Current Japanese regulatory situations of pharmacogenomics in drug administration

Pharmacogenomics (PGx) has the potential impact to improve drug-development efficiencies and proper usages of drugs in clinical practice. However, in order to translate PGx into practical applications, multidisciplinary challenges, such as cost and time in development, processes of genomic biomarker qualification, PGx test availabilities and reimbursements, and education on PGx, still remain in clinical, pharmaceutical and regulatory settings. Japanese regulatory bodies for drug approval (i.e., Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency) have been taking proactive actions, both internally and internationally, toward translating PGx from bench to bedside. In this article, we summarize the current situations and projects in regulatory implementations of PGx in drug administrations in Japan, including activities to promote PGx-based drug/device developments and therapies. Moreover, we also discuss the future tasks for utilization of PGx in drug evaluations and clinical practices.