Senegal and Rwanda achieve WHO Maturity Level 3 in medicines regulation

Senegal and Rwanda have become the seventh and eighth countries in Africa to reach Maturity Level 3 (ML3) in WHO's global classification of national regulatory authorities, underscoring their commitment to ensuring safe, effective and high-quality medical products for their populations.

This designation follows formal benchmarking by WHO, marking significant progress toward regulatory system strengthening on the continent. Other countries at ML3 in Africa are Egypt, Ghana, Nigeria, South Africa, Tanzania and Zimbabwe.

The WHO benchmark, conducted with its Global Benchmarking Tool, evaluates regulatory systems against more than 250 indicators. Maturity Level 4, the highest level, signifies an advanced regulatory system committed to ongoing improvement. Maturity Level 3 indicates a stable, well-functioning, and integrated regulatory system. Senegal's Agence sénégalaise de Réglementation pharmaceutique (ARP) and the Rwanda Food and Drugs Authority (FDA) achieved ML3 through an assessment finalized in October 2024, in close collaboration with the WHO Regional Office for Africa (AFRO) and the WHO country offices in Rwanda and Senegal.

"Achieving Maturity Level 3 is a remarkable achievement for both Senegal and Rwanda, underscoring their commitment to improving public health and regulatory excellence," said Dr Matshidiso Moeti, WHO Regional Director for Africa. "This milestone marks a step forward in Africa's journey toward stronger, more resilient health systems that prioritize the safety and efficacy of medical products. Both countries serve as models for the continent and contribute to the collective vision of a healthier Africa."

The WHO global benchmarking process is part of WHO's programme to strengthen regulatory systems, evaluating core functions such as product authorization, market surveillance and adverse event detection. Regulatory authorities that reach ML3 and ML4 may qualify as WHO-listed Authorities after additional performance assessments.

"This achievement for Senegal and Rwanda reflects the strong commitment of both countries to regulatory excellence," said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. "Senegal's achievement also marks a first for a francophone country in Africa to reach ML3, underscoring the momentum toward the future operationalization of the African Medicines Agency. Rwanda's achievement represents another milestone for the East African Region, being the second country after Tanzania, which became ML3 in 2018."

Effective regulation of medical products is essential for all health systems, ensuring access to quality, safe and effective medicines, vaccines and other medical products. Strong regulatory authorities perform critical functions like rapid product authorization and robust safety monitoring, contributing to better health outcomes.