What's new
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October 7, 2025
Drug
New
English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
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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
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October 2, 2025
New
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
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September 30, 2025
Drug
IVD
List of Approved CDx（Companion Diagnostics）: Updated Sep 19, 2025
