ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline

Guidance on approaches for evaluating the carcinogenic potential of pharmaceuticals. It embraces all pharmaceutical agents that need carcinogenicity testing as indicated in the ICH S1A.

Keywords: Carcinogenic potential, long-term carcinogenicity study, rodent carcinogenicity studies, short or medium-term carcinogenity test, mechanistic studies, choice of species

Current effective version

ICH S1B(R1) Guideline on testing for carcinogenicity of pharmaceuticals Step 5

Adopted Reference Number: EMA/774371/2022 Legal effective date: 16/03/2023

Document history

ICH: S 1 B: Testing for carcinogenicity of pharmaceuticals - Step 5

Adopted Reference Number: CPMP/ICH/299/95 Legal effective date: 01/03/1998

Overview of comments received on Addendum to the ICH guideline S1B on testing for carcinogenicity of pharmaceuticals (EMA/CHMP/ICH/272147/2021)

Reference Number: EMA/628493/2021

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