EFDA – Ethiopian Food and Drug Administration

Welcome to EFDA
Welcome to EFDA's official website. It presents information on organizational structure of EFDA, pharmaceutical guidlines and other resources.
Our Vision
To be a center of excellence in food and health products regulation in Africa!

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i-Import
i-Import is an online application which allows importers to apply for and receive permits to import medicines online and EFDA staff to manage these applications online.

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i-Register
i-Register is an online application which allows importers to apply for and receive medicine registration certificate to import medicines online and EFDA staff to manage these applications online.

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i-License
i-License is an online application that allows importers, exporters, wholesalers and manufacturers to apply for the certificate of competency and EFDA stuff to manage these applications online.”

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Traceability
Traceability is a new system to be applied to track and trace pharmaceutical products using a set of standards and systems.

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Welcome to EFDA!

Our Vision

i-Import

i-Register

i-License

Traceability

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.

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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.

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

Quality Control

Issue License

Undertake Inspection

Product Registration

Initiate Standards

Quality Control

Issue License

Undertake Inspection

Product Registration

Initiate Standards

Quality Control

Issue License

Undertake Inspection