WHO and African Medicines Agency Sign Framework Agreement on Health Product Regulation

The World Health Organization and the African Medicines Agency signed a Framework Agreement for Collaboration on May 22, 2026. The signing took place on the margins of the Seventy-ninth World Health Assembly during a high-level ministerial side event in Geneva.

The agreement establishes a structured partnership to advance regulatory harmonization, convergence and reliance across the continent. It also supports the operationalization of the African Medicines Agency as a specialized agency of the African Union.

Across Africa, fragmented regulatory frameworks, limited local manufacturing, weak market surveillance and complex supply chains continue to delay access to health products. Substandard and falsified medical products remain a challenge in many markets.

The new agreement builds on the renewed African Union-WHO Memorandum of Understanding from May 2025. It sets out joint operational plans for the next three to five years, including priority areas, timelines and deliverables.

Under the agreement, WHO and AMA will work to accelerate access to safe, effective and quality health products. They will also promote regulatory harmonization, strengthen safety surveillance and response to substandard and falsified products, and build regulatory capacity across Africa.

The agreement aims to streamline regulatory processes, reduce duplication and create a more predictable environment for investment. A more aligned system is expected to lower costs for both patients and manufacturers. "Strong regulatory systems are fundamental to health sovereignty, health security and equitable access to quality-assured health products," said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data.

"Strong regulation is about protecting lives and building public trust. E. Dr Delese Mimi Darko, Director-General of AMA. The high-level side event convened Ministers of Health, African Union institutions, national regulatory authorities and global partners.

WHO and AMA urged Member States and partners to advance reforms, accelerate treaty ratification and invest in regulatory systems strengthening.