• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2020, Vol. 37 ›› Issue (6): 405-410.

• 理论与方法前沿 •    下一篇

博弈论视角下仿制药一致性评价中制药企业与监管者的决策行为研究

李勇,邢影影   

  1. 中国药科大学国际医药商学院,江苏 南京 211198
  • 收稿日期:2020-05-28 修回日期:2020-06-23 出版日期:2020-12-28 发布日期:2020-12-28
  • 基金资助:

    国家药品监督管理局信息中心委托课题项目(项目名称:我国仿制药一致性评价执行影响因素及对策研究 );

     教育部人文社会科学研究青年基金项目(项目编号:19YJC790070;项目名称:促进我国分级诊疗制度建设的医疗资源合理配置改革路径研究); 

    江苏省高校哲学社会科学指导项目(项目编号:2017SJB0052;项目名称:促进江苏分级诊疗制度建设的医保支付改革研究)

Game Analysis on Consistency Evaluation of Generic Drugs Between Generic Drug Manufacturers and Government Regulators

 LI Yong, XING Ying-ying   

  1. International Pharmaceutical Business School of China Pharmaceutical University, Jiangsu Nanjing 211198, China
  • Received:2020-05-28 Revised:2020-06-23 Online:2020-12-28 Published:2020-12-28
  • Contact: Yong Li E-mail:Lsyg168@163.com
  • Supported by:

摘要: 仿制药质量和疗效一致性评价是当前乃至今后相当长一段时期内我国仿制药企业所要面临的重要课题。近年来,监管部门为提高仿制药质量出台了多项政策,而政策执行效果好坏取决于各利益相关者的决策行为及其相互影响。本文基于博弈论的基本方法和工具,对一致性评价工作开展前、后,制药企业与监管部门之间的决策行为进行理论探讨和分析,并以此为依据提出针对性的政策建议。
    

关键词: font-size:medium, ">仿制药一致性评价;制药企业;监管部门;博弈论

Abstract: The consistency evaluation of quality and efficacy of generic drugs is an important issue facing China′s generic drug industry for a long time. Although in recent years, the relevant government departments have issued many relevant policies, the effect of these policies depends largely on the decision-making behavior of various stakeholders and their mutual influence in the process of consistency evaluation. There are two categories of most direct stakeholders: generic drug manufacturers and government regulators. The decision-making behavior and results of these two will directly affect the effects of the consistency evaluation policies. Based on the methods and tools of game theory, the paper discusses and analyzes the relationship between generic pharmaceutical manufacturers and government regulators before and after the consistency evaluation, and puts forward some suggestion.
    

Key words: font-size:medium, ">Consistency evaluation of generic drugs;Generic drug manufacturers;Government regulators;Game theory

中图分类号: