ICH S9: Nonclinical Evaluation of Anticancer Pharmaceuticals: A Perspective from Regulators on the Development of the Guideline

The development of a guideline for nonclinical testing strategies for anticancer drugs and biologicals was initiated by the International Conference on Harmonisation (ICH) in 2007. The rationale for developing this guideline was that separate regional guidelines were being or had been developed. By nature, ICH guidelines tend to describe regulatory recommendations rather than the underlying rationale of the recommendations. The purpose of this chapter is not to discuss the document per se but to describe the perspective of regulators on some of the topics discussed during the deliberations in developing the ICH S9 guideline, focusing on major changes to drug development compared to past practices, and to illustrate the principles underlying the recommendations and alternative views that were considered.