CTD Dossier Translation, Module by Module

Quick answer — In the Common Technical Document, Module 1 is region-specific and carries the language requirements, while Modules 2 to 5 are largely common and usually stay in English. Scoping by module is what keeps the cost sane.

Vitra.ai Universe keeps the audit trail with the translation.

Most of the dossier does not get translated

The CTD has five modules. Modules 2 to 5 — summaries, quality, non-clinical, clinical — are the common technical content, and for most procedures they are submitted in English. Module 1 is the regional one. It holds the administrative information and the product information, and it is where language obligations live.

Getting that distinction right at the planning stage is the difference between a sane budget and a wildly inflated one.

Where the language work sits

Within Module 1 the heavy items are the SmPC, the package leaflet and the labelling — which for a centralised procedure means every EU language, on a fixed clock, at the end of the process.

That timing is the real constraint. The linguistic step arrives when the schedule has least slack and the wording is finally stable.

Plan for the linguistic review window

Translations of product information go through a review step with member state input, and comments come back needing turnaround.

Two things make that survivable. Terminology settled long before, so comments are about phrasing rather than vocabulary. And a memory holding every previously approved translation, so a variation two years later starts from approved wording rather than from scratch.

Extracts, not whole reports

Where clinical content is requested locally, it is usually specific sections rather than a whole study report.

Translate the extract and record which version it came from. A translated section with no traceable link to its source document is difficult to defend later.

Use document translation to keep numbering and cross-references intact, and quality control to check the output — with regulatory affairs confirming scope per procedure, since requirements differ between centralised, decentralised and national routes.

FAQ

Which CTD modules need translating? Mainly Module 1, the region-specific module holding administrative information and product information. Modules 2 to 5 are common technical content and are usually submitted in English.

When does dossier translation happen in the timeline? Late, and under pressure. Product information translations come after the wording is stable, which is when the schedule has least slack, and they go through a review step with member state input.

Do clinical study reports get translated in full? Rarely. Where local authorities want clinical content it is usually specific sections, so an extract is translated with a recorded link back to the source document version it came from.

How can dossier translation cost be controlled? By scoping per module rather than treating the dossier as one unit, settling terminology early so review comments are about phrasing, and reusing approved translations from memory on later variations.