V4.0
Markets where eCTD v4.0 is Voluntary
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 Voluntary
TWTaiwan, ChinaTaiwan Food and Drug Administration (TFDA)VoluntaryICH roadmapSince 1 Jan 2022
- Technical pilot
- No pilot; platform opened directly on 1 Jan 2022
- Voluntary
- Since 1 Jan 2022 (new drug & biologics filings)
- Mandatory
- From 1 Jul 2027 (eCTD-only for NDAs & biologics)
- Mandatory scope
- NDA & biologics registrations and post-approval changes; from 1 Jan 2026 eight new-drug categories must file online (eCTD or eSubmission)
EUEuropean UnionEC · EMA (European Commission & European Medicines Agency)VoluntaryICH 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)
USUnited StatesFDA · U.S. Food and Drug AdministrationVoluntaryICH 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
KRRepublic of KoreaMinistry of Food and Drug Safety (MFDS, formerly KFDA)VoluntaryNo official dateFrom 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
WHOWHO PrequalificationWHO Prequalification Unit (PQT)VoluntaryNo official datePhase 0
- Technical pilot
- Not started
- Voluntary
- Phase 0 (ongoing)
- Mandatory
- Phase 2/3 · TBD
- Mandatory scope
- PQ applications (APIMF / API-PQ / FPP / FVP): voluntary eCTD for new products + voluntary dossier conversion
BABosnia and HerzegovinaMedicines Agency of BiH (ALMBIH)VoluntaryNo official dateSince 2 Feb 2026
- Technical pilot
- 1 Aug – 31 Oct 2025 (complete)
- Voluntary
- Since 2 Feb 2026 (first registrations first)
- Mandatory
- Not announced
- Mandatory scope
- Human medicine MA applications (grant/renewal/variations); eCTD and NeeS are both officially valid formats
JOJordanJFDA (Jordan Food and Drug Administration)VoluntaryNo official dateeCTD accepted since Mar 2019
- Technical pilot
- N/A (direct acceptance since Mar 2019)
- Voluntary
- eCTD accepted since Mar 2019
- Mandatory
- TBD
- Mandatory scope
- JFDA has accepted eCTD since Mar 2019; on 30 Jul 2026 it implemented the first consolidated submission and lifecycle guidance systematically integrating eCTD module requirements