Fed Regist. 1998 Sep 24;63(185):51074-84.
The Food and Drug Administration (FDA) is publishing a guidance entitled "Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin, and outlines data that should be submitted in marketing applications.
美国食品药品监督管理局（FDA）正在发布一份题为《源自人或动物源细胞系的生物技术产品的病毒安全性评估》的指南。该指南是在人用药品注册技术要求国际协调会议（ICH）的主持下制定的。该指南描述了源自人或动物源特定细胞系的生物技术产品的病毒安全性检测和评估，并概述了在上市申请中应提交的数据。
