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Ethiopian Food and Drug Authority
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Ethiopian Food and Drug Administration
EFDA
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Guidelines for Quality Agreement in Pharmaceutical Contract Manufacturing

By EFDASeptember 3, 2025

Guidelines for Quality Agreement in Pharmaceutical Contract Manufacturing

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

Guideline for Temporary Marketing Authorization of Medicinal Gasses

By EFDAApril 1, 2025

Guideline for Temporary Marketing Authorization of Medicinal Gasses

Guideline for Registration of Low risk Medicines

By EFDAFebruary 9, 2025

Guideline for Registration of Low risk Medicines

Guideline for Registration of Low risk Medicines

By EFDAFebruary 8, 2025

Guideline for Registration of Low risk Medicines

23.01.2025 Guidelines on procedures and data requirements for changes to approved biotherapeutic products

By EFDAJanuary 23, 2025

23.01.2025 Guidelines on procedures and data requirements for changes to approved biotherapeutic products

Guidelines-on-Reliance-for-Marketing Authorization 2024

By EFDAJanuary 17, 2025

Guidelines-on-Reliance-for-Marketing Authorization 2024

GMP Guideline for Herbal Medicine

By EFDANovember 20, 2024

GMP Guideline for Herbal Medicine

GDPGSP and Re-call Guideline Revised Second edition

By EFDAOctober 21, 2024

GDPGSP and Re-call Guideline Revised Second edition

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