4．New Paradigm for Post-marketing Surveillance in Japan Which is Introduced New Pharmaco-epidemiology Research Design and Integrated Data Center Based Disease Registry

Abstract

Using foreign clinical trial data in new drug submission, new drug can be approved with a few observations of Japanese patients. In current Japanese drug development situation, the importance of post-marketing surveillance (PMS) for Japanese patients has been increased. Rigid PMS system in Japan which has no selective options should be rescinded. In order to perform primary role of PMS which is to keep in safety and efficacy of pharmaceutical and medical devices, the Japanese PMS should change from standard form to selection of study design according to scientific consideration. The paper proposed that new pharmaco-epidemiology research design was applied to PMS and PMS were conducted by independent and integrated data center based disease registry.