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.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第25期2317-2319,共3页
China Pharmacy
关键词
药物临床试验
问题
监管对策
Drug clinical trial
Problem
Regulatory measures