{"entity":{"id":"efda-ethiopia","kind":"institution","name":"Ethiopian Food and Drug Authority (EFDA)","aka":["EFDA","Ethiopian Food, Medicine and Healthcare Administration and Control Authority","EFMHACA","FMHACA"],"tldr":"Ethiopia's medicines regulator. It authorises medicines and clinical trials, has relied on stringent foreign regulators' approvals since 2014, and reached the World Health Organization's maturity level 3 for medicine regulation in September 2025.","summary":"The Ethiopian Food and Drug Authority is an autonomous federal body established under the Definition of Powers and Duties of the Executive Organs Proclamation No. 1263/2021, with its powers set by Council of Ministers Regulation No. 531/2023; it regulates medicines, medical devices, food, cosmetics, alcohol and tobacco. Its earlier name was the Ethiopian Food, Medicine and Healthcare Administration and Control Authority. The coordinates are an approximate Addis Ababa city point.\n\nOn 29 September 2025 EFDA announced that the World Health Organization had rated it at maturity level 3 for medicine regulation, which it described as making Ethiopia the ninth country in Africa to reach that level. Its reliance guideline for GMP inspection (EFDA/GDL/052, issued July 2024) states that the Authority has relied on stringent regulatory authorities for medicine registration and GMP inspection since 2014, and acknowledges that shortages of essential medicines, a limited number of registered medicines and relatively long waiting times for registration remain challenges.\n\nIts clinical trial authorisation guideline (EFDA/GDL/005, version 5, issued 9 June 2025) sets a routine review time of 45 working days for first feedback on a complete application, up to 90 calendar days for a high-risk trial and no more than 30 calendar days for a non-routine application, and allows the Authority to use decisions and reports from WHO, AVAREF, the EMA and the US FDA.","asOf":"2026-11-04","links":[{"label":"EFDA: about EFDA","url":"https://www.efda.gov.et/"},{"label":"EFDA: EFDA attains WHO maturity level 3 in medicine regulation (1 October 2025)","url":"https://www.efda.gov.et/efda-attains-who-maturity-level-3-in-medicine-regulation-2/"},{"label":"EFDA: guideline on reliance for cGMP inspection, EFDA/GDL/052 (PDF)","url":"https://www.efda.gov.et/wp-content/uploads/2024/07/Guideline-on-Reliance-for-GMP-inspection-scan-pdf.pdf"},{"label":"EFDA: guideline for clinical trial authorization 2025, EFDA/GDL/005 (PDF)","url":"https://www.efda.gov.et/wp-content/uploads/2025/08/GUIDELINE-FOR-CLINICAL-TRIAL-AUTHORIZATION-2025-Version-005-3.pdf"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ethiopia-ministry-of-health"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"city":"Addis Ababa","country":"ET","lat":9.02,"lng":38.75,"institutionType":"government","website":"https://www.efda.gov.et","programs":["Marketing authorisation of medicines","Reliance on stringent regulatory authorities (since 2014)","Clinical trial authorisation (EFDA/GDL/005)","Pharmacovigilance and post-market surveillance","Tobacco and alcohol control"]},"route":"/institutions/efda-ethiopia/","neighbours":{"institution":[{"id":"ethiopia-ministry-of-health","kind":"institution","name":"Federal Ministry of Health, Ethiopia","route":"/institutions/ethiopia-ministry-of-health/"}]}}