title: [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.
authors: National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan. kawanish@nihs.go.jp
authors: Toru
authors: T
authors: Kawanishi
mesh_terms: D017277:Drug Approval; D015195:Drug Design; D055808:Drug Discovery / Q000639:trends*; D015316:Genetic Therapy / Q000639:trends; D006801:Humans; D050997:Nanomedicine / Q000639:trends*; D015202:Protein Engineering / Q000639:trends