title: New drug approval process in Japan.
authors.affiliation: National Institute of Health Sciences, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo, 158-8501, Japan. takao@nihs.go.jp
authors.forename: T
authors.initials: T
authors.lastname: Hayakawa
mesh_terms: D001688:Biological Products / Q000592:standards; D001709:Biotechnology / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D006077:Government Agencies / Q000458:organization & administration; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence; D007564:Japan; D012449:Safety
chemical_list: D001688:Biological Products