WHO Level 3 Milestone Positions Ethiopia to Lure Pharma Manufacturers, Expand Market: Health Minister

Addis Ababa, October 3, 2025 (ENA)— Ethiopia’s landmark achievement of attaining World Health Organization (WHO) Level 3 in medicines regulation will position the country as a hub for both local and global pharmaceutical manufacturers, Health Minister Mekdes Daba said.

Ethiopia has been formally recognized by the World Health Organization for achieving Maturity Level 3 (ML3), placing it among nine African countries with this status in WHO’s global classification of national regulatory authorities.

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.

Asked by the Ethiopian News Agency, Health Minister Mekdes Daba emphasized that reaching WHO Level 3 is more than a technical milestone.

She highlighted that it boosts public confidence, strengthens the country’s ability to respond to health threats, and brings Ethiopia closer to the resilient health system that its communities deserve.

 The achievement also supports the nation’s agenda for local production of medicines and vaccines, ensuring sustainable access and self-reliance.

“Level 3 maturity opens opportunities for local manufacturers, expands market access, and, most importantly, guarantees safe and regulated medicines for our communities,” Minister Mekdes  said.

"Ethiopia is extremely proud, happy, and excited to have attained this Level 3 maturity," she underscored.”

Maturity Level 3 is defined by WHO as a stable, well-functioning, and integrated regulatory system, it was learned.

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.

Ethiopia now joins Egypt, Ghana, Nigeria, South Africa, Tanzania, Zimbabwe, Senegal and Rwanda in reaching ML3 on the continent.

“Ethiopia’s achievement is a landmark moment not only for the country but for Africa as a whole,” said Dr Mohamed Yakub Janabi, WHO Regional Director for Africa. “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 level three maturity assessment, which is done with a benchmarking exercise. It has been done at level three maturity under the evaluation that was done by the World Health Organization…..And this assessment puts Ethiopia as one of the countries which is on the forefront of achieving the level three maturity, and then the remaining level is going to be level four,” Dr. Mekdes noted.

The Minister further explained that during Ethiopia’s benchmarking exercise, significant changes were undertaken in a very short period, particularly in laboratory infrastructure and regulatory systems, which also strengthened the research and drug development capacities of various institutions.

She added that the effort extended beyond a single authority, encompassing local manufacturers as well, who were required to meet the standards necessary to ensure quality and compliance.

“This achievement also presents Ethiopia with an important opportunity to join the African market envisioned under the African Medicines Agency, a key pillar of the African Union’s Agenda 2063.”

She further stated: “It reflects the shared dream of producing and using medicines within Africa, ensuring that medical products meet the highest quality standards. Looking ahead, Ethiopia is committed to building on this milestone and deeply appreciates the support of stakeholders that has made it possible.”