Overview of ICH E18 Guideline

Abstract

Genomic data that are obtained from clinical studies could be used in various ways, such as, optimization of patient therapy by the identification of genomic biomarker underlying variability in drug response, and the identification of new drug targets by a better understanding of pharmacological and pathological mechanisms. There was no harmonised International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on genomic sampling and data management from clinical studies at that time. Thus, “ICH E18: Guideline on genomic sampling and management of genomic data” has been developed to foster interactions amongst stakeholders and to encourage genomic research in clinical studies. In this article, we present an overview of the ICH E18 guideline and a development process of this guideline from standpoint as regulatory members in the Expert Working Group.