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October 30, 2025
Review
New
English Translation of Review Report: Kavigale
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October 30, 2025
Review
New
List of Approved Medical Devices: April 2004 to March 2025
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October 28, 2025
Other
New
Recent Publications by PMDA Staff updated
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October 24, 2025
Review
New
Information on biosimilars is updated
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October 22, 2025
Safety
Revisions of PRECAUTIONS: Lubiprostone, etc. posted
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October 22, 2025
Events
PMDA-ATC Pharmacovigilance Seminar 2026 applications open
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October 14, 2025
Review
The information of New Drug Review with Electronic Data updated
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October 10, 2025
Review
New Modalities and NAMs page created
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October 8, 2025
Other
Action Plan for the Use of AI in Operations at the PMDA(News Release) (October 10, 2025)
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October 7, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.423 posted
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October 6, 2025
Review
Rationalization of descriptions in the specification column in approval application forms for prescription drugs, Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with Manufacturing Process Changes, Handling of Prescription Drugs Having Different Crystalline Forms, etc., Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs posted
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October 2, 2025
Review
Concept of New Approach Methodologies (NAMs) use in quasi-drug applications (Early Consideration) and Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker (Early consideration) posted
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October 1, 2025
Int
New PMDA-ATC E-learning content has been released on the Pmda Channel
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September 30, 2025
Review
List of Approved CDx（Companion Diagnostics）: Updated Sep 19, 2025
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September 30, 2025
Int
PMDA Washington D.C. Office Map Refreshed
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September 26, 2025
Events
PMDA-ATC Pharmaceuticals Review Webinar 2025 applications open
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September 26, 2025
Events
PMDA-ATC MRCT/GCP Inspection Seminar 2026 applications open
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September 19, 2025
Safety
PMDA Risk Communications: Lubiprostone, etc. posted
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September 18, 2025
Safety
PMDA Alert for Proper Use of Drugs: No. 7 Compliance with Measurement of Blood Lithium Levels during Treatment with Lithium Carbonate (revision) posted
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September 10, 2025
Events
PMDA-ATC Medical Devices Webinar 2025 for AMDC
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September 8, 2025
Pub cmt
JP Drafts (September 2025) posted
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September 5, 2025
Review
GMP / GCTP Annual Report FY 2024 posted
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September 4, 2025
Events
Report of the PMDA-ATC Review of CGTP products Seminar 2025 for South-East Asian Countries
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September 2, 2025
Review
English translation of review report: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
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September 1, 2025
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (September 2025) posted
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August 28, 2025
Safety
Revisions of PRECAUTIONS: Delandistrogene moxeparvovec posted
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August 25, 2025
JP
PDG Revision of Q-09 Particulate contamination News posted
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August 22, 2025
Int
PMDA Updates (2025 Summer) posted
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August 7, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
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August 1, 2025
Events
Report of PMDA-ATC Pediatric Review Seminar 2025
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July 30, 2025
Review
New radiopharmaceuticals page created
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July 25, 2025
Events
Joint Statement on Cooperation between Japan and the Republic of Korea on Medical Products Regulations
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July 23, 2025
Safety
PMDA Risk Communications (medical devices risk information of ongoing evaluation): Cadaveric dura mater posted
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July 18, 2025
Int
HBD East 2025 Think Tank Meeting
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July 15, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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July 15, 2025
Events
Call for PMDA-ATC Herbal Medicine Review Seminar 2025 has been opened
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July 15, 2025
Int
Call for PMDA-ATC Herbal Medicine Review Seminar 2025 has been opened
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July 1, 2025
Review
List of Approved Drugs: April 2004 to March 2025
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June 30, 2025
Int
Information of IMDRF2025 Sapporo Meeting (September 15 to 19) available now.
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June 10, 2025
Events
ASEAN-Japan Medical Devices Regulatory Symposium 2025 Report
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June 9, 2025
Pub cmt
JP Drafts (June 2025) Part 1 posted
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June 9, 2025
Pub cmt
JP Drafts (June 2025) Part 2 posted
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May 27, 2025
Events
ASEAN-Japan Medical Devices Regulatory Seminar 2025 Report
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May 16, 2025
Events
PMDA-ATC GMP Inspection Seminar 2025
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April 30, 2025
Events
The 3rd Malaysia-Japan Symposium website is opened
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April 28, 2025
Review
English Translation of Review Report: Akuugo
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April 18, 2025
Safety
PMDA Risk Communication: Onasemnogene abeparvovec posted
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April 18, 2025
Review
“Initiatives to Promote Pediatric Drug Development” posted
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April 9, 2025
JP
Implementation of ICH-Q3D into Japanese Pharmacopoeia updated
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April 3, 2025
Events
PMDA-ATC Review of CGTPs Seminar 2025 for South-East Asian countries
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