What's new
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October 14, 2025
Review
New
The information of New Drug Review with Electronic Data updated
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October 10, 2025
Review
New Modalities and NAMs page created
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October 9, 2025
Other
Recent Publications by PMDA Staff updated
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October 8, 2025
Other
Action Plan for the Use of AI in Operations at the PMDA(News Release) (October 10, 2025)
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October 7, 2025
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.423 posted
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October 7, 2025
Review
English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
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October 6, 2025
Review
Rationalization of descriptions in the specification column in approval application forms for prescription drugs, Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with Manufacturing Process Changes, Handling of Prescription Drugs Having Different Crystalline Forms, etc., Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs posted
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October 14, 2025
Drug
New
The information of New Drug Review with Electronic Data updated
-
October 10, 2025
New Modalities and NAMs page created
-
October 7, 2025
Drug
English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
-
October 6, 2025
Rationalization of descriptions in the specification column in approval application forms for prescription drugs, Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with Manufacturing Process Changes, Handling of Prescription Drugs Having Different Crystalline Forms, etc., Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs posted
Currently, there is no applicable information.
Currently, there is no applicable information.
