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Regulatory and procedural guideline: Concept Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems-2022/11/16
2022-11-30查看详情 > -
国家药监局关于发布《已上市药品说明书增加儿童用药信息工作程序（试行）》的公告 （2023年第68号）-2023/5/31
2023-06-01查看详情 > -
国家药监局药审中心关于在药品审评检查长三角分中心、大湾区分中心增设对外受理服务窗口的通知-2023/11/29
2023-12-04查看详情 > -
Bioanalytical Method Validation for Biomarkers-2025/1/21
2025-01-22查看详情 > -
Page: Biosimilar medicines: marketing authorisation-2025/2/24
2025-02-25查看详情 > -
Document: Call for scientific data for the periodic review of the monograph on Psyllii semen-2025/4/1
2025-04-02查看详情 > -
Document: EMA Gender equality plan 2025 - 2030-2025/5/8
2025-05-09查看详情 > -
关于公开征求《带状疱疹疫苗临床研究技术指导原则（征求意见稿）》意见的通知-2025/6/19
2025-06-20查看详情 > -
Document: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)-2025/7/23
2025-07-24查看详情 > -
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure-2025/9/8
2025-09-09查看详情 >
