[关键词]
[摘要]
通过查阅英国药物临床试验法律法规、指南、相关文献,并对历年绩效数据进行统计后发现,英国药物临床试验审评时限比较注重科学性和灵活性,对技术审评与伦理审查程序采取并行的安排,并建立了上市后临床研究和研究者发起的科研性临床研究的审查机制等内容值得我国借鉴。我国现行药物临床试验管理制度,较好地保证了受试者的安全,但仍要把握对临床试验制度要素的控制,不仅在程序上要层层把关,还要尽可能提高审查的效率,使新的疗效好的药物尽快在我国上市,以满足我国人民的用药需求。
[Key word]
[Abstract]
After reviewing the laws and regulations, guidelines, and related literatures on clinical trials of drugs in the United Kingdom, and statistics of performance data over the years, it is found that the review time limit for clinical trials of drugs in the United Kingdom pays more attention to scientificity and flexibility, and the technical review and ethical review procedures are parallel. The arrangement and establishment of post-marketing clinical research and the review mechanism of scientific research clinical research initiated by researchers are worthy of reference for our country. Current drug clinical trial management system in China has better ensure the safety of subjects, but it is still necessary to control the elements of the clinical trial system. Not only the procedures must be checked at all levels, but the efficiency of the review must be improved as much as possible, so that new drugs with good curative effects will be put on the market in China as soon as possible to meet the needs of the Chinese people.
[中图分类号]
R288
[基金项目]