摘要：To analyze the quality of clinical trials in Japan for new applications of pharmaceuticals, compliance with the Good Clinical Practice (GCP) inspection was studied using Review Reports for approvals from fiscal year (FY)1999 to FY2008. Guidelines for GCP in Japan were harmonized with those of other countries at the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Both to protect human rights, safety and welfare and to perform clinical trials scientifically and ethically, ensuring conformity with GCP is necessary when evaluating the safety and efficacy of the clinical data in common technical documents (CTD). In the conformity audit service of the Office of Conformity Audit of Pharmaceuticals and Medical Devices Agency (PMDA), the conformity of the studies and the documents between application materials of CTD attached to application forms for approval and case report forms (CRFs) is reviewed by document-based conformity inspection, and the conformity between medical records and CRFs is reviewed by on-site GCP inspection including oversea inspection. The GCP inspection includes both the on-site GCP inspection and the document-based conformity inspection. The importance of the GCP inspection by the Office of Conformity Audit to protect human rights, safety and welfare is summarized in this study. In conclusion, GCP inspection is conducted in accordance with the latest GCP, and the quality of clinical trials in Japan meets the Review Process by PMDA for marketing authorization. I hope that the GCP inspection protects human rights and improves the GCP conformity of clinical trials in Japan.
关键词：Good Clinical Practice;clinical trial;human subject protection;Inspection;Pharmaceuticals and Medical Devices Agency
