Rwanda FDA Achieves WHO Maturity Level 3 Certification

The Rwanda Food and Drugs Authority (Rwanda FDA) has attained Maturity Level 3 (ML3) for the regulation of medicines and vaccines (non-producing), as certified by the World Health Organization (WHO). This achievement highlights Rwanda FDA’s strong and well-functioning regulatory system capable of ensuring the quality, safety, and efficacy of medical products.

The recognition affirms Rwanda’s dedication to maintaining top-tier public health protection through stringent regulatory oversight. It underscores Rwanda FDA’s ability to monitor and regulate the safety and quality of medicines, vaccines, and medical devices, assuring both the public and international partners of compliance with global standards.

Achieving this milestone followed a thorough assessment of Rwanda’s regulatory framework and the implementation of WHO recommendations. The benchmarking process of Rwanda’s National Regulatory System began in December 2022 and was completed in October 2024 in close collaboration with WHO.

Prof. Emile Bienvenu, Director General of Rwanda FDA, described the achievement as a testament to the government’s sustained investment in the country’s pharmaceutical regulatory systems. “This reflects 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,” he said.

With this certification, Rwanda FDA joins an elite group of 18 global regulatory authorities and becomes one of the first eight African nations to achieve WHO Maturity Level 3.

This recognition positions Rwanda as a leader in regulatory oversight on the continent.