Strengthened Stakeholder Cooperation Needed to Combat Illegal Drug Trafficking
Strengthened Stakeholder Cooperation Needed to Combat Illegal Drug Trafficking It has been emphasized that the cooperation and participation of stakeholders…
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.
EFDA is the National Regulatory Body of Ethiopia which is under the Ministry of Health. The Authority is responsible to ensure the quality, safety and/or efficacy of medicines, food, cosmetics and medical devices.
The EFDA was established as an autonomous federal government body having its own legal personality under the Definition of Powers and Duties of the Executive Organs Proclamation No. 1263/2021, Article 66 (1). The powers, duties, and organization of the Authority is determined under the Definition of Organization, Powers, and Duties of the Ethiopian Food and Drug Authority Council of Ministers Regulation No. 531/2023. As per Article 13 of Regulation No. 531/2023, the budget of the Authority shall be allocated by the government.
The objective of the Authority is to protect the public health by regulating food, medicine and medical devices, blood and blood products, traditional, complementary or alternative medicine, cosmetics, tobacco, quality control service provider, bioequivalence centers and other products and services entrusted to the Authority to regulate.
To protect and promote public health by ensuring the safety, effectiveness, quality and proper use of regulated products through licensing, inspection, registration, laboratory testing, post-marketing surveillance, community participation, and provision of up-to-date regulatory information.
Key Features
i-Register
i-Import
i-License
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