Abstract
The history of ICH (The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) has been passed for over 20 years and more than 80 ICH guidelines including scientific and technical guidelines regarding quality, efficacy and safety of new drugs and guidelines for submission dossier had been developed and harmonized. In addition to the guidelines, training activities are highly important in order to implement the ICH guidelines smoothly and facilitate to expand the ICH guidelines to non-ICH regions. This article summarizes such training activities in three ICH regions (US/EU/JP) and non-ICH regions and discusses how Japan can contribute further. Training activities of ICH guidelines are delegated to each region. In Japan, there were a variety of trainings organized by pharmaceutical industry not only by regulatory agencies. In EU and US, there were cases which nonprofit organizations such as DIA took a role of primary providers of training. In non-ICH regions, main providers of training had been each regulatory agency by around 2011. However, nonprofit organizations such as DIA and PIC/S became major providers recently. In Asia, APEC Harmonization Center has organized a number of trainings. In the meantime, there were examples that same trainings using common training materials developed by ICH were conducted globally for Q trio and E2 series guidelines. Under the circumstances that ICH activities are expanding to non-ICH regions, Japan should contribute to training further especially in Asia and globally. Then Japan should boost its presence as one of the founding ICH members.
