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:
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.