Drug Evaluation Committee Q&A regarding application for authorized pseudonymous processed medical information user business operators based on the Next Generation Medical Infrastructure Act
Medical Information DBTF
March 2026
The Next Generation Medical Infrastructure Act revised in 2024 newly stipulates the handling of pseudonymized processed medical information and establishes the framework of "Authorized Pseudonymous Processed Medical Information User Business Operator" (hereinafter referred to as "Authorized User Business Operator") as an organization to use such information. This obliges users to obtain accreditation in the case of pseudonymized processed medical information.
For application, the Cabinet Office has published guidelines and a model application form, etc., and it is necessary to proceed with the procedures based on these guidelines and form. This deliverable was prepared for the purpose of deepening the understanding of these matters. In preparing this document, we have endeavored to make the contents of this document useful in practice by drawing on the knowledge of experts in a variety of fields.
We hope that this document will contribute to the promotion of understanding of the system and the streamlining of preparatory work for those who are considering the acquisition and operation of user accreditation.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
TF for Promotion of Utilization of Medical Information DB