Ethiopia

The Ethiopian Food and Drug Authority (EFDA), established under Proclamation No. 1112/2019, is 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 in Ethiopia. EFDA operates under the Federal Ministry of Health and replaced the former Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA). All health products intended for the Ethiopian market must undergo a formal registration process, which includes dossier review, laboratory testing where applicable, facility inspection, and approval by EFDA's technical committees before a product can be legally marketed or imported into the country.

Applicants are required to appoint a local legal representative or in-country agent, typically a licensed importer or distributor registered with EFDA, to submit and manage registration dossiers on behalf of foreign manufacturers. EFDA accepts dossiers prepared according to the Common Technical Document (CTD) format, and increasingly aligns its review pathways with African Union and African Medicines Agency (AMA) harmonization frameworks. Ethiopia is a member of the African Medicines Regulatory Harmonization (AMRH) initiative, and EFDA has introduced expedited review pathways for products pre-qualified by the World Health Organization (WHO), approved by stringent regulatory authorities (SRAs) such as the US FDA or EMA, or listed on the WHO Model List of Essential Medicines. Recent reforms have focused on digitizing the registration portal, reducing bureaucratic backlogs, and strengthening post-market surveillance capacity.

Public procurement of health products in Ethiopia is primarily coordinated through the Federal Ministry of Health (FMoH) and executed via the Pharmaceuticals Fund and Supply Agency (PFSA), which serves as the central procurement and supply chain management body for public health facilities at both federal and regional levels. PFSA manages forecasting, tendering, warehousing, and distribution of health commodities across Ethiopia's tiered health system, which includes federal hospitals, regional health bureaus, zonal health departments, and primary health care units. Procurement is conducted through competitive international and national tenders governed by Ethiopia's Public Procurement and Concession Commission (PPCC) directives, with suppliers required to meet registration, quality certification, and local agent requirements as stipulated by EFDA and PFSA guidelines.

Ethiopia relies substantially on donor-funded procurement channels to supplement public sector supply, with major partners including the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID through its global health supply chain programs, UNICEF Supply Division, and Gavi, the Vaccine Alliance, which supports immunization commodity procurement. These donors often procure directly through their own international tendering mechanisms or through PFSA using pooled procurement frameworks, and products procured via these channels are typically required to meet WHO prequalification or SRA approval standards. Ethiopia has articulated a strategic ambition to expand domestic pharmaceutical manufacturing capacity, and government policy increasingly encourages local production through preferential procurement margins, import duty exemptions for raw materials, and investment incentives managed through the Ethiopian Investment Commission, though implementation of local preference policies remains evolving and varies by commodity category.