Moderators: Mr F. Sauer, European Union

The purpose of the International Conference on Harmonization (ICH) is to eliminate duplicative regulatory requirements, use resources more efficiently and ensure quicker access to safe, effective and good quality new pharmaceutical products. A total of 43 ICH guidelines have been published covering quality, efficacy and safety. Future activities will focus on implementation of the Common Technical Document (CTD) which is that part in documentation of a new drug application which will be basically the same in all ICH countries. New guidelines will be developed on emerging new issues that require harmonization and current guidelines will be updated as required. ICH countries have promised to help in globalization of ICH products by offering direct assistance to non-ICH countries and through co-operation with WHO. ICH wishes to serve as a resource of information by organizing conferences and seminars and by publishing guidelines on its Website.