我国药物临床试验审批管理优化改革及成效分析  

Analysis of Approval Policy Reform on Drug Clinical Trials in China and Implementation Effect

作　　者：白庚亮 薛嘉庆 雷琦 杨勇 BAI Gengliang;XUE Jiaqing;LEI Qi;YANG Yong(School of Health Economics and Management,Nanjing University of Chinese Medicine,Nanjing 210023,China;Nanjing Fangteng Medical Technology Co.,Ltd.Nanjing 210023,China)

机构地区：[1]南京中医药大学卫生经济管理学院,南京210023 [2]南京方腾医药技术有限公司,南京210023

出　　处：《中国药学杂志》2023年第20期1882-1888,共7页Chinese Pharmaceutical Journal

基　　金：江苏省高校哲学社会科学研究项目资助(2020SJA0316);南京中医药大学2021年大学生创新创业训练计划项目资助(103152021070);四川省哲学社会科学重点研究基地(四川医事卫生法治研究中心)项目资助(YF20⁃Y07);江苏省社科应用研究精品工程项目资助(20SYC⁃127)。

摘　　要：目的分析我国近年来药物临床试验审批制度改革内容及成效,并提出完善建议。方法运用描述性统计分析从新药临床试验受理与完成数量、登记公示数量、启动耗时、沟通交流会议开展情况、试验机构备案与伦理审查情况等方面分析药物临床试验审批制度改革效果。结果新药临床试验受理与完成量逐年提高且已达到进出平衡;临床试验登记公示数量逐年上涨且涨幅巨大;临床试验启动耗时大幅缩短;沟通交流会议的申请量逐年上涨,但召开率逐渐降低;临床试验机构备案制实施后机构数量有较大提升,但伦理审查效率有待提升。结论我国药物临床试验审批管理制度改革效果显著,临床试验审评效率显著提升。为了达到更好的制度效果,申请人应注意充分利用沟通交流机制,提高申请效率,申办者应强化主体意识,承担全面管理职责,伦理委员会应强化其责任意识,进一步提升伦理审查效率以加快临床试验开展速度。OBJECTIVE To analyze the operation process and effect of the approval policy reform for drug clinical trials in China,and provide recommendations.METHODS Descriptive statistics analysis were used to analyze the effect of the policy reform from 5 aspects:the number of INDs,the registration number of clinical trials,the duration of clinical trial startup,the number of communication meetings,the registration status of drug clinical trial institutions and ethical review.RESULTS Since the implied license policy implementation,the accepted and completed number of INDs are increasing year by year.The registration number of clinical trials have been significantly increased,and the startup duration has been greatly reduced.The number of applications for communication meetings is increasing year by year,but the holding rate is gradually decreasing.The number of clinical trial institutions increased greatly after the implementation of the filing system,but the efficiency of ethical review needs to be improved.CONCLUSION Remarkable achievements have been obtained in approval policy reform,clinical trial review efficiency has been improved significantly.In order to better implement the policy,applicants should make full use of the communication system to improve application efficiency.The sponsor should strengthen the overall management responsibilities.The IEC/IRB should strengthen its responsibility to enhance the efficiency of ethical review to speed up clinical trials development.

关 键 词：药物临床试验 药品审评审批 沟通交流制度 默示许可 临床试验机构备案 

分 类 号：R95[医药卫生—药学]