EFDA – Ethiopian Food and Drug Administration
Source: https://www.efda.gov.et
Archived: 2026-04-23 14:37
EFDA – Ethiopian Food and Drug Administration
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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority
English
አማርኛ
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Home
About Us
About EFDA
Our Vision, Mission and Objectives
Organizational Structure
Advisory Board
Accreditations
Powers and Duties
News and Events
Services
Our Services
e-service
Traceability
FAQ’s
Electronic Regulatory Information System(eRIS)
How eRIS works
e-Reporting of ADR
Food Rapid Alert
Medical Device Safety
Publications
All Publications
Policies, Legislation and Strategic Plan
Policies
Proclamations
Regulations
Strategic Plan
Directives and Guidelines
Medicine Directives
Medical Device Guidelines
Medicine Guidelines
Medical Device Directives
Cosmetic Directive
Food Directives
Pharmacovigilance
Clinical Trials
Clinical Trials
Evaluation Summary Report
Tobacco
Strategies
Manuals
Manuals
Templatess
Drugs lists and formularies
Drug Lists
Drug Formulary
Bulletins and Newsletter
Food Bulletin
Drug Bulletin
Pharmacovigilance Newsletter
EFDA Newsletter
Articles
Ethiopian Traceability System
Directorates
Director General
Food Sector Deputy Director General
Medicine Sector Deputy Director General
Medical Device Sector Deputy Director General
QMS Lead Executive Officer
Director General Office
Branch Coordination Lead Executive Officer
Intelligence & illegal Trade Prevention Lead Executive Officer
Chief Executive Officer
Medicine Sector Deputy Director General
Medicine Manufacturers Inspection and Enforcement Lead Executive Officer
Medicine Quality Control Lead Executive Officer
Medicine Evaluation & Market Authorization Lead Executive Officer
Pharmacovigilance & Clinical Trial Lead Executive Officer
Food Sector Deputy Director General
Food Registration and Licensing Lead Executive Officer
Food Safety and Quality Testing Lead Executive Officer
Food Inspection and Enforcement Lead Executives Officer
Medical Device Sector Deputy Director General
Medical Device Manufacturers Inspection and Enforcement Lead Executive Officer
Medical Device Quality Control Lead Executive Officer
Medical Device Registration & Market Authorization Lead Executive Officer
Chief Executive Officer
Basic Service Executive Officer
Competence & Human Resource Management Executive Officer
Information & Technology Executive Officer
Organizational Change Management Executive Officer
Procurement & Finance Executive Officer
Strategic Affair Executive Officer
Women & Inclusive Social Affair Executive Officer
Branch Office Head
Administration and Finance Team
Entry and Exit Products Inspection Lead Executive Officer
Food & Medicine Quality Control lead Executive Officer
Food Control Lead Executive Officer
Medicine & Medical Device Control Lead Executive Officer
COVID19
COVID19 FAQ’s
COVID19 publications
COVID-19 Quick Access
Privacy Policy
Public Information
Approved Medicine Product Information
Ethiopian Public Assessment Report
Summary of product characteristics
Patient information leaflets
Products and Institutions
Appointed Inspectors
Measure Taken
Announcement
Tender
Notices
Vacancy
Contact
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!
VIEW DETAILS
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.
VIEW DETAILS
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.
VIEW DETAILS
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.”
VIEW DETAILS
Traceability
Traceability is a new system to be applied to track and trace pharmaceutical products using a set of standards and systems.
VIEW DETAILS
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
I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
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.
Events
The Ethiopian Food and Drug Authority (EFDA) is currently celebrating Medicine Safety Week with great enthusiasm under the powerful theme: “We Can All Help Make Medicines Safer.”
