Notifications Related to Safety Measures (Regenerative Medical Products)

Notifications issued from the Ministry of Health, Welfare and Labour (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"   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)
May 22, 2023 PSEHB/PSD 0522 No.1	Partial Revision of the "Instructions for Package Inserts of Regenerative Medical Products (Detailed Rules)"   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)
September 13, 2022 HPB/DPMM 0913 No.3 PSEHB/PSD 0913 No.3	Labeling of Codes on Containers to Identify Regenerative Medical Products, etc.
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.
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.
August 31, 2020 PSEHB 0831 No.10	Reporting of Defects or Adverse Events Relevant to Processed Cells, Etc. in Clinical Studies