What's new
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June 5, 2026
Devices
New
Software as a Medical Device (SaMD) page updated
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June 4, 2026
Drug
New
English Translation of Review Report: Doptelet (Partial Change Approval)
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June 4, 2026
New
English-language Early Considerations 'Considerations for the General Toxicity Evaluation of Monoclonal Antibodies （Early Consideration）' has been published.
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May 29, 2026
Devices
English translation of review report: Coseal
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May 26, 2026
Regen.
English Translation of Review Report: Elevidys and Vyjuvek Gel
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May 22, 2026
The new website “Overview of Orphan Drug Designation“ launched.
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May 22, 2026
The new website “Designation / Early Access“ launched.
