The World Health Organization (WHO) reaffirmed its commitment to strengthening Africa’s regulatory systems during the inaugural African Medicines Agency (AMA) Week and the 11th African Medicines Regulators Conference (AMRC), held from 25 to 30 October 2026 in Kigali, Rwanda. Bringing together African regulators, policy-makers, industry and international partners, the event marked an important milestone in translating continental regulatory ambitions into coordinated action to improve access to safe, effective and quality-assured medical products.
In a video message , WHO Director-General Dr Tedros Adhanom Ghebreyesus highlighted the progress made across the continent, noting that 10 African national regulatory authorities have now reached Maturity Level 3 under WHO’s Global Benchmarking, demonstrating that they have established stable, well-functioning and integrated regulatory systems. He reaffirmed WHO’s commitment to supporting both AMA and national regulators, while calling for sustained political and financial investment and broader ratification of the AMA Treaty.
A major highlight of the event was the inauguration of AMA’s seven technical committees, which will provide independent scientific expertise across key regulatory functions, including medicines and vaccines evaluation, clinical trials oversight, inspections, vigilance and medical devices. The committees represent a significant step towards strengthening science-based decision-making, regulatory reliance and work-sharing across African countries.
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, provide early scientific advice and strengthen regulatory expertise across the continent.
WHO co-convened the 11th African Medicines Regulators Conference (AMRC) with AMA, providing a platform to advance regulatory harmonization, convergence and reliance, while reinforcing the central role of national regulatory authorities in building a resilient continental regulatory ecosystem.
Representing WHO at the event, Hiiti Sillo, WHO’s Head of Regulation and Safety Unit and Acting Director of Regulation and Prequalification Department, emphasized that strong national regulatory authorities are the foundation of a successful AMA. He underscored the importance of investing in African regulatory expertise, strengthening trust between authorities and ensuring that regulatory cooperation delivers tangible public health benefits.
The discussions built on the Framework Agreement for Collaboration signed by WHO and AMA in May 2026, and the subsequent five-year joint operational plan. Together, these provide a foundation for coordinated action to strengthen regulatory capacity, improve safety surveillance, address substandard and falsified medical products, and support innovation and local manufacturing.
As AMA advances its operationalization, WHO will continue supporting African-led regulatory solutions through technical expertise, internationally recognized standards and capacity development.
Stronger national regulatory authorities, working together through a harmonized continental regulatory ecosystem, are essential to ensuring timely access to safe, effective and quality-assured medical products, thereby protecting public health, strengthening health security and advancing universal health coverage across Africa.
