Ethiopia makes history as first IGAD nation to secure WHO’s top medicine safety rating
The recognition, announced by WHO, highlights Ethiopia’s strengthened regulatory framework, ensuring that medicines, vaccines, and other medical products available in the country meet international standards of quality, safety, and efficacy.
Ethiopia has become the first country in the Intergovernmental Authority on Development (IGAD) bloc—and the ninth in Africa—to achieve Regulatory Maturity Level 3 (ML3) in the World Health Organisation’s (WHO) global classification of national regulatory authorities.
The recognition, announced by WHO, highlights Ethiopia’s strengthened regulatory framework, ensuring that medicines, vaccines, and other medical products available in the country meet international standards of quality, safety, and efficacy.
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The Ethiopian Food and Drug Authority (EFDA) underwent a rigorous WHO assessment using the Global Benchmarking Tool, which evaluates regulatory systems against more than 250 indicators.
Maturity Level 3
WHO defines Maturity Level 3 as a stable, well-functioning, and integrated regulatory system. Countries at this level are recognised for their ability to authorise medical products, conduct market surveillance, and monitor safety events effectively.
“This progress is making Africa closer to improving local production and access to safer, quality medicines and medical products,” WHO Director-General Tedros Adhanom Ghebreyesus said.
Ethiopia now joins Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal, and Rwanda as the nine African countries that have reached ML3.
“Ethiopia’s achievement is a landmark moment not only for the country but for Africa as a whole,” WHO Regional Director for Africa Mohamed Yakub Janabi said.
“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 exercise in Ethiopia, completed in September 2025, was supported by the WHO Regional Office for Africa and the WHO Country Office in Addis Ababa.
WHO Assistant Director-General for Health Systems, Access and Data, Yukiko Nakatani, emphasised that effective regulation saves lives.
Leadership and commitment
“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,” Nakatani said.
WHO notes that countries achieving ML3 and ML4 may also qualify as WHO-listed Authorities after further performance evaluations, enabling them to play a greater role in shaping global regulatory standards.
“Ethiopia’s milestone is therefore both a national success and a regional example, showing that Africa can build strong regulatory systems that ensure safe, high-quality medical products are accessible to all communities,” the Authority added.
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