Drug Evaluation Committee
Current Status and Issues of Digital Therapeutics (DTx) in Japan
-Comparison with the German and U.S. systems -Comparison with the German and U.S. systems
Clinical Evaluation Subcommittee
May 2025
Medical Device Programs (SaMD) have been widely adopted in developed countries as a means to provide safe and efficient medical services, and are attracting attention as one of the solutions to the challenges of an aging society and lack of medical resources. On the other hand, the development status of SaMD varies greatly from country to country, and it has been pointed out that the development status of SaMD in Japan lags behind that of Germany and the United States, and that there is a "SaMD lag.
Therefore, the Clinical Evaluation Subcommittee Task Force 1 for FY2024 focused on digital therapy (DTx) among SaMDs and investigated the approval systems, reimbursement systems, and data required for approval in Germany and the United States. We then summarized the reasons why DTx is being developed and commercialized in both countries, including the path to monetization, and presented arguments for promoting DTx development in Japan. We hope that this document will trigger further discussion on the promotion of SaMD development, including DTx.
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