SY4-5 - Kaizen: An Approach for Improving the Environment for Early Drug and Device Development in Japan

Abstract

ABSTRACT In Japan, the notorious drug lag, i.e. delay in the time required for the approval of drugs, for new drug applications and supplemental new drug application approvals has recently become a major social issue. One study reported that the delay between the approval of a new drug in the United States versus approval of the same drug in Japan was ∼2.5 years. Some of the many factors that are responsible for this Japanese drug lag are as follows: unrefined development of investigational compound in preclinical studies, delays in initiating drug development in terms of phase I registration trials, larger and dubious costs of registration trials, bureaucratic and time-consuming paper work, inadequate life science-related human resource employment and infrastructure, connection of basic medical research institution with medical institution, rigidity of regulatory agency stance for drug development, extended length of the regulatory review period in Japan, necessity of revising related acts, less grant support for investigator initiated early phase trials, public health insurance systems, and insufficient provision of information pertaining to phase I registration trials to general public. Currently, academia, industries, and regulatory agencies continue to implement measures for overcoming many of the existing barriers to becoming more competitive at the global level. The Ministry of Health, Labour and Welfare has selected two core centers (Kitazato university, Keio University) for global clinical studies and five core centers for the early development of pharmaceuticals and medical devices. For the centralization of early drug development resources, core centers need to ensure faster, smarter, and cheaper development measures; further translational research and collaboration between core centers and regulatory agencies are required in order to meet the needs of global industries, venture companies, and institutes.