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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
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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
    • 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
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      • Policies
      • Proclamations
      • Regulations
      • Strategic Plan
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      • Medicine Directives
      • Medical Device Guidelines
      • Medicine Guidelines
      • Medical Device Directives
      • Cosmetic Directive
      • Food Directives
      • Pharmacovigilance
      • Clinical Trials
      • Tobacco
    • Strategies
    • Manuals
    • 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 Registration & 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
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guideline for temporary MA of Medicinal Gasses

By EFDAOctober 2, 2024

guideline for temporary MA of Medicinal Gasses

Good Laboratory Practice Guideline

By EFDASeptember 17, 2024

Good Laboratory Practice Guideline

Bioequivalence Studies Guideline

By EFDASeptember 17, 2024

Bioequivalence Studies Guideline

Guideline on Reliance for GMP inspection

By EFDAJuly 22, 2024

Guideline on Reliance for GMP inspection scan pdf

2024.03.01 Guideline for Registration of Medicine

By EFDAJune 14, 2024

2024.03.01 Guideline for Registration of Medicine

2023.09.06 Guideline-for-WHO-Pre-qualified-Medicines-through-Collaborative-Registration-Procedure-

By EFDAJune 14, 2024

2023.09.06 Guideline-for-WHO-Pre-qualified-Medicines-through-Collaborative-Registration-Procedure-

2023.12.20 GUIDELINE FOR NON-ROUTINE REGISTRATION

By EFDAJune 14, 2024

2023.12.20 GUIDELINE FOR NON-ROUTINE REGISTRATION

2023.11.02 Guideline on Variation Application to Registered Medicines

By EFDAJune 14, 2024

2023.11.02 Guideline on Variation Application to Registered Medicines

2023.12.21 Guideline on Medical Products Special import permit

By EFDAJune 14, 2024

2023.12.21 Guideline on Medical Products Special import permit

2024.01.11 Guideline for control of advertising and promotion

By EFDAJune 14, 2024

2024.01.11 Guideline for control of advertising and promotion

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