12 July 2016

The Questions and Answers Document of the ICH S9 Guideline on Non Clinical Evaluation for Anticancer Pharmaceuticals reached Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). 

The ICH S9 Q&As are intended to facilitate the implementation of the S9 Guideline clarifying its scope as well as its interpretation and implementation. 

The draft S9 Q&A document is available for download on the Safety Guideline page on the ICH website. You are invited to provide comments on the draft S9  Q&A document by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, USA, Japan, Canada and Switzerland are encouraged to submit their comments to their respective Regulatory Authorities.