╙7┨ 㐿⊒ᦼ㑆ߣ㑐ଥߔࠆ࿃ሶ
࿑ 34 㐿⊒ᦼ㑆ߩផ⒖㧔ਛᄩ୯㧕㧔⛯߈㧕
82.4 24.8
88.1 16.0
27.6 15.6
35.9 18.6
41.5 17.2
35.7 22.3
54.1 21.3
42.3 19.6
32.1 18.4
0204060801001st CTPN to Approval (months)
2000 2001 2002 2003 2004 2005 2006 2007 2008 1st CTPN to NDA NDA to Approval
ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧ ᛚ↳⺧䌾ᛚ 䋨ᛚᐕ䋩
㐿⊒ᦼ㑆䋨ᢙ䋩
NMEએᄖ
ᵈ㧦⥃ᐥ㐿⊒ᦼ㑆㧔NME 187 ຠ⋡ޔNME એᄖ
155ຠ⋡㧕 ޔክᩏᦼ㑆㧔NME 230 ຠ⋡ޔ
NMEએᄖ
256ຠ⋡㧕߇ߘࠇߙࠇ▚ߢ߈ߚᛚຠ⋡ࠍኻ⽎ߣߒߚ
33 㐿⊒ᦼ㑆ߩផ⒖
⥃ᐥ㐿⊒ᦼ㑆 ክᩏᦼ㑆 㐿⊒ᦼ㑆
ᛚᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD
ో
2000 43 79.6 77.9 34.6 67 28.3 31.9 20.1 43 113.7 110.5 39.1 2001 24 74.5 77.3 32.0 39 16.8 26.1 21.4 24 97.3 99.2 38.1 2002 26 64.1 62.3 30.9 43 17.7 25.2 19.0 26 83.4 87.0 39.2 2003 24 56.0 62.2 34.9 29 19.1 23.2 17.3 24 73.2 86.9 43.2 2004 17 63.6 64.3 30.8 28 18.3 19.4 18.2 17 81.0 88.3 32.0 2005 34 54.2 65.8 42.7 47 24.0 25.4 13.1 34 87.0 93.2 48.2 2006 51 60.9 70.6 53.9 72 22.8 29.1 20.1 51 87.1 100.0 57.7 2007 63 52.4 59.0 36.2 83 20.0 25.1 20.7 63 76.2 85.3 42.4 2008 60 44.6 66.6 52.7 78 19.0 20.0 11.0 60 67.3 88.3 57.4 ว⸘ 342 59.5 67.1 42.1 486 20.6 25.5 18.4 342 85.5 93.3 47.5 NME
2000 33 79.6 78.3 29.2 40 31.8 34.5 22.2 33 115.8 113.1 32.9 2001 17 66.9 69.7 29.8 22 18.5 25.0 18.6 17 93.4 92.9 38.8 2002 22 66.8 68.2 29.9 24 21.0 29.1 22.1 22 94.4 94.8 37.5 2003 14 68.8 67.7 18.8 15 20.5 23.1 14.9 14 87.2 92.4 29.8 2004 11 88.8 74.9 32.1 16 19.9 22.1 23.4 11 115.7 102.6 29.7 2005 16 69.2 71.6 36.0 21 25.0 26.9 15.6 16 99.7 102.6 36.1 2006 19 66.1 75.0 50.0 23 25.1 36.3 28.5 19 94.8 109.4 58.2 2007 28 61.3 70.5 40.5 35 21.4 30.2 28.1 28 92.2 102.7 49.8 2008 27 78.4 91.4 57.1 34 19.1 21.3 13.2 27 104.3 115.5 62.2 ว⸘ 187 70.8 75.1 38.7 230 21.9 28.3 22.0 187 102.4 104.4 44.6 NMEએᄖ
