18 October 2018
Fact-finding mission in Ethiopia
Action plan
18 October 2018
Ethiopia’s current regulation on medicine has been set by the Food, Medicine and Health care Administration and Control proclamation No.661/2009 with the objective of protecting public health from unsafe, inefficacious and poor-quality medicine. The executive organs aimed at enforcing the law are the Ethiopian Food and Drugs Administration (EFDA) and the Regional Health Bureaus (RHB). The FDA has been empowered by the Council of Ministers Legislation 189/2010 as the governing body for medicine regulation in Ethiopia with its organizational structure (www.fmhaca.gov.et/). Its key regulatory functions at federal level are:
– Drug assessment and registration
– Licensing of premises (manufacturers, importers and distributers)
– Onsite inspection of manufacturing facilities and distribution channels
– Adverse drug reaction monitoring
– Post market surveillance
– Quality control analysis
– Control of drug promotion & advertising
– Control of clinical trials
– Enforcement
– Entry-exit port regulation
– Public awareness creation
The EFDA will be the project’s key partner, and collaboration opportunities were identified during the assignment. In addition, key stakeholders were interviewed and a mapping of the local context was carried out.