通用技术文档格式申报资料中非临床研究资料的撰写  

Writing of nonclinical research data in common technical document format dossier of pharmaceutical products

作　　者：周恒 戴学栋 翟云 肖芳 谢松梅 孙涛 ZHOU Heng;DAI Xue-dong;ZHAI Yun;XIAO Fang;XIE Song-mei;SUN Tao(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2022年第23期2365-2368,共4页Chinese Journal of New Drugs

摘　　要：为提高药品注册申报资料中非临床研究资料的撰写质量,推进我国药品研发和监管的全球化,本文从审评角度探讨了国际人用药品注册技术协调会(ICH)《M4:人用药物注册申请通用技术文档(CTD)》中非临床研究资料的组织和撰写要求,并对CTD格式模块2中的非临床综述和总结(2.4和2.6)撰写要求及审评关注点进行了解读和分析,供业界参考。This paper discusses how to organize the non-clinical research data according to the format of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)M4 Common Technical Document(CTD).We interprets and analyzes the writing requirements of nonclinical overview and summaries(2.4 and 2.6)in the module 2 of CTD format.It is hoped to improve the quality of nonclinical research data in drug registration,so as to promote the globalization of China’s new drug research&development and drug administration.

关 键 词：通用技术文档 非临床 综述 总结 药品注册 

分 类 号：R95[医药卫生—药学]