2000 10 82.4 76.7 50.6 27 24.8 27.9 15.9 10 95.2 102.2 56.4 2001 7 88.1 95.9 31.5 17 16.0 27.5 25.1 7 102.7 114.5 34.1 2002 4 27.6 29.5 6.0 19 15.6 20.3 13.2 4 41.9 44.0 5.8 2003 10 35.9 54.4 49.9 14 18.6 23.2 20.1 10 57.0 79.1 58.0 2004 6 41.5 44.7 16.1 12 17.2 15.8 6.6 6 61.8 61.9 14.6 2005 18 35.7 60.7 48.3 26 22.3 24.2 10.9 18 53.6 84.8 56.7 2006 32 54.1 68.0 56.6 49 21.3 25.7 13.7 32 79.5 94.5 57.5 2007 35 42.3 49.7 29.9 48 19.6 21.4 11.9 35 63.8 71.4 29.2 2008 33 32.1 46.4 39.1 44 18.4 18.9 8.9 33 52.4 66.1 42.5 ว⸘ 155 40.0 57.5 44.1 256 19.4 22.9 14.1 155 63.8 80.0 47.5
ᵈ㧦⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆ޔ㐿⊒ᦼ㑆߇ߘࠇߙࠇ▚ߢ߈ߚᛚຠ⋡ࠍኻ⽎ߣߒߚ
7.2. ⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆ޔ㐿⊒ᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ
⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆߅ࠃ߮㐿⊒ᦼ㑆ߩ㐳ߐߦᓇ㗀ࠍਈ߃ࠆ࿃ሶࠍ࿁Ꮻಽᨆߦߡᬌ⸛ߒߚޕ3ߟߩ ᦼ㑆ߩ㐳ߐࠍߘࠇߙࠇⵍ⺑ᄌᢙޔࠕࡦࠤ࠻⺞ᩏߦߡ࠺࠲ࠍ㓸ߒߚᛚຠ⋡ޔ↳⺧ડᬺޔ⥃ᐥ㐿
⊒߅ࠃ߮ᛚክᩏߦ㑐ࠊࠆ࿃ሶ㧔 34㧕ࠍ⺑ᄌᢙߣߒޔⶄᢙߩ࿃ሶߩᓇ㗀ࠍหᤨߦ⺞ᢛߒߚߢޔ ฦᦼ㑆ߦᗧߥᓇ㗀ࠍਈ߃ࠆ․ᕈࠍᦨዊੑਸ਼ᴺߦߡផ⸘ߒߚޕ
34 ࿁Ꮻಽᨆߦ↪ߚ⺑ᄌᢙ
ಽ㘃 ⺑ᄌᢙ
ຠ⋡ ↳⺧ಽ㧔NME/NMEએᄖ㧕
⮎ലಽ㘃
ൻቇวᚑຠ/ࡃࠗࠝ࠹ࠢࡁࡠࠫᔕ↪ක⮎ຠ
ห⒳หല⮎ߩή
↳⺧ડᬺ ડᬺ࿖☋㧔࿖ౝ/ᄖ࿖㧕
⥄␠㐿⊒ຠ/ઁ␠ዉຠ
ᒰ∔ᖚ㗔ၞߦ߅ߌࠆ㐿⊒⚻㛎ߩή
⥃ᐥ㐿⊒ ╙Τ⋧⹜㛎⚳ੌᓟ⋧⺣ታᣉߩή
↳⺧೨⋧⺣ታᣉߩή
ᛚክᩏ PMDA⸳┙೨ᓟߩ↳⺧
ክᩏಽ㧔ㅢᏱክᩏ/ఝవክᩏ㧕
⹏ଔ⾗ᢱߣߒߚ⥃ᐥ⹜㛎ᢙ ᄖ࿖⥃ᐥ࠺࠲ߩ↪
ቇળᖚ⠪࿅ߩⷐᦸᦠߩή ᛚ᧦ઙߩή
7.2.1. ࿖ౝ⥃ᐥ⹜㛎ࠍታᣉߒߚᣂක⮎ຠߩ㐿⊒ᦼ㑆
ߪߓߦޔ2000㨪2008ᐕߦᛚߐࠇߚ486ຠ⋡ߩ߁ߜޔ࿖ౝߢ⥃ᐥ⹜㛎߇ታᣉߐࠇޔ⥃ᐥ㐿⊒ᦼ㑆߅ ࠃ߮ክᩏᦼ㑆ߩਔᣇ߇▚น⢻ߢޔ 34ߦ␜ߒߚ⺑ᄌᢙߩ࠺࠲߇ᓧࠄࠇߚᣂක⮎ຠ306ຠ⋡
㧔63.0%㧕ࠍኻ⽎ߣߒߚޕⵍ⺑ᄌᢙ߅ࠃ߮⺑ᄌᢙߩၮᧄ⛔⸘㊂ࠍ 35ߦ␜ߒߚޕⵍ⺑ᄌᢙߢࠆ
⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆ޔ㐿⊒ᦼ㑆ߩᐔဋ୯rSDߪ67.9r42.7ࡨޔ26.8r18.5ࡨޔ94.6r47.4ࡨ
ߢࠅ㧔 35㧕ޔ╙4┨ߦߡ⥃ᐥ㐿⊒ᦼ㑆ࠍ⸃ᨆߒߚ342ຠ⋡㧔67.1r42.1ࡨޔ 41㧕ޔ╙5┨ߦߡ
35 ⵍ⺑ᄌᢙޔ⺑ᄌᢙߩၮᧄ⛔⸘㊂㧔࿖ౝ⥃ᐥ⹜㛎ࠅߩᣂක⮎ຠ㧕
ᄌᢙ ᐔဋ୯ SD ᦨዊ ᦨᄢ
ⵍ⺑ᄌᢙ
⥃ᐥ㐿⊒ᦼ㑆䋨ᢙ䋩 67.9 42.7 0.9 228.8 ክᩏᦼ㑆䋨ᢙ䋩 26.8 18.5 1.4 135.4 㐿⊒ᦼ㑆䋨ᢙ䋩 94.6 47.7 10.3 253.5
⺑ᄌᢙ*1
ᣂലᚑಽක⮎ຠ㧔NME㧕એᄖ 0.46 0.50 0 1
ࡃࠗࠝක⮎ຠ 0.14 0.34 0 1
ห⒳หല⮎ࠅ 0.73 0.45 0 1
ዉຠ 0.28 0.45 0 1
╙2⋧⚳ੌᓟ⋧⺣ࠍታᣉ 0.38 0.49 0 1
↳⺧೨⋧⺣ࠍታᣉ 0.46 0.50 0 1
2004ᐕ4㧔PMDA⸳┙㧕એ㒠ߩ↳⺧ 0.45 0.50 0 1
ఝవክᩏ 0.23 0.42 0 1
⮎ലಽ㘃 N (%)
ਛᨔ⚻ 21 (6.9)
⸃ᾲ㎾∩ᶖἻ 2 (0.7)
ᧃ᪳⚻ 5 (1.6)
