EFDA – Ethiopian Food and Drug Administration

Welcome to EFDA!

About EFDA

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.

MORE ABOUT EFDA

Organization

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.

Establishment

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.

Objectives

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.

Mission

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.

Services We Provide

Electronic Regulatory Information System

Improved Efficiency

Saves both applicants and EFDA staff time by allowing vendors to register their products and communicate with EFDA staff online

Increased Transparency

Allows both applicants and EFDA to track the status
of applications online.

Workforce Management

Helps EFDA department heads and managers assign applications to employees, track their workload, and follow application statuses.

Improved Data Quality

Provides standard terminologies and dictionaries such as International Non-proprietary Names and the Anatomical Therapeutic Chemical classification system which helps improve data consistency, data quality, and entry time and reduce data errors.

End-to-End Visibility

Integrates the market authorization database into i-Import in a seamless data exchange, thus moving Ethiopia further toward the goal of end-to end visibility along the entire pharmaceutical supply chain.

Key Features

i-Register

Request, review, and approve market authorization certificate for new products.

Request, review, and approve variations on existing products.

Request, review, and approve market re-authorization certificates for existing products.

i-Import

Request, review, approve permits and create licenses.

Assigned import permits to customer service officers, and count of import permits by an applicant

import permit processing time and Requested and Approved import

i-License

Request, review, and approve of facility licensing

Request, review, and approve of facility licensing for existing facilities being renewed

Request, review, and approve certificates for changes on existing facilities

Welcome to EFDA!

About EFDA

Organization

Establishment

Objectives

Mission

Services We Provide

Initiate Standards

Quality Control

Issue License

Undertake Inspection

Product Registration

Electronic Regulatory Information System

Improved Efficiency

Increased Transparency

Workforce Management

Improved Data Quality

End-to-End Visibility

Recent News & Events

The Authority Begins Quality Testing of Drug Samples for African Countries

Ethiopian Food and Drug Authority Inaugurates New Day-care Centre

EFDA, AHRI, and USP/PQM Plus Collaborate with Local Pharmaceutical Manufacturers to Implement National Bioequivalence Roadmap

Strengthened Stakeholder Cooperation Needed to Combat Illegal Drug Trafficking

Public-Private Sector Partnership Crucial to Combat Antimicrobial Resistance

Ethiopian Food Safety Day Emphasizes Long-Term Food Safety Measures