International scientific guidelines: CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment
CPMP/SWP/2592/02 Rev 1 adopted by the Therapeutic Goods Administration (TGA)
Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.