关于中药新药研发创新的几点思考  

Considerations on the research and development of new drug innovation from traditional Chinese medicine

作　　者：张晓东[1] 王海南[2] 张磊[1] 

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100038 [2]国家食品药品监督管理局药品注册司,北京100053

出　　处：《中国新药杂志》2011年第23期2308-2312,共5页Chinese Journal of New Drugs

摘　　要：基于对近年来中药新药研发和注册申请状况的回顾分析,从中药新药技术审评和注册管理的视角,阐述了对"中药新药研发创新"议题的若干观点。包括对中药新药研发创新内涵的理解,对中药新药研发创新具体形式的认识,以及对当前中药新药研发创新方面存在问题的剖析等。The authors expounded their considerations on the issue ＂research and development of new drug innovation from traditional Chinese medicine （TCM）＂. These considerations are based on the perspective of new drugs evaluation, registration management, and the status of development and registration applications of new drugs from TCM in recent years. The specific forms of new drugs development innovation and the existing problems were also analyzed.

关 键 词：新药 研发 创新 中药 

分 类 号：R95[医药卫生—药学]