摘要
基于近年来对于中医药治疗肿瘤作用特点的认识转变,2002年颁布的《中药新药临床研究指导原则》已不能完全适应现代中药新药的研究。2012年4月国家食品药品监督管理总局药品审评中心正式启动了《中药新药治疗恶性肿瘤临床研究技术指导原则》修订工作,现历经3年,通过专家问卷调查、专家论证会、上网公示等形式广泛征询了中、西医肿瘤专家意见,达到了现阶段专家共识,完成了《中药新药治疗恶性肿瘤临床研究技术指导原则》修订工作,并于2015年11月由国家食品药品监督管理总局对外公布。为了更深入了解该原则的指导意义,现将起草背景、关键技术及要点进行了解析。
Based on the new understanding of efficacy of traditional Chinese medicine（ TCM） on cancer treatment in recent years,clinical research guiding principles of new TCM drugs promulgated in 2002 could not completely adapt to the modern research and development of new drugs. In April 2012,the drug approval center of China Food and Drug Administration（ CFDA） launched the revision work of＂Clinical Trial Guideline for New TCM Drugs in Cancer Treatment＂. During the past three years,through expert questionnaire survey,expert consultation meeting,and online public consulting,we widely solicited opinions from cancer experts of Chinese and western medicine and reached consensus. The revised Clinical Trial Guideline for New TCM Drugs in Cancer Treatment has been completed and released by CFDA in November 2015. In order to further understand the significance of the guideline,we introduced the background,key technology,and key points of this guideline in this paper.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第16期1833-1837,共5页
Chinese Journal of New Drugs
