Prepare pharmaceutical files for Chinese review: source revisions, readers, review owners and return formats. Includes a blank file register.
View the file review example ↓View references (2) ↓Identify the document before choosing the Chinese wording
A Chinese project team may need to review an overseas medicine’s professional product information, patient leaflet or both. Record which document is being translated and who will read it. A file called “product information” does not by itself tell a translator whether its reader is a healthcare professional consulting product information or a patient looking for an instruction.
European sources distinguish the summary of product characteristics (SmPC) from the package leaflet. The Dutch Medicines Evaluation Board describes the leaflet as patient-facing and derived from the SmPC. Use those distinctions to identify the supplied files, not to assume that an EU document or its Chinese translation is ready for use in China.
State the Chinese copy’s intended use
For an internal review copy, name the Chinese team, required script and person responsible for comments. Keep the document ID and source revision visible. Ask whether the return should be an editable Chinese file, a bilingual comparison or a marked-up revision; these are different deliverables.
If the intended output is for patients, packaging or a regulatory procedure, say so before the quotation. The responsible medical or regulatory owner should confirm the applicable content, terminology, review and release requirements. Translating a source leaflet is not the same as adapting it for a new market or authorising patient use.
From reading to a project
Separate the review copy from a released product document
Chinese review-file brief · self-created
- Source baseline
- DEMO-PHARMA-01 · source language: [confirm] · revision B · document type: [confirm]
- Readers and status
- DEMO-CN-REVIEW：中文内部审阅稿；请确认读者、简繁体及意见负责人
- Terminology question
- DEMO-Q1 · source section [confirm] · wording reference · owner · open / answered
- Return file
- Source revision B ↔ Chinese review revision 1 · editable or bilingual format as agreed
Review status: questions to confirm
Name the file and reader
Separate professional product information, patient-facing material and internal reference copies. Confirm the intended use before choosing the review scope.
Preserve the source baseline
List the source version, associated tables and reference-only documents. Send the previous matching source and Chinese version for an update.
Assign the wording decisions
Identify the source-question owner and Chinese reviewer. Agree the required checks and keep unanswered items with the return-file list.
Related published experience
Wuhan Weiao PharmaceuticalPortuguese → Chinese
Portuguese-to-Chinese pharmaceutical documentation.
The public Wuhan Weiao case identifies Portuguese-to-Chinese pharmaceutical documentation. It does not specify an SmPC, patient leaflet, medicine or approval outcome. The review brief above is a self-created preparation example, not a reproduction of that project.
Send the source language, actual document type and revision, Chinese readers and script, terminology references, required return files, review scope and deadline. Identify internal-reference and patient-facing outputs separately.
Keep product facts attached to their source
Provide the exact product presentation and source version included in the request. Identify related documents that are reference-only. Where the source distinguishes strengths, pharmaceutical forms, populations or routes of administration, keep those distinctions with the relevant passage rather than combining similar-looking text.
Supply Chinese product and ingredient names already provided or confirmed by your team, with the reference that supports them. Link a wording question to its source location and decision owner. A translator should not resolve conflicting product facts or fill a missing value from another product’s leaflet.
| Item to identify | Keep with the translation |
|---|---|
| Product presentation | Source name, form, strength and the exact revision supplied; flag a conflict to its owner. |
| Warnings and instructions | Conditions, exclusions and the passage to which they apply; do not detach them during layout. |
| Tables and references | Units, footnotes, section numbers and corresponding source locations. |
| Review decision | Question ID, proposed wording, named answer owner and decision status. |
Return a version that the Chinese team can review
For a revision, send the previous Chinese file together with its matching source and the new source version. Identify changed sections and any approved terminology decisions. If that baseline is unavailable, ask for the comparison work to be included in the scope rather than treating the job as a simple text replacement.
Agree the required subject expertise, bilingual review, layout checks and any written QA record for this project. At handover, list the source and return versions and retain unresolved questions. An internal review label should remain visible until the responsible owner confirms how the file may be used.
Use the blank register to list your document set before requesting a quotation. It contains no medicine or client content. Download the blank Chinese review-file register · text file
Questions
Can you translate Portuguese pharmaceutical documents into Chinese?
Is a Chinese internal reference copy ready for patient use?
Do you need the SmPC as well as the package leaflet?
What should we include when requesting a quotation?
Sources
- EMA — Product-information (QRD) templates, human medicinesReference for European product-information document categories. Check the applicable procedure and current template; an EU template does not set Chinese filing requirements.
- Medicines Evaluation Board — Package leafletExplains the patient-facing purpose of a package leaflet and its relationship to the SmPC in the Netherlands. This is not a rule for releasing a Chinese translation.