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May 2, 2025
Review
New
Considerations for Non-Clinical Studies in the Development of Diagnostic Radiopharmaceuticals (Early Consideration) posted
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April 28, 2025
Review
New
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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April 14, 2025
Review
Information on biosimilars is updated
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April 11, 2025
Review
List of Approved Products (New Drugs): April 2004 to December 2024
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April 4, 2025
Review
English Translation of Review Report: Awiqli
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April 4, 2025
Review
English translation of review report: SENTINEL Cerebral Protection System
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March 14, 2025
Review
The information of New Drug Review with Electronic Data updated
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March 4, 2025
Review
Regenerative Medical Products Information posted
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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 25, 2025
Review
List of Approved Products (Medical Devices): April 2004 to September 2024
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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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February 7, 2025
Review
GMP / GCTP Annual Report FY 2023 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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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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