⌒⑼⡊㥦⑼ 14 (4.6)
᛫ࠕ࡞ࠡ 11 (3.6)
ᓴⅣེ 29 (9.5)
ๆེ 6 (2.0)
ᶖൻེ 11 (3.6)
ᶖൻᕈẩ≌ 4 (1.3) ࡎ࡞ࡕࡦ 21 (6.9) ᴲዩ↢ᱺེ 8 (2.6)
ᄖ⊹↪ 8 (2.6)
ઍ⻢ᕈ 47 (15.4)
᛫ᖡᕈ⣲≌ 35 (11.4)
ᕈක⮎ຠ 3 (1.0)
ክᩏᦼ㑆ࠍ⸃ᨆߒߚ486ຠ⋡㧔25.5r18.4ࡨޔ 11㧕ޔ7.1㗄ߦߡ㐿⊒ᦼ㑆ࠍ⸃ᨆߒߚ342ຠ⋡㧔93.3 r47.5ࡨޔ 33㧕ߣߘࠇߙࠇ㘃ૃߒߡ߅ࠅޔ⸃ᨆኻ⽎ߦࠃࠆ㆑ߪࠄࠇߥ߆ߞߚޕ
⺑ᄌᢙߪޔ⹏ଔ⾗ᢱߣߒߚ⥃ᐥ⹜㛎ᢙ߅ࠃ߮⮎ലಽ㘃એᄖߪޔޟᒰߖߕ/ᒰߔࠆޔߥߒ/ࠅޠߩ 2୯ߩ࠳ࡒᄌᢙߢࠅޔ 35ߩ୯ߪ⸃ᨆኻ⽎ߦ߅ߌࠆഀวࠍ0㨪1ߩ▸࿐ߢ␜ߒߡࠆޕߔߥࠊߜޔ
46%ߩຠ⋡߇NMEએᄖߢࠅޔ46%߇↳⺧೨ߦᴦ㛎⋧⺣ࠍታᣉޔ45%߇2004ᐕ4એ㒠ߦPMDAߦ↳
⺧ߐࠇߚຠ⋡ޔ23%߇ఝవክᩏຠ⋡ޔ36%߇ᄖ࿖Phase 2㨪3⹜㛎࠺࠲ࠍ↪ޔ53%߇ᄖ⾗♽ડᬺ*2ߦ ࠃࠆ↳⺧ߢߞߚޕ⹏ଔ⾗ᢱߣߒߚ⥃ᐥ⹜㛎ᢙߩᐔဋ୯ߪ11.40ߢࠅޔ1㨪93⹜㛎ߩ▸࿐ߦߞߚޕ
⮎ലಽ㘃ߪߎࠇ߹ߢߣห᭽ߦޔ⮎ോႎ╬ߢ↪ࠄࠇߡࠆ21ಽ㘃ࠍ↪ߡ⺞ᢛߒߚޕ
࿑ 35ޔ 36ߪ࿁Ꮻಽᨆߩ⚿ᨐࠍ␜ߒߚ߽ߩߢࠆޕ࿑ 35ߪᏀ߆ࠄ㗅ߦ⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆ޔ 㐿⊒ᦼ㑆ߩ⚿ᨐࠍߒߡ߅ࠅޔ࿁Ꮻଥᢙߩ୯ࠍࠣࡈߢ␜ߒߡࠆޕ࿁Ꮻଥᢙ߇ᱜߢࠇ߫ฦᦼ㑆ߪ 㐳ߊޔ⽶ߢࠇ߫⍴ߊߥߞߡ߅ࠅޔ୯߇ᄢ߈߶ߤߘߩᓇ㗀߇ᄢ߈ߎߣࠍߒߡࠆޕ߹ߚޔߘߩᓇ 㗀߇⛔⸘⊛ߦᗧߥ⺑ᄌᢙߦߪࠕࠬ࠹ࠬࠢޟ*ޠࠍઃߒߚ㧔ᗧ᳓Ḱ㧦* p <0.1, ** p <0.05, *** p <0.01㧕ޕ
ᧄ⚿ᨐ߆ࠄޔઁߩ᧦ઙ߇หߓߢࠇ߫ޔNMEߣᲧߴߡNMEએᄖߩຠ⋡ߩ⥃ᐥ㐿⊒ᦼ㑆ߪᗧߦ⍴
ߎߣ߇␜ߐࠇߚޕห᭽ߦޔᛚ᧦ઙࠅߩຠ⋡ޔᄖ࿖Phase 2㨪3⹜㛎࠺࠲ࠍ↪ߒߚຠ⋡ߩ⥃ᐥ㐿⊒
ᦼ㑆߽ᗧߦ⍴߆ߞߚޕ৻ᣇޔᛚຠ⋡ߣหߓ∔ᖚ㗔ၞߢ㐿⊒⚻㛎߇ࠆ႐วߪޔ੍ᗐߦߒߡ⥃ᐥ㐿
⊒ᦼ㑆߇ᗧߦ㐳ߣ߁⚿ᨐ߇ᓧࠄࠇߚޕ↳⺧೨⋧⺣ࠍታᣉߒߚ႐วޔክᩏᦼ㑆߇ᗧߦ⍴߆ߞߚ
㕙ޔ⥃ᐥ㐿⊒ᦼ㑆߇ᗧߦ㐳ߊޔ2ߟࠍวࠊߖߚ㐿⊒ᦼ㑆ߢߪਔ⠪ߩᓇ㗀߇⋧Ვߐࠇߡᓇ㗀ߪࠄࠇ ߥ߆ߞߚޕ߹ߚޔPMDA⸳┙ᓟߩ↳⺧ຠ⋡ޔఝవክᩏຠ⋡ߩክᩏᦼ㑆߽ᗧߦ⍴ߎߣࠍ␜ໂߐࠇߚޕ NMEએᄖߩຠ⋡ޔPMDA⸳┙ᓟߩ↳⺧ޔఝవክᩏޔᛚ᧦ઙࠅޔᄖ࿖⥃ᐥ࠺࠲ߩ↪ߪޔߘࠇߙ ࠇ⥃ᐥ㐿⊒ᦼ㑆߅ࠃ߮ክᩏᦼ㑆ߢ␜ߐࠇߚᗧߥᓇ㗀߇㐿⊒ᦼ㑆ߢ߽ࠄࠇߚޕ
࿑ 35 㐿⊒ᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ࠅߩᣂක⮎ຠ㧕
-7.1
8.9 -9.9
0.2 -13.1
4.5 -8.8
-6.9
11.1 4.3 -6.9
2.9 4.9 -20.6
-20 -10 0 10
-0.7 -2.6 -2.9
0.1 -2.2
0.8 -9.2
-7.6 -6.6
-2.0 2.1 -1.0
1.7 -2.8
-10 0 10
-7.9
6.3 -12.9
0.3 -15.3
5.3 -18.0
-14.5
4.5 2.3 -4.9
1.9 6.7 -23.5
-20 -10 0 10
࿁Ꮻଥᢙ NMEએᄖ
ห⒳หല⮎䈅䉍 ዉຠ
ᄖ⾗♽ડᬺ
╙2⋧⚳ੌᓟ⋧⺣
↳⺧೨⋧⺣
PMDA⸳┙ᓟ䈱↳⺧
ఝవክᩏ ቇળ䊶ᖚ⠪ⷐᦸᦠ ᛚ᧦ઙ䈅䉍 P1䌾3⹜㛎ᢙ ᄖ࿖P2䌾3⹜㛎↪
㐿⊒⚻㛎䈅䉍 䊋䉟䉥ක⮎ຠ
***
**
***
***
**
*** ***
** **
**
***
⥃ᐥ㐿⊒ᦼ㑆 ክᩏᦼ㑆 㐿⊒ᦼ㑆
*
*
ᵈ㧦ᗧ᳓Ḱ㧦* p <0.1, ** p <0.05, *** p <0.01㧧⮎ലಽ㘃ߪ⋭⇛ߒߚ
36 㐿⊒ᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ࠅߩᣂක⮎ຠ㧕
⥃ᐥ㐿⊒ᦼ㑆 ክᩏᦼ㑆 㐿⊒ᦼ㑆
⺑ᄌᢙ ଥᢙ SE p୯ ଥᢙ SE p୯ ଥᢙ SE p୯ ᣂലᚑಽක⮎ຠ㧔NME㧕એᄖ -20.6 5.8 0.000 *** -2.8 2.4 0.239 -23.5 6.2 0.000 ***
