The Africa Centres for Disease Control and Prevention (Africa CDC) has commended the Rwanda Food and Drug Regulatory Authority (Rwanda FDA) and the Senegalese Pharmaceutical Regulatory Agency (ARP) for achieving World Health Organization (WHO) Maturity Level 3 (ML3).
This milestone reflects Africa’s growing capacity to enhance health systems through robust regulatory frameworks, ensuring the quality, safety, and efficacy of essential health products, including medicines, diagnostics, and vaccines.
Achieving ML3 is a testament to Rwanda and Senegal’s regulatory excellence, signifying their ability to perform stringent oversight of medical products and align with international best practices. This achievement paves the way for strengthening Africa’s health security and resilience, contributing to the African Union’s vision of sustainable health sovereignty.
The attainment of ML3 is also a major step toward local manufacturing of vaccines, diagnostics, and therapeutics, essential for reducing dependency on external supplies during public health emergencies. It further instills confidence in Africa’s health systems, encouraging investment and collaboration with global health partners.
With Rwanda and Senegal joining the ranks, the number of African National Regulatory Authorities (NRAs) reaching ML3 has grown from just two in 2021 to eight today, including Egypt, South Africa, Tanzania, Nigeria, Ghana, Zimbabwe, and now Senegal and Rwanda. This rapid progress highlights the continent’s dedication to building robust regulatory systems.
“This achievement by Rwanda and Senegal marks a proud moment for Africa, showcasing the strength of our collective efforts to enhance health systems and ensure access to safe, high-quality health products,” said Dr. Jean Kaseya, Director General of Africa CDC.
Africa CDC has set an ambitious agenda to further advance regulatory capacity on the continent. By 2025, it aims to see at least two African NRAs achieve WHO Maturity Level 4 (ML4)—the highest level of regulatory maturity, signifying full operational capacity to oversee complex medical products.
These efforts align with Africa CDC’s broader mission of empowering NRAs to meet global standards, fostering health equity, and enabling self-reliance in health solutions across Africa. With ML3 as a foundation, the continent is better positioned to lead in producing and distributing life-saving health commodities for its population and beyond.
This landmark achievement reinforces Africa’s journey toward health independence, a critical step in responding effectively to public health challenges and safeguarding the well-being of its people.