The International Council for Harmonisation: Positioning for the future with its recent reform and over 25 years of harmonisation work

Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, also known as “ICH”, is a key international harmonisation initiative founded by the drug regulatory authorities and industry associations from the European Union, Japan and the United States of America. The main objective of ICH is to promote public health globally through the development and implementation of harmonised guidelines and standards. With its recent reform, ICH became an Association under Swiss law, and set the stage to broaden its membership to regulatory authorities and international pharmaceutical industry associations beyond the three founding regions. Building on greater than 25 years of harmonisation work, ICH is now well-positioned to grow into a truly global venue for the development of guidelines and standards to facilitate the registration of human medicines across the world.

Keywords

Pharmaceutical regulation harmonisation guidelines standards

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Visit the ICH website at www.ICH.org/html for more information and links to supporting documents such as the Articles of Association and Rules of Procedure of the Assembly and of the ICH Management Committee.