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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority
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EFDA
Ethiopian Food and Drug Administration
EFDA
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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

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Good Pharmacovigilance Practice Inspection Guideline

By EFDAOctober 14, 2025

GVP Guidline

CEM_DTG

By EFDAJuly 31, 2025

CEM_DTG

ADE aDSM Report

By EFDAJuly 31, 2025

ADE aDSM Report

Risk Based -Post Marketing Surveillance Guidline

By EFDAOctober 7, 2024

Risk Based -Post Marketing Surveillance Guidline

Pharmacovigilance Guideline

By EFDAOctober 7, 2024

Pharmacovigilance Guideline

Guideline for Consumer Reporting of ADEs -English Version

By EFDAOctober 7, 2024

Guideline for Consumer Reporting of ADEs -English Version

Guideline for Consumer Reporting of ADE -l Amharic Version

By EFDAOctober 7, 2024

Guideline for Consumer Reporting of ADE -l Amharic Version

Adverse Event Following Immunization Guideline

By EFDAOctober 7, 2024

Adverse Event Following Immunization Guideline

Sinopharm Covid 19 vaccine active surveillance report

By EFDAApril 16, 2024

Sinopharm Covid 19 vaccine active surveillance report

CEM-ART drugs-2016-2021

By EFDAJune 8, 2023

CEM-ART drugs-2016-2021

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