FDA与EMA关于化学药申请Ⅰ期临床试验相关药学质量文件要求简介

Introduction of the quality documentation requirements on investigational new drug applications for phase 1 studies of drugs in FDA and EMA

FDA与EMA先后颁布了关于临床试验申请申报资料技术要求的指导原则,本文主要介绍其中关于新药I期临床试验申请药学研究技术要求的相关内容,期望能对相关工作提供参考和借鉴,以加速我国创新药进入临床试验的时间。

Guidelines on the requirements to the pharmaceutical quality documentation of investigational medicinal products in clinical trials are issued by FDA and EMA.In this paper,we discribed main contents of the quality documentation requirements concerning investigational new drug applications for phase 1 studies of drugs.It would like to work a source of inspiration,and will help expedite entry of new drugs into clinical testing.