Read More…
Services We Provide
Initiate Standards
Quality Control
Issue License
Undertake Inspection
Product Registration
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
Feb
19
2026
Training and Workshop
Stakeholders Urged to Sustain Support as Ethiopia Eyes Regulatory Excellence in Vaccine Production
Training and Workshop
By
EFDA
February 19, 2026
Stakeholders Urged to Sustain Support as Ethiopia Eyes Regulatory Excellence in Vaccine Production ADDIS ABABA, Ethiopia, The Authority has…
Read more
Oct
1
2025
Medicine
EFDA Attains WHO Maturity Level 3 in Medicine Regulation
Medicine
By
EFDA
October 1, 2025
EFDA Attains WHO Maturity Level 3 in Medicine Regulation For Immediate release Ethiopia has reached Maturity Level 3 (ML3) in…
Read more
Sep
10
2025
Medicine
EFDA Officials Meet with Brazilian Pharmaceutical Investors
Medicine
By
EFDA
September 10, 2025
EFDA Officials Meet with Brazilian Pharmaceutical Investors ADDIS ABABA, ETHIOPIA — The Ethiopian Food and Drug Authority (EFDA) has held…
Read more
Sep
10
2025
Food
Medical Device
Medicine
Ethiopian Food and Drug Authority’s Advisory Board Holds Its Meeting
Food
,
Medical Device
,
Medicine
By
EFDA
September 10, 2025
Ethiopian Food and Drug Authority’s Advisory Board Holds Its Meeting Addis Ababa, August 15, 2025: The Advisory Board established in…
Read more
Sep
9
2025
Medicine
Staff Urged to Actively Participate in Completing and Handing Over the Excellence Center Project
Medicine
By
EFDA
September 9, 2025
Staff Urged to Actively Participate in Completing and Handing Over the Excellence Center Project On June 22, 2025, employees of…
Read more
Sep
9
2025
Food
Medical Device
Medicine
EFDA’s International and National Recognitions Reinforce Its Vision to Become a Center of Regulatory Excellence in Africa
Food
,
Medical Device
,
Medicine
By
EFDA
September 9, 2025
EFDA’s International and National Recognitions Reinforce Its Vision to Become a Center of Regulatory Excellence in Africa Addis Ababa, June…
Read more
Go to Top
Skip to content
የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority
English
አማርኛ
Home
About Us
About EFDA
Our Vision, Mission and Objectives
Organizational Structure
Advisory Board
Accreditations
Powers and Duties
News and Events
Services
Our Services
e-service
Traceability
FAQ’s
Electronic Regulatory Information System(eRIS)
How eRIS works
e-Reporting of ADR
Food Rapid Alert
Medical Device Safety
Publications
All Publications
Policies, Legislation and Strategic Plan
Policies
Proclamations
Regulations
Strategic Plan
Directives and Guidelines
Medicine Directives
Medical Device Guidelines
Medicine Guidelines
Medical Device Directives
Cosmetic Directive
Food Directives
Pharmacovigilance
Clinical Trials
Clinical Trials
Evaluation Summary Report
Tobacco
Strategies
Manuals
Manuals
Templatess
Drugs lists and formularies
Drug Lists
Drug Formulary
Bulletins and Newsletter
Food Bulletin
Drug Bulletin
Pharmacovigilance Newsletter
EFDA Newsletter
Articles
Ethiopian Traceability System
Directorates
Director General
Food Sector Deputy Director General
Medicine Sector Deputy Director General
Medical Device Sector Deputy Director General
QMS Lead Executive Officer
Director General Office
Branch Coordination Lead Executive Officer
Intelligence & illegal Trade Prevention Lead Executive Officer
Chief Executive Officer
Medicine Sector Deputy Director General
Medicine Manufacturers Inspection and Enforcement Lead Executive Officer
Medicine Quality Control Lead Executive Officer
Medicine Evaluation & Market Authorization Lead Executive Officer
Pharmacovigilance & Clinical Trial Lead Executive Officer
Food Sector Deputy Director General
Food Registration and Licensing Lead Executive Officer
Food Safety and Quality Testing Lead Executive Officer
Food Inspection and Enforcement Lead Executives Officer
Medical Device Sector Deputy Director General
Medical Device Manufacturers Inspection and Enforcement Lead Executive Officer
Medical Device Quality Control Lead Executive Officer
Medical Device Registration & Market Authorization Lead Executive Officer
Chief Executive Officer
Basic Service Executive Officer
Competence & Human Resource Management Executive Officer
Information & Technology Executive Officer
Organizational Change Management Executive Officer
Procurement & Finance Executive Officer
Strategic Affair Executive Officer
Women & Inclusive Social Affair Executive Officer
Branch Office Head
Administration and Finance Team
Entry and Exit Products Inspection Lead Executive Officer
Food & Medicine Quality Control lead Executive Officer
Food Control Lead Executive Officer
Medicine & Medical Device Control Lead Executive Officer
COVID19
COVID19 FAQ’s
COVID19 publications
COVID-19 Quick Access
Privacy Policy
Public Information
Approved Medicine Product Information
Ethiopian Public Assessment Report
Summary of product characteristics
Patient information leaflets
Products and Institutions
Appointed Inspectors
Measure Taken
Announcement
Tender
Notices
Vacancy
Contact
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!
