中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2014年
20期
5-7
,共3页
欧盟%质量受权人制度%申请%资质
歐盟%質量受權人製度%申請%資質
구맹%질량수권인제도%신청%자질
European Union%system of quality authorized person%apply%qualification
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。
目的：為推動我國質量受權人製度髮展提齣閤理化建議。方法採用對比分析法，研究中國與歐盟質量受權人製度的差異。結果中國質量受權人製度與歐盟相比仍存在諸多不足，如概唸模糊、法律地位不明確、缺乏支撐體繫等。結論我國仍需從完善法律法規體繫、推行質量受權人審批製及建立支撐體繫方麵加以完善。
목적：위추동아국질량수권인제도발전제출합이화건의。방법채용대비분석법，연구중국여구맹질량수권인제도적차이。결과중국질량수권인제도여구맹상비잉존재제다불족，여개념모호、법률지위불명학、결핍지탱체계등。결론아국잉수종완선법율법규체계、추행질량수권인심비제급건립지탱체계방면가이완선。
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.
