The Roles of Regulatory Science Research in Drug Development at the Pharmaceuticals and Medical Devices Agency of Japan

Abstract

Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices Agency (PMDA), which aims to improve public health in Japan.

Keywords

regulatory science Japan drug development pharmacovigilance public health innovation

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