Marketing Authorization上市许可
A marketing authorization is a legal decision by a national or regional regulatory authority permitting a medicinal product to be placed on a specific market for approved indications and under defined conditions. It appears in the approval letter or marketing authorization application dossier and defines the product information, labeling, packaging, and supply conditions under which the product can be promoted and distributed.
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, marketing authorization appears in regulatory submission dossiers, approval letters, product information, and lifecycle documentation. Translators may support MA applications or post-approval variations by translating summary-of-product-characteristics, labeling, and patient information across EU languages and local markets.
Translation checks
A common mistake is translating “marketing authorization” as “marketing approval” or “product registration” in contexts where that suggests less than the full regulatory decision. Equating MA with patent or trademark rights is also misleading and can confuse labeling, advertising, and supply obligations.
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 → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
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.