Division 5.2.4 Cell culture studyF1

This information must be reported for intracellular replicating micro-organisms, such as viruses, viroids or specific bacteria and protozoa, unless the information from Sections 1, 2 and 3 clearly demonstrates that the micro-organism does not replicate in warm-blooded organisms. A cell culture study shall be performed in human cell or tissue cultures of different organs. Selection can be based on expected target organs after infection. If human cell or tissue cultures of specific organs are not available, other mammal cell and tissue cultures can be used. For viruses, the ability to interact with the human genome is a key consideration.