On August 26, the MHLW released its FY2026 budget, which showed an increase of 550 billion yen from the previous year. The total 2026 budget is planned for about 35 trillion yen. There are many goals of the increased budget, including expediting new drugs, improving Japan’s clinical infrastructure, an increase in early regulatory consulting services, etc. Also, increased funds were allocated for patients with ultra-orphan diseases, maintenance of stable drug supplies, and an “early considerations” program to expedite drug reviews. The early consideration program is geared towards preparing applicants with more information so they can better address the PMDA concerns when standard clinical trials are not practical or when scientific evidence is sparse.
In addition, the MHLW issued a new guideline for non-clinical studies and clinical trial programs for therapeutic radiopharmaceuticals. The guideline specifies that radiopharmaceuticals have different regulatory issues than traditional drugs and outlines different strategies for conducting appropriate studies, etc.
Finally, last month, the MHLW allocated more funds for registration of Software as a Medical Device (SaMD) products due to the increasing influx of these devices into Japan. Going forward, the MHLW hopes to expedite reviews of SaMD products and will now add three SaMD experts to the free consultation services offered by the PMDA.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.