我国实施ICHE系列技术指导原则的策略研究  

Strategic research on implementation of ICH Efficacy Guidelines in China

作　　者：陈震 胡蓓[3] 杨建红 韩鹏 张彦彦 马玉琴 陈宁 张象麟 CHEN Zhen;HU Bei;YANG Jian-hong;HAN Peng;ZHANG Yan-yan;MA Yu-qin;CHEN Ning;ZHANG Xiang-lin(Institute of Drug Discovery and Development,Zhengzhou University,Zhengzhou 450001,China;School of Yeehong Business,Shenyang Pharmaceutical University,Beijing 100027,China;Clinical Pharmacology Research Center,Peking Union Medical College Hospital,Beijing 100032,China)

机构地区：[1]郑州大学药物研究院,河南郑州450001 [2]沈阳药科大学亦弘商学院,北京100027 [3]北京协和医院临床药理研究中心,北京100032

出　　处：《现代药物与临床》2018年第9期2455-2460,共6页Drugs & Clinic

基　　金：国家食品药品监督管理总局药化注册司资助项目

摘　　要：通过对ICH E系列指导原则与我国对应技术指导原则的对比研究,分析我国与ICH在药品注册临床技术要求方面的主要差异。通过对公众、专家、企业进行问卷调查,摸清ICH E系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上,结合ICH的要求,提出ICH E系列指导原则在我国实施的建议。Through the comparative study of ICH Efficacy Guidelines and corresponding Chinese technical guidelines, the main differences in clinical technical requirements for drug registration between China and ICH are analyzed. Through questionnaire survey to the public, experts, and enterprises, the cognition and implementation basis of ICH Efficacy Guidelines in China are found out. On the basis of comparative study and questionnaire survey, combined with the requirements of ICH, the implementation proposals of ICH Efficacy Guidelines in China are put forward in this paper.

关 键 词：ICH E系列 技术指导原则 对比研究 问卷调查 

分 类 号：R913[医药卫生—药学]