临床试验中生物研究用药物质量文件要求指南

摘要

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials was issued by European Medicines Agency (EMA) in 2010. In this paper, we mainly described the information on the biological, chemical and pharmaceutical quality concerning biological investigational medicinal products in clinical trials. Researchers should use the common technical document format to do a detailed description for each part, and put forward a clear technical requirements.%欧洲药品管理局(European Medicines Agency,EMA)于2010年发布了临床试验中生物研究用药物质量文件要求指南.参考该指南,本文主要就生物研究用药物在临床试验申请中的生物学、医学和药学质量文件要求的相关内容做了简要介绍,采用通用技术文件格式对各部分内容做了较为详细的阐述,并提出了明确的技术要求.