The African Medicines Agency: historical perspective of its origins, evolution, institutional structure and future prospects.

Background: The African continent has long faced fragmented regulatory systems, resulting in delayed access to safe, effective, and quality-assured medical products. To address these challenges, the African Medicines Regulatory Harmonisation (AMRH) Programme was launched in 2009 by the African Union, laying the groundwork for the establishment of the African Medicines Agency (AMA). The AMA represents one of the most significant continental developments to harmonize regulatory practices, improve access to quality-assured medical products, and strengthen public health systems across Africa. Objectives: The objectives of this review were to examine the historical development of AMA, its Treaty and proposed institutional framework, as well as operational pilots such as the Continental Listing of Human Medicinal Products implemented by the AMRH since 2023. Methods: A narrative literature review approach was used, sourcing official African Union documents, peer-reviewed publications, and technical reports from African Union Commission, AUDA-NEPAD, WHO, and AMRH stakeholders published between 2005 and 2025. Results: The AMA was formally established by treaty adopted by the AU heads of states and governments in 2019 and entered into force in November 2021. As of June 2025, 31 AU Member States had ratified the Treaty. The agency's governance and organizational structure include a Conference of State Parties, Governing Board, Secretariat, and Technical Committees. Pilot projects such as the AMRH Continental Listing demonstrated the feasibility of reliance mechanisms, though challenges remain in national legal harmonization, funding, and capacity disparities. Conclusion: The AMA represents a transformative step toward regulatory convergence in Africa. While challenges persist, the Treaty framework and pilot outcomes provide a strong foundation for its operationalisation and the long-term success in improving medical product regulation and public health across the continent.