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GLOBAL eCTD IMPLEMENTATION TRACKER Track eCTD versions, pilots, voluntary acceptance, mandatory dates and regulatory changes worldwide.
Regions tracked20
Specs33
Links103
Updated2026-11-07
UPDATES

eCTD regulatory change tracker

Global eCTD regulatory events grouped by month: new specifications, document updates, consultations and milestones. Sourced only from official regulator publications.

2026-11

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

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
2026-10-16
FDA updates the Specification for eCTD v4.0 Validation Criteria to v1.7 (October 2026); Lorenz eValidator 25.2 has validated against it since 25 August 2026
USDocument update
2026-10-15
MFDS launches the eCTD v4.0 submission service: running in parallel with v3.2.2 with a phased transition; v4.0 recommended (not mandatory) for new item licence applications
KRMilestone
2026-10-15
Public consultation: draft Notice to Applicants — Submission Guidance for the CTD for Human Pharmaceutical Products (Version 6), 15–29 Oct 2026
EGConsultation
2026-10-15
Public consultation: draft EG Human Pharmaceutical Module 1 Submission Guidance
EGConsultation
2026-10-14
SAHPRA notice: submission window for the Type II Variations Pilot Project extended twice (latest 14 October 2026)
ZAPolicy
2026-10-14
SFDA publishes the new consolidated submission guidance DS-G-144-V01 (V1.0): covers new MA, variations, renewals and eCTD Baseline submission and migration, effective 1 January 2027
GCCDocument update
2026-10-06
TGA updates its prescription medicines eCTD submission guidance page "Submit data in electronic common technical document (eCTD) format" (page dated 6 October 2026; no change description listed)
AUDocument update

2026-09

2026-09-28
Updates to FDA Regional eCTD v4.0 Module 1 Implementation Guide (v1.9) and FDA Regional CV eCTD v4.0 Package (v1.2)
USDocument update
2026-09-18
Roadmap update: backlog resubmission extended (2025 dossiers to 31 Dec 2026, 2026 dossiers to 31 Mar 2027); renewals eCTD-only with baseline from 1 Jan 2027
TNPolicy
2026-09-04
Page date for eCTD AU module 1 and regional information v3.2 updated to 4 September 2026 (no change description listed in the page history)
AUDocument update
2026-09-03
SAHPRA publishes the Medicines Registry and eCTD Take-On Programme (HPA18-2026/27): sets out key activities and completion dates for electronically onboarding legacy dossiers
ZAMilestone
2026-09-02
Public consultation: EG Module 1 eCTD Specification draft (v1.0/2026), closes 14 Oct 2026
EGConsultation
2026-09-02
Public consultation: Technical Guidance for eCTD Submissions in Egypt draft (v1.0/2026), closes 14 Oct 2026
EGConsultation

2026-08

2026-08-28
Updates to FDA Regional CV eCTD v4.0 Package, FDA Regional eCTD v4.0 IG, and Specification for eCTD v4.0 Validation Criteria
USDocument update
2026-08-14
Util folder (DTD and stylesheets) updated: three stylesheet versions valid until 31 Dec 2026, only the new version thereafter
TNDocument update
2026-08-07
EMA updates the EU eCTD v4.0 timeline: v4.0 voluntary for new CAP MAAs from 22 Dec 2025, strongly recommended from Q1 2027 and mandatory from Q1 2028; a new round of end-to-end testing is ongoing (MAH test submissions invited)
EUMilestone
2026-08
ICH adopts eCTD v4.0 Implementation Guide v1.7, Controlled Vocabulary Package v1.0.3 and Q&A v1.10 (Step 4); the Regional Implementation table (August 2026) updates several regional timelines
GLDocument update
2026-08
DEC updated the eCTD FAQ
UADocument update

