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国家药监局药审中心关于发布《碘[131I]化钠口服溶液仿制药药学研究技术要求》的通告(2026年第15号)-2026/2/9
2026-02-10查看详情 > -
Document: Template for a request for amendments of or addition of active substances or combinations of active substances to the European Union reference-date list-2026/3/17
2026-03-18查看详情 > -
Page: Submission dates-2026/4/20
2026-04-21查看详情 > -
Document: EMA’s API general terms and conditions of use - Terms of use-2026/6/3
2026-06-04查看详情 > -
Document: Severe cutaneous adverse reactions - standard template wording for product information-2026/7/15
2026-07-16查看详情 > -
关于公开征求ICH指导原则《M13A:口服固体速释制剂的生物等效性》意见的通知-2023/02/14
2023-02-14查看详情 > -
关于公开征求《〈已上市化学药品药学变更研究技术指导原则(试行)〉原料药变更的问答(征求意见稿)》意见的通知-2023/9/1
2023-09-01查看详情 > -
国家药监局关于注销颠茄磺苄啶片药品注册证书的公告(2025年第2号)-2025/1/3
2025-01-03查看详情 > -
Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes-2025/2/5
2025-02-10查看详情 > -
国家药监局关于暂停进口KYOWA HAKKO BIO CO.,LTD.谷胱甘肽等5个原料药的公告(2025年第26号)-2025/3/16
2025-03-17查看详情 >