“药审风暴”又来了?药监局三天拒批118款药品

健识局
Dec 19, 2025

本文来自微信公众号:健识局,编辑:江芸贾亭,作者:苗苗12月16日-12月18日三天,国家药监局连续发力否决了118个不同规格的药品上市申请,无一例外都是仿制药。此前,我国仿制药的一致性评价审评十分温和,缺资料企业在4个月内补审就行,一下子拒批如此多仿制药,十分罕见。文末有表格名单领取方式据健识局粗略统计,118个品种共涉及86家企业,不乏京新药业、福元药业、白云山、普利药业、葫芦娃药业等国内...

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