WHO and African Medicines Agency Sign Framework to Strengthen Quality-Assured Health Products Across Africa

On the margins of the Seventy-ninth World Health Assembly, at a ministerial side event, the World Health Organization and the African Medicines Agency signed a Framework Agreement for Collaboration. The document sets up a structured partnership aimed at aligning how medicines, vaccines and other health products are regulated across Africa, and at helping the new agency get fully up and running.

The agency, known as AMA, is a specialized agency of the African Union. Its mandate is to strengthen regulatory capacity and widen access to quality-assured medical products on the continent. The agreement names three connected aims: harmonization, convergence and reliance. In practice, that means national regulators working toward common standards and, where appropriate, leaning on one another's assessments instead of repeating them.

The problems it targets are well known. Fragmented regulatory frameworks, limited local manufacturing, weak market surveillance and complex supply chains continue to delay access to health products across Africa. Substandard and falsified medical products remain a major challenge. The announcement argues that universal health coverage, pandemic preparedness and equitable access increasingly depend on regulatory systems strong enough to handle these pressures.

The agreement builds on the renewed African Union–WHO Memorandum of Understanding from May 2025. It lays the groundwork for joint operational plans over the next three to five years, which will set out priority areas, timelines and deliverables. The work is meant to span national, regional and continental levels.

Five areas of joint work are listed. WHO and AMA will seek to speed access to safe, effective and quality health products; promote harmonization, convergence and reliance; strengthen safety surveillance and the response to substandard and falsified products; build regulatory capacity and workforce across Africa; and support innovation, local production and regulatory preparedness in public health emergencies. A central goal is to streamline approval processes, cutting duplication so that products can be approved faster. The announcement says a more aligned system should improve efficiency, lower costs and offer a more predictable environment for investment, to the benefit of patients and manufacturers alike.

Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, called strong regulatory systems a pillar of resilient health systems and fundamental to health sovereignty and security. She described the agreement as a decisive step toward a more unified regulatory ecosystem in Africa, one that would benefit the world as well as the continent. Dr Delese Mimi Darko, AMA's Director-General, framed it in terms of trust: every person in Africa, she said, should be able to count on the medicines and vaccines they receive meeting the highest standards of quality, safety and efficacy. Dr Mohamed Yakub Janabi, WHO Regional Director for Africa, set a measure for the agency's success: not the existence of an institution but its results, meaning safer medicines, faster access and stronger health security.

The side event brought together Ministers of Health, African Union institutions, national regulatory authorities and global partners. The aim was to build political leadership behind regulatory reform, ratification of the AMA Treaty, and sustained investment in strengthening regulatory systems. WHO and AMA urged Member States and partners to use the momentum to advance reforms, speed up ratification and invest in a trusted, harmonized system. Both organizations also expect AMA to become a model for regional regulatory cooperation beyond Africa.

What to watch next: treaty ratifications by member states, and the first joint operational plans. Those plans will show whether the promised faster approvals actually materialize.