我国GMP临床试验用药品附录实施情况调研分析  

Investigates and Analysis on the Implementation of the GMP Investigational Medicinal Products Appendix in China

作　　者：胡敬峰 吕小红 冯巧巧 周勇 Hu Jingfeng;Lv Xiaohong;Feng Qiaoqiao;Zhou Yong(Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250014,China)

机构地区：[1]山东省食品药品审评查验中心,济南250014

出　　处：《中国药事》2024年第10期1123-1130,共8页Chinese Pharmaceutical Affairs

摘　　要：目的:调研我国GMP临床试验用药品附录(简称附录)自发布以来的实施现状,了解企业执行过程中存在的问题,为附录的有效实施提供建议。方法:采用线上问卷与现场调研相结合的方式对不同省份企业的实施情况进行归纳,分析企业对相关要求的执行情况及存在的问题。结果:参与调研的企业共100家,来自10个省份,产品覆盖面广且具有代表性。调研显示,大部分企业能够符合附录的要求,但仍有部分企业在质量管理体系的建立(8%)、共线评估(9%)、临床试验用药品档案的建立(15%)、对照药品与试验用药品的相似性评价(10%)、留样(24%)、放行(21%)方面存在不足。结论:建议申请人切实履行主体责任,贯彻附录要求,组织更多专业性培训提升人员综合水平;药监部门发布相关的指导性文件,基于风险对临床试验用药品进行专项检查或抽样检验,促进附录要求落实落地。Objective:To investigate the implementation status of the Chinese Good Manufacturing Practice(GMP)Investigational Medicinal Products Appendix(hereinafter referred to as the"Chinese Appendix")since its release,to understand the problems existing in the implementation process,and to provide suggestions for effective implementation of the Chinese Appendix.Methods:The implementation status of enterprises in different provinces was summarized by means of online questionnaire and on-site investigation,and the implementation of relevant requirements and existing problems were analyzed.Results:There were 100 enterprises participating in the survey from 10 provinces,with a wide and representative product coverage.Research showed that most enterprises had already complied with the requirements of the Chinese Appendix,but a few enterprises had shortcomings in establishing quality management systems(8%),conducting collinear evaluations(9%),establishing the clinical trial drug files(15%),evaluating the similarity between control drugs and experimental drugs(10%),retaining samples(24%),and releasing(21%).Conclusion:It is recommended that the applicants earnestly fulfill their main responsibilities,implement the requirements of the Chinese Appendix and organize more professional training to improve the comprehensive level of enterprise personnel.The drug regulatory authorities should issue relevant guidances documents to conduct special inspections or sampling inspections of drugs used in clinical trials based on risks,and promote the implementation of the requirements of Chinese Appendix.

关 键 词：药品生产质量管理规范 临床试验用药品附录 实施情况 申请人 专项检查 

分 类 号：R95[医药卫生—药学]