Egypt
Regulator Egyptian Drug Authority (EDA) Official site ↗
eCTD v3.2.2 · EG M1
Draft / transitionEgypt's eCTD framework is defined by two drafts: the EG Module 1 eCTD Specification (draft v1.0/2026, based on ICH v3.2.2) and the Technical Guidance for eCTD Submissions (draft v1.0/2026). The guidance draft makes eCTD the mandatory format for regulatory submissions across all Egyptian procedure types and sets out the reformat-and-resubmit path from paper or Non-eCTD formats; effective dates in both drafts remain blank pending finalisation, and the consultation that ran 2 Sep – 14 Oct 2026 is now closed with final versions pending. Separately, a draft Notice to Applicants — Submission Guidance for the CTD (Version 6) is open for consultation 15–29 Oct 2026, part of the same Egyptian e-submission framework. Additionally, on 15 Oct 2026 the EDA opened a public consultation on the draft EG Human Pharmaceutical Module 1 Submission Guidance, which together with the EG M1 eCTD Specification and the Technical Guidance forms Egypt's eCTD transition document set.
Both documents are consultation drafts: code, issue date and effective date fields are blank. Filing requirements take effect only upon EDA's final publication — do not prepare submissions against the drafts.
Notices & updates
FAQ
Is eCTD mandatory in Egypt yet?
Not yet. On 2 Sep 2026 the EDA published two drafts for consultation (until 14 Oct 2026, now closed). The technical guidance draft states that eCTD will be the mandatory format for regulatory submissions across all procedure types in Egypt, but the issue and effective dates in both drafts are blank pending finalisation. Separately, a draft Notice to Applicants — Submission Guidance for the CTD (Version 6) is open for consultation from 15 to 29 Oct 2026, and on 15 Oct 2026 the EDA also opened a consultation on the draft EG Human Pharmaceutical Module 1 Submission Guidance; publication of final versions remains to be tracked.
Which ICH eCTD version are the Egyptian drafts based on?
They are based on ICH eCTD v3.2.2 together with the Egyptian Module 1 (EG M1 eCTD Specification draft v1.0/2026). Neither draft mentions v4.0.
How can stakeholders comment on the drafts?
Complete the EDA Stakeholder Feedback Form and email it by 14 Oct 2026 to hdr.regua.acc@edaegypt.gov.eg (pharmaceutical products) or bio.tech@edaegypt.gov.eg (biologics, innovative products and clinical studies).