AMA Prioritises Treaty Ratification, Capacity Development, and Local Manufacturing
Mombasa, Kenya — 11 November 2025: The Director-General of the African Medicines Agency (AMA), Dr Mimi Darko, says the Agency’s current focus is on ensuring all Member States ratify the AMA Treaty, strengthening capacity development, and supporting local manufacturing across Africa.
Speaking during the High-Level Panel Discussion on the Evolution, Linkages and Transition of the African Medicines Regulatory Harmonisation (AMRH) to AMA and Future Roles at the 7th Scientific Conference on Medical Products Regulation in Africa (SCoMRA VII), Dr Darko notes that the Agency stands on a strong foundation established by treaty, with all 55 Member States having endorsed it and 31 ratified so far.
“The AMA has a strong foundation established by treaty. All 55 Member States are signatories, but only 31 have ratified. We must ensure the remaining 24 come on board so that AMA becomes fully continental and African-owned,” she says.
Dr Darko adds that the strength of AMA depends on the capacity of National Regulatory Authorities (NRAs), describing them as the Agency’s champions. She emphasises the need to build capacity and strengthen data systems to support effective regulation.
“The strength of AMA lies in our NRAs — they are our champions. We must build their capacity and strengthen data systems that support efficiency and coordination,” she says.
She also identifies local manufacturing as the third key priority for the Agency, stressing the importance of creating an enabling environment for African industries to grow and meet the continent’s needs.
“Local manufacturing is essential. We must ensure Africa’s pharmaceutical and medical-products industries are supported to thrive,” Dr Darko adds.
The panel, moderated by Chimwemwe Chamdimba (AUDA-NEPAD), included Dr Mimi Darko (AMA), Dr Boitumelo Semete-Makokotlela (AMRH Steering Committee Chair), Mr Hiiti Sillo (WHO), Ms Sakhile Dube (SADC), Dr Assane Coulibaly (Côte d’Ivoire AIRP), Dr Emer Cooke (EMA), Dr Dan Hartman (Bill & Melinda Gates Foundation) and Dr Sarah Adam (IFPMA).
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