Advisory Board
Advisory Board The EFDA is an independent Authority which operates within the framework of the Executive Agencies Proclamation No. 1263/2021. The Advisory Board was established under this Regulation No. 531/2023 article 6 (1). The members of the board including the chairman are appointed by the Minister of the Ministry of Health. The main role of…
Ethiopian Public Assessment Report
Artemether-20-mg-Lumefantrine-120-mg-Dispersible_Lumerax-DT-20120_public-assessment-summary-report_Ipca Laboratories Limited Diclofenac Sodium Injection 75 mg2 ml_Cisen Pharmaceauticals co., ltd Doravirine lamivudine and tenofovir disoproxil fumarate_ Delstrigo-100-mg-300-mg-245-mg-film-coated-tablets_-Public-assessment-summary-report_Package-label Emicizumab_Hemlibra 60 mg per 0.4mL_Public-assessment-summary-reportv_Chugai Pharma Manufacturing Co., Ltd Emicizumab_Hemlibra 30 mg per mL_Public-assessment-summary-reportv_Chugai Pharma Manufacturing Co., Ltd Emicizumab_Hemlibra 105 mg per 0.7mL_Public-assessment-summary-reportv_Chugai Pharma Manufacturing Co., Ltd Emicizumab_Hemlibra 150 mg per mL_Public-assessment-summary-reportv_Chugai Pharma Manufacturing Co., Ltd…
Summary of product characteristics
5-Fluorouracil Ebewe 50 mg per ml – concentrate for solution for infusion_EBEWE Pharma Ges.m.b.H 5- Fluorouracil 250mg per 5ml SOLUTION FOR INFUSION_Urafil-50_Khandelwal Laboratories Pvt. Ltd 2,4 dichlorobenzyl alchol (1.2mg), amylmetacresol(0.6mg)_SUPERIL LOZENGESWITH HONEY-LEMON FLAVOUR_UNIQUE PHARMACEUTICAL LABORATORIES Albendazole_Albendazole 400mg tablets- medicamen Biotech Limited Amphotericin B 50mg _AmBisome_Gilead Sciences, Inc. Amlodipine Besylate Tablets USP 5 mg_AMDIPINE 5_BDA HEALTHCARE…
Measure Taken
Suspended Products list of importer and Wholesaler with regulatory action Alert on Herceptin, Carvedilol and phenytoin regulatory administrative measure taken on importers and wholesalers for the year of 2024 & 2025 2024 Medicine Alert List EFDA 2024 Medicine products recall information initiated by EFDA by the year 2024 Public Alert Notice Counterfeited Herceptin…
Products and Institutions
Registered Medicines Licensed Medicine Manufacturers, Importers & Wholesalers iLicense User Manual v2
Appointed Inspectors
APPOINTED INSPECTORS Article 4 sub article 18 of the Food and Medicine Administration Proclamation No 1112/2019 empowers the Authority to appoint inspectors, and, as appropriate, order the inspection of any premises in accordance with this proclamation. List of GCP inspectors list of Qualified GDP inspector list of inspector at Port of entry GMP Inspector…
Strategic Plan
The Strategic Affair Executive Officer coordinates the process of planning and budgeting at the EFDA. It is also responsible for monitoring and evaluation of the annual and strategic plans. The authority ensures the monitoring and evaluation of the performance of its planned activities. The authority planned strategically on a five years term and it cascades…