Drug Master File药物主文件
A Drug Master File is a confidential submission to a regulatory authority that contains detailed manufacturing, facility, materials, packaging, or process-related information for a drug substance or product. It is referenced by marketing authorization applicants as supporting information, but it is not independently approved; the regulatory authority reviews it to support the safety, quality, and manufacturing assessment of the application.
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Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
In translation and localization, Drug Master Files appear in regulatory submission workflows when an applicant references a third-party manufacturer’s DMF. Translation may involve the open part, authorization letters, quality summaries, or agency queries, while the confidential core remains with the DMF holder and is often not translated for the applicant.
Translation checks
A frequent mistake is translating “Drug Master File” as “drug master archive” or “drug main file,” which may not match the accepted regulatory term. Mislabeling the open part and closed part, or translating them as “open/closed” instead of “public/confidential,” can also create confusion about access rights during regulatory submission 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.
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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.