Common Technical Document通用技术文档
The Common Technical Document is a harmonized structure for organizing regulatory submission information into modules covering administrative data, quality summaries, nonclinical study reports, and clinical study reports in a standardized sequence. It allows applicants to prepare one core dossier that can be adapted, translated, and localized for submission to multiple regulatory authorities, reducing redundant writing and supporting consistent review across regions.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
In translation and localization, CTD/eCTD content appears in marketing authorization applications, lifecycle submissions, deficiency responses, and regulatory correspondence across various regions. Translators work with module-specific terminology, cross-references, heading hierarchy, and eCTD bookmarks, and often rely on translation memory to keep repeated sections such as quality summaries and clinical overviews consistent.
Translation checks
A frequent translation error is altering heading numbering, cross-references, or eCTD bookmark structures, which can break electronic submission validation and delay acceptance. Another common mistake is rendering “summary” and “overview” inconsistently within Module 2, making the relationship between quality and clinical summaries unclear to regulatory reviewers and creating ambiguity during review.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.