Powers and Duties

Pursuant to the Ethiopian Food and Medicines Authority Regulation No. 531/2023, EFDA discharges the following functions:-

1. Initiate and submit to the ministry a policy, strategy and law ideas in regulatory perspective for Regulation of regulated product, quality control service provider, bioequivalence centers and other products and services entrusted to the Authority; as appropriate implement, follow up the implementation same upon approval by the government;
2. Based on applicable criteria, as appropriate, register, acknowledge, issue market authorization, special regulatory license for regulated products and take appropriate administrative measures;
3. Issue and enforce regulatory criteria concerning regulated product; enforce Ethiopian mandatory standards; initiate national standards and implement same upon approval;
4. Issue certificate of competency or special regulatory license to importer, exporter, for cross regional purpose manufacturer or wholesaler of regulated products, quality control service provider and bioequivalence centers;
5. Inspect, investigate, including retail, any place or establishment in regions and collect sample of regulated products that entered into the market with authorization of the Authority or illicit product; take appropriate administrative measures against the product and cause the concerned body to take the appropriate measures against the establishment;
6. Issue import permit to regulated products, raw materials and packaging materials to be used for such products;
7. Issue, when requested, certificate of health to raw, semi- processed or processed food;
8. In accordance with the relevant law, prohibit manufacturing, importing, or sale of food with unhealthy ingredient; cause the amount of unhealthy content or ingredient within a food be restricted; regulate health warning, labeling, advertisement and related matters;
9. Notify and create awareness, as appropriate, to the public and stakeholders about registered or authorized or illicit products, establishments, administrative measures taken and the Authority`s regulatory functions;
10. Establish response system, perspective to regulatory, to emergency caused by a regulated product; establish a system that enables utilization of regulated product for emergency response; work in collaboration with concerned bodies;
11. Issue, revise essential medicine list, list of medicine to be utilized for emergency; and over counter medicine list;
12. Issue food additive list; issue national medicine formulary; categorize medicines into different categories;
13. Issue list or categorize medicines to be possessed by retail medicine establishment in their respective level;
14. Work with concerned bodies on the implementation of rational use of medicine and medical device;
15. Regulate manufacturing, importing, exporting, wholesaling, distributing, prescribing, dispensing, using, recording, reporting and disposal of narcotic drug, psychotropic substance and precursor chemical, and prevent their abuse;
16. Evaluate clinical trial request and authorize; monitor and inspect to ensure the trail performed in accordance with the authorization and good clinical trial practice; evaluate and authorize the use of the result in such a way it benefits the public; when necessary, order at any time, the clinical trial to be suspended or terminated;
17. Undertake or order post market surveillances; take appropriate measures based on the result of the surveillance;
18. Adopt and implement, as appropriate, criteria, standard, methods, pharmacopeia, manufacturer`s in house method or criteria adopted or activity undertaken by the World Health Organization, stringent regulatory authority, mutual or multi-lateral agreement entered by Ethiopia or other International Organization relevant to its regulatory works;
19. Conduct safety monitor of regulated products, collect information; follow-up evidence of existing and new adverse events and information about globally monitored products; notify the public where there is product not to be used, take the appropriate measure;
20. Regulate cross regional advertisement of regulated products in cooperation with the concerned body; regulate promotion of medicine and medical device with promotional materials and professionals;
21. Issue tobacco product special regulatory license; regulate the content and product disclosure, manufacturing, packaging, labeling, design, import, storage, distribution, advertisement, promotion and sponsorship, report, and related aspects of tobacco products in line with the World Health Organization Framework Convention on Tobacco Control and its implementing guideline;
22. Coordinate the implementation of the World Health Organization Framework Convention on Tobacco Control and its implementing guideline; establish national coordinating mechanism to follow-up effective implementation of tobacco control;
23. Concerning regulated products, search any establishment, place, vehicles, premises or other places and things with or without court order as provided by the relevant law; take appropriate measures;
24. Assign employee at entry and exit port of the country; conduct regulatory work on regulated products and collaborate with the appropriate body mandated to control exit and entrance; decide, when necessary, the entry and exit of a regulated product from the exit and entrance established by the appropriate body;
25. Establish and implement modern regulatory system; serve as a regulatory information center;
26. Organize laboratories necessary for the execution of its regulatory function;
27. Accept, as it deemed necessary, quality assurance report, inspection report, declaration and laboratory result conducted by accredited National or International organization for activities it undertakes;
28. Where the Authority suspect that a regulated product is non-compliant to the criteria or standard or it is illicit product; seize, collect sample, investigate; order for recall or return to the country imported from, the product to be kept separately; based on type of violation, confiscate and order disposal or utilize it;
29. Establish and organize control, follow up and measures system to prevent and control illegal activities of regulated products;
30. Issue National regulatory criteria for harmonized and complementary regulatory activities on regulated product at the Federal and Regional levels;
31. Provide, to the possible extent, support to Regional health regulatory and work in collaboration;
32. Work in collaboration with International, Continental, Regional, and Local Organizations and stakeholders in relation to the objective the authority established for;
33. Issue warning letter, suspend or revoke certificate of competency, special license or other license issued by the Authority, enlist into black list person engaged into illicit trade, order recall, disposal; impose fine as per Regulation or take other measures against violation of regulatory laws;
34. Use the same in accordance with appropriate law for the purpose of Health Regulation Collect service fees and fine imposed in administrative measures as per Regulation issued by the Council of Ministers;
35. Register and regulate a person who provide consultancy services in relation to products regulated at Federal level;
36. Establish working procedures of code of conduct, dressing code, participation in good manufacturing practices and laboratories and other related activities of the employee of the Authority or professionals engaged in the Authority`s task;
37. Own and possess property, enter into contracts, sue and be sued in its own name;
38. Where it finds it necessary, delegate part of its Powers and Duties to the appropriate body;
39. Performs other related activities that help to achieve its duties.