TOPPAN Holdings Acquires Type I Certification as Pseudonymously Processed Medical Information Utilization Operator under Next-Generation Medical Infrastructure Law

TOPPAN Holdings Co., Ltd. (Headquarters: Bunkyo-ku, Tokyo; President and COO: Satoshi Oya; hereinafter 'TOPPAN Holdings') has acquired Type I certification as a 'Pseudonymously Processed Medical Information Utilization Operator' (hereinafter 'this certification') under the Next-Generation Medical Infrastructure Law (Note 1) on Monday, July 13, 2026.

This certification is granted under the Next-Generation Medical Infrastructure Law, established to promote the utilization of medical data, to organizations that have established robust security management systems, permitting them to handle pseudonymously processed medical information (Note 2). As a Type I certified operator, TOPPAN Holdings can now provide data analysis environments to pharmaceutical companies and other 'pseudonymously processed medical information utilization operators'.

As a result, TOPPAN Holdings' medical data analysis and provision service 'DATuM IDEA®' (pronounced: Datum Idea), which has been offered since April 2022, will now be able to handle not only anonymized medical information (Note 3) but also pseudonymously processed medical information. Pseudonymously processed medical information includes data such as rare diseases and unique test values that were previously deleted or modified in anonymized medical information to prevent individual identification, thereby significantly expanding the range of usable data.

With this certification, 'DATuM IDEA®' will be able to provide a broader range of real-world data (RWD) (Note 4), contributing to evidence generation for pharmaceutical companies' regulatory approval applications and aiming to provide advanced support for drug discovery and medical research.

Background of the Certification

In the current healthcare industry, the importance of real-world data (RWD) obtained from actual clinical settings is rapidly increasing, particularly in drug discovery research and therapy development. In the pharmaceutical industry, rising development costs and the difficulty of recruiting trial participants for rare diseases have led to longer timelines for new drugs to reach patients. Consequently, there is growing demand for the use of real-world data (RWD) as an effective method to generate evidence on drug efficacy and safety during pharmaceutical development.

However, when utilizing real-world data (RWD), anonymized medical information requires the deletion or modification of unique test values and extremely rare disease names to prevent individual identification. This has imposed limitations on data utilization for rare diseases, where clinical trials and new drug development are particularly challenging.

In contrast, pseudonymously processed medical information can be handled only by authorized users with government-certified secure management systems. This allows the retention of unique test values and disease names without deletion or modification, enabling the use of data that preserves information essential for research and analysis.

TOPPAN Holdings has previously advanced the strengthening of its security management systems to meet high-level analytical demands while providing medical information services based on electronic medical records through 'DATuM IDEA®'. The establishment of an environment capable of handling such medical information and the accumulated expertise in security measures have contributed to the acquisition of this certification.

By providing a wide range of real-world data (RWD) tailored to users' needs—including pseudonymously processed medical information—TOPPAN Holdings will promote support for drug discovery and medical research, including pharmaceutical development for rare diseases.

Features of the Certification

・Utilization of Pseudonymously Processed Medical Information

Pseudonymously processed medical information is secured by a rule that only allows handling by utilization operators certified by the Cabinet Office based on standards for security management. With this certification, 'DATuM IDEA®' provided by TOPPAN Holdings can now retain unique test values and disease names that were previously subject to deletion in anonymized medical information. This enables pharmaceutical companies and other 'pseudonymously processed medical information utilization operators' to understand the actual conditions of patients with extremely rare diseases and conduct detailed analyses of treatment patterns.

・Establishment of a Detailed Data Provision System to Pharmaceutical Companies via Type I Certification

Under the Next-Generation Medical Infrastructure Law, 'pseudonymously processed medical information utilization operators' are categorized into Type I, who can store and use data in their own prepared environments, and Type II, who can only use data within environments provided by Type I certified operators or 'pseudonymously processed medical information creation operators'. As TOPPAN Holdings has become a Type I certified operator, it is now equipped to securely provide pseudonymized medical information usage environments to Type II certified operators such as pharmaceutical companies.

・Expanded Potential for Use in Regulatory Applications

Pharmaceutical companies typically require clinical trial data as evidence when submitting regulatory approval applications to the Ministry of Health, Labour and Welfare for drug manufacturing and marketing. By supplementing this clinical trial data with real-world data (RWD) provided by certified operators like TOPPAN Holdings, diverse cases that were difficult to capture in traditional clinical trials can be considered, contributing to higher-quality drug development. Simultaneously, this also contributes to shortening development timelines.

Future Outlook

Pseudonymously processed medical information is collected and managed under the Next-Generation Medical Infrastructure Law and is expected to be utilized in drug approval applications and similar processes. By commencing the provision of pseudonymously processed medical information following this certification, TOPPAN Holdings will further advance and promote research utilizing real-world data (RWD). This will drive improvements in the quality of drug development and safety evaluations, further contribute to evidence generation, and support the enhancement of healthcare quality and research infrastructure in Japan.

Note 1: Next-Generation Medical Infrastructure Law:

Officially named the 'Act on Anonymously Processed and Pseudonymously Processed Medical Information for Research and Development in the Medical Field.' A legal framework designed to promote the safe utilization of medical data.

Note 2: Pseudonymously Processed Medical Information:

Information processed so that individuals cannot be identified unless cross-referenced with other data. While personal identifiers such as names and IDs are removed, unlike anonymized medical information, unique values and rare disease names do not need to be deleted or modified.

Note 3: Anonymized Medical Information:

Personal information derived from medical data processed so that specific individuals cannot be identified, and the original data cannot be restored.

Note 4: Real-World Data (RWD):

Data on patients' health status and healthcare delivery collected in routine clinical practice, outside of clinical trials (drug trials).

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* The content of this press release is current as of the date of announcement and is subject to change without prior notice.