Mali
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
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 Unspecified
Age of minors Up to 17
Specimens export allowed Unspecified
Regulatory Authority > Regulatory Authority
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2011-753/P-RM of 17 November 2011 - Fixing the Organization and Modalities of Operation of the Directorate of Pharmacy and Medicine (DecreeNo2011-753 - French) (November 17, 2011)
Council of Ministers
Relevant Sections: Chapter 1 (Section 1, Articles 2 and 3) and (Section 2)
(2) (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
Relevant Sections: Title 3 (Article 13)
(3) (Regulation) 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 Affairs
Relevant Sections: Articles 1-8
(4) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Article 18
Summary

Overview

As per DecreeNo2011-753, LawNo09-059, and as described in Additional Resources (A) and (B), in practice, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) and the ethics committees (ECs) are responsible for regulating clinical trials.

More specifically, per DecreeNo2011-753, the 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 take into account the opinion(s) of the EC(s) consulted when reviewing the clinical trial application’s research data.

As set forth in DecreeNo2011-753 and Additional Resource (C), the DPM is a regulatory body under the Ministry of Health and Social Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)). An MSAS-appointed director is authorized to direct, coordinate, oversee, and control the directorate’s pharmaceutical activities.

DecreeNo2011-753 and OrderNo00-3476 further state that the DPM consists of three (3) divisions including the Division of Regulatory Affairs and Follow-up of the Pharmaceutical Profession (also known as the Medicine Regulation Division), the Division of Quality Assurance and Economics of Medicines (also known as the Quality Assurance Division), and the Division of Laboratories for Biomedical Analysis.

Per DecreeNo2011-753, OrderNo00-3476, and Additional Resource (C), the Division of Regulatory Affairs and Follow-up 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 Additional Resource (C) also state that the DPM’s Division of Quality Assurance and Economics of Medicines 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

Contact Information

Per Additional Resource (D), contact information is as follows:

Ministry of Health and Social Affairs
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

Additional Resources
Diadié Maïga, Lise Lamothe, Bryn Williams-Jones, and Régis Blais; Governance Review
Relevant Sections: Context: Mali
Kikule K., S. Diarra, A. Sangare, M. Thumm, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and US Agency for International Development (USAID)
(C) (Manual) Procedure Manual for Registration of Multisource Drugs (French) (Version V2) (August 15, 2008)
Directorate of Pharmacy and Medicine, Ministry of Health and Social Affairs
Relevant Sections: II (The Stakes of the Control of the Procedure) and III (1)
(D) (Website) Directorate of Pharmacy and Medicine (French) (Last Updated January 5, 2019)
Ministry of Health and Social Affairs
Regulatory Authority > Scope of Assessment
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2011-753/P-RM of 17 November 2011 - Fixing the Organization and Modalities of Operation of the Directorate of Pharmacy and Medicine (DecreeNo2011-753 - French) (November 17, 2011)
Council of Ministers
Relevant Sections: Chapter 1 (Section 1, Articles 2 and 3) and (Section 2)
(2) (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
Relevant Sections: Title 3 (Article 13)
(3) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Article 3
Summary

Overview

As indicated in DecreeNo2011-753 and Additional Resource (A), the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) within the Ministry of Health and Social Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)) 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 take into account the opinion(s) of the ethics committees (ECs) consulted when reviewing the clinical trial application’s research data.

According to LawNo09-059 and Additional Resource (B), the DPM review and approval process takes place after the EC review and approval. 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.

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

Clinical Trial Review Process

Per Additional Resource (C), the DPM secretary provides the clinical trial to the DPM director once he or she received it. The DPM director then initially assigns the application to either the Medicine Regulation Division (also known as the Division of Regulatory Affairs and Follow-Up of the Pharmaceutical Profession) or the Quality Assurance Division (also known as the Division of Quality Assurance and Economics of Medicines). 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 Affairs 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 MSAS departments.

Additional Resource (C) 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 is not available.

Additional Resources
Diadié Maïga, Lise Lamothe, Bryn Williams-Jones, and Régis Blais; Governance Review
Relevant Sections: Context: Mali
(B) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 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)
JuriAfrica
Regulatory Authority > Regulatory Fees
Last content review/update: August 21, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

According to Additional Resource (A), applicants do not pay fees for any DPM services.

