ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩ⥃ᐥ㐿⊒ߣᛚክᩏ
⍹ᯅ ᄥ㇢ 㧔ක⮎↥ᬺ╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕 ዊ㊁ ବ 㧔᧲੩ᄢቇᄢቇ㒮⮎ቇ♽⎇ⓥ⑼ ක⮎ຠ⹏ଔ⑼ቇ⻠ᐳ ಎᢎ㧕 ක⮎↥ᬺ╷⎇ⓥᚲ ࠨ࠴ࡍࡄࠪ࠭ No. 47 㧔2009 ᐕ 10 㧕 ᧄࠨ࠴ࡍࡄߪ⎇ⓥߩ⸛⺰ߩߚߦ㈩Ꮣߔࠆ߽ߩߢࠅޔ⪺⠪ߩᛚ⻌ߥߒߦᒁ↪ޔⶄ౮ ߔࠆߎߣࠍߕࠆޕ ᧄࠨ࠴ࡍࡄߦ⸥ߐࠇߚᗧ߿⠨߃ߪ⪺⠪ߩੱ⊛ߥ߽ߩߢࠅޔᣣᧄ⮎Ꮏᬺදળ߅ࠃ߮ ක⮎↥ᬺ╷⎇ⓥᚲߩᑼߥ⸃ߢߪߥޕ ౝኈᾖળవ㧦 ⍹ᯅ ᄥ㇢ ᣣᧄ⮎Ꮏᬺදળ ක⮎↥ᬺ╷⎇ⓥᚲ ޥ103-0023 ᧲੩ㇺਛᄩᣣᧄᯅᧄ↸ 3-4-1 ࠻ࠗᣣᧄᯅࡆ࡞ 5F TEL: 03-5200-2681; FAX: 03-5200-2684 E-mail: [email protected] URL: http://www.jpma.or.jp/opir/ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩ⥃ᐥ㐿⊒ߣᛚክᩏ
⍹ᯅ ᄥ㇢ 㧔ක⮎↥ᬺ╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕 ዊ㊁ ବ 㧔᧲੩ᄢቇᄢቇ㒮⮎ቇ♽⎇ⓥ⑼ ක⮎ຠ⹏ଔ⑼ቇ⻠ᐳ ಎᢎ㧕 ක⮎↥ᬺ╷⎇ⓥᚲ ࠨ࠴ࡍࡄࠪ࠭ No. 47 㧔2009 ᐕ 10 㧕ⷐ⚂ 2000㨪2008 ᐕߦ࿖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ߪ 2000㨪2008 ᐕߩਛᄩ୯߇ 59.5 ࡨ 㧔5.0 ᐕ㧕ޔ2008 ᐕ߇ 44.6 ࡨ㧔3.7 ᐕ㧕ߢࠅޔ㐿⊒ᚢ⇛ߩᄙ᭽ൻࠍᤋߒߡߘߩᄌേ߿߫ࠄߟ߈߇ᄢ ߈߆ߞߚޕ࿖ౝᛚ↳⺧ߩᩮ⾗ᢱߣߒߡߩᄖ࿖⥃ᐥ࠺࠲ߩ↪߇Ⴧടߒߡ߅ࠅޔᦼ㑆⍴❗ߦ⽸₂ߒ ߡߚޕክᩏᦼ㑆ߪ 9 ᐕ㑆ࠍㅢߒߚਛᄩ୯߇ 20.6 ࡨ㧔1.7 ᐕ㧕ޔ2008 ᐕ߇ 19.0 ࡨ㧔1.6 ᐕ㧕ߢࠅޔ 2004ᐕ 4 ߩ PMDA ⸳┙ᓟ⍴❗ะߦߞߚ߇ޔክᩏᦼ㑆ߩ⚂ 3 ಽߩ 2 ࠍභࠆೋ࿁㕙⺣ᓟᾖળ㗄 ߩ࿁╵ឭ߆ࠄㅊടᾖળ㗄ࠍ⚻ߡኾ㐷ද⼏ߦ⥋ࠆࡊࡠࠬߢߪޔ⚻ᤨ⊛ߥᦼ㑆⍴❗߇ࠄࠇߥ߆ߞ ߚޕ⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆߅ࠃ߮㐿⊒ᦼ㑆ߩ㐳ߐߣᛚຠ⋡ޔ↳⺧ડᬺޔ⥃ᐥ㐿⊒߅ࠃ߮ᛚክᩏߦ 㑐ࠊࠆ࿃ሶߩ㑐ଥࠍ࿁Ꮻಽᨆߒߚ⚿ᨐޔ࿖ౝ⥃ᐥ⹜㛎ࠍታᣉߒߚຠ⋡ߢߪ NME એᄖޔᛚ᧦ઙࠅޔ ᄖ࿖⥃ᐥ࠺࠲ࠍ⹏ଔ⾗ᢱߣߒߡᷝઃߒߚຠ⋡ߩ⥃ᐥ㐿⊒ᦼ㑆ߪᗧߦ⍴߆ߞߚޕክᩏᦼ㑆ߦ㑐ߒߡߪޔ PMDA⸳┙ᓟߩ↳⺧ߣఝవክᩏຠ⋡ߪᗧߦ⍴߆ߞߚޕ߹ߚޔ↳⺧೨⋧⺣ࠍታᣉߒߚຠ⋡ߩክᩏᦼ㑆ߪ ᗧߦ⍴߆ߞߚ㕙ޔ⥃ᐥ㐿⊒ᦼ㑆ߪ㐳߆ߞߚޕ↳⺧⠪ߩ PMDA ߦኻߔࠆ⹏ଔߪะߒߡࠆ߇ޔޟ㕟 ᣂ⊛ක⮎ຠක≮ᯏེഃߩߚߩ 5 ࡨᐕᚢ⇛ޠࠍฃߌߡឝߍߚ 2011 ᐕᐲߩ⋡ᮡ୯㆐ᚑߦะߌޔⴕ ߅ࠃ߮↳⺧⠪ᣇߩᜬߜᤨ㑆ࠍߐࠄߦ⍴❗ߔࠆߦߪޔPMDA ⡯ຬߩჇຬޔ೨⹏ଔ⋧⺣ᐲߩዉޔክ ᩏߩㅴ▤ℂߩᒝൻ╬ߦട߃ޔᮡḰ⊛ߥክᩏ࠲ࠗࡓࠗࡦߩ␜ޔᾖળ㗄ߩല₸ൻޔ⮎㘩ຠⴡ↢ ክ⼏ળߩ⋥ߒߣߞߚᣇ╷߽ᬌ⸛ߔࠆᔅⷐ߇ࠆޕ
Changes in clinical development time (initial clinical trial plan notification (CTPN) to NDA), review time (NDA to approval), and development time (initial CTPN to approval) of new drugs approved in Japan during 2000 – 2008 were evaluated. Clinical development times were fluctuating, with a median of 59.5 months (5.0 years) during 2000 – 2008 and 44.6 months (3.7 years) in 2008. Dispersions were also large, reflecting the
