V4.0
Global eCTD v4.0 implementation roadmap
Published migration timelines per regulator. The mandatory date determines when your publishing toolchain and internal processes must be ready.
Global eCTD v4.0 implementation roadmap
2026
2028
EUEuropean UnionEC · EMAVoluntaryICH roadmap2025-12-22
- Technical pilot
- 2024 (CAPs complete) · 2026 forward compatibility (ongoing)
- Voluntary
- 2025-12-22 (new MAA CAPs) · MRP/DCP/NP TBD
- Mandatory
- 2028 · new MAA CAPs (strongly recommended from 2027)
- Mandatory scope
- New marketing authorisation applications (CAPs)
2029
USUnited StatesFDAVoluntaryICH roadmap2024
- Technical pilot
- 2022 – Q2 2023 (complete) · forward compatibility supported from 16 Oct 2026
- Voluntary
- 2024
- Mandatory
- 2029
- Mandatory scope
- NDA, ANDA, BLA, commercial IND, DMF
2030
CHSwitzerlandSwissmedicPlannedICH roadmapJan–Apr 2027
- Technical pilot
- Jan–Apr 2027 (per Swissmedic)
- Voluntary
- 2027
- Mandatory
- 2030
- Mandatory scope
- Human medicinal product applications; Swiss-specific Module 1
Date TBD
KRRepublic of KoreaMFDSVoluntaryICH roadmapFrom 15 Oct 2026
- Technical pilot
- 2026 (complete; live from 15 Oct 2026)
- Voluntary
- From 15 Oct 2026 (v4.0 recommended for new filings)
- Mandatory
- TBD
- Mandatory scope
- The v4.0 service is live and recommended for new item licence applications; existing approved items use the current (v3.2.2) tool
AUAustraliaTGAPilotingAuthority confirmedStarted H2 2025
- Technical pilot
- Started H2 2025 (ongoing · per TGA)
- Voluntary
- 2029 (per ICH table)
- Mandatory
- TBD
- Mandatory scope
- TBD
Source: ICH eCTD v4.0 regional implementation information (updated 2026-08). Always defer to the authority's own publications. ICH eCTD v4.0 regional implementation information ↗