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Document: EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports-2026/3/6
2026-03-09查看详情 > -
Document: New product information wording - Extracts from PRAC recommendations on signals adopted at the 9-12 March 2026 PRAC-2026/4/7
2026-04-08查看详情 > -
国家药监局综合司公开征求《药品标准管理办法（征求意见稿）》意见-2022/12/14
2022-12-15查看详情 > -
关于公开征求《放射性治疗药物非临床研究技术指导原则（征求意见稿）》意见的通知-2023/6/26
2023-06-27查看详情 > -
国家药监局药审中心关于发布《细胞和基因治疗产品临床相关沟通交流技术指导原则》的通告（2023年第60号）-2023/12/29
2024-01-03查看详情 > -
更正说明-2025/1/24
2025-01-24查看详情 > -
Page: ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline-2025/2/26
2025-02-27查看详情 > -
Document: Journey towards a roadmap for regulatory guidance on real-world evidence-2025/4/3
2025-04-07查看详情 > -
Document: Agenda of the COMP meeting 13-15 May 2025-2025/5/14
2025-05-15查看详情 > -
Page: EudraVigilance training and support-2025/6/20
2025-06-23查看详情 >
