[Regulatory science promoting improvement in developing environment of innovative drugs].

Abstract

Importance of regulatory science in development of innovative drugs is pointed out by the Council for Science and Technology Policy in the Cabinet Office, and the pharmaceuticals-related divisions in the NIHS have begun the regulatory science research for promoting improvement in developing environment of innovative drugs since 2012. Nano-medicines, fully engineered protein drugs, nucleic acid drugs, and gene therapy drugs have been selected as innovative drugs, and the point-to-consider documents for evaluating mainly quality and non-clinical safety of these drugs will be developed. In addition, the conditions for the first-in-human trial will be also proposed, especially from the standpoints of quality and non-clinical safety evaluation.