On May 14, 2025, the Japanese government amended the Pharmaceutical and Medical Device Act 2025. Prior to this update, the PMD Act only outlined the roles and responsibilities of the MAH’s key responsible people. It did not have any specific penalties or rules if these responsible people did not perform their duties correctly. Now, if there are quality issues, the MHLW may tell the MAH to change its key responsible people. In addition, the Act says that MAHs are required to appoint both a Safety and Quality Manager, as well as have a more detailed adverse event collection program. These changes will take full effect within two years, or by May 2027.
The Act also discusses supply chain shortages and requires the MAH to designate a Supply System Manager. This manager needs to update the MHLW on supply disruptions in a timely manner.
Furthermore, the Act revises its conditional approval regulations for drugs, devices, and IVD products so that more conditional approvals can be granted for diseases that have strong clinical evidence and no alternative treatments. This change to increase the number of medical products under the conditional approval system will take effect by May 2026. The 2025 Act also establishes a fund to help the development of innovative new drugs, especially for children and rare diseases.
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.