药品生产企业资源重组视角下的新版GMP政策转型升级建议  

Suggestions on improving the current GMP for more efficient resources restructuring in pharmaceutical manufacturing enterprises

作　　者：陈名[1] 颜建周[1] 邵蓉[1] 

机构地区：[1]中国药科大学医药产业发展研究中心,南京211198

出　　处：《中国药科大学学报》2014年第3期373-377,共5页Journal of China Pharmaceutical University

摘　　要：从药品生产企业资源重组角度,进行新版GMP实施存在问题及原因分析,结合我国国情,针对大型、中型和小型3种不同规模药品生产企业,围绕上市许可人制度和委托生产,提出GMP政策转型升级的相关建议。This paper analyzes the problems in the implementation of current GMP in China, and offers some suggestions on improving it for more efficient resources restructuring in pharmaceutical manufacturing enterprises. Focusing on marketing authorization holder mechanism and the commissioned production approach, the paper proposes specific strategies for upgrading the GMP system to improve the efficiency of resources restructuring in the large-, medium- and small-scale enterprises.

关 键 词：资源重组 GMP 上市许可人制度 委托生产 技术转让 

分 类 号：R95[医药卫生—药学]