World-First Achievement: SUSMED's Blockchain-Based Clinical Trial System Supports Successful Marketing Authorization for Pharmaceutical Product

TOKYO--(BUSINESS WIRE)--Nov 4, 2026--

SUSMED, Inc. (TOKYO:4263) announced that "SUSMED SourceDataSync®" ("SUSMED SDS"), its proprietary blockchain-based clinical trial system, has contributed to obtaining marketing authorization for a pharmaceutical product 1,2,3.
This marks the world's first pharmaceutical approval based on the results of an industry-sponsored clinical trial utilizing blockchain technology 4.

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Challenges in Pharmaceutical Development

Global research and development (R&D) expenditure for pharmaceuticals continues to rise, increasing at an annual rate of approximately 8.5% over the past decade 5. Key drivers of the rise in R&D expenditure include advancement of R&D and the increasing complexity of protocols. In Japan, both labor-intensive and over-engineering practices intended to comply with the Good Clinical Practice(GCP) ordinance have been widely highlighted as major contributing factors. It also results in the fact that the number of clinical trial sites managed per Clinical Research Associate (CRA) in Japan is only one-third of that in the United States 6. Consequently, rising development costs lead to serious drug lag and drug loss, which in turn is posing significant challenges to social and economic securities.
In recent years, the updated international guideline for Good Clinical Practice, ICH-E6(R3), outlined the Quality by Design (QbD) approach. The guideline states that the sponsor should avoid unnecessary complexity and not place unnecessary burden on participants and investigators. Implementing an appropriate system to manage quality throughout all stages of the trial process is also required.

Our Solution and Initiatives

SUSMED SDS is a clinical trial management system that utilizes blockchain technology to securely syncronize medical data captured at medical institutions with Case Report Form (CRF) data. This enables a significant reduction in both data entry workload at medical sites and regulatory-mandated monitoring tasks. The verification results in the Regulatory Sandbox system were published in a peer-reviewed international medical journal in June 2020 (Hirano et al., 2020, JMIR ). Based on these findings, SUSMED submitted an application under the "System of Inquiry on Regulatory Gray-Zone Areas" pursuant to the Industrial Competitiveness Enhancement Act and, on December 4, 2020, the Ministry of Health, Labour and Welfare (MHLW) issued an official notification 7 confirming that substituting monitoring tasks with blockchain technology is compliant with Japan's GCP ordinance.
Furthermore, a comparative evaluation between conventional clinical trial workflows and the SUSMED SDS workflow, conducted under the Research and Development Promotion Network Project supported by the Japan Agency for Medical Research and Development (AMED), demonstrated that monitoring workload decreased by 45.9%, medical institution workload decreased by 32.0%, and data queries for verification and correction decreased by 46.7% 8. These findings indicate that, while substantially reducing overall operational overhead, the use of blockchain technology for clinical trial data management contributes significantly to streamlining processes, improving productivity in alignment with Quality by Design (QbD) principles.

Additionally, GAMP 5 Second Edition, the GxP guidance published by the International Society for Pharmaceutical Engineering (ISPE) in 2022, highlighted blockchain technology as a key solution for enhancing data integrity, which signals growing global expectations for the expanded use of blockchain across the clinical trial ecosystem.

Achievements and Future Outlook

The regulatory approval of a pharmaceutical product based on a clinical trial utilizing blockchain technology marks the world-first achievement, driving expectations for the broader implementation of this technology to accelerate the establishment of a modern clinical trial ecosystem.

Comment from Taro Ueno, President and CEO of SUSMED, Inc.:

“I, as a clinician, believe that the issue of Drug Loss, where pharmaceuticals used for patient care overseas remain unavailable in Japan, is a critical challenge.
In 2020, through our participation in the Regulatory Sandbox system and System of Inquiry on Regulatory Gray-Zone Areas under the Industrial Competitiveness Enhancement Act, we demonstrated that utilizing blockchain technology enables efficient compliance with the GCP ordinance.
I am deeply moved that marketing approval has now been granted for a pharmaceutical product based on this deregulation, and that is opening the door to delivering new treatment options to patients. I extend my heartiest gratitude to all stakeholders whose dedicated efforts made this milestone possible.
SUSMED remains committed to contributing to the optimal development of new therapies through the advancement of establishment of an innovative clinical trial ecosystem.”

In addition, Hirohiko Nakahara, Secretary-General, Secretariat of Intellectual Property Strategy Headquarters, Cabinet Office (former Counsellor, Economic Revitalization Bureau, Cabinet Secretariat), and Kazumi Nishikawa, Deputy Director-General, Minister's Secretariat, Ministry of Economy, Trade and Industry (former Director, Healthcare Industries Division, Ministry of Economy, Trade and Industry), sent us the following comments:

Comment from Mr. Hirohiko Nakagawa, Secretary-General, Secretariat ofIntellectual Property Strategy Headquarters, Cabinet Office:

“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. It is profoundly meaningful that this approval was achieved based on the results obtained through the Regulatory Sandbox system. We look forward to seeing innovative technologies and solutions continue to contribute to resolving societal challenges in the future.

Comment from Mr. Kazumi Nishikawa, Deputy Director-General, Minister'sSecretariat, Ministry of Economy, Trade and Industry:

"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. I look forward to their further endeavors toward achieving a 'Well Aging Society' in the future."

This world-first achievement, wherein regulatory marketing approval was granted for a pharmaceutical validated through a clinical trial leveraging blockchain technology following deregulation, represents a major step forward in addressing the challenges such as drug lag and drug loss. We have built a solid track record of reducing both costs and operational workload in clinical development through the utilization of SUSMED SDS, and we look forward to expanding its implementation among a broader range of clinical trials of pharmaceutical companies. Furthermore, by contributing to the establishment of a clinical trial ecosystem anchored in QbD principles, we aim to enhance productivity and quality in drug development, ultimately to support the optimization and long-term sustainability of future social security expenditures.

