Drug Evaluation Committee Quality Control-Fraud Detection Prevention
December 2023
On July 5, 2019, ICH E6 (R2) reached Step 5 in Japan as well, and it was explicitly stipulated that it is the sponsor’s responsibility to implement the Quality Management System (QMS) in clinical trials and research.Approximately four years have passed since then. During this period, the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (hereinafter referred to as the JPMA Data Science Subcommittee) published “[Central Monitoring]—Survey on the Current Status of Risk Indicators and Fraud Detection” in December 2020.The results showed that, compared to QMS and RBM, the number of companies that had implemented FD was still relatively small. This Task Force therefore decided to conduct a new Survey among Member Companies, a vendor survey, and a literature review survey covering the period from 2019 onward. Furthermore, to actively promote the adoption of FD methods, this report introduces specific FD techniques.We hope this report will serve as a reference for companies seeking to promote FD, RBM, and CSM, and ultimately contribute to improving the quality of clinical trials and ensuring transparency.
Japan Pharmaceutical Manufacturers Association (
) Drug Evaluation Committee, Data Science Subcommittee (
) FY2023 Continuing Task Force 5-1