Ethiopia

The Ethiopian Food and Drug Authority (EFDA) is the primary national regulatory body responsible for the oversight of health products in Ethiopia, including pharmaceuticals, medical devices, diagnostics, and digital health solutions. EFDA was established under Proclamation No. 1112/2019, which replaced the earlier Ethiopian Food, Medicine, and Health Care Administration and Control Authority (EFMHACA) and significantly expanded its mandate and enforcement powers. The general approval process involves product registration through EFDA's online portal, technical dossier review, laboratory testing where applicable, and inspection of manufacturing facilities. Products must be registered before they can be legally imported, distributed, or sold in Ethiopia, and registration certificates are typically valid for five years, subject to renewal.

Applicants are required to appoint a local authorized representative or in-country agent who is registered with EFDA and takes legal responsibility for the product on the Ethiopian market. Dossier submissions should conform to the Common Technical Document (CTD) format, which EFDA has increasingly aligned with as part of broader harmonization efforts under the African Medicines Regulatory Harmonization (AMRH) initiative and the African Union's African Medicines Agency (AMA) framework. For medical devices and diagnostics, EFDA follows a risk-based classification system broadly consistent with Global Harmonization Task Force (GHTF) principles. Notable recent reforms include the digitization of the registration process, the introduction of expedited review pathways for essential health products and products pre-approved by stringent regulatory authorities (SRAs) such as the US FDA, EMA, or WHO Prequalification Programme, and ongoing capacity-building efforts to reduce review backlogs and improve transparency.

Public procurement of health products in Ethiopia is centrally coordinated through the Federal Ministry of Health (FMoH) in partnership with the Ethiopian Pharmaceutical Supply Service (EPSS), the state-owned enterprise responsible for the quantification, procurement, warehousing, and distribution of medicines, medical supplies, and equipment to public health facilities across the country. Procurement decisions are guided by national essential medicines lists, standard treatment guidelines, and annual forecasting exercises. Tender processes for large-volume public procurement are managed through the Public Procurement and Property Administration Agency (PPAA) framework, with international competitive bidding required above defined thresholds. Regional health bureaus may conduct supplementary procurement for region-specific needs, creating a layered federal and subnational procurement structure, though the bulk of volume flows through the centralized EPSS channel.

Donor-funded procurement represents a substantial share of health product supply in Ethiopia, given the significant role of external financing in the health sector. Key donor channels include the Global Fund to Fight AIDS, Tuberculosis, and Malaria, the US Government through USAID and PEPFAR implementing partners, Gavi the Vaccine Alliance for immunization commodities, and UNICEF for maternal and child health supplies. These channels often procure through international mechanisms such as UNICEF Supply Division or the Global Fund's pooled procurement framework, sometimes bypassing national tender processes but requiring alignment with FMoH priorities. Ethiopia has an active local pharmaceutical manufacturing sector, and government policy increasingly emphasizes import substitution and local manufacturing preferences, including price preferences for locally produced products in public tenders and incentives under the national pharmaceutical industry development strategy, aimed at reducing import dependency and strengthening supply chain resilience.