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What's New (Reviews)

March 23, 2023 Notifications and Administrative Notices: PSEHB/MDED Notification No. 1213-4 (PSEHB/PSD Notification No. 1213-3) and PSEHB/MDED Notification No.0929-1
March 13, 2023 English translation of review report: Syringe Pump Control Software for Assisting Total Intravenous Anesthesia
March 3, 2023 English Translation of Review Report: Cibinqo and Ostabalo
February 28, 2023 New "Validation Rules" and revised "Data Standards Catalog" posted
February 28, 2023 List of Approved Products (Medical Devices): FY 2022 (April 2022 -June 2022)
February 17, 2023 English Translation of Review Report: Abecma
February 13, 2023 List of Approved Products (New Drugs): FY 2022 (April 2022 - November 2022)
January 25, 2023 Ministerial Ordinance on Good Clinical Practice for Drugs updated
August 19, 2022 List of Approved Products: FY2021 (April 2021 - March 2022)
September 16, 2021 Q&A on the Master File (MF) System, Part III posted
August 10, 2021 Regulatory Information
June 12, 2015 The Pilot Project in The Last Half of FY2014 (Outline and results)

Pmda - Pharmaceuticals and Medical Devices Agency

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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What's New (Reviews)

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