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October 9, 2025
Other
New
Recent Publications by PMDA Staff updated
October 7, 2025
Safety
New
MHLW Pharmaceuticals and Medical Devices Safety Information No.423 posted
October 7, 2025
Review
New
English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
October 6, 2025
Review
New
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
October 2, 2025
Review
Concept of New Approach Methodologies (NAMs) use in quasi-drug applications (Early Consideration) and Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker (Early consideration) posted
October 1, 2025
Int
New PMDA-ATC E-learning content has been released on the Pmda Channel
September 30, 2025
Review
List of Approved CDx(Companion Diagnostics): Updated Sep 19, 2025
September 30, 2025
Int
PMDA Washington D.C. Office Map Refreshed
September 26, 2025
Events
PMDA-ATC Pharmaceuticals Review Webinar 2025 applications open
September 26, 2025
Events
PMDA-ATC MRCT/GCP Inspection Seminar 2026 applications open
October 7, 2025
Drug
New
English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
October 6, 2025
New
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
October 2, 2025
Concept of New Approach Methodologies (NAMs) use in quasi-drug applications (Early Consideration) and Points to Consider for Clinical Evaluation of Drug-Drug Interactions using Endogenous Biomarker (Early consideration) posted
September 30, 2025
Drug
IVD
List of Approved CDx(Companion Diagnostics): Updated Sep 19, 2025
Currently, there is no applicable information.