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What's New
May 26, 2023Cooperation between WHO and PMDA on training for regulatory authorities
May 26, 2023English Translation of Review Report: Vyvgart
May 25, 2023English Translation of Review Report: Carvykti
May 19, 2023PMDA Risk Communication: Nivolumab (genetical recombination), etc. posted
May 17, 2023The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
May 12, 2023Checklist for GCP Inspection for New Drug for Sponsor and Medical Institution posted
May 9, 2023Revisions of PRECAUTIONS: Azilsartan, etc. posted
May 9, 2023PMDA Alert for Proper Use of Drugs: No.10 (Revised)
May 9, 2023Regenerative Medical Products Information posted
May 9, 2023Regulations Regarding Living Modified Organisms (Genetically Modified Organisms) posted
April 27, 2023PMDA Updates (April, 2023) posted
April 27, 2023English translation of review report: Harmony Transcatheter Pulmonary Valve Replacement System
April 25, 2023PDG March 2023 Videoconference Meeting Press Release posted
April 21, 2023List of Approved Products (Medical Devices): FY 2022 (April 2022 -September 2022)
April 20, 2023MHLW Pharmaceuticals and Medical Devices Safety Information No.400
April 11, 2023The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
April 3, 2023FAQs on Electronic Study Data Submission posted