我国药物临床试验实施中的问题及监管对策  

Problems and Regulatory Measures for the Implementation of Drug Clinical Trials in China

作　　者：孙轶康[1,2] 阮秀芳[3] 

机构地区：[1]复旦大学药学院,上海市200032 [2]上海市食品药品监督管理局认证审评中心,上海市200020 [3]上海市食品药品监督管理局,上海市200010

出　　处：《中国药房》2010年第25期2317-2319,共3页China Pharmacy

摘　　要：目的:为药品监管部门对药物临床试验进行有效监管提出建议。方法:分析目前我国药物临床试验实施中存在的问题以及监管部门面临的问题,提出监管对策。结果与结论:建议由事前、事后监管转变为过程控制,将日常监管与注册核查有机结合,完善法律法规,落实相关责任,加强检查员队伍建设。药物临床试验结果是药物开发与评价的关键,只有加强监管才能更好地促进我国药物临床试验整体水平的提高。OBJECTIVE：To put forward suggestions for drug monitoring authorities to effectively supervise drug clinical trials.METHODS：Problems about the implementation of drug clinical trials and the problems faced by authorities were analyzed to propose regulatory measures.RESULTS CONCLUSIONS：It is suggested that supervision and administration before and after the facts turn into process control,daily supervision and administration should integrate with checking register,rules and regulations should be improved and relevant responsibility should be implemented,the capability of supervisors should be improved.Drug clinical trial results are the key to drug development and evaluation.Strengthened supervision is the best way to improve the overall level of drug clinical trials in China.

关 键 词：药物临床试验 问题 监管对策 

分 类 号：R95[医药卫生—药学]