国际药品检查合作计划对我国省级药品检查的启示  

Enlightenment of the Pharmaceutical Inspection Co-Operation Scheme to Provincial Drug Inspection in China

作　　者：游小杰 樊卫 付文亮 牟成成 吴赛 YOU Xiaojie;FAN Wei;FU Wenliang;MOU Chengcheng;WU Sai(Chongqing Center for Drug Evaluation and Inspection,Chongqing,China 401120;The First Inspection Bureau of Chongqing Medical Product Administration,Chongqing,China 401120;The Second Inspection Bureau of Chongqing Medical Product Administration,Chongqing,China 401120)

机构地区：[1]重庆市药品技术审评查验中心,重庆401120 [2]重庆市药品监督管理局检查一局,重庆401120 [3]重庆市药品监督管理局检查二局,重庆401120

出　　处：《中国药业》2024年第12期32-35,共4页China Pharmaceuticals

摘　　要：目的提高我国省级药品检查工作管理质量。方法以国际药品检查合作计划组织(PIC/S)审计清单为对照自查依据,通过文献检索、查阅各省级药品监督管理局官方网站,汇总分析我国省级药品监管检查的机构设置、药品上市后监管计划制订方式、检查员培训管理体系三方面内容与差距,并提出改进建议。结果目前,我国各省级药品监管检查机构设置存在差异,检查质量参差不齐;尚无统一的基于风险的药品上市后监管计划制订方式;检查员培训管理体系存在培训内容不一致、考核方式不明确等问题。结论建议将药品检查机构体系考评纳入省级药品监管机构质量体系,建立定期体系评估机制,确保不同检查机构检查质量符合统一要求;建立统一的上市后监管检查计划制订方式;健全检查员培训管理体系,搭建统一的检查员基础知识培训和能力考核平台,并对检查员进行分级管理。Objective To improve the management quality of provincial drug inspection in China.Methods With the audit checklist of the Pharmaceutical Inspection Co-Operation Scheme(PIC/S)as a reference,the organization structuring of provincial drug regulatory and inspection in China,formulation method of regulatory plan for post-market drugs,training management systems of inspectors and their gaps were summarized and analyzed based on relevant literature and the official websites of various provincial medical product administrations,and the suggestions for improvement were proposed.Results Currently,there are some differences in the structuring of provincial drug regulatory and inspection organizations in China,and the inspection quality is uneven.There is no unified method for formulating regulatory plan for post-market drugs based on risk.The inspector training management system has problems such as inconsistent training content and unclear assessment methods.Conclusion It is suggested that we should incorporate the system evaluation of drug inspection organizations into the quality system of provincial drug regulatory organizations,and establish a regular system evaluation mechanism to ensure that the inspection quality of different inspection organizations meets the unified standards;establish a unified method for formulating regulatory plan for post-market drugs;improve the inspector training management system,provide a unified basic knowledge training and ability assessment platform,and implement hierarchical management for inspectors.

关 键 词：国际药品检查合作计划组织 审计清单 省级 检查机构 监管机构 药品检查 

分 类 号：R95[医药卫生—药学]