WHO and African Medicines Agency launch landmark framework to strengthen access to quality-assured health products in Africa

The World Health Organization (WHO) and the African Medicines Agency (AMA) have announced the launch and signing of a Framework Agreement for Collaboration, marking a major milestone in efforts to strengthen regulatory systems and improve access to safe, effective and quality-assured health products across Africa.

Signed on the margins of the Seventy-ninth World Health Assembly (WHA79) during a high-level ministerial side event, the agreement establishes a structured partnership to advance regulatory harmonization, convergence and reliance across the continent, while supporting the operationalization of AMA as a key continental institution.

WHA79 comes at a critical time, as universal health coverage, pandemic preparedness and equitable access to quality health products increasingly depend on strong regulatory systems. Across Africa, fragmented regulatory frameworks, limited local manufacturing, weak market surveillance and complex supply chains continue to delay access, while substandard and falsified medical products remain a major challenge.

"Strong regulatory systems are a pillar of resilient health systems and fundamental to health sovereignty, health security and equitable access to safe and quality-assured health products," said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. "The launch of this Framework Agreement for Collaboration is a decisive step towards building a more unified, efficient and resilient regulatory ecosystem in Africa, benefiting not only the continent, but the world."

Established as a specialized agency of the African Union, AMA is mandated to strengthen regulatory capacity and improve access to quality-assured medical products across the continent. Its operationalization represents a historic opportunity to address longstanding challenges, including fragmented regulatory systems, limited market oversight, and the persistent threat of substandard and falsified medical products.

"Strong regulation is ultimately about protecting lives and building public trust. Every person in Africa should have confidence that the medicines, vaccines and other health products they receive meet the highest standards of quality, safety and efficaciousness," said H.E. Dr Delese Mimi Darko, Director-General of AMA. "The African Medicines Agency is a historic opportunity to transform how medical products are regulated across the continent - strengthening cooperation, reducing fragmentation and accelerating access to quality-assured health products for all Africans. This collaboration with WHO marks an important step towards turning that vision into reality."

The newly signed Framework Agreement builds on the renewed African Union-WHO Memorandum of Understanding from May 2025, reaffirming a longstanding and strategic partnership. It provides the foundation for joint operational plans over the next 3-5 years, setting out priority areas of collaboration, timelines and deliverables to support regulatory system strengthening at national, regional and continental levels.

Under the agreement, WHO and AMA will work together to:

• accelerate access to safe, effective and quality health products,
• promote regulatory harmonization, convergence and reliance,
• strengthen safety surveillance and response to substandard and falsified products,
• build regulatory capacity and workforce across Africa, and
• support innovation, local production and regulatory preparedness during public health emergencies.

A central objective is to streamline regulatory processes across the continent, reducing duplication and enabling faster approval of medical products. A more aligned system will improve efficiency, lower costs and create a more predictable environment for investment, benefiting both patients and manufacturers.

"The success of the African Medicines Agency will not be measured by the establishment of an institution alone, but by its impact: safer medicines, faster access and stronger health security for all Africans," said Dr Mohamed Yakub Janabi, WHO Regional Director for Africa. "A strong and harmonized regulatory ecosystem is essential to advancing universal health coverage, strengthening confidence in health systems and positioning Africa as a leading actor in the global health architecture."

The high-level side event convened Ministers of Health, African Union institutions, national regulatory authorities and global partners to mobilize political leadership and reinforce commitments to regulatory reform, AMA Treaty ratification, and sustained investment in regulatory systems strengthening.

Beyond Africa, AMA is expected to serve as a model for regional regulatory cooperation, demonstrating how strong national authorities and effective reliance mechanisms can improve access, strengthen manufacturing and enhance global health security.

WHO and AMA urged Member States and partners to build on this momentum to advance reforms, accelerate treaty ratification and invest in a trusted, harmonized regulatory ecosystem for the benefit of all.