中国药物警戒 ›› 2013, Vol. 10 ›› Issue (3): 536-539.

• 政策与法规研究 • 上一篇    

法国与加拿大药品监管机构设置与启示

张昊1,董铎2,程刚2   

  1. 1.沈阳药科大学工商管理学院,辽宁沈阳110016,2国家食品药品监督管理总局药品评价中心,北京100045
  • 收稿日期:2013-08-12 修回日期:2016-03-09 出版日期:2013-09-08 发布日期:2016-03-09
  • 作者简介:张昊,男,在读博士,药事管理。

France and Canada Drug Regulatory Agencies and Implication

ZHANG Hao1, DONG Duo2, CHENG Gang2*   

  1. 1.School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    2.Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2013-08-12 Revised:2016-03-09 Online:2013-09-08 Published:2016-03-09

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摘要： 药品监管机构是实施市场监管的主体,其设置模式与监管组织体系直接影响着政府监管的效率和药品市场的发展活力。本文以法国与加拿大的药品监管机构为研究对象,通过查阅两国药品监管官方网站和相关文献,对药品监管局的责任主体、组织机构和监管人员等方面进行了归纳总结,并与我国药监机构设置与职能进行了深入的比较,为我国药品监管体系的建设与发展提供了意见与建议。

关键词: 法国, 加拿大, 药品监管机构, 启示

Abstract: Drug regulatory agency is the main body of implementing market regulation, the setting pattern and organizational system directly affects the efficiency of government regulation and the development of the pharmaceutical market's vitality. In this article France and Canada drug regulatory agencies were selected the research object. By searching their drug regulatory official websites and related literatures, we summarized the main responsibility of the drug administration, organization and supervisor and compared with drug regulatory institution setting and function of our country. The comments and suggestions were put forward for the construction and development of China's drug regulatory system.

Key words: France, Canada, regulatory agency, implication

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