International Conference on Harmonisation; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability--FDA. Notice

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.

MeSH terms

  • Animals
  • Biological Products / standards*
  • Biotechnology / legislation & jurisprudence
  • Biotechnology / standards*
  • Cell Line / pathology
  • Drug Approval / legislation & jurisprudence*
  • Drug Contamination
  • Guidelines as Topic
  • Humans
  • United States
  • United States Food and Drug Administration
  • Viruses


  • Biological Products