ࡃࠗࠝක⮎ຠ 4.9 7.8 0.529 1.7 3.2 0.588 6.7 8.4 0.429 ห⒳หല⮎䈅䉍 2.9 5.5 0.604 -1.0 2.3 0.657 1.9 6.0 0.755
ዉຠ -6.9 5.5 0.210 2.1 2.3 0.363 -4.9 6.0 0.414
╙2⋧⚳ੌᓟ⋧⺣䉕ታᣉ 4.3 5.1 0.398 -2.0 2.1 0.336 2.3 5.5 0.676
↳⺧೨⋧⺣ࠍታᣉ 11.1 4.9 0.024 ** -6.6 2.0 0.001 *** 4.5 5.3 0.388
2004ᐕ4䋨PMDA⸳┙䋩એ㒠䈱↳⺧ -6.9 5.1 0.180 -7.6 2.1 0.000 *** -14.5 5.5 0.009 ***
ఝవክᩏ -8.8 7.0 0.211 -9.2 2.9 0.002 *** -18.0 7.6 0.018 **
ቇળ䊶ᖚ⠪࿅䈱ⷐᦸᦠ䈅䉍 4.5 5.4 0.410 0.8 2.2 0.724 5.3 5.9 0.369 ᛚ᧦ઙ䈅䉍 -13.1 5.8 0.023 ** -2.2 2.4 0.356 -15.3 6.2 0.014 **
⹏ଔ⾗ᢱ䈫䈚䈢P1䌾3⹜㛎䈱ᢙ 0.2 0.2 0.308 0.1 0.1 0.230 0.3 0.2 0.161 ᄖ࿖P2䌾3⹜㛎䉕↪ -9.9 5.1 0.055 * -2.9 2.1 0.167 -12.9 5.5 0.021 **
ᒰ∔ᖚ㗔ၞ䈱㐿⊒⚻㛎䈅䉍 8.9 5.0 0.074 * -2.6 2.0 0.196 6.3 5.4 0.242 ᄖ⾗♽ડᬺ -7.1 5.4 0.190 -0.7 2.2 0.740 -7.9 5.8 0.179
⮎ലಽ㘃䋨ෳᾖ䉦䊁䉯䊥䊷䋺ਛᨔ⚻䋩
⸃ᾲ㎾∩ᶖἻ -15.5 28.3 0.584 -0.2 11.6 0.983 -15.7 30.5 0.606
ᧃ᪳⚻ 9.5 19.5 0.625 -9.2 8.0 0.253 0.4 21.0 0.986
⌒⑼⡊㥦⑼ -27.3 13.4 0.042 ** -7.2 5.5 0.193 -34.5 14.4 0.018 **
᛫ࠕ࡞ࠡ -33.9 14.5 0.020 ** -9.8 5.9 0.098 * -43.7 15.6 0.005 ***
ᓴⅣེ -10.0 11.1 0.369 -8.7 4.6 0.057 * -18.7 12.0 0.119
ๆེ -36.7 17.9 0.042 ** -9.3 7.4 0.205 -46.0 19.3 0.018 **
ᶖൻེ -31.7 14.9 0.034 ** -10.5 6.1 0.086 * -42.3 16.0 0.009 ***
ᶖൻᕈẩ≌ 74.8 21.3 0.001 *** -4.8 8.7 0.587 70.1 22.9 0.002 ***
ࡎ࡞ࡕࡦ -13.9 12.6 0.271 -4.3 5.2 0.410 -18.1 13.5 0.182 ᴲዩ↢ᱺེ -32.6 16.1 0.044 ** -8.5 6.6 0.200 -41.1 17.3 0.018 **
ᄖ⊹↪ -29.3 16.1 0.071 * -4.9 6.6 0.458 -34.2 17.4 0.050 *
ઍ⻢ᕈ -21.3 10.5 0.042 ** -9.3 4.3 0.032 ** -30.6 11.3 0.007 ***
᛫ᖡᕈ⣲≌ -23.3 11.4 0.042 ** -9.1 4.7 0.053 * -32.3 12.3 0.009 ***
ᕈක⮎ຠ -50.5 24.8 0.042 ** 60.4 10.2 0.000 *** 9.9 26.7 0.712
᛫↢‛⾰ -28.7 13.9 0.040 ** -12.2 5.7 0.033 ** -40.9 15.0 0.007 ***
ൻቇ≮ᴺ -24.5 11.4 0.033 ** -11.9 4.7 0.012 ** -36.3 12.3 0.003 ***
↢‛ቇ⊛ -25.3 13.4 0.061 * -5.3 5.5 0.334 -30.6 14.5 0.036 **
