Ethiopian Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) is empowered by the Council of Ministers Legislation 189/2010 as the governing body for medicine regulation in Ethiopia. It is granted to regulate their manufacture, distribution, marketing, prescription, labelling and dispensing

Medicines registration in Ethiopia is carried out by MRAs to ensure that a medicinal product has been adequately tested and evaluated for safety, efficacy, and quality; and the product information provided by the manufacturer is accurate.
Ethiopia has a legal basis for marketing authorization of the pharmaceutical products with guidance for applicants and standard operating procedures for assessors. EFMHACA has a single advisory committee and is not currently participating in regional harmonization for registration, even though Ethiopia is very recently working towards harmonization of quality assurance for pharmaceutical and medical products with Intergovernmental Authority on Development (IGAD) member countries.

The market authorization process in Ethiopia includes manufacturing premise inspection for GMP compliance, assessment of product dossiers and laboratory testing, where applicable. The requirements for Ethiopian market authorization are: the medicinal product has to be included in to national medicine list, the manufacturing site has to be approved and certified for compliance with GMP either by EFMHACA or other recognized stringent regulatory authorities and such GMP certified or waived manufacturers have to submit application for dossier evaluation and product quality assessment accompanied with application fee.

EFMHACA is responsible for manufacturers, importers and wholesaler’s inspection and licensing. However, EFMHACA’s proclamation does not include requirements for obtaining licenses, terms, and conditions for suspending or revoking activity and product licenses. It does not define the norms, standards, and specifications to be applied in assessing the quality, safety, and efficacy of medicinal products. These points and other similar details were left to be stated in the directives and guidelines to be prepared by EFMHACA based on the proclamation.
The country has a clear guideline on how to avail the pharmaceutical registration and regulation services to the citizens and other parties of interest. It shares this information in its NMRA website and MoH website in detail.