Table 9.
The implementation of PMS for the CGTPs approved in Japan
| Name | All-case surveillance | Re-examination period | Requirements for doctors and medical institution | Dissemination of guideline for proper use |
|---|---|---|---|---|
| Neltependocel [173] | Yes | 10 | Yes | Yes |
| Melanocyte-containing human (autologous) epidermis-derived cell sheet [174] | Yes | 8 | No | No |
| Ciltacabtagene autoleucel [175] | Yes | 10 | Yes | Yes |
| Idecabtagene vicleucel [176] | Yes | 10 | Yes | Yes |
| Human (autologous) oral mucosa-derived epithelial cell sheet using human amniotic membrane substrate [177] | Yes | No | Yes | Yes |
| Darvadstrocel [178] | Yes | No | Yes | Yes |
| Teserpaturev [179] | Yes | No | Yes | Yes |
| Human (autologous) oral mucosa-derived epithelial cell sheet [180] | Yes | No | Yes | Yes |
| Lisocabtagene maraleucel [181] | Yes | No | Yes | Yes |
| Axicabtagene ciloleucel [182] | Yes | 10 | Yes | Yes |
| Onasemnogene abeparvovec [183] | Yes | 10 | Yes | Yes |
| Human (autologous) corneal limbus-derived corneal epithelial cell sheet [184] | Yes | 10 | Yes | Yes |
| Beperminogene perplasmid [185] | Yes | No | Yes | Yes |
| Tisagenlecleucel [186] | No | 10 | Yes | Yes |
| Human (autologous) bone marrow-derived mesenchymal stem cells [187] | Yes | No | Yes | No |
| Human (autologous) epidermal cell sheet [188] | Yes | 10 | Yes | No |
| Human (autologous) skeletal myoblast-derived cell sheet [189] | No | No | Yes | No |
| Human (allogeneic) bone marrow-derived mesenchymal stem cells [190] | No | 10 | No | No |
| Human autologous tissue for transplantation [191] | No | No | No | No |
| Total | 15 | 10 | 16 | 13 |