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What's New
August 12, 2022English Translation of Review Report: Xarelto (Partial Change Approval)
- August 8, 2022PMDA-ATC Medical Devices Webinar 2022 - Explanation of/Insight into IMDRF documents
- August 3, 2022The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
- August 2, 2022The 43rd Science Board Meeting
- August 1, 2022PMDA-ATC E-learning videos are now available on YouTube
- July 29, 2022PMDA Risk Communication: Hydroxychloroquine sulfate, etc. posted
- July 29, 2022Risk Management Plan (RMP) ：RMP Page renewal, Questions and Answers (Qs and As) on Risk Management Plan, Risk Management Plan templates, instructions and publication posted
- July 28, 2022PMDA Updates (July, 2022) posted
- July 20, 2022Revisions of PRECAUTIONS: Eszopiclone, etc. posted
- July 19, 2022Dr. Yasuhiro Fujiwara, Chief Executive of PMDA, re-elected Vice Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) (News Release) (July 19, 2022)
- July 15, 2022English translation of review report: Matsudaito
- July 12, 2022MHLW Pharmaceuticals and Medical Devices Safety Information No.393
- June 29, 2022List of Approved Products (Medical Devices): FY 2021 (April 2021 -December 2021)
- June 28, 2022PDG March 2022 Videoconference Meeting Press Release posted
- June 24, 2022The 5th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
- June 13, 2022The 2nd Malaysia-Japan Symposium
- June 9, 2022List of Approved Products (New Drugs): FY 2021 (April 2021 - March 2022)
- June 2, 2022English Translated Package Inserts page now available. Gadoteridol posted.
- June 2, 2022PMDA Medical Safety Informations: Introduction of Connectors to Prevent Misconnection (for Enteral Applications) posted.
- May 31, 2022Notifications Related to Safety Measures (Medical Devices) : Implementation of Information Provision on Proper use of Automated External Defibrillators and Defibrillator Electrodes for Body Surface posted.
- May 27, 2022Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
- May 27, 2022ICMRA（International Coalition of Medicines Regulatory Authorities）
- May 23, 2022English Translation of Review Report: Alofisel
- April 26, 2022PMDA Alert for Proper Use of Drugs: No.14
- April 20, 2022Notifications and Administrative Notices: Amendment to “Basic Principles on Global Clinical Trials (Reference Cases)”
- April 11, 2022The 4th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes