WHO and African Medicines Agency to Fight Unsafe Medicines and Boost Drug Access

The World Health Organization (WHO) reaffirmed its support for improving medicine regulation during the first African Medicines Agency (AMA) Week and the 11th African Medicines Regulators Conference, held from 25 to 30 October 2026 in Kigali, Rwanda.

Africa is taking important steps towards making medicines, vaccines and other healthcare products safer and more accessible through stronger cooperation between national regulators and international health organisations. The World Health Organization (WHO) reaffirmed its support for improving medicine regulation during the first African Medicines Agency (AMA) Week and the 11th African Medicines Regulators Conference, held from 25 to 30 October 2026 in Kigali, Rwanda. The gathering brought together government officials, medicine regulators, pharmaceutical industry representatives and international partners to discuss how countries can strengthen healthcare safety and improve access to trusted medical products.

The developments were reported in the WHO news article titled "WHO and African Medicines Agency advance regulatory cooperation at inaugural Agency Week in Kigali," published on 10 November 2026. The announcement, which was not published in an academic journal, highlights new regulatory initiatives, stronger national medicine authorities and growing cooperation across African countries. These efforts reflect a shared commitment to building healthcare systems where medicines meet recognised safety and quality standards before reaching patients.

WHO Director-General Dr Tedros Adhanom Ghebreyesus announced that 10 African national regulatory authorities have reached Maturity Level 3 under WHO's Global Benchmarking Tool, meaning they have established stable, integrated and well-functioning regulatory systems. He called for continued political commitment, financial investment and wider ratification of the AMA Treaty to ensure that more countries benefit from stronger medicine regulation.

Ten African Countries Reach Important Medicine Regulation Milestone

Achieving Maturity Level 3 represents meaningful progress because it shows that a national regulatory authority has developed systems capable of overseeing medical products through established procedures and scientific assessments. Strong regulatory institutions help protect patients by evaluating medicine quality, monitoring safety concerns and ensuring that medical products meet appropriate standards. The progress reported by WHO demonstrates growing regulatory capacity across Africa and creates opportunities for stronger cooperation between countries with different levels of technical expertise.

National regulatory authorities remain central to the success of the African Medicines Agency because they are responsible for applying regulatory requirements within their own countries. Hiiti Sillo, WHO's Head of Regulation and Safety Unit and Acting Director of the Regulation and Prequalification Department, stressed the importance of investing in African expertise and building confidence between regulatory institutions. Stronger relationships among these authorities can help reduce duplicated work, improve scientific decision-making and make regulatory cooperation more useful for public health.

Seven New Expert Committees Strengthen Medicine Safety Across Africa

A major achievement during AMA Week was the inauguration of seven technical committees responsible for providing independent scientific guidance on important regulatory activities. Their responsibilities cover areas such as evaluating medicines and vaccines, supervising clinical trials, conducting inspections, monitoring product safety and assessing medical devices. These committees will help countries share scientific knowledge, improve the consistency of regulatory assessments and strengthen decisions about the safety and quality of healthcare products.

The committees also create opportunities for national authorities to work together instead of carrying out every regulatory assessment separately. Shared scientific reviews and greater reliance on trusted regulatory decisions can help countries use their technical resources more effectively without weakening essential safety requirements. This coordinated approach could support more efficient regulatory processes and improve the availability of quality-assured medical products across African healthcare systems.

New Innovation Hubs Support African Pharmaceutical Manufacturing

The African Medicines Agency introduced two important initiatives during the event: the Regulatory Innovation and Manufacturing Readiness Hub and the Capacity Strengthening Hub. These platforms are designed to support pharmaceutical manufacturing within Africa, provide early scientific advice and improve the technical skills of medicine regulators. Their development reflects growing recognition that reliable access to medical products requires strong regulatory institutions alongside the ability to develop and manufacture medicines locally.

The Manufacturing Readiness Hub will help create an environment where pharmaceutical manufacturers can better understand regulatory expectations and receive scientific guidance during product development. The Capacity Strengthening Hub will focus on improving regulatory knowledge and expertise, helping national authorities develop the skills needed to evaluate and monitor healthcare products. Greater cooperation between manufacturers and regulators can support innovation, strengthen quality assurance and contribute to a more resilient pharmaceutical sector across the continent.

WHO and AMA Build a Stronger Future for African Healthcare

The 11th African Medicines Regulators Conference provided an important opportunity for WHO and AMA to strengthen cooperation between national regulatory authorities and promote more consistent regulatory practices. Discussions built on the Framework Agreement for Collaboration signed by both organisations in May 2026 and the five-year joint operational plan developed to guide their shared activities. These arrangements establish a foundation for strengthening regulatory capacity, improving medicine safety monitoring, addressing substandard and falsified medical products, and supporting local pharmaceutical production.

WHO has committed to providing technical knowledge, internationally recognised regulatory standards and capacity-building support as the African Medicines Agency expands its operations. The partnership places particular importance on African-led solutions that respond to the continent's healthcare needs and build trust between national regulators. Continued investment and cooperation will be essential for turning the progress announced in Kigali into lasting improvements in medicine quality, regulatory effectiveness and healthcare accessibility.

The developments announced during AMA Week represent an important opportunity to build stronger healthcare protection across Africa through shared expertise and coordinated regulatory action. Effective national medicine authorities, supported by a continental framework, can help reduce the risks associated with unsafe medical products and strengthen countries' ability to respond to public health challenges. By improving regulatory systems and supporting local manufacturing, WHO and AMA are working towards a future where more people across Africa can access safe, effective and quality-assured medical products, contributing to stronger health security and universal health coverage.