2026-07

2026-07-30
JFDA publishes the consolidated Submission and Lifecycle Management Guidance (V01.02): the first submission guidance systematically integrating eCTD module requirements, covering chemical, herbal and biological products
JODocument update
2026-07-27
Swissmedic publishes the Swiss Implementation Guide v1.1 package (IG v1.1, controlled vocabulary CV v1.1, Validation Criteria v1.1) as the baseline for eCTD v4.0 software development
CHNew specification
2026-07-17
ANMPS webinar: good practices and regulatory requirements for the eCTD format (held 24 Jul 2026)
TNPolicy
2026-07-09
Updates to FDA Regional CV eCTD v4.0 Package; eCTD v4.0 Technical Conformance Guide; Transmission Specifications; FDA Regional forward compatibility XML samples added
USDocument update
2026-07-08
EMA updates the eCTD v4.0 page: the next CAP forward-compatibility pilot is planned for Q4 2026 and the non-CAP new MAA technical pilot for Q3/Q4 2026; the forward-compatibility timetable is pending test results
EUMilestone
2026-07-07
TGA user guide "Submitting data in eCTD format for a non-prescription medicine application" updated (7 July 2026)
AUDocument update
2026-07-07
TGA "Dossier requirements for non-prescription medicines" page updated (7 July 2026)
AUDocument update

2026-06

2026-06-29
EEC Board Decision No. 76 revises the requirements for applications and documents in electronic form of the registration dossier, effective 31 July 2026 (with 13 data transfer package format tables)
EAEUPolicy
2026-06-04
WHO PQT eCTD FAQ updated (4 June 2026 edition)
WHODocument update
2026-06-03
eCTD v4 Domestic Implementation Package updated to v1.6.0.3; v4 Verification Tool and eCTD submission status (PDF) also updated
JPDocument update

2026-05

2026-05-29
Roadmap update on eCTD implementation and MAA submission modalities
TNPolicy
2026-05-28
Updated eCTD implementation Q&A list (27 May 2026 edition)
BADocument update
2026-05-27
CDE opens the eCTD v4.0 Guidance for public comment (with controlled vocabulary and validation criteria annexes)
CNConsultation

2026-04

2026-04-29
Submission modalities for MAA dossiers via eCTD / eSubmission and Trigger file preparation
TNPolicy
2026-04-20
CDE opens the Chinese translation of ICH M8 eCTD v4.0 guidance and Q&A for comment
CNConsultation
2026-04-16
EMA refreshes the eSubmissions resource page, collecting the EU eCTD v4.0 practical guidance, implementation guide (draft v1.2), validation criteria and controlled vocabularies v3, plus the Q1 2026 system demo recording
EUDocument update
2026-04-01
eCTD format officially accepted for regulatory dossier submission from 1 April 2026 (ICH 3.2.2-based, voluntary)
SGMilestone

2026-03

2026-03-19
EMA launches Pilot Phase III for CAP forward compatibility, covering three scenarios over an initial 2–3 months
EUMilestone
2026-03-13
EU eCTD v4.0 Validation Criteria v1.1 is finalised after public consultation and applies from 15 July 2026; tool vendors are expected to start implementing the new rules accordingly
EUDocument update
2026-03-12
First implementation experiences and updated Q&A list
BADocument update
2026-03-04
Update of SG eCTD version 1.1 (specification package v1.1 released)
SGDocument update

2026-02

2026-02-09
WHO PQT eCTD FAQ published (9 February 2026 edition; superseded by the 4 June 2026 edition)
WHONew specification

2026-01

2026-01-27
From 2 February 2026 first registration applications may be filed in eCTD
BAMilestone
2026-01-22
Roadmap update: e-submission mandatory from 1 Apr 2026 for new MAAs, renewals, variations and transfers (eCTD or eSubmission); eCTD-only from 1 Jun 2026
TNPolicy
2026-01-20
ExPRESS platform opens "eCTD Baseline" filings; licences with a baseline must keep filing variations and renewals in eCTD
TWPolicy
2026-01-15
CDE publishes eCTD v3.2.2 technical files (Notice No. 4, 2026), effective 2026-03-01
CNNew specification
2026-01-15
CDE announces update to the eCTD validation software
CNDocument update
2026-01-15
NMPA announces full implementation of eCTD submission for chemical drugs and biological products (Announcement No. 8 of 2026, effective 1 March 2026)
CNPolicy

2026

2026
eCTD v4.0 pilot operation (시범운영) launched; v4.0 submission tool downloadable; MFDS recommends v4.0 for new filings
KRMilestone

2025-12

2025-12-16
Workshop: pilot experiences and implementation guidance — BiH becomes the first country in the region to apply eCTD from February 2026
BAMilestone
2025-12-15
EMA announces that new MAA CAPs may be submitted voluntarily in eCTD v4.0 from 22 December 2025, with prior contact to the EMA eCTD team
EUMilestone
2025-12-10
Reference data on domestic operation of eCTD v4 updated
JPDocument update
2025-12-10
SAHPRA Engagement Portal (eCTD submission gateway) go-live communications: accounts, Application ID, legacy application locating, and variation/renewal/response submissions
ZAMilestone
2025-12-08
Final BiH eCTD Specification v1.3 (4 December 2025) published with technical package
BANew specification
2025-12
EU eCTD v4.0 — Practical Guidance v1 published
EUNew specification

