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What's New
December 5, 2022Revisions of PRECAUTIONS: Amlodipine besilate, etc. posted
- December 2, 2022PMDA Risk Communication: Clopidogrel sulfate, etc. posted
- December 2, 2022The 4th ICH Efficacy Forum: ICH Efficacy Guideline Update
- December 1, 2022PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (December, 2022) posted
- December 1, 2022PMDA-ATC E-learning videos are now available on YouTube
- November 30, 2022English Translation of Review Report: Comirnaty RTU (bivalent, Original/Omicron BA.1) and Spikevax (bivalent, Original/Omicron BA.1)
- November 30, 2022The 2nd Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
- November 29, 2022PMDA Updates (November, 2022) posted
- November 18, 2022COVID-19 Vaccine Review report has been updated
- November 15, 2022The 3rd Vietnam-Japan Symposium
- November 15, 2022The 6th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
- November 11, 2022MHLW Pharmaceuticals and Medical Devices Safety Information No.396
- October 31, 2022PMDA-ATC Pharmacovigilance Webinar 2023
- October 21, 2022A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines
- October 20, 2022English translation of review report: nodoca
- October 14, 2022Notifications Related to Safety Measures (Regenerative Medical Products) : "Labeling of Codes on Containers to Identify Regenerative Medical Products, etc.” posted.
- October 14, 2022PMDA-ATC with National Cancer Center MRCT Webinar 2023
- October 7, 2022PMDA Alert for Proper Use of Drugs: No.14 (Revised)
- October 4, 2022Profile of Services posted
- October 4, 2022Notifications Related to Safety Measures (Medical Devices) : “Labeling of Codes on Containers to Identify Medical Devices, In Vitro Diagnostics, etc.” posted.
- October 4, 2022Notifications Related to Safety Measures (Drugs): “Labeling of Codes on Containers to Identify Prescription Drugs” posted.
- September 30, 2022PMDA-ATC/AMDC Medical Devices Webinar 2022
- September 28, 2022The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
- September 9, 2022PDG September 2022 Press Release posted
- September 6, 2022PMDA-ATC Pharmaceuticals Review Webinar 2022
- September 2, 2022List of Approved Products (New Drugs): FY 2022 (April 2022 - August 2022)
- August 31, 2022Notifications and Administrative Notices: Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products
- August 25, 2022English Translation of Review Report: Sakracy
- August 23, 2022ICMRA (International Coalition of Medicines Regulatory Authorities)
- August 22, 2022The 5th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
- August 19, 2022List of Approved Products: FY2021 (April 2021 - March 2022)
- August 8, 2022APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022
- August 2, 2022The 43rd Science Board Meeting
- 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 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)
- June 29, 2022List of Approved Products (Medical Devices): FY 2021 (April 2021 -December 2021)
- June 13, 2022The 2nd Malaysia-Japan Symposium
- 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 27, 2022Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
- April 11, 2022The 4th Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes