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.
作者
陈震
胡蓓
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)
出处
《现代药物与临床》
CAS
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
关键词
ICH
E系列
技术指导原则
对比研究
问卷调查
ICH Efficacy Guidelines
technical guidelines
comparative study
questionnaire survey
