2014 Volume 4 Issue 3 Pages 189-198
In order to ensure the protection of human subjects and credible clinical trial data, clinical trials are audited by the Pharmaceuticals and Medical Devices Agency (PMDA) to verify Good Clinical Practice (GCP) compliance. There are 2 kinds of GCP inspections in Japan: GCP on-site inspection and document-based inspection. The conformity between raw data and case report forms (CRFs) is assessed through a GCP on-site inspection at specified medical institutions. In pivotal clinical trials, the reliability and conformity between CRFs and product application documents are confirmed by a document-based inspection and data integrity assessment. Changes in GCP compliance were investigated by examining review reports for New Drug Applications (NDAs) between fiscal year (FY) 2010 and FY2012. At some clinical study sites in GCP on-site inspections, violations were found, and the PMDA requested the applicants to exclude some cases from efficacy evaluation and to revise the dossier. The frequency of these cases of pharmaceuticals approved in FY2010, FY2011, and FY2012 were 3.0%, 2.6%, and 2.7%, respectively. At document-based inspections and data integrity assessments, the PMDA often asked the applicants to revise the original dossier. The frequency of these cases of pharmaceuticals approved in FY2010, FY2011, and FY2012 were 0.0%, 2.5%, and 1.3%, respectively. The revised dossiers were found acceptable for evaluation. The quality of the clinical trials was high and sufficient for NDAs. In Japan, it is important to develop new promising drugs for patients who need appropriate treatment while ensuring the protection of human subjects.
