www.mhlw.go.jp/stf/newpage_65484.html

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第２３回 医療機器・体外診断薬の承認審査や安全対策等に関する定期意見交換会 議事録 ｜厚生労働省

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This page contains the proceedings of the 23rd Regular Opinion Exchange Meeting on Medical Device and In Vitro Diagnostic Approval Reviews and Safety Measures, held on September 26, 2025. Hosted by the Pharmaceutical Affairs Bureau of the Ministry of Health, Labour and Welfare, the meeting was conducted in a hybrid format at PMDA conference rooms and online. Director Miyamoto reported the May enactment of the revised Pharmaceutical Affairs Law, clarifying real-world data utilization in pharmaceutical applications and promoting AI-driven medical device development. PMDA President Fujiwara emphasized achieving review timeline targets and advancing the fifth mid-term plan focusing on scientific capability enhancement, internationalization, and operational efficiency improvement.