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.
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.
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.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
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