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April 27, 2026
JP
New
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
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April 27, 2026
JP
New
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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April 27, 2026
Safety
New
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
New
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 13, 2026
Int
PMDA-ATC E-Learning Course contents have been released for FY2026
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April 10, 2026
Review
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
Review
The English versions of Orange Letter No.10~12 have been published.
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April 6, 2026
Review
Software as a Medical Device (SaMD) page updated
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April 6, 2026
Review
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
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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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