Additional Resources
Kikule K., S. Diarra, A. Sangare, M. Thumm, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and US Agency for International Development (USAID)
Ethics Committee > Ethics Committee
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 3 (Article 13)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 5, 17, and 19
(3) (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
(4) (Order) Order No. 2015-2310/MSHP-SG of 22 July 2015 – Announcing the Members of the National Ethics Committee for Health and Life Sciences (OrderNo2015-2310 – French) (July 22, 2015)
Ministry of Health and Social Affairs
(5) (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
Relevant Sections: Chapters I and II, Annex, and Guide to Ethics Committee Protocol Review
Summary

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. DecreeNo2017-0245 states that all clinical research protocols must be submitted to the National Committee of Ethics for Health and Life Sciences (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.

As set forth in LawNo09-059 and Additional Resource (A), EC approval is required prior to obtaining the Directorate of Pharmacy and Medicine’s (la Direction de la Pharmacie et du Médicament (DPM)) 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.

According to Additional Resource (A), Mali’s EC system consists of four (4) committees:

  • National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS))
  • Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS))
  • Institutional Committee of the National Institute for Public Health Research (Comité Institutionnel de l’Institut National de Recherche en Santé Publique (INRSP))
  • 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))

See DecreeNo2015-0864 and OrderNo2015-2310 for details on the appointment of the chair and board members of the CNESS.

As indicated in the FMPOS-USTTB ECProcs and Additional Resource (F), the FMPOS/USTTB EC is the primary EC responsible for reviewing and approving clinical research protocols.

According Additional Resource (F), the CNESS and INRSP only participate in the EC review process with the FMPOS/USTTB EC when the research pertains to an emerging infectious disease, such as during the Ebola virus disease outbreak. The CNESS is also responsible for reviewing and approving protocols submitted by the Mali government. As a general rule, the CRLD EC is only responsible for reviewing research to be conducted within the Center.

Per Additional Resource (F), all four (4) ECs follow the ICH-GCPs-Addendum.

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

FMPOS/USTTB EC Composition

As specified in the FMPOS-USTTB ECProcs, the USTTB EC consists of 14 members including a president, a vice president, a permanent secretary, and members from the Malian community, with two-thirds of the members represented by the FMPOS/USTTB. The FMPOS/USTTB EC may also consult any person it deems necessary.

The FMPOS/USTTB Dean appoints the president and committee members and the institutions represented in the protocol propose the community members. The term of office for committee members is four (4) years and is renewable three (3) times.

FMPOS/USTTB EC Terms of Reference, Review Procedures and Meeting Schedule

According to Additional Resource (A), the FMPOS/USTTB EC has not developed its own good clinical practice (GCP) procedural documentation. However, per the FMPOS-USTTB ECProcs and Additional Resource (A), the committee does comply with GCP guidelines prepared by the Collaborative Institutional Training Initiative (CITI) Program (Additional Resource (D)), the World Health Organization (WHO) (Additional Resource (E)), and the International Council for Harmonisation.

The FMPOS/USTTB EC meets regularly at the invitation of the president or a majority of members. The committee meets in regular sessions two (2) times per month, and a maximum of two (2) protocols are reviewed per session. However, the president may call additional sessions. Sessions are suspended in August each year due to university holidays.

The committee may deliberate only if a quorum is present. A quorum is fixed at half plus one (1) of the members present or having communicated their opinion.

Per the FMPOS-USTTB ECProcs and Additional Resource (A), the EC president determines which protocols are subject to restricted review and selects the review group according to research theme. Only six (6) members are required to conduct these restricted reviews and reviews of amended protocols.

The FMPOS-USTTB ECProcs states that the FMPOS/USTTB EC is a permanent committee; however, the Dean of the Faculty may dissolve the committee in exceptional circumstances and is required to appoint new members within 30 days. See the FMPOS-USTTB ECProcs for detailed EC review procedures.

For information on CNESS composition, terms of reference, review procedures, and meeting schedule, see the Authorizing Body subtopic.

