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	从政治科学、商业利益和公共政策视角研究国外药品安全监管
	胡颖廉 ; 傅凯思 ; Hu Yinglian ; Keith Florig
	2010-05-12 ; 2010-05-12
关键词	药品安全 政府监管 风险管理 政治科学 公共政策 drug safety,government regulation,risk management,political science,public policy F203
其他题名	Political Science,Business Interest and Public Policy:Review of Drug Safety Regulation Research in Foreign Countries
中文摘要	对药品安全进行监管是当代政府的重要职责。近年来我国药害事故频发,严重威胁到人民群众的健康乃至生命安全,促使我们深入思考药品安全问题。众多国外学者的研究表明,除了药品本身所具有的风险和不确定性外,社会政治经济因素也影响到药品安全监管的绩效。通过新药审批和上市后监督的两个阶段划分,综述了学者们对各类药品风险的定义、影响因素分析和研究结论。可以看到,立法机构的政治意愿、监管者的行为目标、制药企业的商业利益以及消费者群体的健康诉求,都会影响药品安全及其风险管理。我们应当从政府治理入手,通盘考虑各利益相关者在政策制定及执行中的相互关系,尤其要关注药品监管机构能力的提升。介绍此类研究不仅有助于我们思考中国现阶段面临的药品安全问题,还可以进一步运用到环境保护、安全生产等其他社会监管领域。; Drug safety regulation is a regular responsibility of modern state.Recent years witnessed several drug accidents in China,which cost tens of lives and posed serious threats to public health,these tragedies lead us to have an in-depth thinking of risk resources of drug safety.Research by foreign scholars show social,political and economic factors other than drug risk and uncertainty can influence drug safety performance.By dividing new drug approval and post-market surveillance,this review collects definitions,influential factors and conclusions of drug risks.Political willing from legislator,policy goal of regulator,business interest of pharmaceutical industry and complaint of consumer groups are all important players of drug risk management.We should address the issue through governance perspective,studying interactions between different stakeholders in agenda setting and policy implementation,especially the enhancing of capacity of drug administration.These studies can not only help us to improve drug safety record in China,but also being applied to environmental protection,workplace safety and other social regulation fields.
语种	中文 ; 中文
内容类型	期刊论文
源URL	[http://hdl.handle.net/123456789/29769]
专题	清华大学
推荐引用方式 GB/T 7714	胡颖廉,傅凯思,Hu Yinglian,等. 从政治科学、商业利益和公共政策视角研究国外药品安全监管[J],2010, 2010.
APA	胡颖廉,傅凯思,Hu Yinglian,&Keith Florig.(2010).从政治科学、商业利益和公共政策视角研究国外药品安全监管..
MLA	胡颖廉,et al."从政治科学、商业利益和公共政策视角研究国外药品安全监管".(2010).

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