Abstract
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is intended to develop technical guidelines for new drug development in the quality, safety, efficacy, and multidisciplinary areas under the initiative of the regulatory authorities and pharmaceutical industry of Japan, the United States, and Europe. With these guidelines, the ICH provides the principles for regulatory documents concerning drug development by the tripartite regulatory authorities. ICH has continuously performed its activities for more than 20 years, and basic guidelines have been developed. Currently, to meet the need for greater international harmonization against the background of recent diversification of processes and new technologies in drug development, the organization is engaged in several new issues as well as the revision of important guidelines. Particularly in the efficacy area, based on the need for higher quality and cost reduction in clinical trials, as well as the universalization of global clinical trials, the ICH is addressing the revision of the Good Clinical Practice guidelines (E6), considering consensus on the concept of Multi-Regional Clinical Trials (E17), and exploring the collection and storage of genomic information (E18). Concerning the introduction of a next-generation review system and the trend toward global simultaneous NDA submissions and approvals in the industry, the organization has started discussions on the introduction of the benefit-risk assessment structure in the Common Technical Document (M4), and the significance of follow-up of dropouts/withdrawals in statistical analysis and the methodology of analysis (E9). These ICH activities have great impact on global drug development. The guidelines developed by the organization are expected to serve as a practical landmark for new drug development.
