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November 13, 2026
Events
New
PMDA-ATC Pharmacovigilance Seminar 2027 applications open
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November 13, 2026
Review
New
Questions and Answers on Clinical Trial Consultations for Pediatric Drug Development posted.
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November 12, 2026
Safety
New
Considerations for the Use of Avacopan Products posted
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November 12, 2026
Review
New
English Translation of Review Report: Lunsumio and Uplizna (Partial Change Approval)
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November 9, 2026
Review
New
The information of New Drug Review with Electronic Data updated
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November 2, 2026
Review
Basic Principles for the Use of AI in Regulatory Activities（Early Consideration） posted.
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November 2, 2026
Int
PMDA-ATC Learning Videos contents have been updated
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October 30, 2026
Safety
PMDA Alert for Proper Use of Drugs: Request for Proper Use of GLP-1 Receptor Agonists and GIP/GLP-1 Receptor Agonists posted
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October 27, 2026
Safety
PMDA Risk Communications: Tapinarof,etc. posted
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October 27, 2026
Safety
Revisions of PRECAUTIONS: Inclisiran sodium,etc.posted
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October 27, 2026
Events
Report of PMDA-ATC GMP Inspection Seminar 2026
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October 26, 2026
Review
List of Approved Regenerative Medical Products: April 2015 to July 2026
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October 14, 2026
Review
SaMD page updated (English translation of “Review Points for Medical Devices Utilizing Generative AI (Draft)” published, consultation schedule updated)
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October 14, 2026
Review
Information on biosimilars is updated
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October 13, 2026
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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October 2, 2026
Review
The new website “Overview of SAKIGAKE Designation“ launched.
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October 2, 2026
Review
The English versions of GMPGCTP Annual Report FY 2025 have been published.
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October 1, 2026
Int
PMDA-ATC Training Materials have been updated
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September 30, 2026
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.431 posted
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September 30, 2026
Int
“For Industry - for development in Japan “ Updated.
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September 30, 2026
Review
"Consultations" Updated
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September 30, 2026
Events
Report of PMDA-ATC Generic Drugs Review Seminar 2026
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September 30, 2026
Int
PMDA Updates (2026 No.3) posted
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September 28, 2026
RS
Regulatory Science Activity Report updated
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September 18, 2026
Events
PMDA-ATC MRCT/GCP Inspection Seminar 2027 applications open
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September 17, 2026
Review
CDx approved for identifying eligible patients (Updated)
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September 17, 2026
JP
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated
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September 17, 2026
Review
List of Approved Medical Devices: April 2004 to December 2025
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September 10, 2026
Review
English Translation of Review Report: remedē System
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September 9, 2026
Events
Report on the PMDA Hokuriku Branch 10th Anniversary Symposium
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September 8, 2026
Pub cmt
JP Drafts (September 2026) Part 1 posted
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September 8, 2026
Pub cmt
JP Drafts (September 2026) Part 2 posted
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September 3, 2026
Review
English Translation of Review Report: Akuugo (Partial Change Approval)
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August 31, 2026
Events
Report of PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026
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August 18, 2026
Review
One-Stop Service Platform by ENSEMBLExJ page 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 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 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 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
-
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.
-
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 12, 2026
Events
PMDA-ATC GMP Inspection Seminar 2026 applications open
-
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 13, 2026
Events
The report for the PMDA-ATC Pharmacovigilance Seminar 2026 has been posted.
-
April 13, 2026
Int
Seminar Schedule
-
April 6, 2026
Events
PMDA-ATC Generic Drugs Review Seminar 2026 applications open
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