MALI REGULATORY REPORTING REQUIREMENTS: A COMPREHENSIVE OVERVIEW
In Mali, the regulatory framework for medicines is complex, with several institutions playing important roles in ensuring the safety and quality of medicines. This article provides an overview of the key requirements and responsibilities.
Overview of Regulatory Institutions
Mali’s regulatory framework is divided among several institutions, each responsible for specific aspects of medicine regulation:
- Directorate of Pharmacy (DPM): Responsible for medicine registration and marketing authorization.
- National Health Laboratory (LNS): Collects and tests samples of medicines to monitor quality.
- Health Inspectorate (ISP): Inspects premises where medicines are handled.
- National Support Center for the Fight against Disease (CNAM): Involved in technical implementation of pharmacovigilance.
Collective Functions
These institutions work together to carry out a range of functions, including:
- Import control
- Pharmacovigilance
- Clinical trials oversight
- Market and quality control
- Licensing
- Drug advertisement and promotion
Marketing Authorization and Registration
All medicines on the market must be registered by law. The process involves submitting an application in paper form and two CDs to the DPM, which then allocates it to the appropriate division.
Inspection Requirements
Inspections are obligatory by law and a prerequisite for licensing and obtaining marketing authorization. However, according to a study by the SIAPS program, there was no evidence of regular inspections at local manufacturers.
Licensing Requirements
Licensing requirements apply to:
- Importers
- Wholesalers
- Distributors
- Pharmacists
- Local manufacturers
- Both domestic and international manufacturers and wholesalers/distributors
Additionally, legislation requires compliance with GMP guidelines and Good Distribution Practices.
Import Control
Import control is carried out by the DPM, which has the authority to authorize the sale of medicines, including importation of medicines that do not require marketing authorization. However, there are no regulations or guidelines on importation and exportation of registered medicines.
Market and Quality Control
Market and quality control are shared responsibilities between the DPM and LNS. The LNS is responsible for monitoring the quality of medicines on the market by collecting and testing samples, and advising on technical standards.
Pharmacovigilance
Pharmacovigilance is a key area of regulation in Mali, with the DPM responsible for policy development and regulation, and CNAM responsible for technical implementation. The Pharmacovigilance National Reference Center at CNAM is responsible for:
- Collecting and disseminating information on adverse drug effects
- Analyzing and evaluating links between health products and adverse effects
- Coordinating reporting activities
Clinical Trials Control
Clinical trials control is carried out by the DPM and Ethics Committee. The 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.
Conclusion
Mali’s regulatory framework for medicines is complex, with multiple institutions playing important roles in ensuring the safety and quality of medicines. This article has provided an overview of the key requirements and responsibilities. While there are some challenges, such as the lack of regular inspections at local manufacturers, the regulatory authorities are working to improve the system.
Additional Information
- Mali’s DPM website is no longer functional.
- The agency uses paper-based systems and Microsoft Office to perform its regulatory functions.