title: Evolution of frameworks for expediting access to new drugs in Japan.
abstract: Japanese clinical research and regulatory frameworks have evolved considerably in the past two decades to reduce the delay in the introduction of new drugs in Japan compared with other major markets. However, recently introduced changes related to access to unapproved drugs might have the opposite effect and might not benefit all patients.
authors.affiliation: Strategic Planning Bureau, National Cancer Center and Department of Breast and Medical Oncology, National Cancer Center Hospital Tsukiji 5-1-1, Chuo-ku, Tokyo 104-0045, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
mesh_terms: D000970:Antineoplastic Agents / Q000600:supply & distribution* / Q000627:therapeutic use; D017277:Drug Approval; D006291:Health Policy / Q000639:trends*; D006297:Health Services Accessibility; D006301:Health Services Needs and Demand; D006801:Humans; D007564:Japan; D009369:Neoplasms / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents