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 2-yr rodent carcinogenicity studies add value to that assessment.
Document details
| Download document | Draft International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline S1 – Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals |
|---|---|
| Reference number | EMA/CHMP/ICH/752486/2012 |
| Status | draft: consultation open |
| First published | 17/12/2012 |
| Last updated | 17/12/2012 |
| Consultation start date | 17/12/2012 |
| Consultation end date | 01/04/2013 |
| Email address for submissions | ich@ema.europa.eu |