The Egyptian Drug Authority (EDA) — represented by the Central Administration for Pharmaceutical Products and the Central Administration for Biological and Innovative Products and Clinical Trials — announces the release of a public consultation regarding the draft regulatory guidance titled:

EG Module 1 eCTD Specification

We are pleased to receive your comments and suggestions via the designated "Stakeholder Feedback Form" sent to the following email addresses:

• Central Administration for Pharmaceutical Products: hdr.regua.acc@edaegypt.gov.eg

• Central Administration for Biological and Innovative Products and Clinical Trials: bio.tech@edaegypt.gov.eg

The feedback period is open from September 2, 2026, until October 14, 2026.

This initiative reflects the commitment of the Egyptian Drug Authority to keep pace with modern scientific and technological advancements in drug regulation and dossier submission, aiming to develop and standardize submission mechanisms to ensure efficient and timely regulatory processes and support digital transformation in human and biological product registration.

To review the draft regulatory guidance, please click the link.