㚟⯻⮎ -49.0 39.8 0.219 -17.3 16.3 0.291 -66.3 42.8 0.123
ㅧᓇ⸻ᢿ⮎ -30.8 15.3 0.045 ** -6.3 6.3 0.313 -37.2 16.5 0.025 **
ߘߩઁ -43.8 14.0 0.002 *** -9.3 5.7 0.106 -53.1 15.1 0.001 ***
Eଥᢙ 99.6 11.0 0.000 *** 46.7 4.5 0.000 *** 146.3 11.9 0.000 ***
Nᢙ 306 306 306
p୯ 0.000 0.000 0.000
⥄↱ᐲୃᱜᷣ䉂ቯଥᢙ 0.226 0.304 0.280
ᵈ㧦ᗧ᳓Ḱ㧦* p <0.1, ** p <0.05, *** p <0.01
7.2.2. ࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠߩክᩏᦼ㑆
ᰴߦޔ࿖ౝߢ⥃ᐥ⹜㛎ࠍታᣉߖߕߦᛚߐࠇߚ․⊛ߥᣂ⮎ࠍ397ຠ⋡ࠍኻ⽎ߦޔክᩏᦼ㑆ߣ㑐 ଥߔࠆ࿃ሶࠍ⸃ᨆߒߚޕⵍ⺑ᄌᢙ߅ࠃ߮⺑ᄌᢙߩၮᧄ⛔⸘㊂ࠍ 37ޔ࿁Ꮻಽᨆߩ⚿ᨐࠍ࿑ 36߅ࠃ
߮ 38ߦ␜ߒߚޕክᩏᦼ㑆ߩᐔဋ୯rSDߪ26.2r18.9ࡨߢࠅޔ7.2.1㗄ߩ࿖ౝ⥃ᐥ⹜㛎ࠅߩᣂ ක⮎ຠߣห᭽ߢߞߚ㧔26.8r18.5ࡨޔ 35㧕ޕ৻ᣇޔ࿖ౝߢ⥃ᐥ⹜㛎ࠍታᣉߒߡߥຠ⋡߇߹
ࠇߡࠆߚޔ࿖ౝ⥃ᐥ⹜㛎ࠅߩ⸃ᨆኻ⽎ߦᲧߴޔNMEએᄖߩຠ⋡ޔఝవክᩏຠ⋡ޔᛚ᧦ઙࠅ
ߣ߁⚿ᨐ߇ᓧࠄࠇߚޕ৻ᣇߢޔߘߩᓇ㗀ߪዊߐߥ߇ࠄޔ⹏ଔ⾗ᢱߣߒߚ࿖ౝᄖߩPhase 1㨪3⹜㛎ᢙ ߇ᄙ߶ߤክᩏᦼ㑆߇ᗧߦ㐳ߎߣ߇␜ໂߐࠇߚޕ
37 ⵍ⺑ᄌᢙޔ⺑ᄌᢙߩၮᧄ⛔⸘㊂㧔࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠ㧕
ᄌᢙ ᐔဋ୯ SD ᦨዊ ᦨᄢ
ⵍ⺑ᄌᢙ
ክᩏᦼ㑆䋨ᢙ䋩 26.2 18.9 1.4 135.4
⺑ᄌᢙ*1
ᣂലᚑಽක⮎ຠ㧔NME㧕એᄖ 0.53 0.50 0 1
ࡃࠗࠝක⮎ຠ 0.13 0.34 0 1
ห⒳หല⮎ࠅ 0.71 0.46 0 1
ዉຠ 0.27 0.45 0 1
╙2⋧⚳ੌᓟ⋧⺣ࠍታᣉ 0.30 0.46 0 1
↳⺧೨⋧⺣ࠍታᣉ 0.39 0.49 0 1
2004ᐕ4㧔PMDA⸳┙㧕એ㒠ߩ↳⺧ 0.43 0.50 0 1
ఝవክᩏ 0.30 0.46 0 1
ቇળᖚ⠪࿅ߩⷐᦸᦠࠅ 0.36 0.48 0 1
ᛚ᧦ઙࠅ 0.41 0.49 0 1
⹏ଔ⾗ᢱߣߒߚP1㨪3⹜㛎ߩᢙ 10.68 12.93 0 93 ᄖ࿖P2㨪3⹜㛎ࠍ↪ 0.37 0.48 0 1 ᒰ∔ᖚ㗔ၞߩ㐿⊒⚻㛎ࠅ 0.51 0.50 0 1
ᄖ⾗♽ડᬺ 0.53 0.50 0 1
Nᢙ*2 397
⮎ലಽ㘃 N (%)
ਛᨔ⚻ 23 (5.8)
⸃ᾲ㎾∩ᶖἻ 3 (0.8)
ᧃ᪳⚻ 6 (1.5)
⌒⑼⡊㥦⑼ 18 (4.5)
᛫ࠕ࡞ࠡ 12 (3.0)
ᓴⅣེ 35 (8.8)
ๆེ 8 (2.0)
ᶖൻེ 12 (3.0)
ᶖൻᕈẩ≌ 9 (2.3) ࡎ࡞ࡕࡦ 29 (7.3) ᴲዩ↢ᱺེ 9 (2.3)
ᄖ⊹↪ 10 (2.5)
ઍ⻢ᕈ 68 (17.1)
᛫ᖡᕈ⣲≌ 41 (10.3)
ᕈක⮎ຠ 3 (0.8)
᛫↢‛⾰ 21 (5.3)
ൻቇ≮ᴺ 42 (10.6)
↢‛ቇ⊛ 23 (5.8)
㚟⯻⮎ 1 (0.3)
ㅧᓇ⸻ᢿ⮎ 10 (2.5)
ߘߩઁ 14 (3.5)
ว⸘ 397 (100.0)
*1 0=ޟᒰߖߕޠ
ޔ ޟߥߒޠ, 1=ޟᒰߔࠆޠ ޔ ޟࠅޠ
*2
ክᩏᦼ㑆߅ࠃ߮ㆬᛯߒߚ⺑ᄌᢙ߇ᓧࠄࠇߚຠ⋡ࠍኻ⽎ߣߒߚ
࿑ 36 ክᩏᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠ㧕
-0.1 -3.7
-5.0
0.1 -3.8
0.8 -7.8
-9.1
-6.1
-1.3
1.4 -1.9
1.7 -2.2
-10 0
࿁Ꮻଥᢙ NMEએᄖ
ห⒳หല⮎䈅䉍 ዉຠ
ᄖ⾗♽ડᬺ
╙2⋧⚳ੌᓟ⋧⺣
↳⺧೨⋧⺣
PMDA⸳┙ᓟ䈱↳⺧
ఝవክᩏ ቇળ䊶ᖚ⠪ⷐᦸᦠ ᛚ᧦ઙ䈅䉍 P1䌾3⹜㛎ᢙ ᄖ࿖P2䌾3⹜㛎↪
㐿⊒⚻㛎䈅䉍 䊋䉟䉥ක⮎ຠ
**
**
**
**
*
