December 8, 2025
Pub cmt
New
JP Drafts (December 2025) posted
December 8, 2025
Safety
New
PMDA Risk Communications: Aspirin-etc. posted
December 8, 2025
Other
New
Information on AI Action Working Group is now available
December 5, 2025
Safety
New
PMDA Risk Communication: Idecabtagene vicleucel etc. posted
December 5, 2025
JP
New
PDG October 2025 News posted
December 4, 2025
Other
New
Recent Publications by PMDA Staff updated
December 3, 2025
Review
Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development Stage(Early Consideration)posted
November 28, 2025
Review
Regulatory Information updated
November 28, 2025
Review
Quasi-Drugs page created
November 28, 2025
Review
Review Reports : Quasi-Drugs page created
November 28, 2025
Review
Others updated
November 26, 2025
Safety
Revisions of PRECAUTIONS: Onasemnogene abeparvovec posted
November 26, 2025
Safety
Revisions of PRECAUTIONS: Bosentan hydrate, etc. posted
November 26, 2025
Review
List of Approved CDx(Companion Diagnostics): Updated Nov 20, 2025
November 26, 2025
Review
English Translation of Review Report: Andembry and Nuvaxovid (Partial Change Approval)
November 25, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.424 posted
December 3, 2025
Quality of Fecal Microbiota Transplantation (FMT) Products at the Initial Development Stage(Early Consideration)posted
November 28, 2025
All
Regulatory Information updated
November 28, 2025
Quasi-Drugs page created
November 28, 2025
Review Reports : Quasi-Drugs page created
November 28, 2025
Others updated
November 26, 2025
Drug
IVD
List of Approved CDx(Companion Diagnostics): Updated Nov 20, 2025
November 26, 2025
Drug
English Translation of Review Report: Andembry and Nuvaxovid (Partial Change Approval)
December 8, 2025
Drug
IVD
New
PMDA Risk Communications: Aspirin-etc. posted
December 5, 2025
Regen.
New
PMDA Risk Communication: Idecabtagene vicleucel etc. posted
November 26, 2025
Regen.
Revisions of PRECAUTIONS: Onasemnogene abeparvovec posted
November 26, 2025
Drug
IVD
Revisions of PRECAUTIONS: Bosentan hydrate, etc. posted
November 25, 2025
All
MHLW Pharmaceuticals and Medical Devices Safety Information No.424 posted
Currently, there is no applicable information.
Currently, there is no applicable information.
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