Senegal and Rwanda have become the seventh and eighth countries in Africa to reach Maturity Level 3 (ML3) global classification of national regulatory authorities, the World Health Organization (WHO) announced on December 5. The level indicates a stable, well-functioning, and integrated regulatory system for medical products. It precedes Maturity Level 4, the highest level, which signifies an advanced regulatory system. ALSO READ: Harmonising medicines regulation critical in making quality drugs – officials In a statement, the UN health agency indicated that the designation followed its formal benchmarking, demonstrating significant progress toward regulatory system strengthening on the continent. The Rwanda Food and Drugs Authority (FDA), and Senegal’s Agence Sénégalaise de Réglementation Pharmaceutique (ARP), achieved ML3 through an assessment finalised in October 2024, in close collaboration with the WHO Regional Office for Africa and the WHO country offices, the agency said. 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. The WHO said effective regulation of medical products is essential for all health systems, ensuring access to quality, safe and effective medicines, vaccines, and other medical products, adding that strong regulatory authorities perform critical functions like rapid product authorisation and robust safety monitoring, contributing to better health outcomes. Rwanda FDA has attained @WHO Maturity Level 3 for the regulation of medicines and vaccines (non-producing). Rwanda joins an elite group of 18 regulatory authorities worldwide and becoming one of the first 8 in Africa to reach this milestone. Check the list here:... pic.twitter.com/EHCs90Y1QI — Rwanda Food and Drugs Authority (@RwandaFDA) December 6, 2024 Rwanda FDA joins an elite group of 18 regulatory authorities worldwide that have reached Maturity Level 3, and is now among the first eight in Africa to attain this milestone, the Rwandan regulator said in a statement on Friday, December 6. “Achieving Maturity Level 3 reflects the Government's sustained investment in strengthening the national pharmaceutical regulatory systems. It is a testament to the unwavering support of the Government of Rwanda in building robust health systems, and the dedication of Rwanda FDA staff, and stakeholders towards public health protection,” said Emile Bienvenu, Director General of Rwanda FDA. Dr Matshidiso Moeti, WHO Regional Director for Africa, said achieving Maturity Level 3 is a remarkable achievement for both Senegal and Rwanda, underscoring their commitment to improving public health and regulatory excellence. This milestone marks a step forward in Africa’s journey toward stronger, more resilient health systems that prioritise 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, Moeti remarked. The WHO global benchmarking process is part of WHO’s programme to strengthen regulatory systems, evaluating core functions such as product authorisation, 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 operationalisation of the African Medicines Agency. Rwanda’s achievement represents another milestone for the East African Region, being the second country after Tanzania, which became ML 3 in 2018,” Nakatani said.
