This division is in charge of regulatory sciences on drug safety. Current major activities are 1) collection, evaluation and release of a variety of drug safety and related regulatory information, and pharmacoepidemiological analysis using real world data, 2) Exploration and validation of safety biomarkers using omics techniques, characterization of molecular mechanisms underlying development of severe adverse drug reactions, and identification of patients’ risk factors on severe adverse drug reactions, 3) Regulatory evaluation on biomarker assay validation. This division also maintains and controls the intra-network of the institute and its security.