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作 者:丁锦希[1] 詹来明[1] 蒋蓉[1] 陆慧[1] 高强
机构地区:[1]中国药科大学国际医药商学院,江苏南京211198 [2]江苏省南京市食品药品监督管理局,江苏南京211198
出 处:《中国医药导报》2012年第33期5-8,共4页China Medical Herald
基 金:2010年度国家社会科学基金项目(项目名称:创新药物研发科技投入与激励法律制度研究;项目编号:10CFX055);江苏省食品药品监督管理局政策研究课题(项目名称:基本药物制度框架下药品电子监管政策研究--基于江苏省药品电子监管的实证分析;项目编号:20110016)
摘 要:目的探索影响医药企业实施药品电子监管政策的关键因素,为相关部门制订和完善监管政策提供依据。方法构建药品电子监管实施影响因素指标体系,运用因子分析法进行定量分析,筛选影响药品电子实施的关键因素。结果实证分析发现影响电子监管政策实施的关键影响因素包括:药品管理法、专门规章、初次投入、标签成本、招标采购、技术标准和信息安全。结论政府部门在药品电子监管推进过程中,应针对上述关键因素制订相应的政策措施,以促进药品全品种、全过程电子监管目标如期实现。Objective To explore the key factors influencing the implementation of drug electronic supervision policy for medical enterprise in Jiangsu Province,and thereby to provide basis for policy-making and improvement on the part of departments concerned.Methods An index system of influencing factors for implementing drug electronic supervision was established,and quantitative analysis by method of factor analysis was conducted so as to select key factors influencing the implementation of drug electronic supervision.Results Key factors influencing the implementation of drug electronic supervision found by empirical analysis were the pharmaceutical administration law,specialized rules,initial investment,tag cost,public bidding,the technical standards and information security.Conclusion During the implementation of drug electronic supervision system,the government should formulate corresponding policies and measures aiming at the above key factors to realize the regulation goal of "all varieties and the overall process" of drug electronic supervision as scheduled.
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