No information is available on the CRLD and the INRSP composition, terms of reference, review procedures, and meeting schedule.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
(B) (Document) USTTB Change in Ethics Committee Announcement (French) (April 27, 2017)
Ministry of Higher Education and Scientific Research and the University of the Sciences, Techniques and Technologies of Bamako, Republic of Mali
Health Research Web
(D) (Website) CITI Program - FAQ (Current as of August 21, 2019)
Collaborative Institutional Training Initiative (CITI) Program
(F) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July - August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3
Kikule K., S. Diarra, A. Sangare, M. Thumm, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and US Agency for International Development (USAID)
Ethics Committee > Scope of Review
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 2 (Article 3) and Title 3 (Articles 10 and 12-15)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 5-6, 14, 18-19, and 21
(3) (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
Relevant Sections: Chapters I and II, Annex, and Guide to Ethics Committee Protocol Review
Summary

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. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. The 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.

Role in Clinical Trial Approval Process

As set forth in LawNo09-059 and Additional Resource (A), EC approval is required prior to obtaining the Directorate of Pharmacy and Medicine’s (la Direction de la Pharmacie et du Médicament (DPM)) 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.

DecreeNo2017-0245 states that all clinical research protocols must be submitted to the National Committee of Ethics for Health and Life Sciences (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. Additional Resource (C) 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.

According to Additional Resource (A) and the FMPOS-USTTB ECProcs, the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)) is the primary EC responsible for reviewing and approving clinical research protocols in Mali.

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 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 and Additional Resource (A), the EC must review and approve any protocol amendments prior to those changes being implemented. Additionally, per the FMPOS-USTTB ECProcs, the EC is required to conduct a continuing review of each approved research protocol at least once a year. A copy of the monitoring report including any required modifications, suspension, termination, or confirmation of the initial decision will be sent to the investigator.

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. In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical and laboratory practices. According to Additional Resource (C), Mali’s ECs follow and require researchers to comply with the ICH-GCPs-Addendum.

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

(See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
JuriAfrica
(C) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 4, 5.5
Kikule K., S. Diarra, A. Sangare, M. Thumm, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and US Agency for International Development (USAID)
Ethics Committee > Ethics Committee Fees
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Chapter I (Section I, Article 8)
Summary

Overview

As stated in the FMPOS-USTTB ECProcs, the cost to submit a protocol for review by the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee (EC) of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)) is 20,000 West African CFA francs.

However, as stated during the March 2017 NIAID meeting with the FMPOS/USTTB EC (Additional Resource (A)), investigators are required to pay a fee of 300,000 West African CFA francs to submit a protocol for EC review and approval.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
Ethics Committee > Authorizing Body
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Article 22
(2) (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) (French) (April 22, 2002)
Council of Ministers
Relevant Sections: Chapters 1-3
(3) (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
(4) (Order) Order No. 2015-2310/MSHP-SG of 22 July 2015 – Announcing the Members of the National Ethics Committee for Health and Life Sciences (OrderNo2015-2310 – French) (July 22, 2015)
Ministry of Health and Social Affairs
Summary

Overview

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

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 Affairs (Ministère de la Santé et des Affaires Sociales) (MSAS)) 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.

CNESS EC Composition

As specified in DecreeNo02-200 and Additional Resource (A), CNESS consists of 37 members, including a president, a vice-president, a chairman, 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-six (26) 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 Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)); the Institutional Committee of the National Institute for Public Health Research (Comité Institutionnel de l’Institut National de Recherche en Santé Publique (INRSP); and the Ethics Committee for the Center for Sickle Cell Disease Research and Control (le Comité d’Éthique de Centre de Recherche et Lutte Contre la Drépanocytose) (CRLD))

Please refer to DecreeNo02-200, for detailed information on member composition.

See DecreeNo2015-0864 and OrderNo2015-2310 for details on the appointment of the chair and board members of the CNESS.

CNESS Terms of Reference, Review Procedures and Meeting Schedule

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 of Social Affairs must approve the SOPs.

Per DecreeNo02-200, the CNESS must convene upon the request of the chairman. 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.

