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Document: Report: European medicines regulatory network’s response to nitrosamine impurities in human medicines-2025/7/29
2025-07-30查看详情 > -
Document: Public call for expression of interest for experts to become members of the European Medicines Agency's Scientific Advisory Group on Immune and Inflammatory Diseases-2025/9/15
2025-09-16查看详情 > -
关于公开征求《化学仿制药参比制剂目录(第九十九批)》(征求意见稿)意见的通知-2025/10/17
2025-10-20查看详情 > -
Document: Regulatory Procedure Management in IRIS roadmap-2025/11/21
2025-11-24查看详情 > -
Document: Start of procedure: Type II variation - Extension of indication under evaluation by the CHMP (14 November - 11 December 2025)-2025/12/16
2025-12-17查看详情 > -
国家药监局药审中心关于发布《细胞治疗药品药学变更研究与评价技术指导原则(试行)》的通告(2026年第13号)-2026/1/30
2026-02-02查看详情 > -
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment-2026/3/9
2026-03-10查看详情 > -
国家药监局药审中心关于发布《药物上市申请临床评价技术指导原则》的通告(2026年第26号)-2026/4/8
2026-04-09查看详情 > -
国家药监局 海关总署关于麻醉药品和精神药品进出口管理有关事宜的公告(2022年第115号 )-2022/12/22
2022-12-29查看详情 > -
Scientific guideline: Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol-2023/7/4
2023-07-05查看详情 >