ክᩏᦼ㑆
ᵈ㧦ᗧ᳓Ḱ㧦* p <0.1, ** p <0.05, *** p <0.01㧧⮎ലಽ㘃ߪ⋭⇛ߒߚ
38 ክᩏᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠ㧕
⺑ᄌᢙ ଥᢙ SE p୯ ᣂലᚑಽක⮎ຠ㧔NME㧕એᄖ -2.2 2.0 0.261 ࡃࠗࠝක⮎ຠ 1.7 2.8 0.545 ห⒳หല⮎ࠅ -1.9 1.9 0.321 ዉຠ 1.4 2.0 0.471
╙2⋧⚳ੌᓟ⋧⺣ࠍታᣉ -1.3 1.9 0.514
↳⺧೨⋧⺣ࠍታᣉ -6.1 1.8 0.001 ***
2004ᐕ4㧔PMDA⸳┙㧕એ㒠ߩ↳⺧ -9.1 1.8 0.000 ***
ఝవክᩏ -7.8 2.3 0.001 ***
ቇળᖚ⠪࿅ߩⷐᦸᦠࠅ 0.8 1.9 0.656 ᛚ᧦ઙࠅ -3.8 2.0 0.055 *
⹏ଔ⾗ᢱߣߒߚP1㨪3⹜㛎ߩᢙ 0.1 0.1 0.061 * ᄖ࿖P2㨪3⹜㛎ࠍ↪ -5.0 1.8 0.006 ***
ᒰ∔ᖚ㗔ၞߩ㐿⊒⚻㛎ࠅ -3.7 1.7 0.033 **
ᄖ⾗♽ડᬺ -0.1 1.9 0.956
⮎ലಽ㘃䋨ෳᾖ䉦䊁䉯䊥䊷䋺ਛᨔ⚻䋩
⸃ᾲ㎾∩ᶖἻ 2.7 9.6 0.781
ᧃ᪳⚻ -9.2 7.3 0.206
⌒⑼⡊㥦⑼ -2.7 5.0 0.587
᛫ࠕ࡞ࠡ -7.2 5.7 0.204
ᓴⅣེ -5.2 4.2 0.220
ๆེ 3.6 6.4 0.573
ᶖൻེ -9.7 5.8 0.093 *
ᶖൻᕈẩ≌ -5.9 6.3 0.348 ࡎ࡞ࡕࡦ -3.9 4.6 0.401 ᴲዩ↢ᱺེ -5.9 6.2 0.345
ᄖ⊹↪ -4.5 6.0 0.453
ઍ⻢ᕈ -8.1 3.9 0.039 **
᛫ᖡᕈ⣲≌ -6.4 4.3 0.137
ᕈක⮎ຠ 62.4 9.9 0.000 ***
᛫↢‛⾰ -11.0 4.8 0.024 **
ൻቇ≮ᴺ -13.3 4.2 0.002 ***
↢‛ቇ⊛ -3.5 5.1 0.497
㚟⯻⮎ -16.9 16.1 0.294
ㅧᓇ⸻ᢿ⮎ -7.1 5.9 0.233
ߘߩઁ -6.9 5.4 0.202
Eଥᢙ 46.6 4.1 0.000 ***
Nᢙ 397
p୯ 0.000
⥄↱ᐲୃᱜᷣ䉂ቯଥᢙ 0.338
ᵈ㧦ᗧ᳓Ḱ㧦* p <0.1, ** p <0.05, *** p <0.01
࿁Ꮻಽᨆߦ⚵ߺࠇߚ⺑ᄌᢙߩ߁ߜޔNMEએᄖߩຠ⋡ޔPMDA⸳┙ᓟߩ↳⺧ߣߞߚ߽ߩߪᚲਈ ߩ․ᕈߢࠆޕ৻ᣇޔ↳⺧೨⋧⺣ߩታᣉޔᄖ࿖⥃ᐥ࠺࠲ߩ↪ޔㆊߩ㐿⊒⚻㛎ߣߞߚ߽ߩߪડᬺ
ߩ㐿⊒ᚢ⇛ߦ㑐ࠊࠆ࿃ሶߢࠅޔᚢ⇛ᰴ╙ߢᄌࠊࠅᓧࠆ߽ߩߢࠆޕߒߚ߇ߞߡޔ⥃ᐥ㐿⊒ߩല₸ൻ߿
ክᩏᦼ㑆ߩ⍴❗ࠍᬌ⸛ߔࠆߢޔߎࠇࠄߩ⚿ᨐߪෳ⠨ߦߥࠆߣ⠨߃ࠄࠇࠆޕ߹ߚޔఝవክᩏຠ⋡߿ᛚ
᧦ઙࠅߩຠ⋡ߦ㑐ߒߡ߽ޔߘࠇߙࠇㅢᏱክᩏຠ⋡ޔᛚ᧦ઙߥߒߩຠ⋡ߣߩ⋧㆑ޔ߃߫೨⠪ߢࠇ
߫ᓙߜᤨ㑆ߩᏅޔᓟ⠪ߢࠇ߫⥃ᐥ࠺࠲ࡄ࠶ࠤࠫߩࡏࡘࡓߩ㆑ߣߞߚὐ߇ᦼ㑆⍴❗ߦะߌ
╙8┨ PMDAߣ↳⺧⠪ߩᛚክᩏߦ㑐ߔࠆࡄࡈࠜࡑࡦࠬ⹏ଔ
↳⺧ડᬺ߆ࠄߺߚPMDA߅ࠃ߮↳⺧ડᬺߩᛚክᩏߦ㑐ߔࠆࡄࡈࠜࡑࡦࠬࠍ⹏ଔߒߚޕ↳⺧ડᬺߪޔ ࠕࡦࠤ࠻⺞ᩏታᣉᒰᤨߦ߅ߌࠆPMDA߅ࠃ߮↳⺧⠪⥄りߩࡄࡈࠜࡑࡦࠬࠍ100ὐḩὐߢណὐߒߚޕ ᛚክᩏߦ㑐ߔࠆࡄࡈࠜࡑࡦࠬߦߪޔ↳⺧⾗ᢱߩክᩏ߿ᾖળ㗄ߩ߿ࠅߣࠅߦട߃ޔPMDAߢࠇ߫
ᴦ㛎⋧⺣߿ᴦ㛎⸘↹ዯ╬ߩኻᔕޔ↳⺧⠪ߢࠇ߫ᴦ㛎⋧⺣߿ᴦ㛎⸘↹ዯߩឭ⾗ᢱߩ⾰ޔⷙᒰዪߣߩ ኻᔕ╬ࠍߚޕ߹ߚޔ⺞ᩏIߦߡ࠺࠲ࠍ㓸ߒߚᛚຠ⋡ߦ㒢ࠄߕޔ⺞ᩏᒰᤨߦ↳⺧ડᬺ߇⚻㛎ߒ ߚઁߩຠ⋡ߦ߅ߌࠆᴦ㛎⋧⺣߿ᴦ㛎⸘↹ዯ╬ߩኻᔕ߽⹏ଔߩኻ⽎ߣߒߚޕᛚຠ⋡߇ⶄᢙࠆ႐ว߽
1ડᬺߚࠅ1ߟߩ⹏ଔߣߒޔห㐿⊒ડᬺߦ߽⹏ଔࠍଐ㗬ߒߚޕ
↳⺧⠪ߦࠃࠆPMDAߩࡄࡈࠜࡑࡦࠬ⹏ଔࠍ࿑ 37ޔ↳⺧⠪⥄りߦኻߔࠆ⹏ଔࠍ࿑ 38ߦ4Ბ㓏⹏ଔ 㧔A㧦80㨪100ὐޔB㧦65㨪79ὐޔC㧦50㨪64ὐޔD㧦0㨪49ὐ㧕ߢ␜ߒߚޕ߹ߚޔὐᢙߩၮᧄ⛔⸘㊂ࠍ
39ߦ␜ߒߚޕPMDAߦኻߔࠆ⹏ଔߪޔߎߩ3ᐕ㑆ߢA⹏ଔޔB⹏ଔߩഀว߇㘧べ⊛ߦჇടߒߡ߅ࠅޔ
↳⺧ડᬺ߇ᦨㄭߩPMDAߩࡄࡈࠜࡑࡦࠬࠍ㜞ߊ⹏ଔߒߡࠆߎߣ߇ુ߃ࠆޕ↳⺧⠪⥄りߦኻߔࠆ⹏ଔ
