This milestone places Rwanda among 18 top regulatory authorities globally and one of the first eight in Africa to reach this level, underscoring its commitment to ensuring safe, effective, and high-quality medical products for its population.
This designation follows formal benchmarking by WHO, marking significant progress toward strengthening regulatory systems across the continent. 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, while Maturity Level 3 indicates a stable, well-functioning, and integrated regulatory system.
The WHO global benchmarking process is part of WHO's program 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.
Rwanda has attained ML3 level alongside Senegal, joining other African nations including Egypt, Ghana, Nigeria, South Africa, Tanzania, and Zimbabwe.
According to WHO, both Rwanda and Senegal 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.
Commenting on the development, 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 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," she added.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, said that this achievement for Senegal and Rwanda reflects the strong commitment of both countries to regulatory excellence.
'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,' she noted.
Rwanda's recognition followed a detailed evaluation conducted by WHO between December 2022 and October 2024. The assessment reviewed Rwanda FDA's regulatory processes, systems, and compliance with international standards.
Achieving ML3 often takes more than five years, but Rwanda accomplished it in just two, reflecting its strong health sector reforms.
This certification allows Rwanda FDA to oversee the quality of locally manufactured vaccines, enabling them to be exported and recognized internationally. In contrast, medicines produced in countries without ML3 status are restricted from international marketing.
Prof. Emile Bienvenu, Director General of Rwanda FDA, expressed pride in the accomplishment, saying it reinforces Rwanda's dedication to fostering sustainable investment and development in the health sector.
He also emphasized that while celebrating this milestone, Rwanda FDA will continue striving to maintain high-quality standards in medicines and vaccine regulation to safeguard public health.
Théophile Niyitegeka
