摘要
2022年1月21日我国正式适用ICH E9(R1)。本文对E9(R1)的基本背景和主要内容以及我国在适用E9(R1)前所开展的准备工作进行了简要介绍,并从监管机构的角度着重阐述了对适用E9(R1)的初步考虑,为在我国开展的药物临床试验适用该指导原则提供参考。
ICH E9(R1)was officially implemented in China on January 21,2022.This paper briefly introduces the background and main contents of E9(R1)and the preparatory work carried out in China before the implementation of E9(R1),and discusses the preliminary considerations of implementing E9(R1)from the perspective of drug regulators,so as to inform clinical trials conducted in China following this guideline.
作者
李新旭
周军
唐智敏
卢明亮
谭明敏
王景朝
LI Xin-xu;ZHOU Jun;TANG Zhi-min;LU Ming-liang;TAN Ming-min;WANG Jing-zhao(Center for Drug Evaluation,National Medical Products Administration)
出处
《中国食品药品监管》
2022年第5期40-47,共8页
China Food & Drug Administration Magazine
关键词
E9(R1)
技术审评
监管考虑
E9(R1)
technical review
regulatory considerations