diversification of development strategies. Use of foreign clinical data in Japanese NDAs was increasing and contributing to abridge clinical development times. Review times were on a decline since the establishment of PMDA in April 2004, with a median of 20.6 months (1.7 years) and 19.0 months (1.6 years) in 2000 – 2008 and 2008, respectively. No improvement, however, was observed in the time spent from submission of responses to the first set of queries after the Interview Meeting and subsequent queries to the Expert Meeting, which accounted for two-thirds of the review time. Multiple regression analyses to estimate factors associated with the length of the three time periods suggested that clinical development times were significantly shorter in non-NMEs, conditional approvals, and drugs utilizing foreign clinical data. Results also indicated that review times were significantly shorter in NDAs submitted to PMDA after April 2004 and drugs designated as priority reviews. Conduct of pre-NDA consultations with PMDA shortened the review process but prolonged clinical development. The applicants’ evaluation of PMDA’s recent performance is rising. Nevertheless, measures such as standardized review timelines with clear milestones, efficient query-and-response procedures, and re-examination of the role of the Pharmaceutical Affairs and Food Sanitation Council should be considered, in addition to the ongoing increase in PMDA staff, implication of pre-NDA evaluation consultations, and strict time management, to further shorten the process time of both the regulatory agencies and applicants and achieve the target review time set for fiscal year 2011 in light of the 5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices.
