Overview of ICH S9 Q & As

Abstract

ICH S9 guideline provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options.“Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals (ICH S9 Q & As)”has developed to add precise and concrete explanation on issues which have been interpreted differently among regulatory agencies, or between such agencies and sponsors, in the operation of the guideline. In this article, we describe an overview of the ICH S9 Q & As and the process of their development, from the standpoint of regulatory members of the ICH S9 Q & As Implementation Working Group.