ALL

eCTD specification index

Official documents, version status and implementation timelines for eCTD 3.2.2 and eCTD v4.0, organised by country and region. Every entry points to the regulator's own publication.

Latest regulatory changes

View all changes →

2026-11-06

Swissmedic announces the eCTD v4.0 pilot scheme: introduction between January and April 2027 in two phases (Phase 1: valid and correct initial submissions; Phase 2: follow-up submissions, lifecycle management and more complex structures), with pilot submissions based on the Swiss Implementation Guide v2.0 package of 26 October 2026. Open to all interested companies; applications for Pilot Phase I close on 27 November 2026

CHMilestone

2026-10-26

Swissmedic publishes the Swiss Implementation Guide v2.0 package (IG v2.0, controlled vocabulary CV v2.0 with Genericicode, Validation Criteria v2.0), replacing the v1.1 package of 27 July 2026 as the baseline for eCTD v4.0 software development

CHNew specification

2026-10-20

EMA reminder: electronic application forms (eAF) for Marketing Authorisation Applications and Variations for centrally authorised products must follow the established naming convention, or may be requested for resubmission

EUPolicy

2026-10-16

FDA (CDER and CBER) announces it will technically reject electronic submissions failing new high-severity validation criteria from 16 January 2027: v3.2.2 rules 2024 and 2025; v4.0 rules eCTD4-084, eCTD4-085 and US-eCTD4-561 through US-eCTD4-564 (91 FR 65749)

USPolicy

2026-10-16

FDA begins supporting eCTD v4.0 forward compatibility: applications originally established in v3.2.2 may submit subsequent materials in v4.0 format (91 FR 65752)

USMilestone

In force 3 Piloting 1 Voluntary 7 eCTD v4.0 eCTD v3.2.2 Compare markets

Global eCTD v4.0 rollout

Published migration timelines per regulator. The mandatory date determines when your publishing toolchain and internal processes must be ready.

JPJapanMHLW · PMDAIn forceAuthority confirmedApril 2026

Technical pilot: Q2 2021 (complete)
Voluntary: 2022
Mandatory: April 2026
Mandatory scope: NDA and some sNDA; ANDA optional

Open

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)

Open

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

Open

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

Open

CACanadaHealth CanadaPlannedICH roadmap2027 – 2028

Technical pilot: 2027 – 2028 (planned)
Voluntary: 2028
Mandatory: 2030
Mandatory scope: TBD

Open

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

Open

AUAustraliaTGAPilotingAuthority confirmedStarted H2 2025

Technical pilot: Started H2 2025 (ongoing · per TGA)
Voluntary: 2029 (per ICH table)
Mandatory: TBD
Mandatory scope: TBD

Open

BRBrazilANVISAPlannedICH roadmapQ4 2026

Technical pilot: Q4 2026 (planned)
Voluntary: 2027
Mandatory: TBD
Mandatory scope: Technical pilot Q4 2026; voluntary from 2027; mandatory TBD

Open

CNChinaCDE (NMPA)PlannedNo official dateNot started

Technical pilot: Not started
Voluntary: TBD
Mandatory: TBD
Mandatory scope: v4.0 in consultation; v3.2.2 mandatory for chemical & biological products

Open

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 ↗

Indexed regions

Open a card for specifications and official documents

USUnited StatesFDA · U.S. Food and Drug Administrationspecs 2 · links 7Open →EUEuropean UnionEC · EMA (European Commission & European Medicines Agency)specs 2 · links 7Open →AUAustraliaTGA · Therapeutic Goods Administrationspecs 2 · links 7Open →JPJapanMHLW · PMDA (Pharmaceuticals and Medical Devices Agency)specs 2 · links 9Open →KRRepublic of KoreaMinistry of Food and Drug Safety (MFDS, formerly KFDA)specs 2 · links 6Open →CACanadaHealth Canadaspecs 2 · links 4Open →CHSwitzerlandSwissmedicspecs 2 · links 5Open →CNChinaCenter for Drug Evaluation (CDE), NMPAspecs 2 · links 4Open →SGSingaporeHSA · Health Sciences Authorityspecs 2 · links 8Open →ZASouth AfricaSAHPRA · South African Health Products Regulatory Authorityspecs 2 · links 7Open →GCCGulf Cooperation Council (GCC)SFDA (Saudi) leads the GCC Module 1 Specificationspecs 2 · links 6Open →WHOWHO PrequalificationWHO Prequalification Unit (PQT)specs 1 · links 4Open →BABosnia and HerzegovinaMedicines Agency of BiH (ALMBIH)specs 1 · links 4Open →tnTunisiaNational Agency for Medicines and Health Products (ANMPS)specs 1 · links 5Open →egEgyptEgyptian Drug Authority (EDA)specs 1 · links 6Open →TWTaiwan, ChinaTaiwan Food and Drug Administration (TFDA)specs 1 · links 4Open →UAUkraineState Expert Center of the Ministry of Health (DEC)specs 1 · links 4Open →EAEUEurasian Economic Union (EAEU)Eurasian Economic Commission (EEC), Technical Regulation and Accreditation Departmentspecs 2 · links 3Open →BRBrazilANVISA (Brazilian Health Regulatory Agency)specs 1 · links 1Open →JOJordanJFDA (Jordan Food and Drug Administration)specs 2 · links 2Open →