Ethiopia - 1.2 Ethiopia Regulatory Departments and Quality Control

The Ethiopian Food and Drug Authority (EFDA) is a federal regulatory body established under Proclamation No. 1263/2021 and its mandate defined under regulation No. 531/2023. EFDA was established to safeguard the public’s health by ensuring the safety and quality of food, the safety, quality, and efficacy of medicines, the safety, quality, and functionality of medical devices, as well as the safety of cosmetics and other health products. It also regulates alcohol and tobacco products to reduce their consumption and protect the public from devastating consequences of death, disability, and disease.  

Before the adoption of regulation No. 531/2023 and proclamation No. 1112/2019, the Authority had been regulating products, professionals, premises, and practices (4Ps). However, after the adoption of the regulation and proclamation, its mandate limited to regulation of regulated products such as food, medicine, medical devices etc. and establishment associated with these products. Accordingly, among others, it regulates the production, importation, exportation, and distribution of regulated products. It registers and issues market authorizations and certificates of competency, authorizes clinical trials, monitors safety of medicine and medical devices etc. and takes administrative measures against non-compliance. Currently the Authority has seven branches across the country and works with regional and city administration regulators. 

For more information on regulatory departments and quality control laboratories’ contact details, please see the following links:  4.1 Ethiopia Government Contact List and 4.3 Ethiopia Laboratory and Quality Testing Company Contact List.

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