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01
Definitions #
The official decision allowing a medicine to be promoted, sold, and distributed in a given market.
Technical The regulatory decision, usually by a national agency, that permits commercial distribution of a pharmaceutical product following positive benefit-risk assessment.
02
Etymology #
From marketing + approval, a common generic term in English-speaking regulatory contexts, used interchangeably with marketing authorization and product licence.
03
Collocations #
- conditional marketing approval 附条件的上市批准，通常要求后续补充数据
- accelerated marketing approval 为短缺药物或重病而加速审评的批准
- refuse marketing approval 拒绝批准上市
04
Real Business Examples #
- The EMA granted conditional marketing approval for the new vaccine subject to post-authorization safety studies.
- Without marketing approval, the company cannot legally sell the product in Japan.
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05
Register & Variants #
- Register: formal
- BrE/AmE: 通用全球
06
Synonyms & Antonyms #
- Synonyms: marketing authorization, product licence
- Antonyms: refusal of authorization
07
Common Errors #
- 混淆 approval 与 clearance（如 FDA clearance 用于医疗器械） 药品用 approval，器械常为 clearance，二者法律含义不同
08
Confusable Terms #
- Trial approval vs marketing approval
- trial approval 允许开展临床试验，不涉及上市销售，与 marketing approval 有本质区别
09
Frequently Asked Questions
拿到营销许可后可以立刻上市吗？?
多数国家还需完成定价、报销谈判、标签审核等，方可实际销售
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