对药用辅料与药品关联审评审批申报资料要求的解读与思考  

Interpretation and thinking of contents of the application dossier for evaluation and approval of pharmaceutical excipients associated with drug products

作　　者：任连杰[1] 马玉楠[1] 蒋煜[1] 张凌超 

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100038 [2]国家食品药品监督管理总局药品化妆品注册管理司,北京100053

出　　处：《中国新药杂志》2017年第18期2128-2135,共8页Chinese Journal of New Drugs

摘　　要：通过对国内外药用辅料注册申报资料要求的梳理分析,对国家食品药品监督管理总局发布的药用辅料与药品关联审评审批申报资料要求(总局通告2016年155号附件2)进行详细解读,并对相关管理模式、尚需解决的问题以及未来的发展要求提出思考。Based on summaries and analyses of the contents of application documents of pharmaceutical excipients both in China and some developed countries,the contents of the application dossiers for evaluation and approval of pharmaceutical excipients associated with drug products were interpreted in depth. The administration modes,issues to be solved and future development of industries were also discussed.

关 键 词：药用辅料 关联审评 申报资料 

分 类 号：R95[医药卫生—药学]