25 1 1713 15 4 1208 1
2
Therapeutic Orphan Off label use 3
4
5
6
7
8
33114 19 569 34 32 6211 4328 9
60 Tsuji K, Tsutani K, 2006 10
21 75%) 20 EU15 Tsuji K, Tsutani K, 2006 11
12
( ) 13
MHLW PMDA JPMA 21 14
21 6 188 17 600 376 223 8 29 30 290 80 15
22 捗 16
17
Best Pharmaceuticals for Children Act Pediatric Research Equity Act 2012 FDAAA EU Regulation (EC) No. 1901/2006) 2007 1 26 18
The EU Paediatric Regulation * PIP 6 Necessary for validation of MAA PIP 6 Necessary for validation PIP 2 10 PIP 10 EC Paediatric Use MA (PUMA) *PIP EMA Dr Agnes Saint Raymond (adapted; with permission) 19