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。
In this article, we introduced the application of information communication mechanism in the EU sampling and testing of the centrally authorized products （CAPs）. Then we provided the reference for the drug evaluation sampling work of CFDA. From the procedures of planning, sampling, testing and disposing, we summarized the flow and application of information in the sampling and testing of CAPs. After analyzing the issues of China＇s drug evaluation sampling work, we put forward some recommendations. Information communication mecha- nism is used throughout the entire EU links; however, in China＇s drug evaluation sampling work it needs to be im- proved and perfected, especially in the area of information collection, exchange, feedback and application. China should establish a risk management system, a quality responsibility system, a test results application system and a information security system as soon as possible. It will make our drug evaluation sampling work more scientific and rational.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第11期1211-1218,共8页
Chinese Journal of New Drugs
关键词
CAPs年度抽验
药品评价抽验
信息沟通机制
sampling and testing of centrally authorised products
China＇s drug evaluation sampling work
information communication mechanism
