欧盟药品质量规制体系对我国的启示  

The pharmaceutical quality regulation systems in European Union and its inspirations

作　　者：杨菲[1] 邵蓉[1] 

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《上海医药》2013年第11期54-57,共4页Shanghai Medical & Pharmaceutical Journal

基　　金：2011年度国家社会科学基金项目"药品质量规制视角下的药品监管法实施效果研究"(项目编号:11BFX098)

摘　　要：在规制相关理论的基础上,运用对比研究方法从政策、法规、执法机构和执法能力3个方面分析我国药品质量规制体系与欧盟的差异。完善我国药品质量规制体系需进一步明确相关法律框架,保障执法机构的独立性,保持与公众的信息对称,并提高执法者的综合能力。Based on the theory of regulation, the differences in the regulation systems of pharmaceutical quality between China and European Union were analyzed in three parts including the policies , regulations and the agencies and capacity of law enforcement. It is necessary to further clear the legal framework, protect the independence of law enforcement agencies, ensure the symmetry of information with the public and improve the ability of law enforcement so as to enhance the pharmaceutical quality regulation systems in China.

关 键 词：药品质量规制体系 政策法规 执法机构 执法能力 

分 类 号：F416.72[经济管理—产业经济] F203