2025-11

2025-11-28
EU M1 v3.1.1 with validation criteria v8.2 becomes mandatory from 1 December 2025; the EU M1 v3.1 / v8.1 combination is no longer accepted
EUMilestone
2025-11-27
Updates to 'Preparation of regulatory activities in non-eCTD format' (27 November 2025 edition)
CADocument update
2025-11-26
Council Decision No. 93 amends the Rules for Registration and Examination of Medicines: 'confidential data' concept, revised variation classification, clarified dossier composition and evaluation procedures
EAEUPolicy
2025-11-06
TGA "Module 1 specifications for eCTD submissions" page updated (page dated 6 November 2025)
AUDocument update
2025-11-01
AU M1 v3.2 becomes the mandatory baseline; the v3.1 transition window closes and v3.0 and earlier are no longer accepted
AUMilestone
2025-11
EU eCTD v4.0 controlled vocabularies v3 published (Excel and Genericode formats)
EUDocument update

2025-10

2025-10-20
Updates to Specification for eCTD Validation Criteria and FDA Regional eCTD v4.0 Module 1 Implementation Guide
USDocument update
2025-10-14
Call for interest: participate in the eCTD portal testing phase
TNConsultation

2025-09

2025-09-30
Launch of eCTD portal for test submissions
SGMilestone
2025-09-25
Backlog management strategy during the eCTD transition
TNPolicy
2025-09-17
eCTD Validation Tool (for ver.3.2.2) updated
JPDocument update
2025-09-16
EMA notifies that EU M1 v3.1.1 with validation criteria v8.2 will become mandatory from 1 December 2025
EUMilestone

2025-08

2025-08-29
Launch of the new ANMPS portal and eCTD
TNMilestone
2025-08-20
Updates to Specification for File Format Types Using eCTD Specifications (v9.3)
USDocument update
2025-08-14
Documents matrix updated: severity for 1.3.1.1 PI (clean) and 1.3.1.2 PI (annotated) under sequence types 54 and 55 reduced from Error to Warning
AUDocument update

2025-07

2025-07-10
Letter: phased eCTD implementation from 1 Jan 2026 (online-only filing in 2026; eCTD-only for NDAs & biologics in 2027)
TWMilestone

2025-06

2025-06-30
eCTD-R2.1 Guidance and eCTD-V-R2.1 Validation Guidance announced (effective 1 Jul 2026; R2 announcement repealed same day)
TWNew specification
2025-06-16
Draft BiH eCTD Specification v1.1 (dated 16 June 2025) published
BAConsultation
2025-06-02
EU M1 v3.1.1 and validation criteria v8.2 published; optional adoption from 1 October 2025
EUNew specification

2025-05

2025-05-19
First draft of the BiH eCTD Specification (v1.0) published to prepare applicants for the transition
BAConsultation
2025-05-06
Communiqué on the launch of the eCTD e-Validator
TNMilestone

2025-04

2025-04-28
eCTD-R2 Guidance and eCTD-V-R2 Validation Guidance announced
TWNew specification
2025-04-01
AU eCTD Module 1 v3.2 takes effect, opening a six-month transition in which v3.1 and v3.2 are both accepted
AUMilestone
2025-04
Publication of eCTD v4.0 AU module 1 and regional information (draft), aligned with the ICH eCTD v4.0 Implementation Guide
AUMilestone

2025-03

2025-03-12
SAHPRA notice: cancellation of health product registrations held without eCTD submission (RIMS communication HPA15)
ZAPolicy

2025-02

2025-02-27
Date support begins for ICH eCTD v4.0 Controlled Vocabulary Package v1.0, ICH Implementation Guide Package v1.6 and eCTD File Format Specifications v9.2
USMilestone

2025-01

2025-01-10
Updates to 'Validation rules for regulatory transactions in eCTD format' (10 January 2025 edition)
CADocument update

