Drug Evaluation Committee The Amended Next-Generation Medical Infrastructure Act and Post-Marketing Drug Safety Surveillance: Required Actions for Pharmaceutical Companies
Pharmacovigilance Subcommittee
April 2026
In April 2024, the “Act on Anonymized and Pseudonymized Medical Information for the Purpose of Contributing to Research and Development in the Medical Field”(the amended Next-Generation Medical Infrastructure Act) came into effect. This enabled the use of pseudonymized medical information, the utilization of data to support pharmaceutical approvals, and the linking of anonymized medical information under the Next-Generation Medical Infrastructure Act with public databases such as the National Database on Drug Safety (NDB). As a result, the scope of data utilization has been significantly expanded, and these changes are expected to bring about a major transformation in Japan’s framework for the utilization of medical data.From a pharmacovigilance (PV) perspective, these legal amendments are expected to create opportunities to utilize data that was previously difficult to access.Furthermore, when using pseudonymized medical information for pharmaceutical regulatory purposes, it will be possible to provide explanations to regulatory authorities based on re-identification; additionally, linking public databases with the NDB will enable the collection of information that was previously difficult to obtain through conventional post-marketing surveillance studies.
Team 6 of the JPMA PV Subcommittee Task Force on Ongoing Issues has compiled a report on the significance of the amended Next-Generation Medical Infrastructure Act from a PV perspective, the status of responses within the pharmaceutical industry based on survey results, and anticipated use cases and challenges in the PV field.This document is primarily intended for personnel at pharmaceutical companies involved in the utilization of medical information databases within the PV field, and is specifically designed to serve as a guideline for initial consideration by companies that have not yet explored the use of the Next-Generation Medical Infrastructure Act database.We hope this document will assist pharmaceutical companies in considering the use of the database established under the amended Next-Generation Medical Infrastructure Act and contribute to the promotion of real-world data (RWD) utilization and the improvement of the quality of pharmaceutical safety monitoring activities.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Pharmacovigilance Subcommittee, Team 6 for Ongoing Issues