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February 14, 2025
Review
New
English Translation of Review Report: Vyvgart (Partial Change Approval)
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February 14, 2025
Review
New
Information on biosimilars is updated
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February 7, 2025
Safety
PMDA Risk Communication: Axicabtagene ciloleucel, etc. posted
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February 7, 2025
Safety
PMDA Risk Communication: Desmopressin acetate hydrate, etc. 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 5, 2025
Review
Points to consider in the clinical development of drugs for transthyretin amyloid cardiomyopathy (Early Consideration) posted
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February 5, 2025
Review
Points to consider in the clinical development of drugs for transthyretin amyloid cardiomyopathy (Early Consideration) posted
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February 4, 2025
Int
Seminar schedule for FY2025 has been open.
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January 30, 2025
Int
PMDA Updates (January 2025 posted
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January 29, 2025
Safety
Revisions of PRECAUTIONS: Ethical combination drugs (Brand name: Twinpal Injection), etc. posted
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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 23, 2025
Other
Recent Publications by PMDA Staff updated
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January 22, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.416 posted
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January 22, 2025
Review
List of Approved Products (Medical Devices): April 2004 to June 2024
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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
Review
English Translation of Review Report: HeartSheet
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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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December 5, 2024
Review
List of Approved Products (New Drugs): April 2004 to September 2024
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December 5, 2024
Int
GMP class has been added to the Pharmaceuticals Review of E-learning Courses.
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December 2, 2024
Review
English translation of review report: Toraymyxin
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November 1, 2024
Int
Information on PMDA Washington D.C. Office 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 20, 2024
Safety
Notifications Related to Safety Measures (Drugs): ”Amendment of the Instructions for Electronic Package Inserts Regarding Results of Studies Using Medical Information Database” and “Points to Consider for Describing the Results of Studies Using Medical Information Database in Electronic Package Inserts” posted
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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
Review
List of Approved Products: FY2023 (April 2023 to December 2023)
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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 8, 2024
Review
The information of New Drug Review with Electronic Data updated
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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)