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

目的:为完善我国Ⅳ期临床试验的监管提出建议。方法:通过概述美国药品上市后研究制度,分析美国FDA对药品上市后研究的监管(包括关键要素、监管流程、配套监管系统和强制措施),提出完善我国Ⅳ期临床试验监管的建议。结果与结论:美国药品上市后研究包括上市后承诺研究(PMR)和上市后要求研究(PMC)。监管过程中的关键要素包括监管主体(由药品评价和研究中心下属的新药办公室负责)、关键文件(包括帮助FDA和申请人达成研究协议的文件和用于对已确定的研究进行过程跟踪和监督的文件)、重要时间节点(明确提交相关材料的特定节点日期);监管流程包括制订研究草案、审核研究报告;美国FDA建立了PMC/PMR数据库作为配套监管系统,并分别针对PMC和PMR制定了相应的强制措施。我国相关监管部门应转换监管思路、充分发挥政府的引导和监督作用,加强药品上市前、后监管的衔接,制订特色化Ⅳ期临床方案,建立Ⅳ期临床试验数据管理系统,加强全过程监管,借鉴FDA"事前制定计划,事中动态追踪,事后依法处理"的监管方式来完善对我国Ⅳ期临床试验的监管。

OBJECTIVE：To put forward suggestions for improving the supervision of phase Ⅳ clinical trials in China. METHODS：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 suggestions for the supervision of phase Ⅳ clinical trials in China was put forward. RESULTS CONCLUSIONS：The drug post-marketing 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 reviewing 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 supervision 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 process 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 phase Ⅳ clinical trials in China.