2024-10

2024-10-28
WHO PQT eCTD Valid Values XML updated (28 October 2024 edition)
WHODocument update
2024-10-18
ePQS related product & application type matrix and initial application documents updated (18 October 2024 editions)
WHODocument update
2024-10
EU eCTD v4.0 Implementation Guide (draft v1.2) published
EUNew specification

2024-09

2024-09-25
Release of SG-HSA Specification Package v1.0 (start of eCTD implementation in Singapore)
SGDocument update
2024-09-20
Industry Workshop: Launch of the SAHPRA Engagement Portal
ZAMilestone
2024-09-16
CDER and CBER begin accepting new regulatory applications in eCTD v4.0 format
USMilestone
2024-09-13
AU M1 v3.2 published: updates to headers and XML elements, sequence types and descriptions; introduction of Work Grouping; removal of the 'Pharmacovigilance' regulatory activity lead value; updates to validation criteria and warning reporting; expanded allowable file types
AUDocument update
2024-09-13
Industry Workshop: Specification 3.1 Processes
ZAPolicy

2024-08

2024-08-22
Draft revised guidance (eCTD-R2 / eCTD-V-R2) opened for 60-day consultation
TWConsultation
2024-08-08
Industry Workshop: eCTD's Introduction of Specification 3.1
ZAPolicy

2024-07

2024-07-19
Industry Webinar on SAHPRA's eCTD Specification 3.0
ZAPolicy
2024-07-18
Swiss Module 1 Specification for eCTD updated to v1.5
CHDocument update

2024-06

2024-06-28
Initial communiqué on ANMPS's adoption of eCTD
TNPolicy
2024-06-17
UA M1 Specification v1.2 published (Ukrainian and English) with annexes, validation criteria and DTD package
UANew specification

2024-05

2024-05-29
MoH Order No. 909: amendments to the eCTD Module 1 specification requirements
UAPolicy

2024-04

2024-04-29
MoH Order No. 733: amendments to the eCTD Module 1 specification requirements
UAPolicy
2024-04-23
MoH Order No. 691: requirements for the eCTD Module 1 electronic format specification and filing recommendations approved
UAPolicy

2024-03

2024-03-19
Release of ZA-SAHPRA eCTD Questions & Answers (Q&A) v5.0 (current FAQ on the eCTD portal)
ZADocument update
2024-03-14
Industry Webinar | Updates on Regulatory Information Management (RIMS) Roll-Out
ZADocument update
2024-03
Release of ZA-SAHPRA eCTD Specifications v3.1 (supersedes v3.0)
ZADocument update
2024-03
Release of ZA-SAHPRA eCTD Validation Criteria v3.1.1 (concurrent with Specifications v3.1, current on the eCTD portal)
ZADocument update

2023-12

2023-12-27
eCTD v4 Domestic Q&A published
JPNew specification
2023-12-11
Post-industry consultation update (eCTD implementation)
SGConsultation
2023-12
MoH published the eCTD implementation roadmap and opened consultation (comments due 8 January 2024)
UAConsultation

2023-10

2023-10
Industry Guidance on eCTD submissions to WHO-PQT V1.0 published (Oct 2023)
WHONew specification

2023-08

2023-08-02
Post-approval changes may be filed in eCTD without a full baseline (licence locked to eCTD once opted in)
TWMilestone

2023-05

2023-05-02
Industry consultation notice (eCTD implementation, 2 May – 12 June 2023)
SGConsultation

2023-04

2023-04-17
Notice to Industry (eCTD implementation in Singapore)
SGMilestone

2021-11

2021-11-22
Letter: eCTD platform to go live on 1 Jan 2022, opening voluntary eCTD filing for new drug and biologics applications
TWMilestone

2021-10

2021-10-29
Call for participants in the eCTD v4.0 pilot test (ended)
JPMilestone

2021-03

2021-03
GCC Module 1 Specifications v1.5 (current regional Module 1 standard; finalised Nov 2015, re-published by SFDA in Mar 2021)
GCCNew specification

2019-08

2019-08-26
Health Canada published the Draft Guidance: Canadian Module 1 Technical Implementation Guide for the eCTD v4.0 Format for consultation (26 Jun – 26 Aug 2019, now closed)
CAConsultation

2015-04

2015-04-11
SFDA publishes GCC Module 1 Specifications (regulation entry)
GCCNew specification

2012-09

2012-09-30
Health Canada began accepting eCTD submissions built with Canadian Module 1 Schema Version 2.2 (the current v3.2.2 basis)
CAMilestone