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July 1, 2025
Review
New
List of Approved Drugs: April 2004 to March 2025
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July 1, 2025
Int
New
Training materials have been updated.
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June 30, 2025
Int
New
Information of IMDRF2025 Sapporo Meeting (September 15 to 19) available now.
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June 24, 2025
Safety
New
Revisions of PRECAUTIONS: Thiamazole, etc. posted
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June 20, 2025
Other
Recent Publications by PMDA Staff updated
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June 18, 2025
Review
English Translation of Review Report: Fabhalta
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June 17, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.420 posted
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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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June 6, 2025
Review
Points to Consider for Clinical Development of Drugs Intended for Treatment of Antimicrobial-resistant Gram-negative Bacterial Infections (Early Consideration) posted
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June 2, 2025
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (June 2025) posted
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May 30, 2025
Safety
PMDA Risk Communication: Thiamazole, etc. posted
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May 30, 2025
Int
PMDA Updates (2025 Spring) posted
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May 27, 2025
Events
ASEAN-Japan Medical Devices Regulatory Seminar 2025 Report
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May 20, 2025
Safety
Revisions of PRECAUTIONS: Onasemnogene abeparvovec posted
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May 20, 2025
Review
List of Approved CDx（Companion Diagnostics）: Updated May 14, 2025
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May 19, 2025
JP
PDG March 2025 Videoconference Press Release posted
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May 16, 2025
Events
PMDA-ATC GMP Inspection Seminar 2025
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May 14, 2025
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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May 14, 2025
Int
Call for 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 14, 2025
Review
Information on biosimilars is updated
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April 9, 2025
JP
Implementation of ICH-Q3D into Japanese Pharmacopoeia updated
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April 4, 2025
Review
English translation of review report: SENTINEL Cerebral Protection System
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April 3, 2025
Events
PMDA-ATC Review of CGTPs Seminar 2025 for South-East Asian countries
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