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Rwanda FDA Attains WHO Maturity Level 3

6 December 2024

Kigali – Rwanda, 6th December 2024 – Rwanda Food and Drugs Authority (Rwanda FDA) attains Maturity Level 3 (ML3) for the regulation of medicines and vaccines (non-producing), a milestone conferred by the World Health Organization (WHO). Maturity level 3 confirms stable, well-functioning and integrated regulatory systems capable of ensuring the quality, safety, and efficacy of medical products.

This recognition affirms Rwanda’s commitment to maintaining the highest standards in public health protection through robust regulatory oversight and demonstrates Rwanda FDA’s capability to effectively regulate and monitor the safety, quality, and efficacy of medicines, vaccines, and medical devices in Rwanda. It assures the public and our partners that Rwanda’s pharmaceutical regulatory framework meets international standards.

This achievement follows a comprehensive assessment process and successful implementation of WHO recommendations. The WHO’s assessment of medicines regulatory authorities examines regulatory systems on their framework and functions. It designates the level of regulatory oversight in countries on a scale of one to four. The benchmarking of the National Regulatory System of Rwanda, represented by Rwanda FDA was formally conducted in December 2022 and concluded in October 2024, in close collaboration with WHO.

“This is a proud moment for Rwanda FDA and Rwanda as a whole. 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. As we celebrate this achievement, we reaffirm our resolve to sustain and build upon these standards to protect the public health,” said Prof. Emile BIENVENU, Director General of Rwanda FDA.

With this achievement, Rwanda FDA joins an elite group of 18 regulatory authorities worldwide that have reached Maturity Level 3, and is now among the first eight (8) in Africa to attain this milestone.