Regulatory science oriented to development of innovative medical products in the National Institute of Health Sciences

Abstract

Importance of regulatory science(RS) in development of innovative medical products is pointed out in the fundamental policy papers by the Cabinet Office, and the promotion of RS is enshrined in Act on Promotion of Development of Medical Products for Public Health which have recently passaged in the Diet. The pharmaceuticals-related divisions in NIHS have began RS research for promoting improvement in developing environment of innovative medical products since 2012. Nano-medicines, fully engineered protein drugs, nucleic acid drugs, gene-therapy drugs, cell-therapy products, tissue-engineered medical products and so on have been selected as innovative medical products, and the point-to-consider documents for evaluating mainly quality and non-clinical safety of these products will be developed. In addition, the requirements for the first-in-human trial will be also framed, especially from the standpoints of quality and non-clinical safety evaluation.