What's new
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October 13, 2026
JP
New
Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated
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October 9, 2026
Review
New
Considerations for Safety Assurance Measures in Bioequivalence Studies in Healthy Adults for the Development of Generic Drugs(Early Consideration) posted.
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October 8, 2026
Safety
New
Revisions of PRECAUTIONS: Anamorelin hydrochloride,etc.posted
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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 29, 2026
Safety
PMDA Risk Communications: Ibuprofen L-Lysine,etc. posted
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September 29, 2026
Review
English Translation of Review Report: Jivi (Partial Change Approval)
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October 9, 2026
New
Considerations for Safety Assurance Measures in Bioequivalence Studies in Healthy Adults for the Development of Generic Drugs(Early Consideration) posted.
-
October 2, 2026
The new website “Overview of SAKIGAKE Designation“ launched.
-
October 2, 2026
Quasi
Drug
The English versions of GMPGCTP Annual Report FY 2025 have been published.
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September 30, 2026
All
“For Industry - for development in Japan “ Updated.
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September 30, 2026
"Consultations" Updated
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September 29, 2026
Drug
English Translation of Review Report: Jivi (Partial Change Approval)
Currently, there is no applicable information.
