Winning WHO Maturity Level 3 Marks Milestone in Ensuring Quality, Safety of Medicines in Ethiopia, Says Health Minister

Addis Ababa, October 2, 2025 — Ethiopia’s attainment of WHO Maturity Level 3 marks a significant milestone in the country’s journey to strengthen its pharmaceutical sector, Health Minister Dr. Mekdes Daba stated.

Speaking to the media today, the Minister explained that Ethiopia was awarded the Level 3 rating for establishing a stable and integrated drug regulatory system. She emphasized that this recognition confirms that the quality, safety, and effectiveness of medicines and medical devices meet international standards.

“This milestone represents a major step forward in ensuring that Ethiopians have continuous access to safe and high-quality medicines, ultimately protecting public health,” Dr. Mekdes said.

The Minister revealed that fewer than 70 countries worldwide have received this recognition, with Ethiopia becoming the ninth African nation to achieve it. She added that the recognition also demonstrates the government’s sustained commitment to improving drug control and regulatory quality.

Dr. Mekdes highlighted that this accomplishment was made possible through strong coordination among relevant institutions. She noted that it enhances Ethiopia’s international competitiveness and holds great significance for drug manufacturers and suppliers.

The Minister further explained that achieving Level 3 will support the country’s efforts to increase import substitution and encourage local pharmaceutical production. She added that Ethiopia’s success in regulating medicines and medical devices can serve as a model for other African countries.

Ethiopian Food and Drug Authority (EFDA) Director-General Heran Gerba stated that the achievement reflects the country’s dedication to ensuring imported medicines and vaccines meet international quality and safety standards.

She also noted that WHO conducted careful inspections of the medicine supply chain before granting Ethiopia the Level 3 status.

Dr. Heran added that Ethiopia is actively working to obtain WHO accreditation for medical device regulation, further strengthening the nation’s health sector.