⋡ᰴ ⷐ⚂ ... 1 ╙ 1 ┨ ߪߓߦ ... 6 ╙ 2 ┨ ⎇ⓥߩ⇛ ... 7 2.1. ኻ⽎ຠ⋡ ... 7 2.2. ⺞ᩏᣇᴺ ... 7 2.3. ⸃ᨆᣇᴺ ... 8 ╙ 3 ┨ ᛚຠ⋡ߩౝ⸶ ... 10 ╙ 4 ┨ ᣂක⮎ຠߩ⥃ᐥ㐿⊒ᦼ㑆 ... 12 4.1. ⥃ᐥ㐿⊒ᦼ㑆㧔ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚ↳⺧ᣣ㧕ߩផ⒖ ... 12 4.2. ↳⺧ಽޔክᩏಽޔ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆 ... 13 4.3. ਥߥࡑࠗ࡞ࠬ࠻ࡦ߆ࠄ↳⺧߹ߢߩᦼ㑆... 16 4.4. ᄖ࿖⥃ᐥ࠺࠲ߩ↪ ... 17 4.5. ኻ㕙ഥ⸒ߩ↪ ... 18 ╙ 5 ┨ ᣂක⮎ຠߩክᩏᦼ㑆 ... 20 5.1. ክᩏᦼ㑆㧔ᛚ↳⺧ᣣ㨪ᛚᣣ㧕ߩផ⒖ ... 20 5.2. ↳⺧ಽޔክᩏಽޔ⮎ലಽ㘃ߩክᩏᦼ㑆 ... 20 5.3. ↳⺧⠪ߩ್ᢿߦࠃࠆޟክᩏㆃᑧޠߩή ... 23 5.4. ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆ߣ⋡ᮡ㆐ᚑ₸... 24 5.5. ክᩏࡊࡠࠬߩ⚦ ... 27 5.6. ೋ࿁㕙⺣ޔᾖળ㗄 ... 39 5.7. ㆡวᕈᦠ㕙⺞ᩏޔGCP ⺞ᩏ ... 43 5.8. GMP ⺞ᩏ ... 47 ╙ 6 ┨ ᣣᧄޔ☨࿖ޔEU ߦ߅ߌࠆክᩏᦼ㑆ߩᲧセ ... 49 ╙ 7 ┨ 㐿⊒ᦼ㑆ߣ㑐ଥߔࠆ࿃ሶ ... 52 7.1. ᣂක⮎ຠߩ㐿⊒ᦼ㑆㧔ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚᣣ㧕 ... 52 7.2. ⥃ᐥ㐿⊒ᦼ㑆ޔክᩏᦼ㑆ޔ㐿⊒ᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ ... 54 ╙ 8 ┨ PMDAߣ↳⺧⠪ߩᛚክᩏߦ㑐ߔࠆࡄࡈࠜࡑࡦࠬ⹏ଔ ... 59 ╙ 9 ┨ ߹ߣ ... 61 ╙ 10 ┨ ᛚክᩏᐲߦኻߔࠆ↳⺧ડᬺߩᗧޔⷐᦸ ... 62 10.1. PMDA⸳┙એ㒠ߩ⚵❱ᯏ⢻ߦ㑐ߔࠆⷐᦸޔᡷༀὐ ... 62 10.2. ክᩏㆃᑧߦ㑐ߔࠆⷐᦸޔክᩏㆊ⒟ߢߩ㗴 ... 67 10.3. ೨⹏ଔ⋧⺣ᐲዉߦ㑐ߔࠆⷐᦸޔᗧ ... 73 10.4. PMDAክᩏຬߩჇຬߦኻߔࠆᦼᓙޔ ᔨ ... 78
࿑⋡ᰴ ࿑ 1 ▫߭ߍ࿑ ... 8 ࿑ 2 2000㨪2008 ᛚຠ⋡ߩᛚᐕޔ↳⺧ᐕ... 9 ࿑ 3 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖ ... 12 ࿑ 4 ↳⺧ಽߩ⥃ᐥ㐿⊒ᦼ㑆 ... 13 ࿑ 5 ክᩏಽߩ⥃ᐥ㐿⊒ᦼ㑆 ... 14 ࿑ 6 ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆㧔NME㧕 ... 15 ࿑ 7 ਥߥࡑࠗ࡞ࠬ࠻ࡦ߆ࠄ↳⺧߹ߢߩᦼ㑆㧔2006㨪2008 ᐕᛚຠ⋡㧕 ... 16 ࿑ 8 ᄖ࿖ Phase 2㨪3 ⹜㛎࠺࠲ߩ↪ ... 17 ࿑ 9 ኻ㕙ഥ⸒ߩ࿁ᢙߩಽᏓ ... 