SUSMED’s blockchain clinical trial system used in pharmaceutical approval

SUSMED, Inc. announced on November 5, 2026, that its proprietary blockchain-based clinical trial system, SUSMED SourceDataSync (SUSMED SDS), has been utilized in a pharmaceutical product’s successful marketing authorization. This milestone represents the world’s first pharmaceutical approval based on the results of an industry-sponsored clinical trial that employed blockchain technology.

Addressing Industry Challenges

The company noted that global research and development expenditure for pharmaceuticals has been increasing at an annual rate of approximately 8.5% over the last decade. In Japan, labor-intensive practices and over-engineering to comply with Good Clinical Practice ordinances have contributed to rising costs and the issue of “drug lag and drug loss.”

Blockchain System Cuts Clinical Trial Monitoring Tasks

SUSMED SDS functions as a clinical trial management system designed to synchronize medical data from institutions with Case Report Form data. By utilizing blockchain, the system aims to reduce data entry workloads at medical sites and decrease the burden of regulatory-mandated monitoring tasks.

The system’s regulatory standing in Japan was established following a submission under the “System of Inquiry on Regulatory Gray-Zone Areas.” On December 4, 2020, the Ministry of Health, Labour and Welfare issued an official notification confirming that the substitution of monitoring tasks with blockchain technology complies with the nation’s Good Clinical Practice ordinance.

Impact on Clinical Trial Efficiency

Evaluations conducted under a project supported by the Japan Agency for Medical Research and Development compared conventional trial workflows against the SUSMED SDS workflow. The findings indicated a reduction in data entry workload and monitoring tasks:

• Monitoring workload decreased by 45.9%.
• Medical institution workload decreased by 32.0%.
• Data queries for verification and correction decreased by 46.7%.

These results align with the Quality by Design approach outlined in the updated international guideline for Good Clinical Practice, ICH-E6(R3), which encourages sponsors to avoid unnecessary complexity in clinical trials. The 2022 GAMP 5 Second Edition guidance from the International Society for Pharmaceutical Engineering identified blockchain as a key solution for enhancing data integrity within the pharmaceutical industry.

Governmental Recognition

Hirohiko Nakagawa, Secretary-General of the Secretariat of Intellectual Property Strategy Headquarters at the Cabinet Office, stated: I would like to offer my sincere congratulations on the marketing approval granted by the Ministry of Health, Labour and Welfare for a pharmaceutical product validated through blockchain-based clinical trial system.

Kazumi Nishikawa, Deputy Director-General of the Minister’s Secretariat at the Ministry of Economy, Trade and Industry, added: I am delighted to see SUSMED’s initiative progressing appropriately as an effort leading the improvement of healthcare quality through the application of technology, as well as a concrete successful example of utilizing the Regulatory Sandbox system.