The following notifications and administrative notices issued by the Ministry of Health, Labor and Welfare (MHLW) or the PMDA were selected for translation among those related to safety measures for regenerative medical products in consideration of priority for translation.
| Date/ Notification No. |
Title |
|---|---|
| June 7, 2024 PSB 0607 No.1 |
Instructions for Electronic Package Inserts of Regenerative Medical Products English-translated notification [219 KB] Original notification in Japanese [192 KB] |
| June 7, 2024 PSB/PSD 0607 No.2 |
Instructions for Electronic Package Inserts of Regenerative Medical Products (Detailed Rules) English-translated notification [176 KB] Original notification in Japanese [218 KB] |
|
May 22, 2023 |
Partial Revision of the "Instructions for Electronic Package Inserts of Regenerative Medical Products" English-translated notification [23.2 KB] Original notification in Japanese [60.8 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) English-translated notification [55.0 KB] Original notification in 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)" English-translated notification [27.1 KB] Original notification in Japanese [79.2 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) English-translated notification [75.7 KB] Original notification in Japanese [170 KB] |
| February 17, 2023 PMDA/CSO No.60 |
Points to Consider, etc. for Consultation Associated With Revision, etc. of Package Inserts, etc. English-translated notification [252 KB] Original notification in 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. English-translated notification [212 KB] Original notification in Japanese [368 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. English-translated notification[152 KB] Original notification in Japanese [186 KB] |
| August 31, 2020 PSEHB 0831 No.10 |
Reporting of Defects or Adverse Events Relevant to Processed Cells, Etc. in Clinical Studies English-translated notification [196 KB] Original notification in Japanese [280 KB] |