The Egyptian Drug Authority (EDA) has issued Decision No. 804 of 2025 regarding the issuance of the regulatory guideline governing the rules and procedures for establishing and operating the National Unified Electronic Drug Traceability System for human and biological pharmaceutical products.
Overall, the decision aligns largely with the draft guideline issued in September, which had already confirmed the previously announced implementation timelines for drug traceability:
February 1, 2026 for imported pharmaceuticals
August 1, 2026 for locally manufactured pharmaceuticals
One of the most important highlights of the final decision is the removal of the requirement to obtain the unique serial number from the national electronic system, which was previously mentioned in the draft version of the guideline.
The system architecture will be Centralized, and the reporting model will follow a Vertical approach.