Continental Story · 12 of 12
The African Medicines
Agency goes live
The Treaty for the Establishment of the African Medicines Agency was adopted in February 2019 and entered into force on 5 November 2021. AMA opened its doors in Kigali in October 2025 under inaugural Director-General Dr Delese Mimi Darko. As of January 2026, 31 of 55 AU member states have ratified — a working majority, but not yet a continent-wide system.
By African Renaissance Trust · Source: AMA Secretariat · African Union Treaty Status List
For most of the post-independence era, medicine regulation in Africa was a patchwork — fifty-five national medicines regulatory authorities (NMRAs) of vastly uneven capacity, fragmented standards, and unequal access to the global pharmaceutical pipeline. Falsified and substandard medicines move easily through that patchwork. So does the slow market entry of life-saving therapeutics. AMA is the African Union’s answer: a continental regulator empowered to coordinate, certify, and progressively harmonise medicines regulation across the continent.
31/55
AU member states that have ratified the AMA Treaty2021
Treaty entered into force, 5 November 2021Oct 2025
AMA operational from its Kigali headquartersGhana
Home country of inaugural Director-General Dr Delese Mimi Darko
Why a continental medicines agency
African Union heads of state set three explicit goals for AMA: improve access to quality, safe and efficacious medical products; coordinate ongoing regulatory systems strengthening efforts and regional harmonisation initiatives; and provide regulatory leadership and a single point of accountability for cross-border health emergencies. Those goals sit alongside Africa CDC, which leads on public-health emergency response, and the Africa Medicines Quality Forum and AMRH (African Medicines Regulatory Harmonization) programme.
Interactive map — AMA Treaty ratification status (Jan 2026). Green = ratified · Amber = signed only · Red = neither.
The ratification gap
Twenty-four AU member states have not yet ratified, including several large pharmaceutical markets — South Africa, Nigeria, Angola, Kenya and Sudan remain outside the ratified bloc as of January 2026. Their absence is not symbolic. The economic and regulatory weight of those five economies is sufficient to delay the de facto continental scope of AMA decisions, even as the Agency itself begins technical work.
A continental medicines regulator without Nigeria and South Africa is like a continental aviation authority without Kenya Airways and Ethiopian Airlines. AMA’s political legitimacy depends on closing the ratification gap.
What advocacy can do next
Civil society, philanthropic partners and development finance institutions have a defined role: support national medicines regulatory authorities to prepare for AMA accession; finance the AMA Secretariat’s early operational base; and elevate national ratification as a measurable outcome in country-level health-system support packages. The 24 outstanding ratifications are the most concrete continental-policy advocacy target of 2026.
What the data does not show
The map shows treaty status, not technical readiness. Maturity levels of national medicines regulatory authorities (the WHO Global Benchmarking Tool framework) vary widely — some ratified states are still at ML2, while some not-yet-ratified states (notably South Africa with its SAHPRA at ML3) operate among the most mature regulators on the continent. The Continental Maps Vault will track maturity-level data as it becomes available.
