refusal of authorisation

Definitions #

The regulator's decision not to give permission to market a medicine, often due to safety, efficacy, or quality concerns.

Technical A formal negative decision on a marketing authorization application, typically based on an unfavorable benefit-risk balance or non-compliance with regulatory requirements.

Etymology #

From refusal (denial) + of + authorisation (permission), standard in European English regulatory texts; American spelling is refusal of authorization.

Collocations #

grounds for refusal 拒绝的法定理由
notification of refusal 拒绝通知，正式文件
appeal against refusal 对拒绝决定的上诉

Real Business Examples #

The agency issued a refusal of authorisation for the new drug after the trial data showed insufficient efficacy.
The pharmaceutical company appealed the refusal of authorisation to the national court.

Register & Variants #

Register: formal
BrE/AmE: 英式拼写（s）；美式用 refusal of authorization

Synonyms & Antonyms #

Synonyms: refusal of approval, non-approval
Antonyms: marketing authorization, product licence grant

Common Errors #

把 refusal 与 rejection 混用（如说 rejected authorization）正式术语是 refusal of authorisation；rejection 指文件退回，非最终决定

Confusable Terms #

Suspension of authorisation vs refusal of authorisation: refusal 是永久不批，suspension 是暂时中止，可能恢复

Frequently Asked Questions

被拒绝后能重新申请吗？?

通常可以，但需补充新证据或修正缺陷，否则可能被拒绝对类似申请产生不利影响

Published: 2026-10-05 Category: