中国药业2024，Vol.33Issue(12)：32-35,4.DOI:10.3969/j.issn.1006-4931.2024.12.008
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
游小杰 1樊卫 1付文亮 1牟成成 2吴赛3
作者信息
- 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
- 折叠
摘要
Abstract
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Key words
Pharmaceutical Inspection Co-Operation Scheme/audit checklist/provincial/inspection organization/regulatory organization/drug inspection分类
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游小杰,樊卫,付文亮,牟成成,吴赛..国际药品检查合作计划对我国省级药品检查的启示[J].中国药业,2024,33(12):32-35,4.
