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Post-marketing Safety Measures
Provision of Information regarding Post-marketing Safety
Regenerative Medical Products
Notifications Related to Safety Measures

Post-marketing Safety Measures

Notifications Related to Safety Measures (regenerative medical products)

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Notifications issued by the MHLW related to safety measures for regenerative medical products are listed here.

Date	Title	Original in Japanese (PDF or Link)
May 22, 2023 PSEHB 0522 No.1	Partial Revision of the "Instructions for Electronic Package Inserts of Regenerative Medical Products" [23.2 KB] Reference: Full text after revision (May 22, 2023 Final revision) Instructions for Electronic Package Inserts of Regenerative Medical Products (PSEHB Notification 0611 No.13 June 11, 2021) [55.0 KB]	Japanese [60.8 KB] Japanese [154 KB]
May 22, 2023 PSEHB/PSD 0522 No.1	Partial Revision of the "Instructions for Package Inserts of Regenerative Medical Products (Detailed Rules)" [27.1 KB] Reference: Full text after revision (May 22, 2023 Final revision) Instructions for Package Inserts of Regenerative Medical Products (Detailed Rules) (PFSB/SD Notification 1002 No.13 October 2, 2014) [75.7 KB]	Japanese [79.2 KB] Japanese [170 KB]
PMDA/CSO No.60 February 17, 2023	Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. [252 KB]	Japanese [1,024 KB]
September 13, 2022 HPB/DPMM 0913 No.3 PSEHB/PSD 0913 No.3	Labeling of Codes on Containers to Identify Regenerative Medical Products, etc. [212 KB]	Japanese [368 KB]
July 29, 2022 PMDA/OIMS No.0729001 PMDA/OPI No.0729001 PMDA/OPII No.0729001 PMDA/OMQVMD No.0729001	Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. [755 KB] Note) Abolished on February 17, 2023.	Japanese [982 KB]
August 31, 2020 PSEHB/MDED 0831 No.11	Points to Consider, etc. for Reporting Clinical Trial Product Defects or Adverse Events, etc. Relevant to Processed Cells, etc. [152 KB]	Japanese [186 KB]
August 31, 2020 PSEHB 0831 No.10	Reporting of Defects or Adverse Events Relevant to Processed Cells, Etc. in Clinical Studies [196 KB]	Japanese [280 KB]