制药企业药品上市后安全政府监管适度性分析  

Appropriateness analysis for the regulation of drug post-marketing safety between the government and pharmaceutical companies

作　　者：张昊[1] 武志昂[1] 

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016

出　　处：《中国新药杂志》2014年第22期2593-2596,2623,共5页Chinese Journal of New Drugs

摘　　要：制药企业药品上市后安全政府监管存在适度性,应对监管概率与监管强度做其研究与分析。本文通过博弈模型和成本效益函数分析,深层次的阐述药品生产企业对药品不良反应报告的动力与阻力,探究政府对药品上市后安全监管的适度性。应加强对药品生产企隐瞒药品安全信息行为的处罚力度,控制监管成本,建立对企业激励相关措施等,提高政府对药品上市后安全监管的效率。Appropriateness exists in the regulation of drug post-marketing safety between the government and pharmaceutical companies. In this article, we analyzed three kinds of game model, and deeply elaborated the force and resistance of adverse drug reaction （ADR） report of the pharmaceutical enterprises and explored the ap- propriateness for the regulation of drug post-marketing safety. We should strengthen the intensity of punishment for the behavior of concealing the drug safety information, control the cost of regulation and establish incentive meas- ures to the enterprise in order to improve the efficiency of the drug post-marketing safety regulation.

关 键 词：药品生产企业 药品不良反应报告 博弈分析 成本效益分析 

分 类 号：R95[医药卫生—药学]