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

This 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.

Keywords: Rodent carcinogenicity testing, animal testing

Current effective version

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

Adopted Consultation dates: 17/12/2012 to 01/04/2013 Reference Number: EMA/CHMP/ICH/536328/2013 Rev. 1 Summary:

A change to the current ICH S1 guidance on rodent carcinogenicity testing is being considered. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which two-year rodent carcinogenicity studies add value to that assessment.

Document under consultation

Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals - Step 2b

Draft: consultation closed Consultation dates: 22/04/2021 to 22/10/2021 Reference Number: EMA/CHMP/ICH/272147/2021