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May 19, 2026
Safety
New
PMDA Risk Communications: Ferric carboxymaltose etc. posted
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May 19, 2026
JP
New
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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May 15, 2026
Review
New
English Translation of Review Report: Setaneo
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May 13, 2026
Review
New
Seven English translations of notifications and administrative notices related to pediatric drug development, including the partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”
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May 12, 2026
Events
PMDA-ATC GMP Inspection Seminar 2026 applications open
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May 11, 2026
Review
Software as a Medical Device (SaMD) page updated
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May 11, 2026
Review
Points to Consider for Small Clinical Trials (Early Consideration) posted
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May 11, 2026
Review
List of therapeutic products for which eligible patients can be identified by Drug-Agnostic CDx,posted
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May 1, 2026
Int
PMDA-ATC Learning videos have been updated
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April 27, 2026
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
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April 27, 2026
Safety
PMDA Medical Safety Information: Use of Insulin-Specific Syringe- Incorrect dose may cause serious adverse health effects- posted
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April 27, 2026
Int
Information on PMDA Asia Office updated
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April 21, 2026
Safety
Revisions of PRECAUTIONS: Infliximab (genetical recombination) and biosimilars , etc. posted
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April 20, 2026
Int
A new page for the Regulatory Symposia has been launched.
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April 14, 2026
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.428 posted
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April 14, 2026
Review
The information of New Drug Review with Electronic Data updated
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April 13, 2026
Events
The report for the PMDA-ATC Pharmacovigilance Seminar 2026 has been posted.
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April 13, 2026
Int
The report for the APEC CoE workshop: PMDA-ATC Pharacovigilance Seminar 2026 has been posted.
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April 8, 2026
Review
The English versions of Orange Letter No.10~12 have been published.
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April 6, 2026
Review
List of Approved Drugs: April 2004 to September 2025
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April 6, 2026
Events
PMDA-ATC Generic Drugs Review Seminar 2026 applications open
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April 3, 2026
Review
English translation of review report: Peripheral Rotablator PRO and Visual-ICE Cryoablation System (Partial Change Approval)
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