- Life Sciences / Healthcare
2025 Amendments to Pharmaceutical and Medical Device Act of Japan
This past September marked the five-year anniversary of the enforcement of the major amendments to the Pharmaceutical and Medical Device Act (the “2019 Amendments”), which were called the “Great Amendments in the Reiwa-Era,” on September 1, 2020. In one of the supplementary provisions of the 2019 Amendments, it was provided that each law after the 2019 Amendments would be reviewed approximately five years after enforcement, and necessary measures would be taken based on the results of that review. Based on this provision, discussions reflecting the status of enforcement had been underway since April 2024; as a result, on May 14, 2025, the 2025 amendments to the PMD Act (the “2025 Amendments”) were enacted. This newsletter provides an outline of the 2025 Amendments, focusing on...To read the full article, please see the PDF file
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Life Sciences / Healthcare Newsletter
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Yoko’s practice focuses on representation of life sciences and technology companies that develop and market pharmaceuticals, biologics, vaccines, diagnostics, medical devices, and digital health products. She specializes in corporate transactions involving complex intellectual property and pharmaceutical regulatory issues, including mergers and acquisitions, joint ventures, strategic alliances and asset transfers. In addition, she counsels clients on matters involving research and development collaborations, clinical trials, technology licensing, supply and distribution agreements, and co-promotion arrangements. She also advises clients in connection with privacy and personal data protection matters.