See DecreeNo02-200 for detailed information on CNESS composition and responsibilities. No information is available on registration, auditing, and accreditation responsibilities by CNESS.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
Clinical Trial Lifecycle > Submission Process
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22 and 23)
(2) (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 Affairs
(3) (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
Relevant Sections: Annex
(4) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Article 3
Summary

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 Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)). According to LawNo09-059 and Additional Resource (A), the investigator is required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. According to Additional Resource (A), the primary EC for reviewing clinical research protocols in Mali is the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’ Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)).

The DPM review and approval process may not be conducted in parallel with the ethics committee (EC) review. LawNo09-059 indicates that the sponsor or the PI must send the EC’s opinion with its application to the DPM prior to the agency commencing its review. (See the Submission Content subtopic for detailed submission requirements).

Delivery Address for Clinical Trial Application

Per Additional Resource (B), address information is as follows:

Ministry of Health and Social Affairs
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

Assembly and Number of Copies

As per DPM-ClinTrialDocs, applicants must submit one (1) hard copy of the application with a commitment signed by the sponsor. One (1) hard copy of each of the clinical trial application documents must also be submitted. Per Additional Resource (C), there are no guidelines on the format and content of the clinical trial application or proposed protocol amendments.

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

Clinical Trial Application Language Requirements

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.

According to the FMPOS-USTTB ECProcs, documents provided to the FMPOS/USTTB EC must be in French.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
(B) (Website) Directorate of Pharmacy and Medicine (French) (Last Updated January 5, 2019)
Ministry of Health and Social Affairs
Kikule K., S. Diarra, A. Sangare, M. Thumm, Systems for Improved Access to Pharmaceuticals and Services (SIAPS) and US Agency for International Development (USAID)
JuriAfrica
Clinical Trial Lifecycle > Submission Content
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22 and 23)
(2) (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 Affairs
(3) (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
Relevant Sections: Chapter I, Section II, Annex, and Guide to Ethics Committee Protocol Review
(4) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3-5
Summary

Overview

As set forth in LawNo09-059 and DPM-ClinTrialDocs, Mali requires the sponsor (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)). According to LawNo09-059 and Additional Resource (A), the investigator is required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. According to Additional Resource (A), the primary EC for reviewing clinical research protocols in Mali is the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)). Per LawNo09-059 and Additional Resource (A), the DPM’s review and approval of a clinical trial application is dependent upon obtaining written proof of the ethics committee (EC) approvals.

DPM Requirements

As specified in DPM-ClinTrialDocs, the following documentation must be submitted to the DPM:

  • Clinical trial application
  • Copy of the 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 Additional Resource (B), there are no guidelines on the format and content of the clinical trial application or proposed protocol amendments.

FMPOS/USTTB Requirements

As per the FMPOS-USTTB ECProcs, investigators must submit the following documentation in the clinical trial application packet:

  • Application letter
  • Application form (dated and signed)
  • Protocol (dated and in print and electronic form) with supporting documents/annexes
  • Protocol synopsis (non-technical language, if possible)
  • Description of research related ethical considerations
  • Summary of 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 Sponsorship topic, Compensation subtopic for additional information)
  • Participant information (e.g., booklet of observations, patient diaries, and questionnaires)
  • Booklet of observations, patient diaries, and other questionnaires for research participants
  • 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 FMPOS/USTTB EC submission requirements.

Clinical Protocol Requirements

Per Additional Resource (A), the clinical study protocol should include the following elements:

  • Protocol summary
  • Sponsor information
  • 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 Additional Resource (C) Mali’s ECs require researchers to comply with the ICH-GCPs-Addendum.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 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)
(C) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 3 (Article 13)
(2) (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
Relevant Sections: Section II and Annex
Summary

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 Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)). According to LawNo09-059 and Additional Resource (A), the investigator is required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. According to Additional Resource (A), the primary EC for reviewing clinical research protocols in Mali is the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’ Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)).

The DPM review and approval process may not be conducted in parallel with the ethics committee (EC) review. Rather, LawNo09-059 indicates that the sponsor or principal investigator (PI) must send the EC’s opinion with its application to the DPM prior to the agency commencing its review. Per LawNo09-059 and Additional Resource (A), the DPM’s review and approval of a clinical trial application is dependent upon obtaining written proof of the EC approvals.

