| 冯红云,智会静,李浩,周凌芸,邵颖,吕心欢,杨建红.新药临床试验期间药物警戒和风险控制研究四:临床试验期间安全性定期报告监管要求研究[J].中国药事,2022,36(6):637-643 |
| 新药临床试验期间药物警戒和风险控制研究四:临床试验期间安全性定期报告监管要求研究 |
| Research IV on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: A Study on Regulatory Requirements for Periodic Safety Report in Clinical Trials |
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| DOI：10.16153/j.1002-7777.2022.06.006 |
| 中文关键词: 定期安全性报告 研发期间安全性更新报告 年度报告 临床试验 药品监管 |
| 英文关键词: periodic safety reports Development Safety Update Reports (DSUR) annual reports clinical trials drug regulatio |
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| 中文摘要: |
| 目的：比较分析国内外关于临床试验期间安全性定期报告的相关法规和指导原则要求的异同点， 为加强我国试验用新药临床试验期间安全性定期报告的管理提供理论依据。方法：采用文献对比方法， 通过比较ICH、美国、欧盟、中国在临床试验期间安全性定期报告相关法规及指导原则情况，分析各国家/地区对试验用药物临床试验期间安全性报告监管要求的差异。结果与结论：在试验用药物临床试验期间的安全性定期报告方面，我国、FDA、欧盟均提出了明确的监管要求。各国家/地区均接受ICH E2F研发期间安全性更新报告的格式、内容及报告周期的要求，但在区域附件部分，各国家/地区均有各自的特殊要求。 |
| 英文摘要: |
| Objective: By comparing and analyzing the similarities and diff erences between domestic and foreign regulations and guidelines on periodic safety reports during clinical trials, this study is to provide theoretical references for strengthening the management of periodic safety reports during clinical trials of investigational new drugs in China. Methods: With literature comparison method, the diff erences of regulatory requirements for periodic safety reports during clinical trials of investigational drugs in various countries/regions were analyzed by comparing the relevant regulations and guidelines for periodic safety reports during clinical trials in ICH, USA, EU and China. Results and Conclusion: In terms of periodic safety reports during clinical trials of new drugs, China, FDA and EU have all issued clear regulatory requirements. Each country/region has accepted the format, content and the regular reporting requirement of ICH E2F safety update reports during development, but each has its own special requirements in the regional annex. |
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