新时代下药品监管模式的探讨与实践
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摘要
随着我国药品审评审批制度改革的不断推进,药品监管科学与事业的发展进入了新时代。本文结合改革创新的时代背景,概述我国目前的药品监管模式及其存在的缺陷,分析当前药品监管的形势,对药品监管模式进行探讨,并对欧美国家的药品监管情况作了简要介绍。本文还介绍了生物药新的监管模式的初步实践情况,对药品监管模式的创新探索作了展望。
Along with the comprehensive progress made in the reform of the drug review and approval system in China, the development of the science and undertakings of drug regulation has been entered into a new era. The current regulation mode in China and its imperfections are summarized by combining the era backgrounds of reform and innovation, the current situation of drug regulation in China is analyzed and the advantages and disadvantages of this drug regulation mode are discussed as well as the drug regulation status in European Union and the United States is briefly introduced. Meanwhile, the tentative practice of new regulation mode for biologics in China is introduced, and the innovative explorations of drug regulation mode is also prospected.
Along with the comprehensive progress made in the reform of the drug review and approval system in China, the development of the science and undertakings of drug regulation has been entered into a new era. The current regulation mode in China and its imperfections are summarized by combining the era backgrounds of reform and innovation, the current situation of drug regulation in China is analyzed and the advantages and disadvantages of this drug regulation mode are discussed as well as the drug regulation status in European Union and the United States is briefly introduced. Meanwhile, the tentative practice of new regulation mode for biologics in China is introduced, and the innovative explorations of drug regulation mode is also prospected.
引文
[1]王麟达,陈伟,陈桂良.新药研发与法规管理[M]//白东鲁,陈凯先.高等药物化学.北京:化学工业出版社,2011:504-532.
[2]唐民皓.药品安全:从“监管”向“治理”的转型[J].财经法学,2015,1(4):40-48.
[3]孙咸泽.用现代信息科技磨砺监管利器——食品药品监管信息化的建设与发展[J].中国食品药品监管,2012(3):12-15.
[4]唐民皓,许瑾,史岚,等.地方食品药品监管行政指导制度的构建与对策[J].中国卫生资源,2011,14(6):379-383.
[5]Garg L,Elshorbagy S,Gupta V,et al.The impact of information systems on management performance in the pharmaceutical industry[J].J Cases Inf Technol,2015,17(3):56-73.
[6]韩胜昔,叶露.中美两国药品安全监管体制的比较研究[J].中国药房,2015,26(10):1309-1312.
[7]高敏洁.美国FDA对新药临床试验申办者和合同研究组织的监管模式[J].中国新药与临床杂志,2016,35(2):109-113.
[8]杨依晗,王广平,高惠君.美国食品药品监管大数据实践简介及对我国的启示[J].上海医药,2017,38(9):60-65.
[2]唐民皓.药品安全:从“监管”向“治理”的转型[J].财经法学,2015,1(4):40-48.
[3]孙咸泽.用现代信息科技磨砺监管利器——食品药品监管信息化的建设与发展[J].中国食品药品监管,2012(3):12-15.
[4]唐民皓,许瑾,史岚,等.地方食品药品监管行政指导制度的构建与对策[J].中国卫生资源,2011,14(6):379-383.
[5]Garg L,Elshorbagy S,Gupta V,et al.The impact of information systems on management performance in the pharmaceutical industry[J].J Cases Inf Technol,2015,17(3):56-73.
[6]韩胜昔,叶露.中美两国药品安全监管体制的比较研究[J].中国药房,2015,26(10):1309-1312.
[7]高敏洁.美国FDA对新药临床试验申办者和合同研究组织的监管模式[J].中国新药与临床杂志,2016,35(2):109-113.
[8]杨依晗,王广平,高惠君.美国食品药品监管大数据实践简介及对我国的启示[J].上海医药,2017,38(9):60-65.