What African Medicines Agency Ratification Means for Registering Products Across Africa

Kenya ratified the treaty establishing the African Medicines Agency in November 2023, and the Agency itself was formally launched in Mombasa in November 2025. Neither event means a company can now file one continental application and sell across Africa. A life sciences company weighing what AMA ratification actually changes for product registration needs to separate the treaty milestone from the operational reality, which is still years from a single continental marketing authorization.

Kenya’s Own Ratification Timeline

The Treaty for the Establishment of the African Medicines Agency entered into force on 5 November 2021, once the 15th African Union member state deposited its instrument of ratification. Kenya’s Cabinet approved moving toward ratification in May 2022, after which the process required National Assembly action under Kenya’s Treaty Making and Ratification Act 2012 before an instrument could be deposited with the African Union. The Pharmacy and Poisons Board’s own website commemorates Kenya’s ratification on 24 November 2023, roughly eighteen months after Cabinet approval. As of May 2026, the AMA’s own published ratifications tracker records 32 African Union member states as having ratified the treaty. Two of the continent’s largest pharmaceutical markets, South Africa and Nigeria, have not, and both have signalled a preference for managing their own national regulatory systems rather than ceding authority to a continental body.

What the Agency Actually Does Today

The AMA is headquartered in Kigali, Rwanda, not Kenya, despite Kenyan hopes of hosting it during the 2022 ratification push. Its first Director-General, Dr Delese Mimi Darko, formerly head of Ghana’s Food and Drugs Authority, was appointed on 4 June 2025, and the Agency was formally launched at the Seventh Biennial Scientific Conference on Medical Products Regulation in Africa, held in Mombasa beginning 11 November 2025. Formal launch is not the same as full operational capacity. National regulators already participating describe the AMA’s current practical function as enabling joint reviews of clinical trial applications and the assessment of particularly complex product dossiers, such as vaccines and biosimilars, alongside reliance mechanisms that let one country’s assessment inform another’s decision faster. On 21 May 2026, WHO and the AMA signed a framework agreement covering five priority areas, including regulatory harmonization and reliance, with joint operational plans described as unfolding over the following three to five years. That timeline itself signals the Agency is still building out its core functions rather than running a mature continental approval system.

Registration in Kenya Still Runs Through the PPB

Nothing in the current framework replaces national registration. A company seeking to sell a pharmaceutical product in Kenya still applies to the Pharmacy and Poisons Board under the ordinary Cap 244 process, and the same holds for every other AU member state’s national regulator. What AMA participation adds, at this stage, is eligibility for joint scientific assessment on dossiers a manufacturer chooses to route through it, and closer alignment with existing regional harmonization work such as the East African Community’s own joint assessment procedure, which Kenya has used for years independently of the AMA. A regulatory consultant quoted in recent coverage of the Mombasa launch put the practical risk plainly: joint continental assessment only saves a manufacturer time and cost if participating countries actually rely on it instead of still insisting on separate national dossiers and separate national fees. Until that reliance culture is proven at scale, and until South Africa and Nigeria are inside the treaty, a company should plan its Africa market entry around each target country’s own national process, not around an assumption that AMA ratification has already created a single gateway.

What This Means for Market Entry Planning

For a company planning multi-country African registration from a Kenyan base, the practical value of AMA participation today is incremental rather than transformative. It is worth building AMA’s joint assessment pathway into a regulatory strategy where the product qualifies as high-complexity (a vaccine, biologic, or biosimilar) and the target countries are AMA-engaged, since that is where the joint-review function is furthest along. For most conventional pharmaceutical products, the PPB’s own registration timeline and the existing East African Community harmonization route remain the more predictable path, and a company should budget for country-by-country registration across any market where AMA reliance has not yet been demonstrated in practice, including South Africa and Nigeria by definition, since neither has ratified.