【作者】 刘欢； 张钟艺； 杨悦；

【Author】 Liu Huan;Zhang Zhongyi;Yang Yue;School of Business Administration, Shenyang Pharmaceutical University;International Food & Drug Policy and Law Research Center, Liaoning Shenyang Pharmaceutical University;

【机构】 沈阳药科大学工商管理学院； 沈阳药科大学国际食品药品政策与法律研究中心；

【摘要】 目的为改善我国新药临床试验安全性报告管理提供建议。方法通过查阅FDA及中英文数据库,分析美国新药临床试验安全性报告最终规则制定背景、主要内容、实施绩效及实施壁垒。结果美国在2010年最终规则中详细规定了报告标准、报告时限及报告主体等,以提高报告质量。结论我国应在药品管理法中增加安全性报告相关条款,修订完善《药物临床试验质量管理规范》,并建立上市前与上市后安全性信息的关联。更多还原

【Abstract】 Objective To provide proposals on strengthing and improving the safety reporting of Investigational New Drug(IND)clinical trials in China. Methods By reviewing the database and US FDA website, thoroughly analyzing the content of the FDA IND safety report final rule,the implementation effect and barriers of the final rule,and compared with China. Result FDA IND safety report final rule clarified the terms definition,specified reporting standards,reportingtime limits, and so on. Conclusion We should continue to revising Drug Administration Act and Good Clinical Practice(GCP), and establish the correlation between pre-marketing and post-marketing safety information.更多还原