Mr A. Kawahara, Japan

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals (ICH) was established in 1990 as a joint initiative between regulatory agencies and the research-based pharmaceutical industry in Japan, the European Union and the United States of America. The main purpose of ICH has been to eliminate duplication of work and procedures caused by different regulatory requirements and cut back on waste of resources. What is most important is the facilitated development of drugs which primarily benefits patients and public health through quicker access to innovative drugs. This has been the main motivation for regulators in promoting harmonization. The ICH process has greatly facilitated communication among participants and within this process we have made every effort to acquire information as well as seeking suggestions from the all parties involved.

We are also hopeful that ICH products, especially the guidelines, should be used as widely as possible beyond the borders of three participating regions. ICH guidelines can be used free of charge, of course, by any party, be it a regulatory authority or an industry. ICH is proactive in assisting non-ICH countries to adopt the guidelines by providing the necessary information and interpretation. The importance of developing new drugs to improve people’,5 welfare can never be overemphasized. ICH has contributed to rationalizing the process, to realize quicker access of patients to good drugs. The Japanese Ministry of Health and Welfare is, as one of the participating authorities, committed to pursuing this activity.