Ethiopia

The Ethiopian Food and Drug Authority (EFDA), established under Proclamation No. 1112/2019, serves as the primary national regulatory authority responsible for the registration, licensing, and post-market surveillance of health products including pharmaceuticals, medical devices, diagnostics, and digital health solutions. EFDA replaced the former Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) and operates under the Federal Ministry of Health. The general approval process requires applicants to submit a dossier for product registration, undergo technical review by EFDA's evaluation committees, and obtain a Certificate of Registration before any health product may be legally marketed or distributed in Ethiopia. Products may also be subject to laboratory testing and facility inspections as part of the review process.

Applicants seeking product registration in Ethiopia must appoint a local authorized representative or agent who is licensed by EFDA and legally registered in the country. Dossier submissions generally follow the Common Technical Document (CTD) format, and EFDA increasingly references guidelines from the World Health Organization (WHO) and the African Medicines Regulatory Harmonization (AMRH) initiative. Ethiopia is a member of the African Union's African Medicines Agency (AMA) framework and participates in regional harmonization efforts through the East African Community (EAC) and the Intergovernmental Authority on Development (IGAD). Notable recent reforms include the introduction of expedited review pathways for WHO-prequalified products and those approved by stringent regulatory authorities (SRAs), as well as a growing focus on regulating in vitro diagnostics and digital health technologies under updated regulatory frameworks.

Public procurement of health products in Ethiopia is primarily coordinated through the Federal Ministry of Health (FMoH) and its affiliated agencies, most notably the Ethiopian Pharmaceutical Supply Service (EPSS), which serves as the central procurement and distribution body for public sector health commodities. EPSS manages national-level tendering, warehousing, and logistics for pharmaceuticals, medical devices, and diagnostics supplied to federal and regional health facilities. Procurement follows the Public Procurement and Property Administration Proclamation, and large-value tenders are subject to review by the Public Procurement and Property Administration Agency (PPAA). Regional Health Bureaus may conduct supplementary procurement for state-level facilities, though the bulk of essential health commodity procurement is centralized at the federal level to achieve economies of scale and ensure supply chain efficiency.

Donor-funded procurement channels play a substantial role in Ethiopia's health product market, with significant volumes of commodities financed and supplied through the Global Fund to Fight AIDS, Tuberculosis and Malaria; the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) via USAID; Gavi, the Vaccine Alliance; and UNICEF's Supply Division. These channels often operate under their own procurement rules and may bypass standard EPSS tender processes, though alignment with EFDA registration requirements is increasingly enforced. The private pharmaceutical sector, including retail pharmacies and private hospitals, procures through licensed importers and distributors. Ethiopia has introduced local manufacturing preference policies as part of its Pharmaceutical Industry Development Strategy, offering incentives for domestically manufactured products and seeking to reduce import dependency over time. International suppliers are encouraged to explore partnerships with local manufacturers or distributors to strengthen market access and comply with evolving localization requirements.