Recent Trends in New Topic Discussion of ICH Guidelines and Challenges for the Future, from Industry Perspectives

Abstract

In October 2015, the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation that was set up in 1990, established the ICH association, a legal entity under Swiss law, aiming for further expansion of ICH membership and global outreach for implementation of ICH guidelines. Given its successful track record of delivering more than 80 harmonized guidelines, development of harmonized guidelines continues to be the central role of the ICH. At the same time, almost all major topics for ICH guidelines have been covered, and with the growing diversity of the ICH membership their delivery is considered to become more challenging in the future. This article summarizes a process for new topic proposal and selection, and discusses the issues and future challenges surrounding new ICH topics by touching on the recent trends from the ICH Osaka meeting in November 2016. In that meeting, for the first time the ICH adopted a “strategic theme” to handle multiple guideline developments in a comprehensive manner. Along with planned “strategic themes,” new topic discussions are expected to arise in the future ICH. Considering this situation as a new opportunity, we believe that 1) facilitating dialogue between various stakeholders and 2) well-planned identification of, and training for advanced technical experts would be important in order to develop and implement effective ICH guidelines which facilitate delivery of new medicines for patients around the world. International harmonization starts with people; we believe this concept would trigger further enhancement of multiple platforms across the stakeholders which may lead to more ICH guidelines originating from Japan.