EU Perspective on ICH

Abstract

This chapter is considering ICH I in the context of the EU regulatory perspective, starting with a history of ICH in 1989, a time when the EU was pioneering a single pharmaceutical market in the EU. One major achievement of ICH, the agreed Common Technical Document for regulatory submission, is described in detail. Furthermore, the chapter explains how the ICH guidelines are implemented by the European Medicines Agency in the EU regulatory system. Given the fact that ICH has already a 20-year history, this chapter also elaborates on how important it is to maintain the guidelines, once adopted, by revising them or complementing them with addendums and/or questions and answers document updates based on new science or to ensure harmonised implementation. Finally, the chapter describes the efforts of ICH to provide training to developing countries, newly instituting their own pharmaceutical regulations and guidance, and to reach out beyond the EU, Japan and the USA and encompass new regions which have become important in drug development since the formation of ICH.