The Africa Centres for Disease Control and Prevention (Africa CDC) congratulates the Ethiopian Food and Drug Authority (EFDA) on achieving the World Health Organization (WHO) Maturity Level 3 (ML3) for its medicines regulatory system. This milestone is a major step forward in ensuring the safety, quality, and effectiveness of medicines in Ethiopia.

With this achievement, Ethiopia joins a select group of African nations, including Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda, that have attained WHO Maturity Level 3 (ML3). This milestone underscores Ethiopia’s leadership and steadfast dedication to enhancing regulatory systems that guarantee equitable access to safe, effective, and high-quality health products.

“Ethiopia’s attainment of WHO Maturity Level 3 is a commendable national achievement and a proud moment for our continent. It demonstrates the unwavering commitment of the Government of Ethiopia and the Ministry of Health, through EFDA, to building strong regulatory systems that safeguard public health, expand equitable access to quality-assured medical products, and advance our shared vision under the African Union’s Agenda 2063.

Strong and trusted regulatory authorities are essential not only for health security but also for fostering African pharmaceutical manufacturing and operationalizing initiatives such as the African Pooled Procurement Mechanism (APPM),” said H.E. Dr. Jean Kaseya, Director General of Africa CDC.

The WHO Global Benchmarking Tool (GBT) is the international gold standard for assessing the maturity of regulatory systems. By achieving Maturity Level 3 (ML3), EFDA has demonstrated that its regulatory system is stable, well-functioning, and capable of delivering essential regulatory functions effectively. This milestone underscores Ethiopia’s commitment to ensuring the quality, safety, and accessibility of medicines for its population as well as contributing to regulatory strength across the broader region.

With EFDA’s achievement of WHO Maturity Level 3, Africa CDC warmly welcomes Ethiopia to join the landmark Memorandum of Understanding (MoU) on Strengthening Collaboration Among Africa’s Leading Medicines Regulators, an initiative led by the eight African National Regulatory Authorities (NRAs) that have attained ML3.

This milestone reinforces continental collaboration, regulatory efficiency, and mutual recognition of decisions, while marking a significant step toward Africa’s broader goal of achieving regulatory sovereignty. It underscores Africa’s commitment to exercising regulatory leadership in line with its priorities, safeguarding the health of its people, and fostering a collaborative approach that supports global health security and shared prosperity.

Africa CDC reaffirms its steadfast commitment to partnering with AU Member States on their path toward regulatory excellence. This milestone highlights the critical role of collaboration, capacity-building, and adherence to international standards in improving health outcomes and advancing Africa’s pharmaceutical manufacturing agenda.

About Africa CDC

The Africa Centres for Disease Control and Prevention (Africa CDC) is the autonomous public health agency of the African Union, supporting Member States in strengthening health systems, improving disease surveillance, emergency preparedness, and health product manufacturing. Africa CDC