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PXL/HO/Cir-009/2025-26 Date: 21.04.2025
Hyderabad
Subject: Ethiopian FDA-Notification on Revision of GMP Inspection Validity Period
We would like to inform all concerned that the Ethiopian Food and Drug Authority (EFDA), under the mandate of Proclamation No. 1112/2019, has revised its directive governing the inspection of pharmaceutical manufacturers to enhance the safety, quality, and efficacy of health products in accordance with international standards.
Key Updates from EFDA – Directive No. 1055/2025 (Replacing Directive No. 999/2024):
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GMP Re-inspection Frequency: The interval for re-inspection of GMP-compliant facilities has been reduced from 5 years to 3 years.
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Validity of Fees: The fees paid for GMP inspection or GMP waiver are now valid for 3 years from the date of receipt by EFDA.
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Re-inspection Requirement: Manufacturers currently holding a 5-year valid cGMP certificate (based on physical inspection) must now apply for re-inspection after 3 years as per the revised directive.
EFDA will be notifying the concerned applicants shortlyregarding re-application for cGMP validity compliance.
We urge all foreign pharmaceutical manufacturers exporting to Ethiopia to align with the updated requirements and initiate preparations for timely re-inspection to avoid regulatory delays.
We appreciate your cooperation in adhering to these updated guidelines.
Warm Regards,
Raja Bhanu
Director General
Encl: EFDA letter dt:14/04/2025
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