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What's New (FY2021)
March 30, 2022The 42nd Science Board Meeting
- March 23, 2022Revisions of PRECAUTIONS: Ticagrelor, etc. posted
- March 11, 2022PMDA Alert for Proper Use of Medical Devices: Bleeding Caused by the Use of IMPELLA Circulatory Assistance Pump Catheter, posted
- March 8, 2022MHLW Pharmaceuticals and Medical Devices Safety Information No.390
- January 24, 2022The 41st Science Board Meeting
- January 24, 2022The 3rd Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
- January 11, 2022Report of the PMDA-ATC Pharmaceuticals Review Webinar 2021
- January 11, 2022Report of the PMDA-ATC GMP Inspection Webinar 2021
- January 11, 2022Report of the PMDA-ATC Medical Devices Webinar 2021
- January 4, 2022Chief Executive’s Statement: For patients, with patients -PMDA is further endeavoring “Patients First” in 2022 -
- December 28, 2021ICMRA Statement on Need for Continued Focus on COVID-19 Therapeutics
- December 24, 2021Revisions of PRECAUTIONS (Medical Devices): Power Morcellators posted
- December 24, 2021The 40th Science Board Meeting
- December 9, 2021The 8th Thailand-Japan Symposium
- December 7, 2021JP Drafts (December 2021) posted
- December 7, 2021ICH Quality Forum updated
- November 29, 2021Provision of Information regarding Post-marketing Safety updated
- November 29, 2021Information regarding Newly Introduced Electronic Package Inserts posted
- November 22, 2021PMDA-ATC with NCC MRCT Webinar 2022
- November 18, 2021ICMRA AMR campaign is in progress, November 18 to 24, 2021.
- November 8, 2021JP Drafts (November 2021) posted
- November 8, 2021JP Drafts (September 2021) No.2 updated
- November 2, 2021Report of "ICH Public Web Conference for ICH E6 Guideline for Good Clinical Practice - Update on Progress" posted
- October 29, 2021PMDA-ATC Pharmacovigilance Webinar 2022
- October 27, 2021Report of the PMDA-ATC & U.S. FDA Pediatric Review Webinar 2021
- October 26, 2021Chief Executive’s Statement: Towards “Drug and Health Week” - Consideration with relief services for adverse health effects -
- October 8, 2021The 2nd Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
- October 5, 2021The 7th Subcommittee on Microbiome
- September 16, 2021Q&A on the Master File (MF) System, Part III posted
- September 7, 2021JP Drafts (September 2021) No.1 posted
- August 30, 2021PMDA-ATC Pharmaceuticals Review Webinar 2021
- August 24, 2021Chief Executive’s Statement: PMDA facing towards “Drug-induced Suffering”- Exhibition Room for Remembrance of History of Drug-induced Suffering in PMDA -
- August 18, 2021PMDA-ATC Medical Devices Webinar 2021
- August 13, 2021The 1st Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
- August 12, 2021Chief Executive’s Statement
- August 4, 2021RAPS Convergence 2021 Workshop, Forum, and Session for Medical Device Regulation
- August 3, 2021The 6th Subcommittee on Microbiome
- July 29, 2021Report of the PMDA-ATC Quality Control (Herbal Medicine) Webinar 2021
- July 27, 2021Joint MHLW/PMDA-USP Workshop 'Role of Quality in Pharmaceuticals': Slides have been uploaded
- June 17, 2021Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility
- June 17, 2021Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
- June 17, 2021Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
- June 17, 2021China and Japan Regional Joint Public Meeting on ICH
- June 7, 2021JP Drafts (June 2021) No.2 posted
- June 7, 2021JP Drafts (June 2021) No.1 posted
- June 1, 2021Urgent Safety Information (the blue letter) Joyclu, has been posted.
- May 24, 2021Chief Executive’s Statement: Toward the Earlier Marketing of Innovative Medical Devices
- May 19, 2021Update the page for RWD WG：MHLW notifications on Registry utilization and data reliability
- May 19, 2021The 5th Subcommittee on Microbiome
- May 12, 2021The 39th Science Board Meeting
- April 27, 2021NCC was endorsed to become joint formal CoE with PMDA for "MRCT/GCP inspection" PWA by APEC-LSIF-RHSC.
- April 7, 2021Information on implementation of ICH-Q3D into the Japanese Pharmacopoeia posted