VIEW DETAILS
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.
VIEW DETAILS
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.
VIEW DETAILS
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.”
VIEW DETAILS
Traceability
Traceability is a new system to be applied to track and trace pharmaceutical products using a set of standards and systems.
VIEW DETAILS
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
I am text block. Click edit button to change this text. Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.
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.
Events
The Ethiopian Food and Drug Authority (EFDA) is currently celebrating Medicine Safety Week with great enthusiasm under the powerful theme: “We Can All Help Make Medicines Safer.”
Read More…
Services We Provide
Initiate Standards
Quality Control
Issue License
Undertake Inspection
Product Registration
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
Feb
19
2026
Training and Workshop
Stakeholders Urged to Sustain Support as Ethiopia Eyes Regulatory Excellence in Vaccine Production
Training and Workshop
By
EFDA
February 19, 2026
Stakeholders Urged to Sustain Support as Ethiopia Eyes Regulatory Excellence in Vaccine Production ADDIS ABABA, Ethiopia, The Authority has…
Read more
Oct
1
2025
Medicine
EFDA Attains WHO Maturity Level 3 in Medicine Regulation
Medicine
By
EFDA
October 1, 2025
EFDA Attains WHO Maturity Level 3 in Medicine Regulation For Immediate release Ethiopia has reached Maturity Level 3 (ML3) in…
Read more
Sep
10
2025
Medicine
EFDA Officials Meet with Brazilian Pharmaceutical Investors
Medicine
By
EFDA
September 10, 2025
EFDA Officials Meet with Brazilian Pharmaceutical Investors ADDIS ABABA, ETHIOPIA — The Ethiopian Food and Drug Authority (EFDA) has held…
Read more
Sep
10
2025
Food
Medical Device
Medicine
Ethiopian Food and Drug Authority’s Advisory Board Holds Its Meeting
Food
,
Medical Device
,
Medicine
By
EFDA
September 10, 2025
Ethiopian Food and Drug Authority’s Advisory Board Holds Its Meeting Addis Ababa, August 15, 2025: The Advisory Board established in…
Read more
Sep
9
2025
Medicine
Staff Urged to Actively Participate in Completing and Handing Over the Excellence Center Project
Medicine
By
EFDA
September 9, 2025
Staff Urged to Actively Participate in Completing and Handing Over the Excellence Center Project On June 22, 2025, employees of…
Read more
Sep
9
2025
Food
Medical Device
Medicine
EFDA’s International and National Recognitions Reinforce Its Vision to Become a Center of Regulatory Excellence in Africa
Food
,
Medical Device
,
Medicine
By
EFDA
September 9, 2025
EFDA’s International and National Recognitions Reinforce Its Vision to Become a Center of Regulatory Excellence in Africa Addis Ababa, June…
Read more
Go to Top