中国药房2017，Vol.28Issue(31)：4330-4334,5.DOI:10.6039/j.issn.1001-0408.2017.31.03
美国药品上市后研究的监管制度及其对我国的启示
Supervision System on Drug Post-marketing Research in America and Its Enlightenments to China
摘要
Abstract
OBJECTIVE:To put forward suggestions for improving the supervision of phase Ⅳ clinical trials in China. METH-ODS:According to summarizing the post-marketing research in America,FDA's supervision(including key elements,supervision flow,auxiliary supervision system and enforcement measures)for drug post-marketing research in America was analyzed,and sug-gestions for the supervision of phaseⅣclinical trials in China was put forward. RESULTS&CONCLUSIONS:The drug post-mar-keting research in America included post-marketing commitment research(PMR)and post-marketing requirement research(PMC). The key elements included supervision subjects(dealt by Office of New Drugs affiliated to Drug Evaluation and Research Center), key document (including the documents helping FDA and applicants reached a research agreement,and documents for process tracking and supervision in identified studies)and important time node. The supervision flow included developing drafts and review-ing reports. FDA had established PMC/PMR database,which was used as auxiliary supervision system,and relevant enforcement measures were respectively developed for PMC and PMR. Relevant supervision departments in China should converse the supervi-sion ideas,give full play to the government's guidance and supervision,enhance the connection of supervision between pre- and post-marketing,specially develop phase Ⅳ clinical program,establish system for phase Ⅳ clinical trial data,enhance whole pro-cess supervision,draw lessons from"pre-process plan,dynamic tracking in the process,and post-process decision according to law"of FDA to improve the supervision of phaseⅣclinical trials in China.关键词
上市后承诺研究/上市后要求研究/监管/Ⅳ期临床试验/美国Key words
Post-marketing commitment research/Post-marketing requirement research/Supervision/Phase Ⅳ clinical trials/America分类
医药卫生引用本文复制引用
罗雪燕,赖寒,陈绍成,李俊..美国药品上市后研究的监管制度及其对我国的启示[J].中国药房,2017,28(31):4330-4334,5.基金项目
重庆市教委2015年度科学技术研究项目:基于"三医联动"模式下的药品采购制度研究——以重庆市为例(No. KJ1501417) （No. KJ1501417）
重庆第二师范学院2015年度校级科研项目:基本医疗保险药品价格谈判机制研究——以重庆市为例(No.KY201511B) （No.KY201511B）
