V4.0
Markets where eCTD v4.0 is In force
Markets grouped by their current eCTD v4.0 implementation stage. Dates carry source-confidence badges; expand a row for the full timeline.
Markets where eCTD v4.0 is In force
UAUkraineState Expert Center of the Ministry of Health (DEC)In forceICH roadmapSince 18 Aug 2025
- Technical pilot
- 1 May – 31 Dec 2024
- Voluntary
- 1 Jan – 17 Aug 2025 (dual-format transition)
- Mandatory
- Since 18 Aug 2025 (new registrations)
- Mandatory scope
- Registrations, re-registrations and variations; the "authenticity" (Order No. 1391) and "recognition" (Order No. 1245) procedures are excluded
tnTunisiaNational Agency for Medicines and Health Products (ANMPS)In forceICH roadmap1 Jun 2026
- Technical pilot
- Portal testing from Oct 2025
- Voluntary
- 1 Apr – 31 May 2026 (eCTD or eSubmission)
- Mandatory
- 1 Jun 2026 · renewals baseline 1 Jan 2027
- Mandatory scope
- New MAAs, renewals, variations & transfers; backlog resubmission by 31 Dec 2026 (2025 dossiers) / 31 Mar 2027 (2026 dossiers), after which the original priority date is forfeited