Overview on the Amendments of Provisions for Drug Registration in China
Overview on the Amendments of Provisions for Drug Registration in China
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DOI：
10.1002/jcph.1700
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发表时间：
2021-01-01
影响因子：
2.9
通讯作者：
Su, Ling
中科院分区：
文献类型：
--
作者：
Dai, Weijun;Zhong, Mingru;Su, Ling
修订后的《药品注册管理规定》由国家市场监管总局中国于2020年3月公布，并于2020年7月1日起施行。介绍了中国药品注册管理制度的历史沿革，说明了2020年修订《药品注册规定》的背景，介绍了2020年《药品注册规定》在注册分类、药品临床试验申请、药品上市许可申请、药品注册加速程序、工作时间表、监督管理等方面的主要修改情况。本文旨在为那些希望在中国提交药品注册申请的人或那些想要更多地了解中国药品注册的人提供一个简要的概述。
The revised Provisions for Drug Registration was promulgated by the State Administration for Market Regulation of China in March 2020 and came into force on July 1, 2020. This article describes the history of the drug registration management system in China, explains the background of the revision of the Provisions for Drug Registration in 2020, and introduces the main modifications of the Provisions for Drug Registration in 2020 in the aspects of registration classification, application for clinical trial on drug, application for drug marketing authorization, accelerated procedure for drug registration, working timeline, and supervision and administration. This article is intended to give a brief overview for those who wish to submit a drug registration application in China or for those who would like to get more acquainted with drug registration in China.