Multi-Regional eCTD — 16 Regions, Each With Its Own Rules

Sixteen regions, each with its own rules

Modules 2–5 travel; Module 1, the envelope and the validation criteria do not. DnXT builds each region from the authority’s own specification, so a sequence that is right for one market is checked properly for the next.

16regions

2,500+criteria

Per regionseverity and vocabulary

A dossier that is right in one market fails in the next

Every authority defines its own Module 1, envelope, vocabulary and validation criteria. Some use DTDs, others XML schemas that reject metadata a DTD lets through. A team that files in several regions rebuilds the same knowledge for each one — or finds the differences at the gateway.

DnXT carries each region’s rules in the product, built from the authority’s own published files.

Built for the people who own the outcome

Global regulatory operations

Publish the same product to several authorities without maintaining a separate procedure per region.

Teams adding a market

Start a new region from an existing dossier and see exactly which Module 1 content must be produced locally.

Publishing partners

Serve clients filing in regions you see less often, with the region’s criteria applied for you.

Adding a region to a product

Clone or create

Clone the dossier to the region to carry products, substances and applicant; or create it fresh.

Build Module 1

The region’s Module 1 structure, envelope and vocabulary are in place; produce the local documents.

Reuse Modules 2–5

Place the shared content, re-checked against the region’s PDF and file rules.

Validate for that region

Run that region’s criteria at its severity before publishing.

What changes by region — and what DnXT handles

Module 1 structure

Each region’s sections, including country segmentation in the EU, GCC and Bosnia and Herzegovina.

Envelope and vocabulary

Application and submission types, procedures and codes from the region’s own lists.

Backbone format

DTD-based and XML-schema-based regional backbones, and PMDA’s eCTD 4.0 message for Japan.

Validation criteria

Each region’s criteria and severity — more than 2,500 across the 16 regions.

Lifecycle per application

Each region is its own application with its own sequence history; the current view is per region.

Specification updates

New Module 1 versions and criteria are added to the product from the authority’s own published files.

Frequently asked

Which regions are supported?

The United States, EU, Japan, Canada, Australia, Switzerland, South Africa, the GCC, Singapore, Thailand, Taiwan, Ukraine, Tunisia, China, Bosnia and Herzegovina, and WHO Prequalification.

Can one sequence go to several regions?

Each region receives its own sequence with its own Module 1 and envelope. Modules 2–5 content is reused. The GCC is the exception: one GCC sequence can address several Gulf states.