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国家药监局综合司关于同意北京市药品检验研究院调整生物制品批签发证明文件授权签发人的复函 药监综药管函〔2024〕90号-2024/3/1
2024-03-12查看详情 > -
Page: Qualification of non-mutagenic impurities - Scientific guideline-2025/2/3
2025-02-05查看详情 > -
关于公开征求《化学仿制药参比制剂目录(第九十一批)》(征求意见稿)意见的通知-2025/3/12
2025-03-13查看详情 > -
Document: Overview of NCAs participating in the voluntary Simultaneous National Scientific Advice (SNSA) project-2025/4/11
2025-04-13查看详情 > -
Document: Timetable: Type II variation and worksharing application weekly assessment-2025/5/23
2025-05-26查看详情 > -
Page: Lurasidone product-specific bioequivalence guidance-2025/6/30
2025-07-01查看详情 > -
Page: Business hours and holidays-2025/7/31
2025-08-01查看详情 > -
Document: Procedural advice on appointment and responsibilities of the CVMP rapporteur and co-rapporteur in accordance with Article 140(6) of Regulation (EU) 2019/6, and peer reviewer-2025/9/19
2025-09-22查看详情 > -
Document: Agenda of the PRAC meeting 27 - 30 October 2025-2025/10/27
2025-10-28查看详情 > -
Page: Submitting results of paediatric studies-2025/11/26
2025-11-27查看详情 >