Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
GCP Inspection of Clinical Trials of New Drugs Approved in Japan from FY2013 to FY2017 and FDA GCP Inspection in Japan
Kazuha WADATamiko SUZUKI-NISHIMURA
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JOURNAL FREE ACCESS

2019 Volume 9 Issue 3 Pages 151-163

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Abstract

Good Clinical Practice (GCP) are guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The Office of Non-clinical and Clinical Compliance of Pharmaceuticals and Medical Devices Agency (PMDA) engages in onsite GCP inspection and document-based GCP inspection. In Japan, these two types of inspections are important to ensure the integrity of raw data including medical records, examination slips, and patient journals for application materials. We examined the compliance of GCP using review reports of new drugs discussed at the Pharmaceutical Affairs and Food Sanitation Council between FY2013 and FY2017. There were four new drugs related to inappropriate cases at some study sites, and PMDA asked the applicants to withdraw these cases from the dossier (a frequency of less than 3%). The revised dossier was acceptable for PMDA evaluation. All clinical trial information should be recorded, handled, and stored in a way that allows accurate reporting, interpretation, and verification, but medical records of some study sites were not found for some clinical trials of three new drugs. However, for document-based GCP inspection, the frequency of Voluntary Action Indicated (VAI) for GCP increased to 12.7% in FY2017. We also studied the Bioresearch Monitoring by Center for Drug Evaluation and Research (CDER) between 2013 and 2017 in Japan and found two VAI investigators. The clinical trial environment in Japan is improving, but more effort is needed to increase reliability and data integrity.

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© 2019 Society for Regulatory Science of Medical Products
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