18 ࿑ 10 ኻ㕙ഥ⸒ߩ࿁ᢙߣታᣉ₸ߩផ⒖ ... 19 ࿑ 11 ክᩏᦼ㑆ߩផ⒖ ... 20 ࿑ 12 ↳⺧ಽߩክᩏᦼ㑆 ... 21 ࿑ 13 ክᩏಽߩክᩏᦼ㑆 ... 21 ࿑ 14 ⮎ലಽ㘃ߩክᩏᦼ㑆 ... 22 ࿑ 15 ↳⺧⠪ߩ್ᢿߦࠃࠆޟክᩏㆃᑧޠߩή㧔2005㨪2008 ᐕᛚຠ⋡㧕 ... 23 ࿑ 16 ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆㧔ਛᄩ୯㧕... 24 ࿑ 17 2008 ᐕᛚຠ⋡ߩᜬߜᤨ㑆ߩಽᏓߣ⋡ᮡ㆐ᚑ₸ ... 26 ࿑ 18 2008 ᐕᛚຠ⋡ߩ 2011 ᐕᐲ⋡ᮡ୯ߩ㆐ᚑ₸ ... 27 ࿑ 19 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆 ... 27 ࿑ 20 ክᩏࡊࡠࠬߦⷐߒߚᦼ㑆㧔ਛᄩ୯㧕 ... 29 ࿑ 21 ฦࡊࡠࠬߩᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡ޔਛᄩ୯㧕 ... 31 ࿑ 22 ฦࡊࡠࠬߩᦼ㑆ߩផ⒖㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡ޔਛᄩ୯㧕 ... 32 ࿑ 23 ክᩏಽ㊁ߩฦࡊࡠࠬߩᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡ޔਛᄩ୯㧕 ... 34 ࿑ 24 ክᩏಽ㊁ߩክᩏᦼ㑆ߩផ⒖㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 37 ࿑ 25 ↳⺧ಽޔክᩏಽޔ↳⺧೨⋧⺣ߣೋ࿁㕙⺣ߩή㧔2008 ᐕᛚຠ⋡㧕 ... 40 ࿑ 26 ೋ࿁ᾖળ㗄ߦⷐߒߚᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡ޔਛᄩ୯㧕 ... 41 ࿑ 27 ㅊടᾖળ㗄ߩᒻᑼ㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 42 ࿑ 28 ㅊടᾖળ㗄ߦⷐߒߚᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡ޔਛᄩ୯㧕 ... 42 ࿑ 29 ㆡวᕈᦠ㕙⺞ᩏߦⷐߒߚᦼ㑆㧔ਛᄩ୯㧕 ... 44 ࿑ 30 ࿖ౝ GCP ⺞ᩏߦⷐߒߚᦼ㑆㧔ਛᄩ୯㧕 ... 44 ࿑ 31 ᄖ࿖ GCP ⺞ᩏߦⷐߒߚᦼ㑆 ... 47 ࿑ 32 GMP ⺞ᩏߦⷐߒߚᦼ㑆㧔2005㨪2008 ᐕᛚຠ⋡㧕 ... 48 ࿑ 33 ᣣ☨᰷ߦ߅ߌࠆክᩏᦼ㑆ߩᲧセ ... 50 ࿑ 34 㐿⊒ᦼ㑆ߩផ⒖㧔ਛᄩ୯㧕 ... 52 ࿑ 35 㐿⊒ᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ࠅߩᣂක⮎ຠ㧕 ... 55 ࿑ 36 ክᩏᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠ㧕 ... 57 ࿑ 37 ᛚክᩏߦ㑐ߔࠆ PMDA ߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2006㨪2008 ᐕ㧕 ... 59 ࿑ 38 ᛚክᩏߦ㑐ߔࠆ↳⺧⠪⥄りߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2006㨪2008 ᐕ㧕 ... 59
