import & Export

Last content review/update: September 15, 2022
No relevant provisions.

Sources > Requirements

(Legislation) Law No. 09-059/of 28 December 2009 Governing Biomedical Research on Humans (LawNo09-059 - English, unofficial translation) (French) (December 28, 2009)
Republic of Mali
(Legislation) Law No. 2013-015 of May 21, 2013 on the Protection of Personal Data in the Republic of Mali (Mali-DPL - French) (May 21, 2013)
Republic of Mali
(Legislation) Law No. 2019-023/of 3 July 2019 - Ratifying Order No. 2019-011/P-RM of 27 March 2019 Establishing the National Institute of Public Health (INSP) (LawNo2019-023 - French) (July 3, 2019)
Republic of Mali
(Legislation) The Mandates of the Actors and Bodies in Health Development: The 2009 Organization Chart of the Ministry of Health (Law-MOHOrg - French) (Last Updated April 22, 2009)
Ministry of Health and Social Development
(Regulation) Decision No. 2020-001817/MSDS-SG of 18 November 2020 - Appointing the Ethics Committee Members of the National Institute of Public Health (INSP) (D-No2020-001817 - French) (November 18, 2020)
Ministry of Health and Social Development
(Regulation) Decision No. 2021-0415/USTTB-R/SG-SAJE - On the Establishment, Organization and Operation of the Institutional Ethics Committee for Health and Life Sciences Research of the University of Sciences, Techniques and Technologies of Bamako (D-No2021-0415 - French) (December 23, 2021)
Ministry of Higher Education and Scientific Research; University of Sciences, Techniques and Technologies of Bamako
(Regulation) Decision No. 2021-0416/USTTB-R/SG-SAJE - Establishing the Institutional Ethics Committee Member List for Health and Life Sciences Research of the University of Sciences, Techniques and Technologies of Bamako (D-No2021-0416 - French) (December 23, 2021)
Ministry of Higher Education and Scientific Research; University of Sciences, Techniques and Technologies of Bamako
(Regulation) Decree No. 02-200/P-RM of 22 April 2002 - Establishing the National Ethics Committee for Health and Life Sciences (DecreeNo02-200 - English, unofficial translation) (April 22, 2002)
Council of Ministers
(Regulation) Decree No. 2011-753/P-RM of 17 November 2011 - Establishing the Organization and Operating Methods of the Directorate of Pharmacy and Medicine (DecreeNo2011-753 - French) (November 17, 2011)
Council of Ministers
(Regulation) Decree No. 2015-0864/P-RM of 31 December 2015 - Appointing the President of the National Ethics Committee for Health and Life Sciences (DecreeNo2015-0864 - French) (December 31, 2015)
President of the Republic
(Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 - Establishing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 - French) (GoogleTranslate-DecreeNo2017-0245) (March 13, 2017)
Council of Ministers
(Regulation) Decree No. 2019-0246/P-RM of 27 March 2019 - Establishing the Organization and Operating Methods of the Bamako Dermatology Hospital (DecreeNo2019-0246 - French) (March 27, 2019)
President of the Republic
(Regulation) Decree No. 2019-0247/P-RM of 27 March 2019 – Establishing the Organization and Operating Methods of the National Institute of Public Health (DecreeNo2019-0247 - French) (March 27, 2019)
President of the Republic
(Regulation) Documents to be Provided for a Clinical Trial (DPM-ClinTrialDocs - English, unofficial translation) (French) (July 3, 2014)
General Secretariat, Department of Pharmacy and Medicine, Ministry of Health and Social Development
(Regulation) Rules of Procedure of the FMPOS Ethics Committee (FMPOS-USTTB-ECProcs - English, unofficial translation) (French) (January 14, 2012)
Faculty of Medicine of Pharmacy and Odontostomatology
(Order) Order No. 00-3476/Ms-Sg - Setting Out the Details of the Organization of the Sections of the Directorate of Pharmacy and Medicine (OrderNo00-3476 - French) (December 29, 2000)
Ministry of Health and Social Development
(Order) Order No. 2019-011/P-RM - Creating the National Institute of Public Health (OrderNo2019-011 - French) (March 27, 2019)
Ministry of Health and Social Development
(Order) Order No. 2019-5050/MSAS-SG of 31 December 2019 - Amending the Nominative List of Members of the National Ethics Committee for Health and Life Sciences (OrderNo2019-5050 - French) (December 31, 2019)
Ministry of Health and Social Development
(Order) Order No. 2021-5895/MSDS-SG of 31 December 2021 - Appointing the Members of the Institutional Ethics Committee of the Bamako Dermatology Hospital (HDB) (OrderNo2021-5895 - French) (December 31, 2021)
Ministry of Health and Social Development

Sources > Additional Resources

(Article) Factors Influencing the Regulation of Clinical Trials in Mali (MLI-2 - French) (Winter 2011)
Diadié Maïga, Lise Lamothe, Bryn Williams-Jones, and Régis Blais; Governance Review
(Document) Assessment of DPM Medicine Regulatory System, Mali (MLI-9) (October 2017)
Kikule K., S. Diarra, A. Sangare, M. Thumm, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and US Agency for International Development (USAID)
(Document) Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (MLI-3) (2005)
World Health Organization
(Document) Nagoya Protocol on Access and Benefit-sharing (MLI-6) (2011)
Convention on Biological Diversity, United Nations
(Document) Procedure Manual for Registration of Multisource Drugs (MLI-8 - French) (Version V2) (August 15, 2008)
Directorate of Pharmacy and Medicine, Ministry of Health and Social Development
(Document) Validation Workshop of the Project to Create the Scientific Committee of Alioune Blondin Beye Peacekeeping School (EMP-ABB) of Bamako (MLI-19 - French) (April 2022)
EMP-ABB News
(International Guidance) Declaration of Helsinki (MLI-16) (October 19, 2013)
World Medical Association
(International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (MLI-7) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Not Available Online) NIAID Correspondence with the CIESS/USTTB (June-September 2022) (MLI-17)
(Webpage) CITI Program - FAQ (MLI-13) (Current as of August 23, 2021)
Collaborative Institutional Training Initiative (CITI) Program
(Webpage) Country Profile: Mali (MLI-14) (Current as of August 23, 2021)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(Webpage) Directorate of Pharmacy and Medicine (MLI-10 - French) (Last Updated January 5, 2019)
Ministry of Health and Social Affairs
(Webpage) Directory Search: Directorate of Pharmacy and Medicine (MLI-11 - French) (Last Updated January 5, 2019)
Ministry of Health and Social Affairs
(Webpage) National Institute of Research in Public Health: BP 1771 Bamako - Mali (MLI-15 - French) (Last Updated July 16, 2021)
Geneva Foundation for Medical Education and Research (GFMER)

Sources > Forms

No Forms available.
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Details on the most recent Mali updates are available here.

Directorate of Pharmacy and Medicine Website

The Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) website is currently offline, but we are monitoring the situation and will update the Mali profile as needed.

COVID-19 Guidance

African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews (April 20, 2020)

This message was reviewed on November 30, 2022