美国药品安全监管机制研究及启示

发布时间：2018-05-26 18:38

本文选题：药品安全 + 监管机制　；参考：《中国药房》2017年04期

【摘要】：目的:为我国药品安全监管机制的完善提供参考。方法:基于市场失灵、合约失灵和政府失灵理论,选取美国具有代表性的药品安全监管机制进行分析和评价。结果与结论:美国在药品安全监管机制的实施和运用方面取得的成效显著,其具有代表性的药品安全监管机制有处方药申报者付费机制、药品安全信息沟通机制、惩罚与激励机制、公私合作伙伴机制以及被动监测和主动监测相结合机制,这些机制缓解了FDA的政府失灵,在一定程度上破解了市场失灵和合约失灵的难题。我国在完善药品安全监管机制时应细化法律保障、充分调动外部力量、吸收利用现代信息技术、预防与处置并重、注重不同机制之间的协调、力求过程公开和结果透明。
[Abstract]:Objective: to provide reference for the perfection of drug safety supervision mechanism in China. Methods: based on the theories of market failure, contract failure and government failure, the representative drug safety regulatory mechanism in the United States was analyzed and evaluated. Results & conclusion: the United States has achieved remarkable results in the implementation and application of drug safety regulatory mechanisms. The representative drug safety regulatory mechanisms include the payment mechanism for prescription drug registrants and the communication mechanism for drug safety information. Punishment and incentive mechanism, public-private partnership mechanism and passive monitoring and active monitoring mechanism, these mechanisms alleviate the government failure of FDA, and to some extent solve the problem of market failure and contract failure. In perfecting the mechanism of drug safety supervision, our country should refine the legal guarantee, fully mobilize external forces, absorb and utilize modern information technology, pay equal attention to prevention and disposal, pay attention to the coordination among different mechanisms, and strive for openness of the process and transparency of the results.
【作者单位】：沈阳药科大学工商管理学院;
【基金】：国家社会科学基金资助项目(No.13CFX086) 辽宁省教育厅科学研究一般项目(No.W2014119) 沈阳药科大学中青年教师事业发展支持计划
【分类号】：R95

【相似文献】