我国药品管理部门间协调关系网络特征与优化路径  

The Features and Optimization Path of Coordination Relationship Network among Chinese Drug Administration Departments

作　　者：王广平 Wang Guangping(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,Shanghai 200040,China)

机构地区：[1]上海市药品和医疗器械不良反应监测中心,上海200040

出　　处：《中国药事》2023年第2期123-133,共11页Chinese Pharmaceutical Affairs

基　　金：国家市场监督管理总局2021年度政策研究课题(编号202104);中国药品监督管理研究会2022年度研究课题(编号2022-Y-012)。

摘　　要：目的:为解决药品监管领域的产品结构和治理结构复杂性问题,尝试构建跨部门、跨领域、跨区域乃至跨国的协调机制。方法:采用霍尔(Hall)三维空间结构系统工程方法分析药品管理部门协调制度安排,采用社会网络分析方法(SNA)分析药品管理协调关系网络。结果:药品监管部门间协调机制的制度安排可分为法律制度、规划发展和协调组织的三维框架结构。基于药品监管部门间协调机制的法律法规、部际联席会议和区域协同规划的社会网络实证分析(SNA),数据显示:8部产品法律法规中,药品监管与卫生健康两部门为核心部门,与相关部门关系紧密;36项部际联席会议制度中,发展改革、市场监管和卫生健康等部门为核心协调部门,药品监管、公安和海关等部门为重要部门,药品监管和卫生健康的K-neighbours、Closeness值相等并有相同的需要协调部门数。结论:运用药品监管部门间协调政策工具,例如政府流程再造、绩效考评、规划实施和国际合作等,可优化部门间协调机制,推进药品监管质量管理规范(GRP)建设和产业高质量发展。Objective:It required the establishment of a coordination mechanism for cross-departmental,crossfi eld,cross-regional and cross-country based on the complexity of product structure and governance structure among drug regulation fi eld.Methods:System engineering method of Three-Dimensional spatial Structure of A.D.Hall was used to analyze the coordination system arrangement of drug management departments,and Social Network Analysis(SNA)method was used to analyze the coordination relationship network of drug management.Results:The institutional arrangement of the coordination mechanism among drug regulatory departments could be divided into a three-dimensional framework structure of the regulation system,planning development and coordination organization.Based on the Social Network Analysis(SNA)of laws and regulations of coordination mechanism among the drug regulatory departments,inter-ministerial joint meeting,and regional collaborative planning,the data shows that among the eight product laws and regulations,the drug regulatory and health department are the core departments with close relationship with relavant departments.The development&reform commission,market administration and health department are the core departments among the 36 inter-ministerial joint neeting,the drug supervision,the Ministry of Public Security and the General Administration of Customs are important departments.The K-neighbours value and closeness value of the drug administration and health department are equal,which have the same number of departments that need to be coordinated.Conclusion:The policy tools for inter-regulatory coordination,such as the government process reengineering,performance appraisal,planning implementation,and international cooperation were used to optimize the inter-departmental coordination mechanism,and promote the establishment of Good Drug Regulatory System(GRP)and the high-quality development of the industry.

关 键 词：药品监管 部门间 协调关系网络 联席会议 社会网络分析(SNA) 

分 类 号：R95[医药卫生—药学]