What's new
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February 6, 2026
JP
New
PDG October 2025 Meeting Highlights posted
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February 6, 2026
Int
New
PMDA Updates (2026 No.1) posted
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February 5, 2026
Review
New
Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation (Early Consideration), Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals (Early Consideration),Consideration in the development of drugs for hypertrophic cardiomyopathy (Early Consideration) posted
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February 4, 2026
Safety
New
English Translated Package Inserts page: Ensure Liquid updated
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February 4, 2026
Review
New
List of Approved Medical Devices: April 2004 to June 2025
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February 2, 2026
Int
New PMDA-ATC Learning Video content has been released on the Pmda Channel
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January 29, 2026
Review
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
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January 29, 2026
Other
Recent Publications by PMDA Staff updated
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January 26, 2026
Review
Software as a Medical Device (SaMD) page updated
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February 5, 2026
New
Thoughts on the Use of Weight of Evidence Approach in Nonclinical Safety Evaluation (Early Consideration), Use of the Weight of Evidence approach as an alternative to nonhuman primate developmental and reproductive toxicity testing for biopharmaceuticals (Early Consideration),Consideration in the development of drugs for hypertrophic cardiomyopathy (Early Consideration) posted
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February 4, 2026
Devices
New
List of Approved Medical Devices: April 2004 to June 2025
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January 29, 2026
Drug
IVD
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
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January 26, 2026
Devices
Software as a Medical Device (SaMD) page updated
Currently, there is no applicable information.
