中国与欧盟质量受权人制度比较及其启示  

Comparison of Quality Authorized Person System between China and European Union and Its Enlightenment to Our Country

作　　者：陈永法[1] 杜一坤[1] 

机构地区：[1]中国药科大学国际医药商学院,江苏南京211198

出　　处：《中国药业》2014年第20期5-7,共3页China Pharmaceuticals

摘　　要：目的为推动我国质量受权人制度发展提出合理化建议。方法采用对比分析法,研究中国与欧盟质量受权人制度的差异。结果中国质量受权人制度与欧盟相比仍存在诸多不足,如概念模糊、法律地位不明确、缺乏支撑体系等。结论我国仍需从完善法律法规体系、推行质量受权人审批制及建立支撑体系方面加以完善。Objective To propose the rationalization proposal for promoting the development of the quality authorized person system. Methods The differences in the quality authorized person system between China and Europe were studied by adopting the comparative analysis method. Results Many disadvantages still existed in the quality authorized person system of China,such as the ambiguous con-cept,the undefined legal status and the lack of support system. Conclusion The laws and regulations system is still perfected in china, which are perfected in the aspects of the examination and approval system of the quality authorized person and the establishment of support system.

关 键 词：欧盟 质量受权人制度 申请 资质 

分 类 号：R954[医药卫生—药学]