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የኢትዮጵያ ምግብና መድኃኒት ባለስልጣን
Ethiopian Food and Drug Authority
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Ethiopian Food and Drug Administration
EFDA
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  • Home
  • About Us
    • About EFDA
    • Our Vision, Mission and Objectives
    • Organizational Structure
    • Accreditations
    • Powers and Duties
    • Appointed Inspectors
  • News and Events
  • Services
    • Our Services
    • e-service
    • Traceability
      • FAQ’s
    • Electronic Regulatory Information System(eRIS)
    • e-Reporting of ADR
    • Food Rapid Alert
  • Publications
    • All Publications
    • Policies, Legislation and Strategic Plan
      • Policies
      • Proclamations
      • Regulations
      • Strategic Plan
    • Directives and Guidelines
      • Medicine Directives
      • Medical Device Guidelines
      • Medicine Guidelines
      • Cosmetic Directive
      • Food Directives
      • Pharmacovigilance
      • Clinical Trials
    • Strategies
    • Manuals
    • Drugs lists and formularies
      • Drug Lists
      • Drug Formulary
    • Bulletins and Newsletter
      • Drug Bulletin
      • Food Bulletin
      • Pharmacovigilance Newsletter
      • EFDA Newsletter
    • Ethiopian public assessment report
    • 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
  • Announcement
    • Tender
    • Notices
    • Vacancy
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Guidelines for Registration of Similar Biotherapeutic Products (SBPs)

By EFDAJune 7, 2023

Guidelines for Registration of Similar Biotherapeutic Products (SBPs)

Guidelines for Registration of Biotherapeutic Protein Products

By EFDAJune 7, 2023

Guidelines for Registration of Biotherapeutic Protein Products

List of authorized pharmaceutical product importer Inspectors at POE

By EFDAJune 4, 2023

List of authorized pharmaceutical product importer Inspectors at POE

list of GCP Inspectors

By EFDAJune 4, 2023

list of GCP Inspectors

List of GMP inspectors

By EFDAJune 4, 2023

List of GMP inspectors

List of pharmaceutical Importer and Wholesaler inspector

By EFDAJune 4, 2023

List of pharmaceutical Importer and Wholesaler inspector

EFDA GMP Guideline for pharmaceutical products second edition

By EFDAJune 2, 2023

EFDA GMP Guideline for pharmaceutical products second edition

GUIDELINE FOR PREPARATION AND PUBLICATION OF PUBLIC ASSESSMENT REPORTS FOR APPROVED MEDICINES

By EFDAMay 23, 2023

GUIDELINE FOR PREPARATION AND PUBLICATION OF PUBLIC ASSESSMENT REPORTS FOR APPROVED MEDICINES

Guideline for Renewal of Medicines Marketing Authorization

By EFDAMay 15, 2023

Guideline for Renewal of Medicines Marketing Authorization

Guidelines on Reliance for Regulatory Decision Making

By EFDAApril 25, 2023

Guidelines on Reliance for Regulatory Decision Making

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