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Ethiopia Strengthens Regulation of Medicines and Medical Devices
ADDIS ABABA, Ethiopia — 16 September 2026
Ethiopia is strengthening its regulatory systems for medicines and medical devices through expanded collaboration between the Ethiopian Food and Drug Authority (EFDA) and the World Health Organization (WHO).
A 16 September meeting between WHO Ethiopia, the African Union, the UN Economic Commission for Africa and EFDA focused on strengthening the country's regulatory capacity, particularly for medical devices. EFDA is working towards achieving WHO Maturity Level 3 for medical-device regulation, a level associated with a stable, well-functioning and integrated regulatory system.
The process follows Ethiopia's achievement of Maturity Level 3 for medicines regulation. WHO said an assisted self-benchmarking exercise had identified areas where further institutional strengthening is required.
Priority areas include human resources, infrastructure, digital regulatory systems and technical assistance. The organisations also discussed advancing vaccine lot-release regulation towards Maturity Level 3.
The regulatory improvements have implications beyond oversight. Stronger national regulatory systems can support access to quality-assured medicines, vaccines and medical devices while providing a foundation for domestic pharmaceutical and vaccine manufacturing.
For Ethiopia, the work forms part of wider efforts to strengthen health-system resilience and move towards greater self-reliance in the production and regulation of essential health products.
Verified source: WHO Regional Office for Africa — official release
Urge Inside Health| East Africa. Urge- DevWire
WHO Representative to Ethiopia, Professor Francis Chisaka Kasolo, and the Director General of the Ethiopian Food and Drug Authority (EFDA), Ms. Heran Gerba,Courtesy Photo
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