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

  • Email
  • Help
Current effective version

Regulatory notice

Reference numberEMA/CHMP/ICH/536328/2013 Rev. 1
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 helpful is this page?

Average rating:

 Based on 41 ratings

Add your rating:

See all ratings
8 ratings
8 ratings
9 ratings
8 ratings
8 ratings

Tell us more