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Ethiopian Food and Drug Administration
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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
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  • Contact

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Guideline for Quality Agreement in pharmaceutical contract manufacturing Version 002, 2025

By EFDANovember 27, 2025

Guideline for Quality Agreement in pharmaceutical contract manufacturing Version 002, 2025

Guideline for Registration of Monoclonal Antibodies and Related Products 2025

By EFDANovember 12, 2025

Guideline for Registration of Monoclonal Antibodies and Related Products 2025

Guideline for Renewal of MA

By EFDASeptember 13, 2025

Guideline for Renewal of MA

Guideline For Medicine and Medicine Raw Material Port Clearance version 001 2025

By EFDASeptember 12, 2025

Guideline For Medicine and Medicine Raw Material Port Clearance version 001 2025

Guideline For Risk Management Process For Regulatory Systems version 002 2025

By EFDASeptember 12, 2025

Guideline For Risk Management Process For Regulatory Systems version 002 2025

Guidance for Registration of Radio pharmaceuticals

By EFDASeptember 9, 2025

Guidance for Registration of Radiopharmaceuticals

Guideline for Medicinal product information

By EFDASeptember 9, 2025

Guideline for Medicinal product information

Guideline For Remote GMP Inspection

By EFDASeptember 3, 2025

Guideline For Remote GMP Inspection

Guideline for the registration of Plasma derived Medical Products

By EFDAAugust 8, 2025

Guideline for the registration of Plasma derived Medical Products

GMP Guideline, 4th Edition

By EFDAAugust 7, 2025

GMP Guideline, 4th Edition

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