ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals

Current effective version

PDF iconRegulatory notice

Reference numberEMA/CHMP/ICH/536328/2013 Rev. 1
Published02/03/2016
KeywordsRodent carcinogenicity testing, animal testing
DescriptionThis document concerns the need for a change to current ICH S1 guidance on rodent carcinogenicity testing. The potential change intends to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals. It also aims to define conditions under which 2-year rat carcinogenicity studies add value to that assessment.


Related content


How useful was this page?

Add your rating