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Notifications and Administrative Notices

The following English translations of Japanese notifications and administrative notices are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. The PMDA shall not be responsible for any consequence resulting from use of the English version.
 

Drugs Medical Devices Regenerative Medical Products In Vitro Diagnostics

 

Drugs

March 29, 2024
PSB/PED Notification No. 0329-1

 

March 29, 2024
Administrative Notice

 

January 16, 2024
PSB/PED Notification No. 0116-1・PSB/MDED Notification No. 0116-1

 

January 16, 2024
Administrative Notice

 

January 16, 2024
PSB/PED Notification No. 0116-3

 

January 12, 2024
PSB/PED Notification No. 0112-3

 

December 25, 2023
PSB/PED Notification No. 1225-2

 

December 25, 2023
PSB/PED Administrative Notice

 

July 3, 2023
PMDA/CPE Notification No. 325

 

March 30, 2023
PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1

 

September 14, 2022
PSEHB/PED Administrative Notice

 

June 9, 2022
PSEHB/PED Administrative Notice

 

May 25, 2022
PMDA/CPE Notification No. 0525001

 

December 10, 2021
PSEHB/PED Administrative Notice

 

September 14, 2021
PSEHB/PED Administrative Notice

 

July 19, 2021
PSEHB/PED Administrative Notice

 

March 23, 2021
PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1

 

March 23, 2021
PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2

 

December 21, 2020
PSEHB/PED Notification No. 1221-1

 

November 26, 2020
Administrative Notice

 

November 16, 2020
PMDA/CPE Notification No. 1116002

 

August 31, 2020
PSEHB/PED Notification No. 0831-5

 

August 31, 2020
PSEHB Notification No. 0831-11

 

June 30, 2020
PSEHB/PED Administrative Notice

 

March 30, 2020
PSEHB/PED Notification No. 0330-1

 

June 8, 2020
PSEHB/PED Administrative Notice

 

June 19, 2019
PSEHB/PED Administrative Notice

 

June 19, 2019
PSEHB/PED Administrative Notice

 

September 27, 2018
PSEHB/PED Notification No. 0927-3

 

July 10, 2018
HPB/RDD Notification No. 0710-4
PSEHB/PED Notification No. 0710-2
PSEHB/MDED Notification No. 0710-2

 

July 10, 2018

 

February 21, 2018
PSEHB/PED Notification No. 0221-1

 

October 23, 2017
PSEHB/PED Notification No. 1023-3

 

October 20, 2017
PSEHB/PED Notification No. 1020-1

 

September 15, 2017
PSEHB/PED Notification No. 0915-1
HIB/MED Notification No. 0915-1

 

January 22, 2016
PSEHB/ELD Notification No. 0122-7

 

October 27, 2014
PFSB/ELD Administrative Notice

 

June 20, 2014
PFSB/ELD Notification No. 0620-6

 

June 20, 2014
PFSB/ELD Administrative Notice

 

July 1, 2013
PFSB/ELD Administrative Notice

 

April 4, 2013
PFSB/ELD Notification No. 0404-1

 

September 5, 2012
PFSB/ELD Administrative Notice

 

April 18, 2012
PFSB/ELD Administrative Notice

 

March 30, 2012
PFSB/ELD Administrative Notice

 

January 17, 2011
PFSB/ELD Administrative Notice

 

July 9, 2010
PFSB/ELD Notification No. 0709-1

 

July 9, 2010
PFSB/ELD Administrative Notice

 

June 9, 2010
PFSB/ELD-CND Administrative Notice

 

September 7, 2009
PFSB/ELD-SD Administrative Notice

 

June 13, 2008
PFSB Notification No. 0613007

 

September 28, 2007
PFSB/ELD Notification No. 0928010

 

February 8, 2006
PFSB/ELD Notification No. 0208001

 

October 24, 2005
PFSB/ELD Notification No. 1024002

 

March 30, 2005
PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005

 

February 10, 2005
PFSB/ELD Notification No. 0210001

 

February 10, 2005
PFSB/ELD Notification No. 0210004


Biosimilars

February 4, 2020
PSEHD/PED Notification No. 0204-1

 

January 25, 2024
PSB/PED Administrative Notice

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Medical Devices

March 30, 2023
PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1

 

December 13, 2022
PSEHB/MDED Notification No. 1213-4
PSEHB/PSD Notification No. 1213-3

 

September 29, 2021
PSEHB/MDED Notification No.0929-1

 

March 23, 2021
PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1

 

March 23, 2021
PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2

 

December 19, 2018
PSEHB/MDED Notification No. 1219-4

 

November 17, 2017
PSEHB/MDED Notification No.1117-1
PSEHB/SD Notification No.1117-1

 

November 17, 2017
PSEHB/MDED Administrative Notice

 

August 16, 2017
PSEHB/MDE Notification No. 0816-6

 

August 16, 2017
PSEHB/MDE Notification No. 0816-3

 

July 31, 2017
PSEHB/MDE Notification No. 0731-8
PSEHB/PSD Notification No. 0731-5
PSEHB/CND Notification No. 0731-1

 

July 31, 2017
PSEHB/CND Notification No. 0731-12

 

July 31, 2017
PSEHB Notification No. 0731-7

 

July 31, 2017
PSEHB Notification No. 0731-1

 

March 31, 2016
PFSB/MDRMPED Administrative Notice

 

February19, 2015
PFSB/MDRMPED Notification No. 0219-1

 

November 25, 2014
PFSB/MDRMPED Administrative Notice

 

November 25, 2014
PFSB/MDRMPED Notification No. 1125-6

 

November 21, 2014
PFSB/MDRMPED Notification No. 1121-33
PFSB/SD Notification No. 1121-1
PFSB/CND Notification No. 1121-29

 

February 6, 2009
PMDA Notification No. 0206007

 

June 13, 2008
PFSB Notification No. 0613010

 

June 23, 2006
PFSB/ELD/ OMDE Administrative Notice

 

March 31, 2006
PFSB/MDE Notification No. 0331006

 

March 30, 2005
PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005

 

February 16, 2005
PFSB/ELD/ OMDE Notification No. 0216003

 

February 16, 2005
PFSB Notification No. 0216002

 

February 16, 2005
PFSB/ELD/ OMDE Notification No. 0216001

 

February 13, 2003
PFSB/ELD Notification No. 0213001

 

March 31, 1997
PAB/MHW Notification No. 479

 

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Regenerative Medical Products

July 3, 2023
PMDA/CPE Notification No. 325

 

March 31, 2023
PSEHB/MDED Administrative Notice

 

March 30, 2023
PSEHB/PED Notification No. 0330-6
PSEHB/MDED Notification No. 0330-1

 

May 25, 2022
PMDA/CPE Notification No. 0525001

 

March 23, 2021
PSEHB/PED Notification No. 0323-1
PSEHB/MDED Notification No. 0323-1

 

March 23, 2021
PSEHB/PED Notification No. 0323-2
PSEHB/MDED Notification No. 0323-2

 

November 16, 2020
PMDA/CPE Notification No. 1116002

 

March 23, 2020
PSEHB/MDED Notification No. 0323-4

 

July 9, 2019
PSEHB/MDED Notification No.0709-2

 

March 8, 2019
PSEHB/PED Notification No. 0308-1
PSEHB/MDED Notification No.0308-1

 

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In Vitro Diagnostics

November 21, 2014
PFSB/ELD/OMDE Notification No. 1121-16

 

November 21, 2014
PFSB Notification No. 1121-15

 

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