title: [Development of an anticancer drug in Japan based on a new clinical trial system].
abstract: According to the revision of Pharmaceutical Affairs Law in 1996, the GCP has been enacted into the law. Next year the new GCP was established based on the ICH-GCP and it has been active since April, 1997. Though the new GCP makes it possible for the regulatory authorities (Japan, the United States and European Union) to accept clinical trial data mutually, the circumstances of clinical trial in Japan have been required big changes. But considerable investigators/institutions in Japan which carry out clinical trials seem to have not still adapted their usual clinical trial system to a new one yet. At the first time, in this article are described the process of both the revision of Japanese pharmaceutical law and the establishment of the new Japanese GCP. The second, the characteristics of the new Japanese GCP especially about the roles and responsibilities of investigators are discussed. Furthermore approaches of the US FDA for new anticancer drugs development are also described.
authors.affiliation: Dept. of Clinical Pharmacology and Therapeutics, Oita Medical University.
authors.forename: H
authors.initials: H
authors.lastname: Nakashima
authors.forename: S
authors.initials: S
authors.lastname: Nakano
mesh_terms: D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000639:trends*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016903:Drug Monitoring; D006801:Humans; D007564:Japan; D007880:Legislation, Drug; D012108:Research Personnel / Q000639:trends
chemical_list: D000970:Antineoplastic Agents