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    • e-service
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    • Electronic Regulatory Information System(eRIS)
    • e-Reporting of ADR
    • Food Rapid Alert
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    • All Publications
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      • Policies
      • Proclamations
      • Regulations
    • Directives and Guidelines
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      • Medicine Guidelines
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      • Food Directives
      • Pharmacovigilance
      • Clinical Trials
    • Strategies
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      • Drug Formulary
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      • Drug Bulletin
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    • Medicine Facility Inspection Directorate
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Guideline for Conditional Approval of Medicines

By EFDAJanuary 29, 2021

Guideline for Conditional Approval of Medicines

Guideline for Conditional approval of medicines 2020

By EFDADecember 16, 2020

Guideline for Conditional approval of medicines 2020

ETHIOPIAN ESSENTIAL MEDICINES LIST SIXTH EDITION 2020

By EFDADecember 9, 2020

EML sixth edition

Traditional Medicine Clinical Trial guidance 2020

By EFDANovember 9, 2020

Traditional Medicine Clinical Trial guidance 2020

Supplementary guideline for Clinical trial Authorization 2020

By EFDANovember 9, 2020

Supplementary guideline for Clinical trial Authorization 2020

Guideline for Registration of oral care skin care products with therapeutic claim

By EFDAOctober 9, 2020

Guideline for Registration of oral care skin care products with therapeutic claim

Good Review Practices (GRevPs) Guideline

By EFDAOctober 1, 2020

Good Review Practices (GRevPs) Guideline

Guideline for WHO Pre-qualified Medicines through Collaborative Registration Procedure

By EFDAOctober 1, 2020

Guideline for WHO Pre-qualified Medicines through Collaborative Registration Procedure

Guideline for Registration of Low-risk Medicines

By EFDAOctober 1, 2020

Guideline for Registration of Low-risk Medicines

Risk-based Guideline for Post-Marketing Quality Surveillance

By EFDASeptember 25, 2020

PMS Guideline 2020

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