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01
Definitions #
The official approval given by a drug regulator that allows a medicine to be sold and used in the country or region where that approval applies.
Technical Under EU pharmaceutical legislation, a regulatory approval granted by EMA or a national competent authority for placing a medicinal product on the market.
Example The company submitted a marketing authorisation application to the EMA for the new oncology product.
02
Etymology #
From marketing (bringing to market) + authorisation (legal permission), used in pharmaceutical regulation.
03
Collocations #
- marketing authorisation application (MAA) 上市许可申请
- marketing authorisation holder (MAH) 上市许可持有人
- conditional marketing authorisation 附条件上市许可
- scientific evaluation 科学评估
04
Real Business Examples #
- The MAH must maintain pharmacovigilance systems after marketing authorisation is granted.
- The draft decision recommends granting marketing authorisation subject to risk-management measures.
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05
Register & Variants #
- Register: formal
- BrE/AmE: 英式拼写主要用于英国/欧盟，美式用法为 marketing authorization
06
Synonyms & Antonyms #
- Synonyms: product licence, marketing approval
- Antonyms: refusal of authorisation
07
Common Errors #
- Confusing marketing authorisation with clinical trial approval Marketing authorisation is for market placement after trial results; trial approval is for conducting the trial itself.
08
Confusable Terms #
- marketing authorization (US) vs Marketing authorisation
- Same concept but US spelling; FDA issues a license rather than an authorisation.
09
Frequently Asked Questions
How long does a marketing authorisation take??
Typically 6-12 months for an EMA centralised procedure, depending on the product type and discussions.
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