The African continent faces fragmented regulatory systems, which slows down access to safe, effective and quality medical products. The African Union launched the African Medicines Regulatory Harmonization (AMRH) Program in 2009, which laid the foundation for the African Medicines Agency (AMA). The AMA was formally established by a treaty adopted by the Heads of State and Government of the African Union in 2019, which entered into force in November 2021. Member States entered into the treaty on 3 June 2025. The governing structure includes the Conference of States Parties, a Governing Council, a Secretariat and Technical Committees. Pilot projects, such as the Continental Listing of Human Medicinal Products from 2023, have demonstrated the feasibility of trust mechanisms despite problems with national legal harmonisation, funding and capacity differences. The AMA is supposed to harmonize regulatory practices and improve public health in Africa.