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Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices-2025/12/18
2025-12-19查看详情 > -
国家药监局药审中心关于发布《慢性失眠治疗药物临床试验技术指导原则（试行）》的通告（2026年第1号）-2026/2/4
2026-02-05查看详情 > -
Document: Minutes of the COMP meeting 20-22 January 2026-2026/3/11
2026-03-12查看详情 > -
Document: Template for sharing EMA documents by Industry to support reliance-2026/4/9
2026-04-10查看详情 > -
Content of Human Factors Information in Medical Device Marketing Submissions-2026/5/29
2026-05-29查看详情 > -
Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment-2026/7/10
2026-07-11查看详情 > -
Document: Presentation - Artificial intelligence for drug development in cardiovascular medicine (C. Mittman)-2026/8/14
2026-08-17查看详情 > -
Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)-2022/12/21
2022-12-21查看详情 > -
关于公开征求《放射性标记人体物质平衡研究技术指导原则（征求意见稿）》意见的通知-2023/7/24
2023-07-28查看详情 > -
Final Guidance: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment-2024/2/21
2024-03-11查看详情 >
