title: [Implementation of new Japanese GCP and the quality of clinical trials--from the standpoint of the pharmaceutical industry].
abstract: As a part of the amendment of the pharmaceutical law and regulations in Japan, the GCP has been revised and enacted into the law and regulations. The new GCP is based on ICH-GCP and aims at upholding the quality of the Japanese clinical trials to an internationally acceptable level. The roles of the people involved in clinical trials have been renewed. The sponsor is responsible for management of clinical trials. At the same time, the procedures for quality assurance and quality control have extensively been brought into the new GCP. Not only monitoring but also audit of clinical trials are now the obligations of the sponsor. In this article are described major responsibilities newly assigned to the sponsor, medical institutions and investigators as well as the matters to be tackled. Discussion was also made extending the theme to matters other than GCP for upholding the quality of clinical trials in Japan to the internationally acceptable level. It is evident that we will confront many difficulties to solve these matters, but the implementation of the new GCP should give us a good chance to improve the quality of clinical studies performed in Japan.
authors.affiliation: Regulatory Affairs, Takeda Chemical Ind., Ltd., Tokyo, Japan.
authors.forename: O
authors.initials: O
authors.lastname: Ebi
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D004345:Drug Industry; D016903:Drug Monitoring; D005161:Facility Regulation and Control / Q000592:standards; D006801:Humans; D007564:Japan; D011785:Quality Assurance, Health Care / Q000592:standards