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Review of the Ethiopia Health Regulatory Agency Reform

Field of Expertise:
Medical Products, Technologies; Policy/Strategy/DRA; Drug Regulatory Authority
Narrative description of project:
Ethiopia has begun implementing the Health Sector Transformation Plan (HSTP, 2015–2020). One of the HSTP strategies to improve the quality of care is to reform the Ethiopian Food, Medicine and Health Care Administration and Control Authority (EFMHACA), which was set up in 2009. EFMHACA succeeded the Drug Administration and Control Authority (DACA), whose mandate included human and veterinary medicines only.
The Assessment of the Ethiopian Food, medicines and health care Administration and Control Authority (EFMHACA) was requested by the Federal Minister of Health and is funded by DFID Ethiopia. It follows other assessments of the pharmaceutical regulatory system by the WHO and United States Pharmacopeia (USP) Promoting the Qualify of Medicines (PQM) programme. The objectives were to assess the capacity, motivation, external environment and current performance of EFMHACA; and identify change options to enable EFMHACA to achieve its desired level of performance and its organizational goals.