Announcements
Egyptian Drug Authority (EDA) Announces Public Consultation on the New Guideline for Biological Products Registration Guideline for content file of biological products for registration & re-registration file
10 February 2026
In line with the Egyptian Drug Authority’s commitment to staying abreast of the latest scientific developments, ensuring the availability of advanced high-tech products while maintaining their quality, safety, and efficacy;
The Central Administration for Biological and Innovative Products and Clinical Studies has published the following draft regulatory guideline:
Guideline for content file of biological products for registration & re-registration file
We are pleased to receive your feedback via the "Public Consultation Form" at the following email address:Biots.da@edaegypt.gov.eg
The consultation period is open from February 10, 2026, to March 3, 2026, via the official Egyptian Drug Authority Website.