Ethiopia has received formal recognition from the World Health Organization (WHO) for achieving Maturity Level 3 (ML3) in its medicines regulation, a significant advancement that positions the nation among nine African countries with this status. This milestone highlights the dedication of the Ethiopian Food and Drug Authority (EFDA) to ensure that medicines and imported vaccines in the country comply with international standards of quality, safety, and efficacy.
The achievement follows a thorough assessment conducted by WHO using its Global Benchmarking Tool. This tool examines regulatory systems based on over 250 indicators, evaluating their effectiveness. Maturity Level 3 indicates a regulatory system that is stable, well-functioning, and integrated. Countries at this level are acknowledged for their ability to authorize medical products, conduct market surveillance, and effectively monitor safety events.
Significance of the Achievement
With this designation, Ethiopia joins the ranks of other African nations such as Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda that have reached ML3. Dr. Mohamed Yakub Janabi, WHO Regional Director for Africa, remarked, “Ethiopia’s achievement is a landmark moment not only for the country but for Africa as a whole. A strong regulatory system means patients can trust that the medicines they take are safe, effective, and of assured quality. This is a foundation for universal health coverage and healthier futures.”
The benchmarking process in Ethiopia was finalized in September 2025, with support from the WHO Regional Office for Africa and the WHO Country Office in Addis Ababa. The WHO global benchmarking initiative is part of a broader program aimed at strengthening regulatory systems worldwide, assessing core functions including product authorization, market surveillance, and adverse event detection.
Countries that successfully achieve ML3 and ML4 may qualify as WHO-listed Authorities after further evaluations of their performance. This designation allows them to play a more significant role in shaping global regulatory standards.
Impact on Health Systems
Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized the importance of effective regulation, stating, “Effective regulation saves lives. By reaching Maturity Level 3, Ethiopia has demonstrated leadership and commitment to protecting its population, strengthening its health system, and contributing to regional and global efforts to improve access to quality-assured medical products.”
The effective regulation of medical products is crucial for all health systems, ensuring access to quality, safe, and effective medicines and vaccines. Strong regulatory authorities perform essential functions such as rapid product authorization and robust safety monitoring, contributing to improved health outcomes.
Ethiopia’s success is not merely a national achievement; it serves as a beacon for the region. It illustrates that with sustained commitment, African nations can influence the future of health product regulation, ensuring safe, high-quality medical products are accessible to every community. This progress underscores the potential of a unified approach to health regulations across the continent, paving the way for a healthier future for millions.
