AMATA Statement at the 76th WHO Regional Committee for Africa

Agenda item 11: Regional strategy on regulation of medical products in the African Region, 2026–2035

The members of the African Medicines Agency Treaty Alliance (AMATA) welcome and strongly support the adoption of the Regional Strategy on Regulation of Medical Products in the African Region, 2026–2035.

Access to safe, effective, quality-assured medical products depends on a strong regulatory system. However, a truly harmonised and effective regulatory system cannot be achieved without continental coordination and leadership.

We therefore strongly call on  all AU Member States that have not yet done so  to ratify and domesticate the Treaty for the establishment of the African Medicines Agency, to deposit their instruments of ratification with the African Union Commission, and on all Member States to support the Agency’s effective and sustained  operationalisation.

Universal ratification of the African Medicines Agency (AMA) Treaty, its effective implementation and strengthened collaboration among AMA, national regulatory authorities and regional economic communities would:

• strengthen regulatory coherence across the continent, helping to harmonise standards and reduce duplication through reliance, work-sharing and joint assessment across the regulation of medical products.
• facilitate faster and more equitable access to safe, effective and quality-assured  medical products, while strengthening national and regional capacity to detect and respond to substandard and falsified medical products.
• reinforce Africa’s regulatory sovereignty, enabling African institutions and Member States to collectively shape regulatory priorities in line with the continent’s health needs.
• support a more coordinated and resilient continental response to public-health emergencies, including rapid joint assessment and continental scientific recommendation, followed by national authorisation and deployment of essential medicines, vaccines, medical devices and in vitro diagnostics.

We call on African Union Member States to renew their political commitment and translate it into predictable and sustainable financing, including timely Member State contributions, to support AMA’s functionality, independence and  sustainability.

Ratification of the AMA Treaty and sustainable financing of its implementation are not merely bureaucratic exercises. They are an investment in saving lives, protecting patients from substandard and falsified products, and expanding equitable access to safe, effective and quality-assured medicines, vaccines, medical devices and in vitro diagnostics.