欧盟药品质量规制体系对我国的启示*

摘要

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.%　　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。