4 - Regulatory Experience at the FDA, EMA, and PMDA: Regulatory Experience at the PMDA

Abstract

Pharmacogenomics (PGx) and biomarkers have gradually been recognized as useful tools for use throughout the life cycle of a drug or device, from development through post-approval activities. In September 2005, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) established the PGx Discussion Group (PDG) to appropriately manage PGx issues in Japan’s regulatory process. The PDG only covered PGx issues, but recently, interest in other ‘omics’ areas, such as proteomics, metabonomics and metabolomics have rapidly increased. Therefore, in April 2009, the PDG was re-organized as the PMDA Omics Project (POP), which covers not only PGx but also proteomics, metabonomics, metabolomics and related issues.