法国与加拿大药品监管机构设置与启示

France and Canada Drug Regulatory Agencies and Implication

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。

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