eCTD Regional Reference 2026: 16 Regions Side by Side
eCTD Regional Reference 2026
Sixteen regulatory regions side by side: Module 1 format, current specification, eCTD 4.0 position, and what trips teams up when they add a market.
Modules 2–5 travel. Module 1 does not.
ICH harmonised the quality, nonclinical and clinical modules, so most of a dossier’s pages can be filed anywhere. Module 1 and the envelope are not harmonised, and that is where a sequence that passed in one region fails in the next: a different backbone, different required metadata, different vocabularies, different validation criteria.
The report puts the sixteen regions DnXT publishes to side by side, with the practical detail a publishing team needs to plan a multi-region filing.
Sixteen regions, one table
Module 1 format and current specification. The report adds authority details, eCTD 4.0 position and region-by-region pitfalls.
US regional DTD · Module 1 v3.3, required since March 2022
EU regional DTD · EU Module 1 v3.1; validation criteria v8.2 mandatory from 1 December 2025
eCTD 4.0 message (HL7 RPS) · eCTD 4.0 mandatory for new applications from 1 April 2026
Canadian XML schema · Module 1 schema v2.2; validation rules v5.3 (May 2025)
Australian XML schema · AU Module 1 v3.2
Swiss regional DTD · Module 1 v1.5
South African XML schema · Module 1 v3.1 (May 2024), replacing the v2.1 DTD
GCC backbone DTD · GCC Module 1 specification v1.5
Singapore XML schema · SG-eCTD v1.1, mandatory from 1 April 2026
Chinese XML schema · Package V1.1, effective 1 March 2026
Thai XML schema · Module 1 v1.0
Taiwan backbone DTD · TW backbone 1.0 / 1.1
Ukrainian regional DTD · Backbone 1.0; specification text v1.2 (June 2024)
Tunisian XML schema · Specification Rev 1.1 (February 2025)
EU-style regional DTD · Module 1 DTD v1.3
WHO regional DTD · Module 1 specification v1.01
Three things that cause rework
Backbone technology
Eight regions validate Module 1 against a DTD; seven use an XML schema that enforces data types and enumerations. Metadata a DTD lets through, a schema rejects.
Envelope vocabulary
Every region has its own list of application and submission types. The US uses a three-level taxonomy; the EU is driven by procedure; WHO Prequalification has no country at all.
Lifecycle per application
Each region is its own application with its own sequence history. Treat “the dossier” as one object and the regions drift apart without anyone noticing.
The full reference, for planning a multi-region filing
A practical reference for regulatory operations, publishing and IT teams.
- All sixteen regions in one table — authority, Module 1 format, current specification, eCTD 4.0 position
- What is shared and what is rebuilt for every market
- Region profiles: the rules that cause rework or rejection in each
- eCTD 4.0 by region, and what to do now
- Adding a new market: a before, during and after checklist
Frequently asked
Which regions require eCTD 4.0?
As of October 2026, Japan requires eCTD 4.0 for new applications (from 1 April 2026). The FDA accepts 4.0 for new applications on a voluntary basis. The other regions in this reference file in eCTD 3.2.2 with their own Module 1.
Can one sequence be filed in several regions?
Modules 2–5 content can be reused, but each region receives its own sequence with its own Module 1, envelope and numbering. The GCC is the exception that proves the rule: one GCC sequence can address several Gulf states because they share a Module 1.
Why does a sequence pass validation in one region and fail in another?
Because Module 1, the envelope vocabulary and the validation criteria are regional. A schema-based region also enforces data types that a DTD-based region does not check.
How often do regional specifications change?
Often enough to plan for. In the eighteen months to October 2026, the EU, Japan, Singapore, Canada and China all moved to new versions or new mandatory dates.
Publishing to sixteen regions from one platform
DnXT Publisher builds each region’s Module 1 and envelope from its own specification and validates every sequence against that region’s criteria before it is sent.
