Registration of pharmaceuticals requires a comprehensive assessment of their genotoxic potential as required by the ICH. Based on these regulations, a battery of in vitro and in vivo tests for genotoxicity are mandatory when testing new drugs both in bacteria and mammalian cells (in vitro and in vivo). 

These determinations are part of the regulatory toxicology package necessary during the progress of drug development to demonstrate their safety regarding gene mutations and effects of clastogens and anuegens in genetic material.