Welcome to EFDA!

About The Authority

The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines. This has evolved over the years to improve the medicine dossier evaluation system.

MORE ABOUT FDA

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

EFDA was established under the Ethiopian  Food and Drug Administration establishment council of Ministers Regulation No. 189/2010. After repealing the drug administration and control proclamation 176/1999, EFDA became operational as of July 17, 2010. Its budget is from the Ethiopian government. It is mandated by the Food, Medicines and Health care Administration and Control Proclamation 661/2009.

Objectives

To protect the health of consumers by ensuring:-

  • Food safety and quality
  • Safety, efficacy, quality and proper use of medicines
  • Safety, quality and performance of medical device

Mission

To promote and protect the public health by ensuring safety, efficacy and quality of health and health-related products and services through product quality assessment and registration; licensing and inspection of health professionals, health institutions, pharmaceutical and food establishments, and provision of up-to-date regulatory information while promoting proper use of health and health-related products and services including proper use of medicines.

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

Recent News & Events