January 29, 2026
Review
New
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
January 29, 2026
Other
New
Recent Publications by PMDA Staff updated
January 26, 2026
Review
New
Software as a Medical Device (SaMD) page updated
January 22, 2026
Review
English Translation of Review Report: Lialda (Partial Change Approval) and Zepbound
January 22, 2026
Review
Points to Consider for Replacement of Conventional Tests for Viruses with Next Generation Sequencing (NGS) Assays (Early Consideration) posted
January 19, 2026
Review
Information on biosimilars is updated
January 29, 2026
Drug
IVD
New
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
January 26, 2026
Devices
New
Software as a Medical Device (SaMD) page updated
January 22, 2026
Drug
English Translation of Review Report: Lialda (Partial Change Approval) and Zepbound
January 22, 2026
Points to Consider for Replacement of Conventional Tests for Viruses with Next Generation Sequencing (NGS) Assays (Early Consideration) posted
January 19, 2026
Drug
Information on biosimilars is updated
Currently, there is no applicable information.
Currently, there is no applicable information.
Currently, there is no applicable information.
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