Ethiopia

The Ethiopian Food and Drug Authority (EFDA) serves as the primary national regulatory authority responsible for overseeing the safety, efficacy, and quality of health products in Ethiopia, including pharmaceuticals, medical devices, diagnostics, and digital health solutions. Established under Proclamation No. 1112/2019, which replaced the earlier Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA), EFDA operates under the Federal Ministry of Health and enforces its mandate through a risk-based regulatory framework. The general approval process requires applicants to submit a formal registration dossier, undergo technical review by EFDA's product assessment teams, and receive a marketing authorization before any health product may be legally imported, distributed, or sold within Ethiopia. Inspections of manufacturing facilities, either locally or via documentary evidence from recognized reference authorities, may also form part of the evaluation process.

Applicants seeking product registration in Ethiopia are required to appoint a local authorized representative or agent who is registered with EFDA and holds a valid license to operate in the country. Dossier submissions are generally expected to follow the Common Technical Document (CTD) format, and EFDA increasingly recognizes approvals granted by stringent regulatory authorities (SRAs) such as the US FDA, EMA, and WHO Prequalification as supportive evidence that can facilitate expedited review pathways. Ethiopia has undertaken notable regulatory reforms in recent years, including the introduction of reliance and recognition procedures intended to reduce duplication and accelerate market access for products already cleared by trusted reference agencies. EFDA has also been expanding its capacity for post-market surveillance, adverse event reporting, and the regulation of emerging product categories such as in vitro diagnostics and digital health technologies, aligning progressively with African Union regulatory harmonization initiatives under the African Medicines Regulatory Harmonization (AMRH) program.

Public procurement of health products in Ethiopia is primarily coordinated through the Federal Ministry of Health (FMoH) and its dedicated procurement and supply chain arm, the Pharmaceutical Fund and Supply Agency (PFSA), which was restructured and rebranded as the Ethiopian Pharmaceutical Supply Service (EPSS). EPSS manages the centralized quantification, procurement, warehousing, and distribution of medicines, medical devices, and diagnostics for the public health system, operating through a network of regional hubs that supply health facilities at federal, regional, zonal, and woreda levels. Procurement for the public sector is conducted through competitive tendering processes governed by the Public Procurement and Property Administration Agency (PPAA) and applicable federal procurement directives. Suppliers must be registered with EPSS and meet defined quality assurance requirements, including WHO Prequalification or SRA approval for most product categories, in order to participate in public tenders.

Beyond the public procurement channel, Ethiopia's health product market is significantly shaped by donor-funded and multilateral procurement streams. Key partners include the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID and its implementing mechanisms such as PEPFAR and the President's Malaria Initiative, UNICEF Supply Division, and Gavi, the Vaccine Alliance, all of which support substantial volumes of health commodity procurement for Ethiopia's disease programs. These channels often follow their own procurement rules and pre-approved supplier lists, creating parallel pathways to market that are particularly important for diagnostics, vaccines, and essential medicines. Ethiopia has articulated policies encouraging local manufacturing as part of its broader industrial development strategy, with EPSS and the FMoH giving preference to domestically produced health products where quality and supply security can be assured, and the government has established industrial parks and incentive frameworks aimed at attracting pharmaceutical manufacturing investment to reduce import dependence over the long term.