⚿ᨐߪޔPMDAߦኻߔࠆ⹏ଔࠃࠅᏱߦ㜞ߊޔ2008ᐕߪA⹏ଔ߇31.0%ޔB⹏ଔ߇50.0%ߢߞߚޕክᩏ ㇱߩណὐ߽ⴕߞߚ2008ᐕᛚຠ⋡ߢߪޔᒰᤨߩᣂ⮎ክᩏ╙৻ㇱ㧔╙1ಽ㊁ޔ╙4ಽ㊁ޔ᛫ᖡಽ㊁ޔ
ࠛࠗ࠭ක⮎ຠಽ㊁㧕߇ਛᄩ୯ޔᐔဋଔߣ߽ߦᦨ߽㜞߆ߞߚ߇ޔㇱ⟑㑆ߩᏅߪዊߐߊޔߨห᭽ߩ୯ߢ
ߞߚ㧔࿑ 39ޔ 40㧕ޕ
࿑ 37 ᛚክᩏߦ㑐ߔࠆPMDAߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2006㨪2008ᐕ㧕
18.6 60.5 18.6 2.3
4.4 35.6 57.8 2.2
2.6 23.7 65.8 7.9
0 20 40 60 80 100
% of PMDA's Grades 2008
2007 2006
A: 80-100 B: 65-79 C: 50-64 D: 0-49
䋨ᛚᐕ䋩
PMDA䈱⹏ଔ䋨%䋩
࿑ 38 ᛚክᩏߦ㑐ߔࠆ↳⺧⠪⥄りߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2006㨪2008ᐕ㧕
31.0 50.0 14.3 4.8
15.6 53.3 28.9 2.2
24.3 45.9 27.0 2.7
0 20 40 60 80 100
% of Applicant's Grades 2008
2007 2006
A: 80-100 B: 65-79 C: 50-64 D: 0-49
䋨ᛚᐕ䋩
↳⺧⠪䈱⹏ଔ䋨%䋩
39 ᛚክᩏߦ㑐ߔࠆࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2006㨪2008ᐕ㧕
ᛚᐕ N ਛᄩ୯ ᐔဋ୯ SD ᦨዊ ᦨᄢ PMDA
2006 38 60.0 57.9 8.6 40 85
2007 45 60.0 61.4 10.2 20 80
2008 43 70.0 69.4 8.2 40 83
ว⸘ 126 63.3 63.1 10.2 20 85
↳⺧⠪
2006 37 70.0 66.8 10.6 45 85
2007 45 70.0 66.6 9.4 45 80
2008 42 70.0 70.5 12.2 20 90
ว⸘ 124 70.0 68.0 10.8 20 90 Ꮕ䋨PMDA-↳⺧⠪䋩
2006 37 -5.0 -8.6 11.1 -30 15
2007 45 -5.0 -5.3 12.5 -45 25
2008 42 0.0 -1.1 12.5 -30 35
ว⸘ 124 -5.0 -4.9 12.4 -45 35
࿑ 39 ክᩏㇱߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2008ᐕ㧕
0 10 20 30 40 50 60 70 80 90 100
Grades
New Drug 1 New Drug 2 New Drug 3 New Drug 4
Bio 1 Bio 2 Overall
ᣂ⮎╙৻ㇱ ᣂ⮎╙ੑㇱ ᣂ⮎╙ਃㇱ ᣂ⮎╙྾ㇱ
↢‛╙৻ㇱ ↢‛╙ੑㇱ PMDAో
PMDA䈱ὐᢙ
70.0 65.0
ਛᄩ୯ 75.0
70.0 70.0
70.0 67.5
ᵈ㧦ὐ✢ߪోߩਛᄩ୯
70.0ὐ
40 ክᩏㇱߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2008ᐕ㧕
ክᩏㇱ N ਛᄩ୯ ᐔဋ୯ SD ᦨዊ ᦨᄢ ᣂ⮎ክᩏ╙৻ㇱ 29 75.0 72.1 9.5 50 90 ᣂ⮎ክᩏ╙ੑㇱ 29 65.0 62.2 14.8 30 85 ᣂ⮎ክᩏ╙ਃㇱ 25 70.0 70.6 12.0 40 90 ᣂ⮎ክᩏ╙྾ㇱ 28 67.5 67.5 9.5 50 90
↢‛♽ክᩏ╙৻ㇱ 9 70.0 71.1 10.5 60 90
↢‛♽ክᩏ╙ੑㇱ 3 70.0 63.3 11.5 50 70
╙9┨ ߹ߣ
2000㨪2008ᐕߦ࿖ౝߢᛚߐࠇߚᣂක⮎ຠࠍኻ⽎ߦޔ⥃ᐥ㐿⊒ᦼ㑆㧔ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚ↳
