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ETHIOPIA—The Africa Centres for Disease Control and Prevention (Africa CDC) has applauded the Rwanda Food and Drug Authority (Rwanda FDA) and the Senegalese Pharmaceutical Regulatory Agency (ARP) for achieving the World Health Organization (WHO) Maturity Level 3 (ML3).
This recognition reflects Africa’s growing ability to strengthen its health systems through effective regulatory frameworks that ensure the safety, quality, and effectiveness of medicines, vaccines, diagnostics, and other essential health products.
This milestone highlights the continent’s dedication to advancing health security and resilience.
It also highlights Africa’s commitment to building robust systems that instill confidence in the quality of locally manufactured health solutions.
Rwanda and Senegal’s achievement of ML3 aligns with the vision of the African Union and Africa CDC to promote the local production of health commodities, including vaccines, therapeutics, and diagnostic tools.
Since 2021, the number of African National Regulatory Authorities (NRAs) achieving ML3 status has increased significantly from just two to eight.
In addition to Rwanda and Senegal, countries such as Egypt, South Africa, Tanzania, Nigeria, Ghana, and Zimbabwe have reached this level.
This remarkable progress showcases the continent’s ability to sustain momentum in improving health systems.
Commenting on this success, Dr. Jean Kaseya, Director General of Africa CDC, described it as a proud moment for Africa.
He emphasized that these achievements demonstrate the effectiveness of collective efforts to improve regulatory systems and provide access to high-quality health products.
Dr. Kaseya reaffirmed Africa CDC’s commitment to supporting other NRAs in their journey toward ML3 and beyond.
Africa CDC plans to work with the WHO to assess more regulatory authorities for ML3 status and aims to advance at least two NRAs to Maturity Level 4 (ML4) by 2025.
Achieving ML4 will be a critical step toward Africa’s health sovereignty, enabling the continent to rely on sustainable, locally manufactured health solutions.
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