WHO and African Medicines Agency Advance Regulatory Cooperation at Inaugural AMA Week

The World Health Organization (WHO) and the African Medicines Agency (AMA) advanced their regulatory cooperation at the inaugural AMA Week and the 11th African Medicines Regulators Conference (AMRC), held from 25 to 30 October 2026 in Kigali, Rwanda. The event brought together African regulators, policy-makers, industry and international partners to translate continental regulatory ambitions into coordinated action for access to safe, effective and quality-assured medical products.

In a video message, WHO Director-General Dr Tedros Adhanom Ghebreyesus noted that 10 African national regulatory authorities have now reached Maturity Level 3 under WHO's Global Benchmarking, indicating stable, well-functioning and integrated regulatory systems. He called for sustained political and financial investment and broader ratification of the AMA Treaty.

A major outcome of the week was the inauguration of AMA's seven technical committees, which will provide independent scientific expertise across medicines and vaccines evaluation, clinical trials oversight, inspections, vigilance and medical devices. The week also saw the launch of AMA's Regulatory Innovation and Manufacturing Readiness Hub and Capacity Strengthening Hub, designed to support local pharmaceutical manufacturing, early scientific advice and regulatory expertise across the continent. WHO co-convened the AMRC with AMA to advance regulatory harmonization, convergence and reliance among national authorities.

The discussions build on the Framework Agreement for Collaboration signed by WHO and AMA in May 2026 and a subsequent five-year joint operational plan covering regulatory capacity, safety surveillance, substandard and falsified medical products, and local manufacturing.

For pharmaceutical suppliers and procurement partners, the operationalization of AMA signals a gradual shift toward harmonized registration and reliance-based review across African markets. Manufacturers able to present WHO-standard dossiers and evidence of GMP compliance are likely to find a progressively more predictable pathway into multiple African countries as these committees and hubs mature, while buyers can expect stronger regional safeguards against substandard and falsified products.

Source: WHO, WHO and African Medicines Agency advance regulatory cooperation at inaugural Agency Week in Kigali, https://www.who.int/news/item/10-11-2026-who-and-african-medicines-agency-advance-regulatory-cooperation-at-inaugural-agency-week-in-kigali