What's new
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April 14, 2026
Drug
New
The information of New Drug Review with Electronic Data updated
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April 10, 2026
New
Considerations for clinical development of intravenous formulations containing the same active ingredient as oral products for patients who are temporarily unable to receive oral administration in epilepsy treatment （Early consideration） posted
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April 8, 2026
Quasi
Drug
The English versions of Orange Letter No.10~12 have been published.
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April 6, 2026
Devices
Software as a Medical Device (SaMD) page updated
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April 6, 2026
Drug
IVD
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
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April 6, 2026
Drug
List of Approved Drugs: April 2004 to September 2025
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April 3, 2026
Devices
English translation of review report: Peripheral Rotablator PRO and Visual-ICE Cryoablation System (Partial Change Approval)
