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September 3, 2026
Review
New
English Translation of Review Report: Akuugo (Partial Change Approval)
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September 3, 2026
Review
New
Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.
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September 1, 2026
Int
New
PMDA-ATC Training Materials have been updated
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August 31, 2026
Review
New
Available schedule for consultation by the Office of Software as a Medical Device updated
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August 31, 2026
Events
New
Report of PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026
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August 28, 2026
Safety
New
MHLW Pharmaceuticals and Medical Devices Safety Information No.430 posted
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August 28, 2026
Safety
New
Revisions of PRECAUTIONS: Tucatinib ethanolate, etc. posted
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August 28, 2026
Review
New
CDx approved for identifying eligible patients (Updated)
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August 25, 2026
Safety
PMDA Risk Communications: Azathioprine etc. posted
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August 18, 2026
Review
One-Stop Service Platform by ENSEMBLExJ page updated
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August 17, 2026
Review
English Translation of Review Report: Beovu (Partial Change Approval)
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August 14, 2026
Review
English Translation of Review Report: Optune Lua and Esprit BTK Everolimus Eluting Resorbable Scaffold System
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August 5, 2026
Review
List of Approved Regenerative Medical Products: April 2015 to May 2026
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August 3, 2026
Review
Information on biosimilars is updated
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July 28, 2026
Events
ASEAN-Japan Medical Devices Regulatory Symposium 2026 Report
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July 24, 2026
Events
PMDA-ATC Blood Products Seminar 2026 for PPWG Applications open.
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July 24, 2026
Events
ASEAN-Japan Medical Devices Regulatory Seminar 2026
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July 24, 2026
Events
PMDA-ATC Herbal Medicine Seminar 2026
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July 24, 2026
Int
The 8th Asian Network Meeting (ANM) summary has been posted
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July 13, 2026
JP
Press Release regarding international activities related to Pharmacopoeia posted
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July 10, 2026
Int
PMDA Updates (2026 No.2) posted
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July 7, 2026
Other
PMDA Concludes a Memorandum of Understanding with the London School of Hygiene & Tropical Medicine (LSHTM) (News Release) (July 6, 2026) [222KB]
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July 1, 2026
Other
Conclusion of a Memorandum of Understanding between the Medical University of Vienna and the Pharmaceuticals and Medical Devices Agency (PMDA) (News Release) (June 30, 2026) [263KB]
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June 30, 2026
Safety
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 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 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 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 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
-
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
-
April 14, 2026
Review
The information of New Drug Review with Electronic Data updated
-
April 13, 2026
Events
The report for the PMDA-ATC Pharmacovigilance Seminar 2026 has been posted.
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April 13, 2026
Int
Seminar Schedule
-
April 8, 2026
Review
The English versions of Orange Letter No.10~12 have been published.
-
April 6, 2026
Events
PMDA-ATC Generic Drugs Review Seminar 2026 applications open
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