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June 30, 2026
Safety
New
Revisions of PRECAUTIONS: Cefcapene Pivoxil Hydrochloride Hydrate, etc. posted
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June 30, 2026
Safety
New
PMDA Alert for Proper Use of Drugs: Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group (follow-up report) posted
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June 30, 2026
Review
New
English Translation of Review Report: SUSMED App for Insomnia Medcle (Partial Change Approval)
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June 29, 2026
Review
New
Information Regarding Explanations to Driver Mutations in the Development of Anti-cancer Drugs（Early Consideration）posted.
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June 23, 2026
Review
English Translation of Review Report: Vabysmo (Partial Change Approval)
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June 22, 2026
Review
CDx approved for identifying eligible patients (Updated June 16, 2026)
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June 22, 2026
Review
List of Approved Drugs: April 2004 to February 2026
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June 19, 2026
Events
The report for the PMDA Asia office GCP workshop 2026 has been posted.
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June 19, 2026
Events
The report for the PMDA Asia office GMP Workshop Training 2026 has been posted.
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June 16, 2026
Safety
PMDA Risk Communications: Omeprazole etc. posted
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June 12, 2026
JP
PDG March 2026 News posted
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June 11, 2026
Review
List of Approved Medical Devices: April 2004 to September 2025
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June 10, 2026
Events
Workshop on New Approach Methodologies (NAMs) Held following ICCR-20
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June 8, 2026
Other
"Project team for Consideration of Guiding Principles for AI Utilization" has been added in “Projects Across Multi-Offices”
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June 5, 2026
Review
Software as a Medical Device (SaMD) page updated
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June 4, 2026
Events
Report on the PMDA-ATC 10th Anniversary Ceremony has been posted.
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June 1, 2026
Events
Symposium for the 10 anniversary of the PMDA Hokuriku Branch
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May 27, 2026
JP
Schedule of JP19-I Publication posted
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May 26, 2026
Review
English Translation of Review Report: Elevidys and Vyjuvek Gel
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May 25, 2026
Int
Registration for the ASEAN-Japan Medical Devices Regulatory Symposium is now open.
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May 22, 2026
Review
The new website “Overview of Orphan Drug Designation“ launched.
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May 22, 2026
Review
The new website “Designation / Early Access“ launched.
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May 21, 2026
Safety
Urgent Safety Information (the blue letter) tavneos, has been posted.
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May 19, 2026
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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May 13, 2026
Review
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 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 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
Events
PMDA-ATC Generic Drugs Review Seminar 2026 applications open
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