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.
出处
《上海医药》
CAS
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)
关键词
药品质量规制体系
政策法规
执法机构
执法能力
pharmaceutical quality regulation systems
policy and regulation
law enforcement agency
law enforcement capacity
