信息沟通机制在欧盟CAPs年度抽验中的应用及对我国药品评价抽验的启示

发布时间：2018-04-10 18:11

本文选题：CAPs年度抽验 + 药品评价抽验　；参考：《中国新药杂志》2015年11期

【摘要】：本文研究欧盟CAPs年度抽验中信息沟通机制的应用,为优化我国药品监管机构的药品评价抽验工作提供参考。从计划、抽查、检验评价以及后续行动5个环节,对欧盟CAPs年度抽验模式中信息流向问题进行研究,总结信息沟通机制在该模式中的建立与应用。同时,与我国进行对比,分析我国现阶段药品评价抽验模式存在的问题并提出建议。信息沟通机制贯穿欧盟CAPs年度抽验整个环节,而在我国药品评价抽验模式中,该机制还存在信息收集、信息交流、信息反馈与应用等方面的缺失,有待提高和完善。我国应尽快建立风险管理体系、质量责任体系、检验结果应用体系以及信息沟通保障体系,使药品评价抽验更加科学合理。
[Abstract]:This paper studies the application of information communication mechanism in EU CAPs annual sampling inspection, which provides a reference for optimizing the drug evaluation and sampling work of drug regulatory agencies in China.This paper studies the flow of information in the EU CAPs annual sampling mode from five aspects: plan, spot check, test evaluation and follow-up action, and summarizes the establishment and application of information communication mechanism in this model.At the same time, compared with our country, this paper analyzes the problems existing in the mode of drug evaluation and sample inspection in our country and puts forward some suggestions.The information communication mechanism runs through the whole process of CAPs annual sampling inspection in EU, but in the mode of drug evaluation and sampling inspection in our country, there are still some deficiencies in information collection, information exchange, information feedback and application, which need to be improved and improved.Risk management system, quality responsibility system, test result application system and information communication guarantee system should be established as soon as possible in China to make drug evaluation sampling and inspection more scientific and reasonable.
【作者单位】：中国药科大学国际医药商学院;浙江工业大学药学院;
【分类号】：R95

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