1.1 Background

The International Conference on Harmonisation (ICH) (www.ich.org) is a tripartite collaboration of the European Union, Japan and the United States of America to harmonise the technical requirements for registration of pharmaceuticals for human use. The conference brings together regulatory authorities and pharmaceutical industry experts from three regions to discuss and agree technical aspects of pharmaceuticals for registration.

The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. This mission is embodied in the Revised ICH Terms of Reference.