14 May 2012

In April 2012, the Steering Committee approved the S1 Concept Paper and Business Plan proposing to develop new guidance on rodent carcinogenicity testing. The aim of this new topic is to introduce a more comprehensive and integrated approach to addressing the risk of human carcinogenicity of pharmaceuticals, and also to clarify and update, without compromising safety, the criteria for deciding whether the conduct of a two-year rodent carcinogenicity study of a given pharmaceutical would add value to this risk assessment.

For more details, see the S1 Concept Paper and Business Plan on the Safety Guideline page.