⺧ᣣ㧕ޔክᩏᦼ㑆㧔ᛚ↳⺧ᣣ㨪ᛚᣣ㧕ޔਔ⠪ࠍวࠊߖߚ㐿⊒ᦼ㑆㧔ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚᣣ㧕 ߩផ⒖߅ࠃ߮ߘߩ㐳ߐߣ㑐ଥߔࠆ࿃ሶࠍᬌ⸛ߒߚޕ⥃ᐥ㐿⊒ᦼ㑆ߪ2000㨪2008ᐕߩਛᄩ୯߇59.5ࡨ
㧔5.0ᐕ㧕ޔ2008ᐕ߇44.6ࡨ㧔3.7ᐕ㧕ߢࠅޔ㐿⊒ᚢ⇛ߩᄙ᭽ൻࠍᤋߒߡߘߩᄌേ߿߫ࠄߟ߈ߪᄢ ߈߆ߞߚޕᄖ࿖Phase 2㨪3⹜㛎ᚑ❣ࠍ࿖ౝᛚ↳⺧ߩᩮ⾗ᢱߣߒߡ↪ߔࠆߎߣ߇৻⥸ൻߒߡ߈ߡ߅ ࠅޔNMEߢߪᄖ࿖⥃ᐥ࠺࠲ࠍ↪ߒߚຠ⋡ߩ⥃ᐥ㐿⊒ᦼ㑆ߪᗧߦ⍴߆ߞߚޕ2008ᐕߦᛚߐࠇߚ 78ຠ⋡ߩ߁ߜޔ࿖㓙หᴦ㛎ߩᚑ❣ࠍ⹏ଔ⾗ᢱߣߒߚߩߪ1ຠ⋡ߩߺߢߞߚ߇ޔ࿖㓙หᴦ㛎ߦ㑐ߔ ࠆኻ㕙ഥ⸒߿ᴦ㛎⸘↹ዯ߇ᦨㄭჇടߒߡࠆߎߣ߆ࠄޔ⥃ᐥ࠺࠲ࠍ࿖㓙⊛ߦ⋧↪ߔࠆ㐿⊒߇ᓟ Ⴧ߃ߡߊߣ੍ᗐߐࠇࠆޕ࿖㓙หᴦ㛎ߦࠃߞߡ⥃ᐥ㐿⊒ᦼ㑆߇⍴ߊߥࠆߩ߆ޔⶄᢙ࿖ߢታᣉߔࠆߎߣ
╬ߦࠃߞߡ㐳ߊߥࠆߩ߆ޔࠆߪᄢ߈ߊᄌࠊࠄߥߩ߆ߪ߹ߛਇߢࠅޔ࿖ౝᄖߦ߅ߌࠆ⥃ᐥ㐿⊒
ߩ⌕ᚻᤨᦼ߿↳⺧ᤨᦼ߳ߩᓇ㗀߽ߡޔᓟᬌ⸛߇ᔅⷐߢࠆޕ
ክᩏᦼ㑆ߪ2004ᐕ4ߩPMDA⸳┙ᓟ⍴❗ะߦࠅޔ9ᐕ㑆ࠍㅢߒߚਛᄩ୯ߪ20.6ࡨ㧔1.7ᐕ㧕ޔ 2008ᐕߪ19.0ࡨ㧔1.6ᐕ㧕ߢߞߚޕ↳⺧⠪ߪክᩏᦼ㑆߇ㄭᐕ⍴ߊߥߞߡࠆߎߣࠍ⼂ߒߡ߅ࠅޔ PMDAߦኻߔࠆ⹏ଔ߽ᐕޘะߒߡࠆ߇ޔೋ࿁㕙⺣ᓟᾖળ㗄ߩ࿁╵ឭ߆ࠄㅊടᾖળ㗄ࠍ⚻ߡኾ 㐷ද⼏ߦ⥋ࠆࡊࡠࠬߦᄙߊߩᤨ㑆ࠍⷐߒߡ߅ࠅޔ2008ᐕߩታ❣ߣޟ㕟ᣂ⊛ක⮎ຠක≮ᯏེഃߩߚ
ߩ5ࡨᐕᚢ⇛ޠࠍฃߌߡឝߍߚ2011ᐕᐲߩ⋡ᮡ୯ߣߩ㑆ߦߪଐὼߣߒߡᄢ߈ߥᏅ߇ሽߔࠆޕ ⴕޔ↳⺧⠪ᣇߩᜬߜᤨ㑆ࠍߐࠄߦ⍴❗ߔࠆߚߦߪޔㅴⴕਛߩPMDA⡯ຬߩჇຬޔ೨⹏ଔ⋧⺣
ᐲߩዉࠍᴦ㛎⋧⺣ߩలޔክᩏߩㅴ▤ℂߩᒝൻߣߞߚᣉ╷ࠍታലᕈߩࠆᒻߢታߔࠆߎ ߣ߇㊀ⷐߢࠆޕ߹ߚޔ↳⺧⠪߽ᴦ㛎⋧⺣߿ᄖ࿖⥃ᐥ࠺࠲ߩലᨐ⊛ߥᵴ↪ޔ⾰ߩ㜞↳⺧⾗ᢱߩឭޔ ᾖળ㗄ߦኻߔࠆㄦㅦߥ࿁╵ឭ╬ࠍታⴕߔࠆߣߣ߽ߦޔޘߩડᬺౝߩᚻ㗅߿ߩ⋥ߒࠍ⠨ᘦߔ ࠆᔅⷐ߇ࠆߣ⠨߃ࠄࠇࠆޕPMDA⡯ຬߩჇടߦ㑐ߒߡߪޔߘߩലᨐߦᦼᓙߔࠆߣߣ߽ߦޔᧂ⚻㛎⠪ߩ ᕆჇ߿⚵❱ߩᄌᦝߦࠃߞߡPMDAߩታ❣߿⹏ଔ߇ࡑࠗ࠽ࠬߦォߓߥࠃ߁චಽߥੱ᧚⢒ᚑߣㆡಾߥੱ
ຬ㈩⟎߇ታᣉߐࠇࠆߎߣࠍ㗿߁ޕ
2009ᐕᐲࠃࠅ⹜㛎⊛ߦዉߐࠇߚ೨⹏ଔ⋧⺣ᐲߦ㑐ߒߡߪޔᛚ↳⺧೨ߦឭน⢻ߥຠ⾰ޔ㕖⥃
ᐥޔ⥃ᐥ࠺࠲ࠍᴦ㛎⋧⺣ߩᨒ⚵ߺߩਛߢ⹏ଔߒޔ㗴ὐ߿⺖㗴ࠍࠄ߆ߓ․ቯߔࠆߎߣߦࠃߞߡክ ᩏߩല₸ൻߣᦼ㑆⍴❗ࠍ࿑ࠅޔክᩏࠍታ⾰⊛ߦ೨ୟߒߔࠆߎߣࠍ⋡⊛ߣߒߡࠆߣ߃ࠆޕ೨⹏ଔ⋧
⺣ᐲߩᚑᨐ߇ᛚຠ⋡ߩክᩏᦼ㑆ߦᤋߐࠇࠆߩߪ2010ᐕએ㒠ߦߥࠆߣ੍ᗐߐࠇࠆ߇ޔᧄᐲ߇7.2.1 㗄ߢᬌ⸛ߒߚ↳⺧೨⋧⺣ߩࠃ߁ߦክᩏᦼ㑆߇⍴ߊߥࠆಽޔ⥃ᐥ㐿⊒ᦼ㑆߇ᑧ߮ࠆߎߣߥߊޔክᩏᦼ㑆߅ ࠃ߮㐿⊒ᦼ㑆ోࠍᗧߦ⍴❗ߒޔઁߩຠ⋡ߩክᩏࠍᅹߍࠆߎߣ߇ߥᒻߢታⴕߐࠇࠆߎߣࠍᦼᓙߔࠆޕ
߹ߚޔ೨⹏ଔ⋧⺣ࠍ↪ߒߚຠ⋡ߪ↪ߒߥ߆ߞߚຠ⋡ࠃࠅㄦㅦߦክᩏߐࠇࠆߎߣࠍ⸽ߔࠆ⚵ߺ ߇᭴▽ߐࠇޔㅊട⾌↪ࠍ⽶ᜂߔࠆ↳⺧⠪ߦߘߩࡌࡀࡈࠖ࠶࠻߇⏕ߦ␜ߐࠇࠆᔅⷐ߽ࠆޕߐࠄߦޔክ ᩏㇱޔክᩏಽ㊁ޔᜂᒰ⠪㑆ߢ߫ࠄߟ߈ߩࠆክᩏࡊࡠࠬߩᐔḰൻ߿ޔክᩏߩㅢߒߩะߦߟߥ߇ࠆ ታലᕈߩࠆᮡḰ⊛ߥክᩏ࠲ࠗࡓࠗࡦߩ␜ޔᾖળ㗄ߩല₸ൻޔ⮎㘩ຠⴡ↢ክ⼏ળߩක⮎ຠㇱ ળ߅ࠃ߮⮎ಽ⑼ળߩ৻ᧄൻࠆߪ㐿㗫ᐲߩ⋥ߒߣߞߚὐ߽ᬌ⸛ߦ୯ߔࠆߣ⠨߃ࠄࠇࠆޕ
ޔડᬺ㑆ߥࠄ߮ߦPMDAߣડᬺߩ㑆ߢޔᛚ↳⺧߅ࠃ߮ክᩏߩല₸ൻߦะߌߚߩ߿ද⼏
߇ㅴࠎߢࠆޕᣂ⮎߳ߩࠕࠢࠬะߦะߌޔᓟ߽ⴕߣ↳⺧⠪߇ቯᦼ⊛ߥታ❣⹏ଔ߿ᗧ឵ࠍㅢ ߓߡᣇߩᬺോࠍᡷༀߒޔߘߩᚑᨐ߇⥃ᐥ㐿⊒ᦼ㑆ߣክᩏᦼ㑆ࠍวࠊߖߚ㐿⊒ᦼ㑆ߩ⍴❗ߣߒߡࠇࠆ ߎߣࠍᦼᓙߔࠆޕ
╙10┨ ᛚክᩏᐲߦኻߔࠆ↳⺧ડᬺߩᗧޔⷐᦸ
ᛚክᩏᐲߦኻߔࠆ↳⺧ડᬺߩᗧ߿ⷐᦸࠍᢙ୯ߢߔߎߣߪ࿎㔍ߢࠆߚޔᛚຠ⋡ߦ㑐ߔࠆ
⺞ᩏIߣߪߦޔ⺞ᩏIIߦߡ2008ᐕߩᛚຠ⋡ߩ↳⺧ડᬺ㧔ห㐿⊒ડᬺࠍ㧕ߦએਅߩ4ὐ ߦߟߡ࿁╵ࠍଐ㗬ߒߚޕ࿁╵ߪޔ↪⺆߿ᢥࠍᢛߒߚઁߪޔ࿁╵ડᬺ߿ຠ⋡╬߇․ቯߐࠇߥ▸࿐
ߢේᢥߩ߹߹ߣߒߚޕ
1. PMDA⸳┙એ㒠ߩ⚵❱ᯏ⢻ߦ㑐ߔࠆⷐᦸޔᡷༀὐ
2. ክᩏㆃᑧߦ㑐ߔࠆⷐᦸޔክᩏㆊ⒟ߢߩ㗴
3. ೨⹏ଔ⋧⺣ᐲዉߦ㑐ߔࠆⷐᦸޔᗧ
4. PMDAክᩏຬߩჇຬߦኻߔࠆᦼᓙޔ ᔨ