Mekelle/Tel Aviv/Nairobi/Pretoria/London
Ethiopia Reaches WHO Maturity Level 3 in Medicines Regulation
Ethiopia has been recognized by the World Health Organization (WHO) for achieving Maturity Level 3 (ML3) in the global classification of national regulatory authorities, marking a significant step forward in the country’s health system development.
The recognition, announced following a WHO assessment conducted in September 2025, places Ethiopia among nine African nations to have reached ML3. Other countries with this status include Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda.
Maturity Level 3 indicates that a country has a stable, well-functioning, and integrated regulatory system. It reflects the capacity to authorize medical products, monitor their safety, and conduct market surveillance effectively. The highest rating, Maturity Level 4, is reserved for countries with advanced systems that show a strong commitment to continuous improvement.
The assessment of Ethiopia was carried out using WHO’s Global Benchmarking Tool, which evaluates national regulatory systems against more than 250 indicators. The Ethiopian Food and Drug Authority (EFDA) led the process domestically, with technical support from the WHO Regional Office for Africa and the WHO Country Office in Addis Ababa.
WHO officials highlighted the importance of the milestone for both Ethiopia and the continent. Dr. Mohamed Yakub Janabi, WHO Regional Director for Africa, described the achievement as a foundation for strengthening public trust in medicines and advancing universal health coverage. WHO Assistant Director-General Dr. Yukiko Nakatani emphasized that effective regulation is essential to safeguard patients and expand access to quality-assured medical products.
According to WHO, countries that achieve Maturity Level 3 or 4 may also become eligible for designation as WHO-listed Authorities following further performance evaluations. Such recognition would enable them to influence global standards for medicines regulation.
Health experts note that regulatory authorities play a critical role in ensuring access to safe and effective medicines and vaccines. By strengthening these functions, countries can improve health outcomes and enhance preparedness for emerging public health challenges.
Ethiopia’s progress is seen as part of a wider effort across Africa to build stronger regulatory systems. WHO officials expressed confidence that the achievement would inspire further advances in the region’s capacity to oversee medical products.