࿑ 39 ክᩏㇱߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2008 ᐕ㧕 ... 60 ࿑ 40 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖㧔↳⺧ᐕ㧕 ... 85 ࿑ 41 ክᩏᦼ㑆ߩផ⒖㧔↳⺧ᐕ㧕 ... 86 1 ࠕࡦࠤ࠻⺞ᩏߩኻ⽎㧔2000㨪2008 ᐕ㧕 ... 7 2 ⸃ᨆኻ⽎ߩౝ⸶ ... 10 3 ⸃ᨆኻ⽎ߩ⮎ലಽ㘃 ...11 4 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖ ... 12 5 ↳⺧ಽߩ⥃ᐥ㐿⊒ᦼ㑆 ... 13 6 ክᩏಽߩ⥃ᐥ㐿⊒ᦼ㑆 ... 14 7 ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆 ... 15 8 ਥߥࡑࠗ࡞ࠬ࠻ࡦ߆ࠄ↳⺧߹ߢߩᦼ㑆㧔2006㨪2008 ᐕᛚຠ⋡㧕 ... 16 9 ᄖ࿖⥃ᐥ࠺࠲ߩ↪ߣ⥃ᐥ㐿⊒ᦼ㑆... 17 10 ኻ㕙ഥ⸒ߩ࿁ᢙߣታᣉ₸ߩផ⒖ ... 19 11 ክᩏᦼ㑆ߩផ⒖ ... 20 12 ↳⺧ಽߩክᩏᦼ㑆 ... 21 13 ክᩏಽߩክᩏᦼ㑆 ... 22 14 ⮎ലಽ㘃ߩክᩏᦼ㑆 ... 23 15 ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆 ... 25 16 PMDA ߩክᩏᦼ㑆ߩ⋡ᮡ୯㧔ਛᄩ୯㧕 ... 25 17 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆 ... 28 18 ክᩏࡊࡠࠬߦⷐߒߚᦼ㑆 ... 30 19 ฦࡊࡠࠬߩᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 31 20 ฦࡊࡠࠬߩᦼ㑆ߩផ⒖㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 33 21 ክᩏಽ㊁ߩฦࡊࡠࠬߩᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 35 22 ክᩏಽ㊁ߣ⮎ല㗔ၞ㧔2008 ᐕ 12 㧕13 ... 37 23 ክᩏಽ㊁ߩክᩏᦼ㑆ߩផ⒖㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 38 24 ೋ࿁㕙⺣ߩήߣೋ࿁ᾖળ㗄ᚻ߹ߢߩᦼ㑆㧔2008 ᐕᛚຠ⋡㧕 ... 40 25 ೋ࿁ᾖળ㗄ߦⷐߒߚᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 41 26 ㅊടᾖળ㗄ߦⷐߒߚᦼ㑆㧔2004 ᐕ 4 એ㒠↳⺧ߩ 2005㨪2008 ᐕᛚຠ⋡㧕 ... 43 27 ㆡวᕈᦠ㕙⺞ᩏߦⷐߒߚᦼ㑆 ... 45 28 ࿖ౝ GCP ⺞ᩏߦⷐߒߚᦼ㑆 ... 46 29 ᄖ࿖ GCP ⺞ᩏߦⷐߒߚᦼ㑆 ... 47 30 GMP ⺞ᩏߦⷐߒߚᦼ㑆㧔2005㨪2008 ᐕᛚຠ⋡㧕 ... 48