DPM Approval

Per Additional Resource (B), 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 DPM director then initially assigns the application to either the Medicine Regulation Division (also known as the Division of Regulatory Affairs and Follow-Up of the Pharmaceutical Profession) or the Quality Assurance Division (also known as the Division of Quality Assurance and Economics of Medicines). 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 Affairs 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 Ministry of Health and Social Affairs departments.

Additional Resource (B) 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.

FMPOS/USTTB EC Approval

As specified in the FMPOS-USTTB ECProcs, the investigator must submit a request to the FMPOS/USTTB President at least 15 days before the date of the EC’s meeting to review the protocol. The FMPOS/USTTB EC will then acknowledge receipt of the application and will inform the investigator if the application is complete. The FMPOS/USTTB EC 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 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.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 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)
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 5, 14, 15, and 21
(2) (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
Relevant Sections: Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22 and 23)
(3) (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 Affairs
Summary

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 Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)). According to LawNo09-059 and Additional Resource (A), the investigator is also required to obtain approval from a scientific committee and ethics committee (EC) prior to obtaining the DPM’s approval. According to Additional Resource (A), the primary EC for reviewing clinical research protocols in Mali is the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’ Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)). No waiting period is required following the applicant’s receipt of these approvals.

Per DecreeNo2017-0245, the research must 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

Per Additional Resource (B), Mali’s ethics committees (ECs) require researchers to comply with the ICH-GCPs-Addendum.

In addition, per Additional Resource (A), the applicant is required to obtain an import license from the DPM for the shipment of an investigational product to be used in the trial. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

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.

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.

EC Confirmation of Review and Approval

LawNo09-059 and Additional Resource (A) require the investigator to obtain approval from an EC prior to obtaining the DPM’s approval.

Per DecreeNo2017-0245, the PI must notify the DPM regarding the approval. In addition, the National Ethics Committee for Health and Life Sciences (Comité National d’Éthique pour la Santé et les Sciences de la Vie (CNESS)) must be informed when an institutional EC, such as the USTTB, approves a research protocol.

(See the Ethics Committee topic, Scope of Review subtopic for detailed information on the EC review and approval process).

Clinical Trial Registry

According to Additional Resource (A), the FMPOS does not currently require the investigator or sponsor to register with a domestic or international clinical trial registry.

Data Safety Monitoring Board

The ICH-GCPs-Addendum notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
(B) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 4, 5.5
JuriAfrica
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
(2) (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
Relevant Sections: Article 21
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (B), Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum, 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 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

Reporting Requirements for AEs/ADRs

As specified in the FMPOS-USTTB ECProcs and Additional Resource (A), all SAEs/SADRs that occur during the study must be reported within 72 hours of the event. All AEs/ ADRs and non-serious AEs/ADRs should be identified in the continuing review report.

Form Completion and Delivery Requirements

No information is currently available.

Data Safety Monitoring Board

The ICH-GCPs-Addendum notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
(B) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1, 4.11, 5.5, and 5.16
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Section III (Articles 19 and 22)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 15, 18, and 20
Summary

Overview

In accordance with the FMPOS-USTTB ECProcs, the principal investigator (PI) must submit a progress report on the status of the clinical trial and a final report upon the trial’s completion.

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A) Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, which notes that the investigator should promptly provide written reports to the sponsor and the institutional ethics committee (EC) on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

Progress Reports

As delineated in the FMPOS-USTTB ECProcs, the PI must submit an annual progress report to the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)).

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

Final Report

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

Per DecreeNo2017-0245, Malian sponsors must inform the national authorities of the research results.

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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10 and 4.13
Sponsorship > Definition of Sponsor
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 1 (Chapter 2, Article 2)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 15-16, and 18
Summary

Overview

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.

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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.

The ICH-GCPs-Addendum 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 foreign.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.53, 1.54, 5.1 and 5.2
Sponsorship > Trial Authorization
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 1 (Chapter 2, Article 2), Title 3 (Article 13), and Title 4 (Articles 22 and 23)
(2) (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 Affairs
(3) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 15-16
Summary

Overview

In accordance with LawNo09-059 and DPM-ClinTrialDocs, the sponsor (also known as the promoter in Mali) or the principal investigator (PI) is responsible for submitting a clinical trial application to the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) to obtain authorization to conduct a clinical trial.

