Table 7.

The implementation of PMS for the CGTPs approved in the EU

Name	Routine RMM					Additional RMM				Additional PVP
	Aa		Bb	Cc		Aa	Bb	Cc		Aa	Bb	Cc
Exagamglogene autotemcel [145]	100		100	100		100	100	33		100	100	100
Etranacogene dezaparvovec [43]	100		100	100		50	83	33		100	100	100
Tabelecleucel [121]	100		100	75		0	0	0		100	100	100
Lisocabtagene maraleucel [122]	100		75	50		29	13	0		100	63	100
Valoctocogene roxaparvovec [123]	100		100	100		50	100	33		100	100	67
Eladocagene exuparvovec [124]	100		100	100		100	33	0		100	100	100
Ciltacabtagene autoleucel [125]	100		100	83		40	20	0		100	100	100
Idecabtagene vicleucel [126]	100		80	100		60	0	0		100	80	67
Elivaldogene autotemcel [127]	100		100	100		100	100	0		100	100	100
Autologous CD34 + cells encoding ARSA gene [128]	100		100	100		100	100	100		100	100	100
Brexucabtagene autoleucel [129]	100		100	100		40	0	0		100	100	100
Onasemnogene abeparvovec [130]	100		100	50		0	0	0		100	100	100
Betibeglogene autotemcel [131]	100		100	100		100	100	50		100	100	50
Voretigene neparvovec [132]	100		100	100		100	33	0		100	100	100
Axicabtagene ciloleucel [133]	100		100	50		40	0	0		100	71	100
Tisagenlecleucel [134]	100		63	80		33	13	0		100	100	100
Autologous CD34 + cells encoding ARSA gene [128]	N.A		100	100		N.A	29	0		N.A	100	100
Spheroids of human autologous matrix-associated chondrocytes[136]	100		100	100		100	100	100		100	100	100
ACD34 + ECF [137]	100		80	100		50	20	0		75	100	100
gmATC [138]	100		100	100		33	10	0		100	100	100
Talimogene laherparepvec [139]	100		73	40		29	55	20		29	55	60
Ex vivo expanded autologous human corneal epithelial cells containing stem cells [140]	100		83	60		100	83	0		100	100	100
Sipuleucel-T [141]	100		71	50		100	100	100		25	43	17
Matrix-applied characterized autologous cultured chondrocytes [142]	100		100	50		100	100	0		0	25	33
Characterized viable autologous cartilage cells expanded ex vivo expressing specific marker proteins [144]	100		100	100		100	100	100		17	0	100

Abbreviations: ACD34 + ECF, autologous CD34 + enriched cell fraction that contains CD34 + cells transduced with retroviral vector that encodes for the human ADA cDNA sequence; gmATC, allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor and the herpes simplex I virus thymidine kinase

 N. A. indicates not applicable

 If there are 6 important identified risks, and relative measures are taken for three of them, the proportion in the table will be 50%

^aThe proportion of important identified risks, %

^bThe proportion of important potential risks, %

^cThe proportion of missing information