Tunisia
Regulator National Agency for Medicines and Health Products (ANMPS) Official site ↗
eCTD v3.2.2 · TN M1
In forceTunisia's eCTD builds on ICH v3.2.2 and is defined by the TN-ANMPS eCTD Specification and Guidance for Module 1 and Regional Information (v1.1, 27 Feb 2025), with the CTD eSubmission Specification v1.1, Trigger File Specification v1.0, validation criteria v1.1 and Q&A v1.1. Electronic submission became mandatory for new MAAs, renewals, variations and transfers on 1 Apr 2026 (initially eCTD or eSubmission), with eCTD as the sole accepted format from 1 Jun 2026. Section 1.3 of the specification mentions v4.0 only as a future migration intention.
The util folder (DTD and stylesheets) was updated on 14 Aug 2026: all three stylesheet versions remain valid until 31 Dec 2026, after which only the new version is accepted. Validate against the latest document-matrix and submission-type-matrix (updated 17 Apr 2026) before filing.
Notices & updates
FAQ
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.