To complete the clinical trial application package, the sponsor or the PI must use the DPM’s clinical trial application form listed in the DPM-ClinTrialDocs. In addition to the completed application, the sponsor or the PI must also provide the ethics committee (EC) approval letter(s), the clinical protocol signed by the sponsor, the informed consent form, a statement of commitment signed by the sponsor, a copy of the product manufacturing certificate, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

National Sponsor Obligations

Per DecreeNo2017-0245, national sponsors are required to:

  • Have a written undertaking of acceptance and collaboration of the team leader for each institution where the research activities take place
  • Provide insurance for the study, researchers, and participants
  • Follow approved research in accordance with the EC’s opinion
  • Inform the national authorities of the research results

International Sponsor Obligations

Per DecreeNo2017-0245, 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
Additional Resources
No additional resources
Sponsorship > Insurance
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 2 (Article 8) and Title 4 (Article 23)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 7 and 15
(3) (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 Affairs
Summary

Overview

According to the 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.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Article 3, Article 14, Article 18
(2) (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
Relevant Sections: Title 2 (Chapter 2, Articles 2, 8, and 9) and Title 3 (Article 16)
(3) (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
Relevant Sections: Annex
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A) Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum, which provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

As 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.

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.

With respect to compensation to the participant who suffers any trial-related injuries, the sponsor conducting a human clinical research study must carry an insurance policy guaranteeing his liability as well as the liability of any other stakeholders (e.g., host institution and investigator(s)), regardless of the type of contractual relationship established between the parties and the sponsor.

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 its conclusion.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8 and 5.8
Sponsorship > Quality, Data & Records Management
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
(2) (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
Relevant Sections: Title 1 (Article 2) and Title 3 (Articles 13 and 18)
(3) (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
Relevant Sections: Title 1 (Chapter III) and Section III (Articles 18 and 21)
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A) Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum, which provides details on quality, data, and records management. Per the ICH-GCPs-Addendum, 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

Electronic Data Processing System

Per the ICH-GCPs-Addendum, 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 the ICH-GCPs-Addendum for additional information.

Record 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 the ICH-GCPs-Addendum, 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, the ICH-GCPs-Addendum 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.

Audit Requirements

Per the ICH-GCPs-Addendum, 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 of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Éthique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)), 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.

Premature Study Termination/Suspension

LawNo09-059 states the sponsor must inform the Ministry of Health and Social Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)) of any premature termination of the investigation and explain the reason for this decision. The FMPOS-USTTB ECProcs also states that in the case of suspension or termination of the study, the investigator must inform the EC within 72 hours and provide reasons for this decision.

Multicenter Studies

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

As delineated in the ICH-GCPs-Addendum, 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
Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.65, 5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
Sponsorship > Site/Investigator Selection
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 3 (Article 13) and Title 4 (Article 20)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 14, 17-18
Summary

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

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

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices (GCPs). According to Additional Resource (A), Mali’s ECs follow and require researchers to comply with the ICH-GCPs-Addendum, which provides guidance to sponsors on investigator and site selection. According to the ICH-GCPs-Addendum:

  • 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.

Furthermore, the sponsor should obtain the investigator's/institution's agreement to:

  • Conduct the trial in compliance with GCPs, 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.

Foreign Sponsor Responsibilities

No information is currently available specifying requirements for foreign sponsors.

Data Safety Monitoring Board

The ICH-GCPs-Addendum 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.6
JuriAfrica
Informed Consent > Documentation Requirements
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 3 (Articles 10 and 12)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 8-10, 13-14, and 18
(3) (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
Relevant Sections: Annex and Guide to Ethics Committee Protocol Review
Summary

Overview

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 Additional Resource (A), Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum.

As per Additional Resource (C) and the FMPOS-USTTB ECProcs, DecreeNo2017-0245, and the ICH-GCPs-Addendum, 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 Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

LawNo09-059, DecreeNo2017-0245, and the ICH-GCPs-Addendum states 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 has reached a decision without coercion.

