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中日药品数据保护制度的比较研究

庞晓丛,杜冠华,刘艾林   

  1. 中国医学科学院 北京协和医学院药物研究所 北京 100050,中国医学科学院 北京协和医学院药物研究所 北京 100050,中国医学科学院 北京协和医学院药物研究所 北京 100050
  • 收稿日期:2015-11-16 修回日期:2015-12-10 出版日期:2016-02-25 发布日期:2016-01-25
  • 基金资助:
    十二五重大新药创制项目 (2012ZX09304003-003;项目名称:新药信息化技术平台研究-新药研发政策库建设)

Comparative Study on Pharmaceutical Data Protection System of China and Japan

杜冠华 and 刘艾林   

  1. Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,,Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College
  • Received:2015-11-16 Revised:2015-12-10 Online:2016-02-25 Published:2016-01-25

摘要: [摘 要]中国正式加入世界贸易组织(WTO)之后,依照TRIPS 协议相关规定实行药品数据保护,但是目前我国在药品数据保护制度方面还有许多不完善之处。日本医药产业的迅速崛起,与该国医药产业相关政策的实施密不可分,尤其是日本的药品再审查政策不仅在鼓励企业创新方面发挥作用,同时有效地减轻了数据保护的负面效应。本文通过中日药品数据保护制度的比较研究,发现我国在药品数据保护过程中的不足之处,为我国进一步完善数据保护制度提供借鉴和参考。

Abstract: [Abstract]After joining World Trade Organization(WTO), the Chinese government carried out pharmaceutical data protection under the TRIPS agreement, but there are still some deficiencies in the pharmaceutical data protection system of China. The rapid progress in the pharmaceutical industry of Japan was tightly related to the implement of pharmaceutical industry related polices, the re-investigation policy of post-marketing drugs in Japan not only played an important role in stimulating the initiatives of drug research companies, but also effectively weakened the side effects of the data protection system. By comparative study on pharmaceutical data protection system of China and Japan, this paper aims to find out the shortcomings existing in the process of the pharmaceutical data protection in China and provide some feasible suggestion for the further improvement of Chinese pharmaceutical data protection system.