埃及
主管機關 埃及藥品管理局（EDA） 官方網站 ↗
eCTD v3.2.2 · EG M1
擬定 / 過渡埃及的 eCTD 框架由兩份草案定義：EG Module 1 eCTD 規範（v1.0/2026 草案，基於 ICH v3.2.2）與 eCTD 遞交技術指南（v1.0/2026 草案）。指南草案明確 eCTD 將是埃及所有程序類型註冊遞交的強制格式，並規定了從紙本/NeeS 切換的改版重送路徑；兩份草案的生效日期均待定稿確定，2026-09-02 起公開徵詢至 10-14（現已截止，正式版待發布）。另《CTD 提交指南（第 6 版）》（Notice to Applicants）草案自 2026-10-15 起公開徵詢至 10-29，同屬埃及遞交電子化框架；此外 EDA 於 2026-10-15 同步發布《EG Human Pharmaceutical Module 1 Submission Guidance》（人用藥 Module 1 遞交指引）草案並公開徵詢，與 EG M1 eCTD 規範、eCTD 技術指南共同構成 EG eCTD 過渡文件體系。
兩份草案仍是徵求意見稿：編號、發布日期與生效日期欄均空白。實際遞交要求以 EDA 定稿公告為準，定稿前請勿按草案口徑準備遞交。
公告與動態
常見問題
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).