Ethiopia achieves WHO Maturity Level 3: a milestone in medicines regulation and health systems strengthening

In September 2025, Ethiopia achieved a major public health milestone by reaching World Health Organization (WHO) Maturity Level 3 (ML3) for its medicines and vaccines regulatory system. This recognition, granted through WHO's Global Benchmarking Tool (GBT), confirms that the Ethiopian Food and Drug Authority (EFDA) operate a stable, well-functioning and integrated regulatory system capable of ensuring the safety, efficacy, and quality of medical products.

Ethiopia's journey began in 2017, when EFDA underwent a rapid benchmarking exercise. The results laid the foundation for a comprehensive Institutional Development Plan (IDP), which guided the country's efforts to strengthen its regulatory functions. Over the years, Ethiopia has demonstrated sustained commitment to regulatory improvement, supported by WHO and partners through capacity building, technical assistance, and repeated formal benchmarking.

"This 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."

- Dr Mohamed Yakub Janabi, WHO Regional Director for Africa

The achievement aligns with one of the Fourteenth General Programme of Work (GPW 14) Outputs, which highlights WHO's role in supporting countries to implement measures for better access to and use of effective, quality-assured health products. It also contributes to the Pandemic influenza Preparedness Framework: Partnership Contribution High-Level Implementation Plan III 2024-2030(HLIP III) output on improving access to pandemic countermeasures.

"Effective regulation saves lives," emphasized Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. "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."

Ethiopia's success story is a testament to what can be achieved through strategic planning, national ownership, and strong partnerships. It sets a powerful example for other countries working to strengthen their regulatory systems and ensure equitable access to essential health products.