30 April 2018

The ICH S9 Q&As on Nonclinical Evaluation for Anticancer Pharmaceuticals reached Step 4 of the ICH Process in April 2018 and now enters into the implementation period (Step 5).

This new Q&As is proposed to facilitate the implementation of the ICH S9 Guideline on Nonclinical Evaluation for Anticancer Pharmaceuticals by clarifying the scope of the ICH S9 Guideline as well as promoting a consistent interpretation and implementation by ICH Members and Observers countries/regions and, of additional benefit, to continue progress in the 3Rs of reduction, refinement, and replacement.

The ICH S9 Q&As is available for download on the Safety Guideline page of the ICH website.