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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