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September 18, 2026
Review
New
SaMD page updated (guide revised, seminar videos and materials published, consultation schedule updated)
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September 17, 2026
Review
New
CDx approved for identifying eligible patients (Updated)
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September 17, 2026
Review
New
English Translation of Review Report: Opsumit (Partial Change Approval)
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September 17, 2026
Review
New
List of Approved Medical Devices: April 2004 to December 2025
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September 10, 2026
Review
English Translation of Review Report: remedē System
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September 3, 2026
Review
English Translation of Review Report: Akuugo (Partial Change Approval)
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September 3, 2026
Review
Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.
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August 18, 2026
Review
One-Stop Service Platform by ENSEMBLExJ page updated
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August 5, 2026
Review
List of Approved Regenerative Medical Products: April 2015 to May 2026
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August 3, 2026
Review
Information on biosimilars is updated
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June 22, 2026
Review
List of Approved Drugs: April 2004 to February 2026
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May 22, 2026
Review
The new website “Overview of Orphan Drug Designation“ launched.
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May 22, 2026
Review
The new website “Designation / Early Access“ launched.
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May 13, 2026
Review
Seven English translations of notifications and administrative notices related to pediatric drug development, including the partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”
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April 14, 2026
Review
The information of New Drug Review with Electronic Data updated
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April 8, 2026
Review
The English versions of Orange Letter No.10~12 have been published.
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March 27, 2026
Review
Document-based Inspection to CTD M3(Quality studies)/M4(Non-clinical studies other than GLP studies) data page created
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November 28, 2025
Review
Regulatory Information updated
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November 28, 2025
Review
Quasi-Drugs page created
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November 28, 2025
Review
Review Reports : Quasi-Drugs page created
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November 28, 2025
Review
Others updated
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November 14, 2025
Review
Information on new modalities is now available
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October 10, 2025
Review
New Modalities and NAMs page created
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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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July 30, 2025
Review
New radiopharmaceuticals page created
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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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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)
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