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March 27, 2025
Int
PMDA Updates (March 2025) posted
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March 17, 2025
Int
PMDA Washington D.C. Office General Consultation Service posted
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March 17, 2025
Safety
Notification Related to Safety Measures (Drugs): Questions and Answers (Qs & As) on the Guidance for Provision of Dear Healthcare Professional Letters of Emergent/Rapid Safety Communications posted
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March 14, 2025
Review
The information of New Drug Review with Electronic Data updated
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March 5, 2025
Safety
Revisions of PRECAUTIONS: Axicabtagene ciloleucel, etc. posted
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March 5, 2025
Safety
Revisions of PRECAUTIONS: Ethical combination drugs (Brand name: Twinpal Injection), etc. posted
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March 4, 2025
Review
Regenerative Medical Products Information posted
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March 3, 2025
Review
List of Approved Products: April 2015 to September 2024
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February 28, 2025
Int
The new website “For Industry - for development in Japan “ launched.
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February 28, 2025
JP
PDG October 2024 Meeting Highlights posted
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February 26, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.417 posted
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February 25, 2025
Review
List of Approved Products (Medical Devices): April 2004 to September 2024
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February 19, 2025
Events
PMDA-ATC Pediatric Review Seminar 2025
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February 17, 2025
Review
Consideration in the development of drugs for pulmonary arterial hypertension (Early Consideration) posted
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February 7, 2025
Review
GMP / GCTP Annual Report FY 2023 posted
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February 5, 2025
Safety
PMDA Medical Safety Information: Cases of Air Embolism Due to the Use of Central Venous Catheters (No. 71) posted
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February 4, 2025
Int
Seminar schedule for FY2025 has been open.
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January 29, 2025
Events
PMDA-ATC Medical Devices Webinar 2025 for AMDC
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January 24, 2025
JP
Revised PDG Working Procedure posted
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January 21, 2025
JP
PDG October 2024 Press Release posted
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January 20, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
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January 20, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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January 17, 2025
Int
IMDRF2025 information available now.
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January 7, 2025
Other
New PMDA Logo towards a New Chapter: Celebrating 20 Years (News Release) (January 7, 2025)
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January 6, 2025
Safety
Notification Related to Safety Measures (Regenerative Medical Products) : Instructions for Electronic Package Inserts of Regenerative Medical Products posted
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December 24, 2024
JP
JP 18th Edition Supplement II (English version) posted
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December 17, 2024
Safety
PMDA Alert for Proper Use of Drugs: Administration of Treatment Drugs for COVID-19 (Xocova Tablets and Lagevrio Capsules) to Women of Childbearing Potential posted
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December 17, 2024
Safety
Notification Related to Safety Measures (Regenerative Medical Products) : Instructions for Electronic Package Inserts of Regenerative Medical Products posted
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December 17, 2024
Review
Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)
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December 9, 2024
Pub cmt
JP Drafts (December 2024) posted
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November 1, 2024
Other
Establishment of PMDA Washington, D.C. Office - as First US Base - (News Release) (November 1, 2024) [434KB]
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October 30, 2024
Other
"Project team for Consideration of Inquiries Concerning Pediatric Drugs Development Program” has been added in “Projects Across Multi-Offices”
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October 28, 2024
Events
Report of International Symposium for Asia Regulatory Coordination posted
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October 24, 2024
Safety
Update: Publication of MIHARI project
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October 23, 2024
Events
PMDA-ATC Pharmacovigilance Seminar 2025
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October 18, 2024
Other
Profile of Services posted
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October 7, 2024
Pub cmt
JP Drafts (September 30, 2024) posted
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September 17, 2024
Events
Call for PMDA-ATC MRCT/GCP Inspection Seminar 2025 has been opened
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September 10, 2024
Events
Call for PMDA-ATC Pharmaceuticals Review Webinar 2024
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September 9, 2024
Pub cmt
JP Drafts (September 2, 2024) No.2 posted
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September 9, 2024
Pub cmt
JP Drafts (September 2, 2024) No.1 posted
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August 23, 2024
Review
PMDA’s Support to Venture Companies posted
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August 22, 2024
Events
Call for PMDA-ATC Medical Devices Workshop 2024
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August 20, 2024
Int
Information on PMDA Asia Office posted
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August 20, 2024
Other
Outcome Document of the Subcommittee on Cell and Gene Therapy Products Produced in vivo posted
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July 16, 2024
Events
USP-MHLW/PMDA Joint Workshop
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July 16, 2024
JP
USP-MHLW/PMDA Joint Workshop - Registration started
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July 9, 2024
Events
Call for PMDA-ATC Herbal Medicine Review Seminar 2024 has been opened
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July 1, 2024
Other
Establishment of PMDA Asia Office - as First Overseas Base - (News Release) (July 1, 2024) [266.84KB]
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June 21, 2024
Review
GMP compliance inspection updated
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June 7, 2024
Pub cmt
JP Drafts (June 2024) No.2 posted
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June 7, 2024
Pub cmt
JP Drafts (June 2024) No.1 posted
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June 6, 2024
Int
Asian Network Meeting (ANM) posted
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June 6, 2024
Events
Call for PMDA-ATC GMP Inspection Seminar 2024 has been opened
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June 3, 2024
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (June 2024) posted
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May 30, 2024
Review
Pamphlet of Regulatory Science Consultations is posted
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May 7, 2024
Int
ICMRA COVID-19 Virus Variants Workshop held in February 2024 posted
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April 10, 2024
Safety
Notifications Related to Safety Measures (medical devices): Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. (Part 2) posted
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April 1, 2024
Other
The new Purpose established on the 20th anniversary of the PMDA – PMDA will move to a new stage to make everyone’s brighter lives.- (News Release)
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