Reference Material

Key Implementation Examples of SUSMED SDS

New Technology Demonstration system (The Regulatory Sandbox system)

The "New Technology Demonstration system" (commonly known as the Regulatory Sandbox system) was established under the Act on Special Measures for Productivity Improvement to promote business activities utilizing novel technologies and innovative business models. By limiting participants and timeframes, this framework creates a controlled environment that allows companies to conduct real-world demonstrations without being bound by existing regulations. This system enables rapid verification, and allows to leverage the resulting data and evidence to drive regulatory reform.

About SUSMED, Inc.

SUSMED, Inc. is a R&D driven enterprise dedicated to advancing digital healthcare. In addition to developing digital therapeutics (DTx), including a therapeutic application for insomnia disorder. SUSMED provides a clinical development support system powered by blockchain technology. Grounded in robust technology, SUSMED is driving the evolution of digital healthcare through a proprietary intellectual property portfolio covering various patents in digital therapeutics and medical applications of blockchain technology.
Top page: https://www.susmed.co.jp/en/
SUSMED SDS: https://www.susmed.co.jp/en/system/

Notes
The information regarding pharmaceutical products contained in this release is intended solely for corporate disclosure purposes and does not constitute an advertisement or promotion of them.

SUSMED SDS enables the conduct of high quality and efficient clinical trials.

Alan Jones, the Australian who became the first driver to win a Formula 1 title with Williams, has died, his family said Thursday.

Jones, the 1980 Formula 1 world champion, died after a brief illness. He was 80.

“We are extremely saddened to announce the passing of our beloved Alan,” his wife, Amanda, said in a statement. “He will be dearly missed and fondly remembered by those closest to him, as well as the many fans whose support he was always grateful for.”

Jones, an Australian Motorsport Hall of Fame and Sport Australia Hall of Fame inductee born in Melbourne in 1946, was the second and so far last Australian to win the Formula 1 world title, the highlight of an F1 career that featured 12 victories and 24 podium finishes.

He followed Jack Brabham, won three F1 world drivers' titles for Australia.

Jones was known for his aggressive driving style and abrasive personality. “If someone passed me, I took it personally,” he said on a 2019 podcast.

In an era when deaths and serious injuries weren’t uncommon in F1, Jones started each year by checking his life insurance and making travel plans for his wife to return to Australia if he was killed, but said he never personally feared death in a race.

“I never worried about the dangers,” he said. “I worried about the money.”

Jones found the right team with Williams, whose founder Frank Williams was adept at defusing his temper and keeping him focused. His driving style and physical strength were a good fit for the team’s FW07 car.

Jones didn’t seek to make friends with other F1 drivers.

“They were just things that had to be passed,” was how he described his rivals in the 2019 podcast “Beyond The Grid.” After one public feud with his Argentinian teammate Carlos Reutemann, Jones needed a police escort for his next race in Argentina.

Disappointed that Ferrari had gone back on what Jones later claimed was a signed contract for him to drive for the Italian team in 1977, he bore a grudge.

“When I used to drive down pit lane and they were working on their cars, I’d give them a little wave,” he said later. “Now, I might have only used one finger, but it was a wave!”

Jones grew up in Australia as the son of a successful amateur racing driver and moved to Britain in the late 1960s, funding his journey toward F1 by buying and selling old vans.

Jones drove for a series of small teams when he arrived in F1. His first win for Shadow in 1977 from 14th on the grid came as such a surprise to organizers of the Austrian Grand Prix that they hadn’t prepared a recording of the Australian national anthem for the podium ceremony. Jones later recalled that “a drunk played ‘Happy Birthday’ on a trumpet” instead.

After an unsuccessful title defense in 1981 — Jones believed he’d driven better than before but the car let him down — he headed back to Australia and bought a farm. Homesickness and a dislike for the British weather played a part.

Still, Jones was soon bored of his new life as a cattle breeder and made a one-off F1 comeback in 1983 with Arrows before returning with Haas — no relation to the current F1 team of the same name. The car wasn’t competitive and Jones had a best finish of fourth before leaving F1 again in 1986.

Away from F1, Jones won the 1978 Can-Am sportscar title and was third in his only IndyCar race in 1983. Jones kept racing in Australia’s V8 Supercars series until 2002, when he was 55.

Jones stayed around the paddock as a TV commentator and race steward but was critical of modern drivers, who he called “prima donnas” and “too corporate.”

Original team owner Frank Williams, who died in November 2021, was fond of Jones and once described him as “a man’s man” who was “great fun to be with.”

“He never needed propping up mentally, because he was a very determined and bullish character,” Williams said. “He didn’t need any babysitting or hand-holding and that’s the way it should be. It shouldn’t be necessary for me to ask a driver if he is happy, or if he needs his underwear changed.”

AP Sports Writer Dennis Passa contributed from Brisbane, Australia.

See AP’s full auto racing coverage here

FILE -Australian F1 driver Alan Jones, sits in the pit complex before the Qualifying round of the GP Masters at Kylami race circuit in Johannesburg, South Africa, Saturday, Nov. 12, 2005. (AP Photo/Themba Hadebe, File)

FILE -Three legends of Formula One racing and all ex world champions from left Alan Jones, Australia, Stirling Moss, Great Britain and Jack Brabham, Australia in discussion at the track in Melbourne, March 7, 1996.(AP Photo/Steve Holland, File)