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1.江西省药品认证审评中心,南昌 330006
2.太极计算机股份有限公司江西分公司,南昌 330096
Published:15 January 2024,
Received:20 June 2023,
Revised:22 November 2023,
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漆亮,王琪,刘雅慧等.基于药品企业质量风险大数据的现场监管策略优化研究 Δ[J].中国药房,2024,35(01):10-14.
QI Liang,WANG Qi,LIU Yahui,et al.Optimization of on-site supervision strategy based on big data of quality risk in drug enterprises[J].ZHONGGUO YAOFANG,2024,35(01):10-14.
漆亮,王琪,刘雅慧等.基于药品企业质量风险大数据的现场监管策略优化研究 Δ[J].中国药房,2024,35(01):10-14. DOI: 10.6039/j.issn.1001-0408.2024.01.02.
QI Liang,WANG Qi,LIU Yahui,et al.Optimization of on-site supervision strategy based on big data of quality risk in drug enterprises[J].ZHONGGUO YAOFANG,2024,35(01):10-14. DOI: 10.6039/j.issn.1001-0408.2024.01.02.
药品现场监管是一种以风险为本的监管体系,要求针对药品企业质量风险和隐患科学地制定监管计划,并结合其风险水平合理配置监管资源,实施分类监管措施。本研究通过分析药品现场监管工作的难点,建立了药品企业质量风险专题库、药品企业质量风险监测指标体系,以此构建药品企业质量风险监测业务支撑体系,并依托该支撑体系建立了质量风险分类方法、差异化抽查策略和业务辅助可视化系统,运用该支撑体系获知药品企业风险等级,从而创新了药品现场监管方法,优化了监管策略。以江西省为例,验证了该支撑体系可引导对样本药品企业的风险评估,可在药品现场监管的技术审评、方案编制、现场执行及综合评估过程中提升检查的靶向性,有效提高监管质量和效率。
On-site supervision is a risk-based regulatory system that requires the scientific development of supervision plans for quality risks and hidden dangers in pharmaceutical enterprises, the rational allocation of supervision resources based on their risk levels, and the implementation of classified supervision measures. In this study, the quality risk monitoring business support system is set up for pharmaceutical enterprises by establishing the quality risk expert database and quality risk monitoring index system for pharmaceutical enterprises based on the difficulty analysis of on-site drug supervision. Based on this support system, the quality risk classification method, the differentiated spot check strategy and business auxiliary visualization system are established. This support system is used to learn the risk level of pharmaceutical enterprises, so as to innovate supervision methods and optimize monitoring strategies. Taking Jiangxi Province as an example, it is verified that the support system can guide the risk assessment of sample enterprises, can improve the targeting of on-site drug supervision in the process of technical review, scheme editing, on-site implementation and comprehensive evaluation, and can effectively improve the quality and efficiency of supervision.
药品企业药品监管质量风险大数据现场监管策略优化
drug supervisionquality riskbig dataon-site supervisionstrategy optimization
WILLAMS C A,HEINE R M. Risk management and insurance[M]. New York:McGraw-Hill,1985:6-8.
MOWBRAY A H,BlANCHARD R H. Insurance:its theory and practice in the United States[M]. New York:McGraw-Hill,1995:3-9.
ROSENB J S.A case study in risk management[M]. New York:Meredith Corp,1972:11-12.
国家药监局.国家药监局关于印发《国家药品监督管理局关于加快推进药品智慧监管的行动计划》的通知[EB/OL].[2023-05-21].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20190524175201644.htmlhttps://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20190524175201644.html.
National Medical Products Administration. Notice of the National Medical Products Administration on issuing the action plan of the National Medical Products Administration on accelerating the promotion of intelligent drug supervision[EB/OL].[2023-05-21].https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20190524175201644.htmlhttps://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20190524175201644.html.
尹孝勉. 迈向实质法治的智慧政府建设[J].求索,2023(2):171-179.
YIN X M.Building a smart government towards the substantive rule of law[J]. Seeker,2023(2):171-179.
郑立伟,刘中华,倪超. 大数据技术对市场监管的启发:数据驱动的质量风险评估[J]. 技术经济,2021,40(8):33-40.
ZHENG L W,LIU Z H,NI C. Elicitation of big data technology on market supervision:data-driven quality risk assessment[J]. J Technol Econ,2021,40(8):33-40.
国家药监局.国家药监局等8部门联合印发《“十四五”国家药品安全及促进高质量发展规划》[EB/OL]. [2023-05-21].https://www.nmpa.gov.cn/yaowen/ypjgyw/20211- 230145247117.htmlhttps://www.nmpa.gov.cn/yaowen/ypjgyw/20211-230145247117.html.
National Medical Products Administration. The National Medical Products Administration and other 8 departments jointly issued the 14th five-year plan for national drug safety and promotion of high-quality development[EB/OL].[2023-05-21].https://www.nmpa.gov.cn/yaowen/ypjgyw/20211230145247117.htmlhttps://www.nmpa.gov.cn/yaowen/ypjgyw/20211230145247117.html.
林琳.回应性监管理论在我国药品安全监管模式中的应用[J].沈阳药科大学学报,2022,39(3):339-345.
LIN L. The application of responsive regulatory theory in China’s drug safety regulatory model[J]. J Shenyang Pharm Univ,2022,39(3):339-345.
赖秋洁,茅宁莹.我国省级药品检查机构的改革困境分析[J].中国药事,2021,35(5):487-496.
LAI Q J,MAO N Y. On the reform predicament of the provincial drug inspection institutions in China[J]. Chin Pharm Aff,2021,35(5):487-496.
国家药监局.药品监督管理统计年度数据:2022年 [EB/OL].[2023-05-21]. https://www.nmpa.gov.cn/directory/web/nmpa/images/1681866563446076174.pdfhttps://www.nmpa.gov.cn/directory/web/nmpa/images/1681866563446076174.pdf.
National Medical Products Administration. Annual data of pharmaceutical supervision and management statistics:2022[EB/OL].[2023-05-21].https://www.nmpa.gov.cn/directory/web/nmpa/images/1681866563446076174.pdfhttps://www.nmpa.gov.cn/directory/web/nmpa/images/1681866563446076174.pdf.
段晓祥,王淑玲.基于DEA模型和Malmquist指数的我国药品安全监管效率评价[J].中国药房,2022,33(15):1814-1819.
DUAN X X,WANG S L. Evaluation of efficiency of drug safety supervision in China based on DEA model and Malmquist index[J]. China Pharm,2022,33(15):1814-1819.
刘杰,张怡,何清清.以制促治:我国地方药品监管能力提升路径[J].中国行政管理,2022(8):157-160.
LIU J,ZHANG Y,HE Q Q. Promoting governance through control:the way to improve the local drug supervision ability in China[J]. Chin Public Adm,2022(8):157-160.
阎春宁.风险管理学[M].上海:上海大学出版社,2002:4-6.
YAN C N. Risk management science[M]. Shanghai:Shanghai University Press,2002:4-6.
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