This guideline provides advice on the viral safety data and documentation that should be submitted in a request for authorisation of a clinical trial of a human biotechnological medicinal product. The guideline provides for a harmonised approach throughout the European Union, for both sponsors and regulators, with regard to the assessment of viral safety of biotechnological IMPs during clinical development. This will be especially beneficial for multi-centre studies, potentially involving several different member states.
This guideline applies to human biotechnological IMPs prepared from cells cultivated in vitro from characterised cell banks of human or animal origin as described in Q5A. Many IMPs are derived from well-characterised rodent cell lines such as CHO, NS0 or SP2/0, although a variety of other cell lines are in use and under development and should be considered on a case-by-case basis.