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.

Documentation Requirements

LawNo09-059, DecreeNo2017-0245, and the ICH-GCPs-Addendum 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.

The ICH-GCPs-Addendum 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 4.4, 4.8, 8.2, and 8.3
(C) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 2017)
Informed Consent > Required Elements
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 9-10, 12-13, and 18
(2) (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
Relevant Sections: Title 3 (Article 10)
(3) (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
Relevant Sections: Annex and Guide to Ethics Committee Protocol Review
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum.

As delineated in LawNo09-059, DecreeNo2017-0245, the FMPOS-USTTB ECProcs, and the ICH-GCPs-Addendum, prior to beginning a clinical trial, the investigator is required to obtain EC approval for the written informed consent form (ICF) and any other information being provided to the research participant. The FMPOS-USTTB ECProcs states that information about the research study should be presented in easily understandable language.

No Coercion

Per DecreeNo2017-0245, the participant's involvement in clinical research must be strictly voluntary. The potential participant must not be subjected to any coercion, influence, undue inducement, or intimidation. 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 the ICH-GCPs-Addendum, 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.

ICF Required Elements

Based on LawNo09-059, DecreeNo2017-0245, and ICH-GCPs-Addendum, the ICF should include the following statements or descriptions, as applicable (note that specific items might not be included 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; when there is no intended clinical benefit, it should be made clear
  • 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
Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.4 and 4.8
Informed Consent > Compensation Disclosure
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Annex
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 12, and 18
Summary

Overview

In accordance with the FMPOS-USTTB ECProcs and DecreeNo2017-0245, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial. In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum, which also requires the ICF to include details regarding compensation or medical treatment.

Compensation for Participation in Research

As specified in the FMPOS-USTTB ECProcs, trial participants may be compensated for their participation in a clinical trial including a refund of fees and access to medical care. DecreeNo2017-0245 requires details regarding compensation to be provided in the ICF.

Compensation for Injury

As the FMPOS-USTTB ECProcs, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. DecreeNo2017-0245 requires details regarding the support available in the case of adverse events to be provided in the ICF.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3.1 and 4.8
Informed Consent > Participant Rights
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 3 (Article 10)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 9, 11- 14, and 18
Summary

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. In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, which addresses participant rights.

Furthermore, DecreeNo2017-0245 notes the researcher must ensure that the local community has access to post-study benefits after its conclusion.

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

The Right to Participate, Abstain, or Withdraw

As set forth in LawNo09-059, DecreeNo2017-0245, and the ICH-GCPs-Addendum, 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, the ICH-GCPs-Addendum, 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 Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality

Per DecreeNo2017-0245 and the ICH-GCPs-Addendum, 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 the ICH-GCPs-Addendum, 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 Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare

DecreeNo2017-0245 and the ICH-GCPs-Addendum principles that state 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 3.1, and 4.8
Informed Consent > Special Circumstances/Emergencies
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 3 (Article 11)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 6, and 18
Summary

Overview

DecreeNo2017-0245 states that the rights of participants unable to express themselves with full cognizance must be particularly protected. LawNo09-059 makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances, including medical emergencies.

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum, which addresses consent in the case of medical emergencies.

Medical Emergencies

As per LawNo09-059 and the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Vulnerable Populations
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Title 2 (Articles 4-7) and Title 3 (Article 12)
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 6, and 18
Summary

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.

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A) Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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 Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; and Prisoners for additional information about these vulnerable populations.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61 and 4.8
Informed Consent > Children/Minors
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 6, and 18
(2) (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
Relevant Sections: Title 2 (Article 7) and Title 3 (Article 12)
Summary

Overview

DecreeNo2017-0245 states that the rights of participants who are minors must be particularly protected. According to a subject matter expert, 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

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 6, and 18
(2) (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
Relevant Sections: Title 2 (Article 5)
Summary

Overview

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.

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A) Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Prisoners
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Article 6
(2) (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
Relevant Sections: Title 2 (Article 6)
Summary

Overview

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.

