In Mali, separate institutions are involved in medicine regulatory functions and are independently mandated as such by law. The Directorate of Pharmacy is responsible for medicine registration and granting marketing authorization. The National Health Laboratory (LNS) is responsible for collecting and laboratory testing of medicine samples. The Health Inspectorate (ISP) is responsible for inspecting premises where medicines are handled, and the National Support Center for the Fight against Disease (CNAM) is responsible for technical implementation of Pharmacovigilance (Kikule, Diarra, Sangare, & Thumm, 2017).
The collective functions carried out by these bodies include import control, pharmacovigilance, clinical trials oversight, market and quality control, licensing, and drug advertisement and promotion. DPM is an active member of WHO, the Economic Community of West African States (ECOWAS), and the West African Economic and Monetary Union (UEMOA), but it does not have a country-specific policy for recognizing and relying on other national regulatory authority decisions (World Health Organization, 2011).

It is required by law that all medicines on the market be registered. The process of registration involves the submission of an application in the form of a paper dossier and two CDs. The application is sent to the director who then allocates it to the appropriate division. After the application is allocated to the division, the head of the division allocates the dossier to the regulation officer for assignment. Assessment of dossiers is conducted by the internal staff and, when possible, technical review by selected external experts. However, the external expert meetings are not frequent because of limited funding. There is legislation that insist a GMP inspection report and/or certificate be part of the registration process. The evaluation reports are reviewed by the National Drug Commission and the outcome is submitted in the form of recommendations to the minister of health for endorsement. The decision of the minister is communicated by the director of DPM to the applicant.

Inspections are obligatory by law and are a pre-requisite for licensing and obtaining marketing authorization. The ISP is responsible for monitoring the application of laws and regulations in both public and private practice, including licensing of pharmaceutical manufacturers and wholesalers. However, according to a study by the SIAPS programme, there was no evidence of regular inspections as the local manufacturer (Usine Malienne de Produits Pharmaceutiques) visited did not have a valid GMP license.

There are legal provisions that require importers, wholesalers, distributors, pharmacists and local manufacturers to be licensed. There is also legislation that requires both domestic and international manufacturers to comply with GMP guidelines, and wholesalers and distributors to comply with Good Distribution Practices.

Decree 04-557/P-RM empowers DPM to authorize the sale of medicines, including importation of medicines that do not require MA. It is does not clearly specify the requirements for importation and exportation of registered medicines. Furthermore, there are no regulations or guidelines on importation and exportation of medicines.

The mandate for market and quality control is shared by the DPM and the LNS. The LNS is responsible for monitoring the quality of medicines on the market by collecting and testing samples and advising on the technical standards of the medicines tested. DPM is responsible for registering products and controlling the import of medicines into the country. DPM does not have personnel at the points of entry, the department relies on customs for quality inspection to check medicines imported into the country. However, there is no memorandum of understanding established for this collaboration ().

DPM is responsible for policy development and regulation and CNAM is responsible for technical implementation of the PV program, according to decree no. 2011- 4201. DPM is charged with defining the guidelines for pharmacovigilance, initiating regulatory acts on pharmacovigilance, coordinating the activities of different stakeholders at the national level, being the focal point for cooperation sub-regionally and ensuring compliance with the standards and operating procedures of pharmacovigilance. The Pharmacovigilance National Reference Center created within CNAM is responsible for the following:
•      Collecting and disseminating information on adverse drug effects.
•      Analyzing and evaluating the link between health products and adverse effects through accountability.
•      Coordinating reporting activities within health structures and programs.
•      Collecting adverse reaction reports of health products from health professionals in the public and private sectors, health programs, and the pharmaceutical industry.
•      Documenting and archiving information on adverse effects of health products in a database.
•      Following up and providing feedback to reporters of adverse effects of health products
•      Responding to requests for information on adverse drug effects
•      Communicating with the WHO International Pharmacovigilance Center (Uppsala Monitoring Center) and submitting reports.
•      Scheduling and carrying out pharmacovigilance surveys.
•      Providing continuing education for health professionals on pharmacovigilance.
•      Generating pharmacovigilance signals and alerts.

The DPM and Ethics Committee are responsible for regulating Clinical Trials. 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. The DPM review and approval process takes place after the Ethics Committees’ review and approval. The Ethics Committee must communicate its opinion on the research project to the DPM. In addition, the Ethics Committees’ opinions of the research data must be submitted along with the application to the DPM prior to the agency commencing its review (National Institute of Allergy and Infectious Diseases, 2019).
The Clinical Trial application review process involves receipt of the application by the secretary, who forwards it to the director of DPM for allocation to either the Medicine Regulation or Quality Assurance Division. Once allocated to the Quality Assurance Division, the application is forwarded to the head of the division who reviews and sends it to the head of the section. After the application is evaluated, it is forwarded to the minister of health for approval prior to issuing a ministerial decision to conduct the Clinical Trial. If additional information is requested from the applicant when required. A certificate is issued after a technical evaluation and a regulatory decision on the application. The MOH issues a ministerial decision, which is distributed to regional offices, the applicant, all health professional councils, health inspectors, and all departments of MOH for information and execution (National Institute of Allergy and Infectious Diseases, 2019).

According to the WHO Pharmaceutical Sector Country Profile, Mali’s DPM has its own website: www.dirpharma.org. However, no website can be found upon following this link. DPM uses paper-based systems and Microsoft Office to perform its regulatory functions. The electronic system for medicine registration, SIAMED, which was installed two years ago, is no longer functional (Kikule, Diarra, Sangare, & Thumm, 2017).