摘要
药品生产经营和消费等领域新业态、新模式和新技术的不断涌现,对药品监管安全风险预警模式提出了新命题和新要求。传统的监管手段已很难防控日渐复杂的市场安全风险。药品监管信息化,是在药品监管职能转变和《药品管理法》《疫苗管理法》宣贯背景下,通过监管业务和信息化二者的互动效应实现了监管业务的服务提升和优化升级。本研究基于对药品监管业务流程与信息化建设的二元全生命周期管理分析,以及监管信息化建设与职能转变制度安排的阐述,拟对药品监管信息化建设中的监管业务流程、信息化技术、数据要素3方面进行剖析,提出药品监管业务流程与信息化建设全生命周期管理正反馈机制,并提出新体制下药品监管信息化发展路径,以期提供借鉴与决策参考。
With the continuous emergence of new business formats,new models and new technologies in the fields of pharmaceutical production,operation and consumption,the drug regulatory safety risk early warning model puts forward new propositions and new requirements.Traditional regulatory methods have been difficult to prevent and control the increasingly complex market security risks.The drug supervision informatization is the promotion and optimization of supervision business services through the interactive effect of supervision process and informatization under the background of the transformation of drug supervision functions and the promotion and implementation of the Drug Administration Act and Vaccine Administration Act.Based on status of the institutional functions transformation and being promoted would achieved optimization&upgrade and served the regulatory process through the interactive effects between the drug supervision process and informatization.Above all,the author discussed the dual life cycle management between regulatory business and information construction,and the system arrangements among the regulatory information construction and functional transformation.Then the paper analyzed the supervision process,information technology,and data elements during the drug supervision information construction,proposed a positive feedback mechanism for the full life cycle management between supervision business and information construction.Finally the paper summarized the development path of drug supervision information,in order to provide reference and decision-making reference.
作者
杜学礼
程婕
王广平
DU Xueli;CHENG Jie;WANG Guangping(Shanghai University of Medicine & Health Science, Shanghai 201318, China;Scientific and Technical Institude of Shanghai Municipal Food and Drug Administration, Shanghai 200233, China;Shanghai Institute for Food and Drug Safety, Shanghai 200233, China)
出处
《中国医药导刊》
2021年第1期54-59,共6页
Chinese Journal of Medicinal Guide
基金
2020年度浙江省哲学社会科学规划课题(项目编号:20NDJC221YB,项目名称:大数据战略下浙江省药品高质量发展协同共治路径研究)
2020年度中国药品监督管理研究会资助项目(项目名称:药品安全风险预警大数据决策模型设计和方法学研究)。
关键词
药品监管
信息化
正向反馈
全生命周期管理
业务流程
Drug supervision
Informatization
Positive feedback
Life cycle management process
