A clinical trial using a blockchain-based data verification system has received marketing approval in Japan. The product concerned is Wakix Tablets, with marketing approval obtained by Viatris Pharmaceuticals.
A case has been disclosed in which blockchain technology provided by SUSMED was used to verify clinical trial data. SUSMED SDS records patients' conditions and the effects of medication, then verifies whether the records match the source data held by medical institutions. In this case, the objectives were to improve the reliability of clinical trial data and reduce manual work.
The company conducted a demonstration under the regulatory sandbox program to validate the system from a regulatory perspective. It also obtained a response from the Ministry of Health, Labour and Welfare stating that blockchain-based data verification could replace conventional procedures. This led to the system's implementation in clinical trials in Japan.
The approved product is Wakix Tablets, indicated for narcolepsy and excessive daytime sleepiness. The marketing approval is positioned as Japan's first case based on clinical trial data verification using blockchain. SUSMED's system provided the evidence supporting the verification of the clinical trial data.
Future attention will focus on the reduction in workload from clinical trial data verification and the expansion of applications into other fields. Following this approval, SUSMED is looking to promote the technology as part of efforts to improve the efficiency of pharmaceutical development.