New Approaches to Reform and Reactivation of the ICH

Abstract

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was set up in April, 1990, with the aim of international harmonization through the bringing together of regulatory authorities and the pharmaceutical industries of Europe, Japan and the US in order to discuss the scientific and technical aspects of drug registration. Since then, approximately 80 guidelines such as technical guidelines regarding efficacy, safety and quality of drugs as well as various formats for new drug application, etc., have been harmonized. The benefits of international harmonisation for better global health can be realized worldwide and the outcomes of ICH activities have contributed to the reduction of international barriers, duplicative clinical trials, and drug development and research resources as well as information-sharing with Non-ICH countries. Recently, the circumstances surrounding drug development, manufacturing and distribution have been changed significantly, which have facilitated the transition from Europe, Japan and the US to variety of sites worldwide. The rapid changes related to drug regulation calls for worldwide cooperation. ICH, a leading organization promoting schemes for international harmonization, is in the midst of its greatest transformation. It has been encouraging to the continuation of discussions related to ICH's reform and reactivation. Through improvement work, ICH has promoted organizational reform such as the expansion of ICH members. In order to achieve the reactivation of ICH, the ICH steering committee has recently adopted the implementation of eight new topics. The ICH has intensified its global efforts in conjunction with the promotion of outreach activities through the provision of training services to Non-ICH countries.