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Document: Timetable: Companion diagnostic initial consultation - ATMP-2025/10/3
2025-10-08查看详情 > -
Document: Highlights – Fourth EMA-Vaccines Europe bilateral meeting-2025/11/12
2025-11-13查看详情 > -
Document: Combination Products Operational Group (COMBO) - Terms of reference-2025/12/9
2025-12-10查看详情 > -
国家药监局药审中心关于发布《药物临床试验中应用贝叶斯外部信息借用方法的指导原则（试行）》的通告（2026年第6号）-2026/1/21
2026-01-22查看详情 > -
Document: EudraVigilance support guide-2026/2/24
2026-02-27查看详情 > -
Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure-2026/3/27
2026-03-30查看详情 > -
Submitting Continuous Glucose Monitoring Data in Clinical Trials-2026/5/6
2026-05-08查看详情 > -
Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells (updated)-2022/10/26
2022-11-15查看详情 > -
国家药监局关于改革完善放射性药品审评审批管理体系的意见 国药监药注〔2023〕20号-2023/4/25
2023-04-26查看详情 > -
关于公开征求《中药制剂稳定性研究技术指导原则（征求意见稿）》意见的通知-2023/10/30
2023-11-06查看详情 >
