突尼西亞
主管機關 國家藥品與健康產品局（ANMPS） 官方網站 ↗
eCTD v3.2.2 · TN M1
現行突尼西亞的 eCTD 基於 ICH v3.2.2，由 TN-ANMPS Module 1 與地區資訊規範（v1.1，2025-02-27）定義，配套 eSubmission 規範 v1.1、Trigger File 規範 v1.0、驗證標準 v1.1 與 Q&A v1.1。電子遞交自 2026-04-01 起對新 AMM、續展、變更與轉移強制（初期 eCTD 或 eSubmission 雙格式），2026-06-01 起僅收 eCTD。規範 §1.3 提及 v4.0 僅為未來遷移意向。
DTD 與 Stylesheet 工具包（util）2026-08-14 更新：三版 Stylesheet 並行有效至 2026-12-31，此後僅接受新版。送件前務必使用最新的 document-matrix 與 submission-type-matrix（2026-04-17 更新）自檢。
公告與動態
常見問題
Is eCTD mandatory in Tunisia now?
Yes. Electronic submission became mandatory for new MAAs, renewals, variations and transfers on 1 Apr 2026 (eCTD or eSubmission), and exclusively eCTD from 1 Jun 2026. Renewals require eCTD with a prior baseline from 1 Jan 2027.
What about dossiers already submitted (the backlog)?
New-AMM dossiers submitted in 2025 that were untouched and not prioritised may be resubmitted in eCTD until 31 Dec 2026; those submitted in 2026 until 31 Mar 2027. Missing the deadline forfeits the original submission-date priority, which then resets to the actual eCTD filing date.
Which ICH eCTD version is the Tunisian specification based on?
It is based on ICH eCTD v3.2.2 with the Tunisian Module 1 (TN-ANMPS specification v1.1, Feb 2025). The specification mentions v4.0 only as a future migration intention; no dates have been announced.