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October 7, 2025
Review
New
English Translation of Review Report: Datroway and Kostaive (Partial Change Approval)
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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
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October 2, 2025
Review
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
Review
List of Approved CDx(Companion Diagnostics): Updated Sep 19, 2025
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September 5, 2025
Review
GMP / GCTP Annual Report FY 2024 posted
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September 2, 2025
Review
English translation of review report: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
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August 7, 2025
Review
List of Approved Medical Devices: April 2004 to December 2024
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July 30, 2025
Review
New radiopharmaceuticals page created
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July 11, 2025
Review
Information on biosimilars is updated
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July 1, 2025
Review
List of Approved Drugs: April 2004 to March 2025
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April 28, 2025
Review
English Translation of Review Report: Akuugo
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April 18, 2025
Review
"Initiatives to Promote Pediatric Drug Development" posted
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March 14, 2025
Review
The information of New Drug Review with Electronic Data updated
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March 3, 2025
Review
List of Approved Products: April 2015 to September 2024
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February 28, 2025
Int
The new website "For Industry - for development in Japan " launched.
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February 17, 2025
Review
Consideration in the development of drugs for pulmonary arterial hypertension (Early Consideration) posted
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December 17, 2024
Review
Check List for 30-day-Clinical Trial Notification Review on an Initial Clinical Trial Notification (Oncology Drugs)
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August 23, 2024
Review
PMDA’s Support to Venture Companies posted
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June 21, 2024
Review
GMP compliance inspection updated
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May 30, 2024
Review
Pamphlet of Regulatory Science Consultations is posted
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September 26, 2023
Review
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
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May 9, 2023
Review
Regulations Regarding Living Modified Organisms (Genetically Modified Organisms) posted
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May 9, 2023
Review
Regenerative Medical Products Information posted
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January 25, 2023
Review
Ministerial Ordinance on Good Clinical Practice for Drugs updated
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September 16, 2021
Review
Q&A on the Master File (MF) System, Part III posted
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June 12, 2015
Review
The Pilot Project in The Last Half of FY2014 (Outline and results)