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。结论我国现行《药物临床试验质量管理规范》应继续完善修订,并建立上市前与上市后安全性信息的关联。
Objective To provide proposals on strengthening and improving the safety reporting of investigational new drug(IND) clinical trials in China. Methods Based on the FDA safety reporting rules, the backgrounds, main contents, implementation effect and barriers of the final rule were thoroughly analyzed. Results The FDA IND safety report final rule clarified the terms definition, specified reporting standards, reporting time limits, and so on, so as to improve the quality of the report. Conclusion We should continue revising Good Clinical Practice(GCP), and establishing the correlation between pre-marketing and post-marketing safety information.
作者
刘欢
张钟艺
杨悦
LIU Huan;ZHANG Zhongyi;YANG Yue(School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;International Food & Drug Policy and Law Research Center, Liaoning Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China)
出处
《中国药物警戒》
2019年第2期88-93,共6页
Chinese Journal of Pharmacovigilance
关键词
新药
临床试验
安全性报告
最终规则
investigational new drug
clinical trials
safety report
final rule
