Ethiopia joins Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda in reaching ML3 on the continent.
WHO said in its official press release yesterday, 30th September 2025 that, this milestone reflects the Ethiopian Food and Drug Authority’s (EFDA) commitment to ensuring that medicines and imported vaccines available in the country meet international standards of quality, safety and efficacy. The designation follows a comprehensive WHO assessment using its Global Benchmarking Tool, which evaluates regulatory systems against more than 250 indicators.
Maturity Level 3 is defined by WHO as a stable, well-functioning, and integrated regulatory system. Countries that reach this level are recognized for their capacity to authorize medical products, conduct market surveillance and monitor safety events effectively. Maturity Level 4, the highest level, signifies an advanced regulatory system committed to ongoing improvement.
East Africa Regulatory Affairs Professionals Association (EARAPA) would like to extend warmest congratulations to EFDA and fellow Ethiopians for achieving this major milestone in medicine regulation.
Well-deserved recognition! Congratulations again!
Can you join us to congratulate Ethiopia and the agency?