Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products

July 10, 2006

London, 07 Jul 2006

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The purpose of this document is to provide scientific guidance relating to the viral safety of biotechnological medicinal products used in clinical trials. Guidance is provided with respect to:

  • the criteria for and the extent of viral safety evaluation studies, especially validation studies, that are required prior to and during clinical development.

  • the extent to which manufacturers are able to refer to in-house experience concerning virus safety evaluation.

  • the risk assessment which should form part of the safety evaluation.


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    European Agency for the Evaluation of Medicinal Products - EMEA

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