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April 11, 2024
Review
English Translation of Review Report: Lytgobi
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April 10, 2024
Review
List of Approved Products (New Drugs): April 2004 to January 2024
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April 8, 2024
Review
The information of New Drug Review with Electronic Data updated
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April 5, 2024
Review
English translation of review report: Zilver Vena Venous Stent
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March 27, 2024
Review
Information on biosimilars is now available
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March 27, 2024
Review
English translation of ‘Guideline for Ensuring Quality, Safety, and Efficacy of Biosimilars’ is now available
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March 27, 2024
Review
GMP / GCTP Annual Report FY 2022 posted
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February 20, 2024
Review
PMDA’s Support to Venture Companies posted
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February 14, 2024
Review
English Translation of Review Report: Luxturna
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January 24, 2024
Review
List of Approved Products (Medical Devices): April 2004 to June 2023
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October 5, 2023
Review
List of Approved Products: FY2022 (April 2022 to March 2023) and FY2023 (April 2023 to June 2023)
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September 26, 2023
Review
GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
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September 26, 2023
Review
GMP compliance inspection
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August 9, 2023
Review
The information of Regulatory Science Consultations updated
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May 9, 2023
Review
Regenerative Medical Products Information posted
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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)