Viral Safety Perspective from the Paul-Ehrlich-Institut in Europe

References

1. 1.↵
   EU. Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001. European Parliament and the Council of the European Union, Luxembourg, 2001.
2. 2.↵
   EMEA. EMEA/CHMP/BWP/398498/2005: Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products. Committee for Medicinal Products for Human Use, Biologics Working Party: London, 2008.
3. 3.↵
   ICH. Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origen. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 1999.
4. 4.↵
   CPMP. CPMP/BWP/268/95: Note for guidance on virus validation studies: The design, contribution, and interpretation of studies validating the inactivation and removal of viruses, revised. Committee for Proprietary Medicinal Products: London, 1996.