The African Medicines Agency (AMA) is a new continental regulatory body that was officially launched in 2025 in Mombasa, Kenya during the SCoMRA VII conference. Based in Kigali, Rwanda, it acts as the African Union's specialized agency for the regulation and supervision of medicines. The AMA coordinates continent-wide reviews of clinical trials, harmonizes regulations for health products, and strengthens oversight of drug manufacturing. The aim is to unify fragmented regulatory systems, reduce fragmentation and ensure access to safe, effective and high-quality medicines. The treaty on its establishment has already been signed by 27 African countries, other countries will complete the process soon. The European Medicines Agency (EMA) is providing support, including a €10 million European Commission grant for capacity building and experience sharing. AMA follows the initiative of African Medicines Regulatory Harmonization (AMRH) and fights against counterfeit and low-quality medicines. According to the director Dr. Delese Mimi Darko focuses on sustainable finance, strategic planning and the private sector.[1][2][3][5][6][7]