The International Conference on Harmonization (ICH) is a joint initiative involving both regulators and industry as equal partners in the scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality and efficacy of novel medicines. Six parties constitute the founding members of ICH. These represent the regulatory bodies and research - based pharmaceutical industry in the European Union, Japan and the United States of America (1).

ICH members and observers met in Japan in May 2001 to evaluate progress and focus on future areas of importance. Among items discussed was the expected implementation date for the common technical document (CTD) for the three regions, which was confirmed as July 2003. The ICH Web-site will be the forum for a Questions and Answers facility to provide explanations and clarifications of the process (2). Real-case testing of the electronic CTD will take place in six countries and is expected to begin in October 2001.

Important progress has also been made with the release of the ICH terminology, MedDRA 4.0. A large number of changes have been made to the existing system and include new and modified terms and changes in linkages. The report of a recent meeting on post-marketing activities was also presented and three areas outlined for future activities: periodic safety update report information, rollout of new drug products, and case reports. Work has also been initiated on a Safety Pharmacology Guideline (S7B) on Non-Clinical Studies for Assessing Risk Repolarization - Associated Ventricular Tachyarrhythmia for Human Pharmaceuticals.

References

1. ICH Information Brochure. ICH Global Cooperation Group, IFPMA, 1211 Geneva 13.

2. ICH Press Release, http://www.ich.org