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