Directorate of Pharmacy and Medicine (DPM)

Per DecreeNo2011-753, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) is the competent authority responsible for regulating clinical trials, examining applications to import investigational drugs, and reviewing clinical trial authorization records for drugs to be registered in Mali. In addition, as stated in LawNo09-059, prior to a clinical trial’s commencement, the DPM must review the clinical trial application research data submitted by the sponsor or principal investigator, as well as the opinion(s) of the ethics committee(s) consulted.

As set forth in DecreeNo2011-753, the DPM is a regulatory body under the Ministry of Health and Social Development (Ministère de la Santé et du Développement Social (MSDS)). An MSDS-appointed director is authorized to direct, coordinate, oversee, and control the directorate’s pharmaceutical activities. LawNo01-040 and Law-MOHOrg also note that the DPM’s mission is to define pharmaceutical regulations, examine and monitor drug marketing authorization dossiers, develop and implement national programs for essential drugs, and create support tools in the rational use of medicines.

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

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

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

Per DecreeNo2017-0245, the DPM must:

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

Other Considerations

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

Contact Information

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

Direction de la Pharmacie et du Médicament (DPM)
Darsalam
BPE 5202
Bamako, Mali

Phone: +223 20 22 24 63 and +223 2022 65 70
Email: info@dirpharma.ml

Overview

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

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

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

Clinical Trial Review Process

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

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

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

Directorate of Pharmacy and Medicine (DPM)

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

Payment Instructions

No information is available regarding payment instructions.

Overview

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

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

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

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

Ethics Committee Composition

National Ethics Committee for Health and Life Sciences (CNESS)

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

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

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

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

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

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

National Institute of Public Health (INSP) Ethics Committee

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

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

Terms of Reference, Review Procedures, and Meeting Schedule

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

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

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

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

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

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

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

National Institute of Public Health (INSP) Ethics Committee

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

Overview

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

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

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

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

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

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

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

National Institute of Public Health (INSP) Ethics Committee

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

Role in Clinical Trial Approval Process

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

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

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

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

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

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

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

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

National Institute of Public Health (INSP) Ethics Committee

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

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

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

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

Payment Instructions

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

National Institute of Public Health (INSP) Ethics Committee

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

Overview

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

Registration, Auditing, and Accreditation

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

Overview

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

Regulatory Submission

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

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

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

Ethics Review Submission

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

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

National Institute of Public Health (INSP) Ethics Committee

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

Regulatory Authority Requirements

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

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

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

Ethics Committee Requirements

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

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

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

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

National Institute of Public Health (INSP) Ethics Committee

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

Clinical Protocol

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

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

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

Overview

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

Regulatory Authority Approval

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

Ethics Committee Approval

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

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

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

National Ethics Committee for Health and Life Sciences (CNESS)

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

National Institute of Public Health (INSP) Ethics Committee

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

Overview

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

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

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

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

Clinical Trial Agreement

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

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

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

Clinical Trial Registration

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

Safety Reporting Definitions

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

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

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

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

Safety Reporting Requirements

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

OrderNo2011-4201 further delineates the following reporting obligations:

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

Sponsor Responsibilities

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

Form Completion & Delivery Requirements

No information is available regarding form completion and delivery requirements.

Interim and Annual Progress Reports

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

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

Final Report

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

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

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

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

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

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

Overview

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

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

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

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

Foreign Sponsor Responsibilities

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

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

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

Data and Safety Monitoring Board

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

Multicenter Studies

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

Insurance

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

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

Compensation

Injury or Death

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

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

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

Trial Participation

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

Post-Trial Access

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

Quality Assurance/Quality Control

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

Monitoring Requirements

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

Premature Study Termination/Suspension

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

Electronic Data Processing System

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

Records Management

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

Responsible Parties

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

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

Data Protection

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

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

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

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

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

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

Consent for Processing Personal Data

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

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

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

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

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

Obtaining Consent

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

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

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

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

See also MLI-5 for additional consent requirements.

Re-Consent

No information is available regarding re-consent requirements.

Language Requirements

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

Documenting Consent

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

Waiver of Consent

No information is available regarding waiver of consent requirements.

Based on LawNo09-059 and DecreeNo2017-0245, the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in each source, which provide overlapping and unique elements):

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

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

Overview

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

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

The Right to Participate, Abstain, or Withdraw

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

The Right to Information

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

The Right to Privacy and Confidentiality

Per DecreeNo2017-0245, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. It is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

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

The Right of Inquiry/Appeal

Per DecreeNo2017-0245, the research participant or the legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of the participant’s rights. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Safety and Welfare

DecreeNo2017-0245 states that a research participant’s right to safety and the protection of their health and welfare must take precedence over the interests of science and society.

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

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

Overview

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

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

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

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

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

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

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

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

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

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

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

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

Assent Requirements

No information is available regarding assent requirements.

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

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

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

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

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

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

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

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

Manufacturing

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

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

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

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

Import

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

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

Investigator’s Brochure

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

Quality Management

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

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

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

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

Supply, Storage, and Handling Requirements

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

Record Requirements

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

No applicable requirements

No applicable requirements

Per DecreeNo2017-0245, during the informed consent process, the participant must be informed that withdrawal is possible at any time, and that the withdrawal of the participant’s data and biological material may also be requested.