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3, 6, and 18
Summary

Overview

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

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.1, and 4.8
Investigational Products > Definition of Investigational Product
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
Investigational Products > Manufacturing & Import
Last content review/update: August 21, 2019
Requirements
(1) (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 Affairs
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
Summary

Overview

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 Clinical Trial Lifecycle topic, Submission Process subtopic for detailed application requirements).

According to Additional Resource (A), the Ministry of Health and Social Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)) 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 MSAS, noting that the protocol has met all of the requirements and is approved. The MSAS, in turn, signs the 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 Regulatory Authority topic, Scope of Assessment subtopic for more details on the clinical trial application review process).

Per Additional Resource (B), 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 Additional Resource (C), Mali’s ECs also follow and require researchers to comply with the ICH-GCPs-Addendum, which requires IPs to be manufactured, handled, and stored in accordance with applicable GMPs and used in accordance with the approved protocol.

Additional Resources
(A) NIAID Meeting with the FMPOS/USTTB EC (not available online) (March 13, 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)
(C) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12 and 5.13
Investigational Products > IMP/IND Quality Requirements
Last content review/update: August 21, 2019
Requirements
(1) (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
Relevant Sections: Annex
(2) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
Summary

Overview

In accordance with the FMPOS-USTTB ECProcs, an applicant must provide the Institutional Ethics Committee of the University of Sciences, Techniques and Technologies of Bamako (USTTB) (formerly the Ethics Committee of the Faculty of Medicine of Pharmacy and Odontostomatology) (Comité d’Ethique de la Faculté de Médecine de Pharmacie et d’Odontostomatologie (FMPOS)) with the following investigational product (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 Investigator’s Brochure, publication(s), and summarized product characteristics)

In addition, DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, which provides detailed Investigator’s Brochure (IB) requirements. The ICH-GCPs-Addendum specifies that the IB must contain all of the relevant information on the 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.

Additionally, the ICH-GCPs-Addendum requires IPs to be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practices (GMPs).

IB Content Requirements

As specified in the ICH-GCPs-Addendum, 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 the ICH-GCPs-Addendum for detailed content guidelines.

Certificate of Analysis (CoA) and Drug Manufacturing Certificate Requirements

Per the ICH-GCPs-Addendum, the sponsor must maintain a CoA to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13, 5.14, 7, and 8.2
Investigational Products > Labeling & Packaging
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A), Mali’s ethics committees follow and require researchers to comply with the ICH-GCPs-Addendum, 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.

Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
Investigational Products > Product Management
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 3 and 18
Summary

Overview

DecreeNo2017-0245 mandates that clinical research must follow good clinical practices. According to Additional Resource (A) Mali’s ethics committees (ECs) follow and require researchers to comply with the ICH-GCPs-Addendum, which provides guidance on product management. The ICH-GCPs-Addendum provides detailed IB requirements. Also, the ICH-GCPs-Addendum specifies that the Investigator’s Brochure (IB) must contain all of the relevant information on the investigational product(s) (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.

Investigational Product Supply, Storage, and Handling Requirements

Per the ICH-GCPs-Addendum, the sponsor must supply the investigator(s)/institution(s) with the IP(s). The sponsor should not supply either party with the IP(s) until he/she obtains approvals from the Ministry of Health and Social Affairs (Ministère de la Santé et des Affaires Sociales (MSAS)) 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 the ICH-GCPs-Addendum, 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
Additional Resources
(A) NIAID Correspondence with the FMPOS/USTTB EC (not available online) (July – August 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12, 5.5, 5.12, 5.13, 5.14, and 7
Specimens > Definition of Specimen
Last content review/update: August 21, 2019
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: August 21, 2019
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Specimens > Consent for Specimen
Last content review/update: August 21, 2019
Requirements
(1) (Regulation) Decree No. 2017-0245/P-RM of 13 March 2017 – Fixing the Terms of Application of Law No. 09-059 of December 28, 2009 Governing Biomedical Research on Humans (DecreeNo2017-0245 – French) (March 13, 2017)
Council of Ministers
Relevant Sections: Articles 9, 11, and 13
Summary

Overview

Per DecreeNo2017-0245, during the informed consent process, the participant must be informed that he/she can withdraw at any time and may request the withdrawal of his/her data and biological material.

Additional Resources
No additional resources
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