What's new
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March 27, 2026
Safety
New
PMDA Risk Communications: Infliximab (genetical recombination) etc. posted
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March 27, 2026
Review
New
Document-based Inspection to CTD M3(Quality studies)/M4(Non-clinical studies other than GLP studies) data page created
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March 25, 2026
Review
New
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
-
March 25, 2026
Review
New
The information of New Drug Review with Electronic Data updated
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March 23, 2026
Other
New
Recent Publications by PMDA Staff updated
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March 17, 2026
Safety
Revisions of PRECAUTIONS: Triazolam, etc. posted
-
March 16, 2026
Review
Points to Consider in the Clinical Development of Radiopharmaceuticals for Positron Emission Tomography Targeting Prostate Specific Membrane Antigen (PSMA PET) (Early Consideration) posted
-
March 27, 2026
Drug
Regen.
New
Document-based Inspection to CTD M3(Quality studies)/M4(Non-clinical studies other than GLP studies) data page created
-
March 25, 2026
Drug
IVD
New
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
-
March 25, 2026
Drug
New
The information of New Drug Review with Electronic Data updated
-
March 16, 2026
Points to Consider in the Clinical Development of Radiopharmaceuticals for Positron Emission Tomography Targeting Prostate Specific Membrane Antigen (PSMA PET) (Early Consideration) posted
Currently, there is no applicable information.
Currently, there is no applicable information.