37 ⵍ⺑ᄌᢙޔ⺑ᄌᢙߩၮᧄ⛔⸘㊂㧔࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠ㧕 ... 57 38 ክᩏᦼ㑆ߦᓇ㗀ࠍਈ߃ࠆ࿃ሶ㧔࿖ౝ⥃ᐥ⹜㛎ߩήࠍࠊߥᣂක⮎ຠ㧕 ... 58 39 ᛚክᩏߦ㑐ߔࠆࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2006㨪2008 ᐕ㧕 ... 60 40 ክᩏㇱߩࡄࡈࠜࡑࡦࠬ⹏ଔ㧔2008 ᐕ㧕 ... 60 41 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖㧔↳⺧ᐕ㧕 ... 85 42 ክᩏᦼ㑆ߩផ⒖㧔↳⺧ᐕ㧕 ... 86 43 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆㧔↳⺧ᐕ㧕 ... 87 44 ክᩏࡊࡠࠬߦⷐߒߚᦼ㑆㧔↳⺧ᐕ㧕 ... 89 45 ㆡวᕈᦠ㕙⺞ᩏߦⷐߒߚᦼ㑆㧔↳⺧ᐕ㧕 ... 91 46 ࿖ౝ GCP ⺞ᩏߦⷐߒߚᦼ㑆㧔↳⺧ᐕ㧕 ... 92 47 PMDA ߩክᩏᦼ㑆ߩ⋡ᮡ୯㧔ਛᄩ୯㧕 ... 93 48 ክᩏᦼ㑆ߩਛᄩ୯ߣ⋡ᮡ㆐ᚑ₸ ... 94 49 ✚ክᩏᦼ㑆߅ࠃ߮ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆㧔ਛᄩ୯㧕 ... 94
╙1┨ ߪߓߦ ᐭߪᣂߒ⑼ቇᛛⴚࠍᣂ⮎㐿⊒ߦߟߥߍޔ↪ߥක⮎ຠࠍㅦ߿߆ߦ࿖᳃ߦឭଏߔࠆߚߩᣇ╷ߩ߭ ߣߟߣߒߡޔ2007 ᐕ 4 ߦ⊒ⴕߒߚޟ㕟ᣂ⊛ක⮎ຠක≮ᯏེഃߩߚߩ 5 ࡨᐕᚢ⇛ޠ1ߢޔᣂ⮎ߩ ⇇ೋᏒ߆ࠄ࿖ౝߢ↪ߢ߈ࠆ߹ߢߩᦼ㑆ࠍ 2011 ᐕᐲ߹ߢߦ 2.5 ᐕ⍴❗ߒޔᣂ⮎߳ߩࠕࠢࠬࠍ᰷☨ ߣห᭽ߦߔࠆ⋡ᮡࠍឝߍߡࠆޕ2.5 ᐕߩౝ⸶ߪᛚ↳⺧߹ߢߩ 1.5 ᐕߣᛚ↳⺧߆ࠄᛚ߹ߢߩ 1 ᐕߢ ࠅ2ޔᓟ⠪ߦ㑐ߒߡߪ 2011 ᐕᐲߩ⋡ᮡ㆐ᚑߦะߌߡޔ✚ክᩏᦼ㑆߿ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆ߩᢙ୯⋡ ᮡࠍᐕᐲߏߣߦ⸳ቯߒޔߘߩᚑᨐࠍߒߡࠆ3ޕߒ߆ߒߥ߇ࠄޔᐭߪክᩏᦼ㑆ߩ⚦߿⥃ᐥ㐿⊒ߦ 㑐ߔࠆ࠺࠲ࠍ㓸Ⓧߒߡߥߚޔታ❣߿╷ߩ⹏ଔߪචಽߢߪߥޕ ᒰ⎇ⓥᚲߪޔ᧲੩ᄢቇᄢቇ㒮⮎ቇ♽⎇ⓥ⑼ߣหߢޔ1996 ᐕએ㒠ߦᛚߐࠇߚᣂක⮎ຠߩ↳⺧ડᬺߦ ኻߒߡࠕࡦࠤ࠻⺞ᩏࠍ⛮⛯⊛ߦታᣉߒޔ࿖ౝߦ߅ߌࠆᣂ⮎㐿⊒ߦ㑐ߔࠆ⚦ߥ࠺࠲ࠍ㓸ߒߡࠆ 㧔వⴕ⎇ⓥߩ㗄ࠍෳᾖ㧕ޕ⥃ᐥ⹜㛎߅ࠃ߮ᛚክᩏߦⷐߒߚᤨ㑆ࠍߪߓޔ᭽ޘߥᜰᮡࠍᬌ⸛ߒޔ࿖ౝ ߦ߅ߌࠆᣂ⮎㐿⊒ߩታ❣߿⮎ડᬺ߅ࠃ߮ⷙᒰዪߩࡄࡈࠜࡑࡦࠬޔᣂ⮎Ꮢߩㄦㅦൻߦะߌߚᣉ╷ ߩᚑᨐࠍቯ㊂⊛ߦ⹏ଔߒߡࠆޕ⎇ⓥᚑᨐߪ╷⎇ࠨ࠴ࡍࡄ4ޔ╷⎇࠾ࡘࠬ5,6ޔቇળ7╬ߦ ߡߒߡ߅ࠅޔ⥃ᐥ㐿⊒ߩല₸ൻޔⷙߩஜోߥㆇ↪ޔᛚክᩏᐲߩᡷༀ╬ߦะߌߚ╷ឭ⸒ߩၮ ␆⾗ᢱߣߒߡᵴ↪ߐࠇߡࠆޕ߹ߚޔ⥃ᐥ㐿⊒߅ࠃ߮ᛚክᩏߩࡑࠗ࡞ࠬ࠻ࡦߏߣߩ⸃ᨆ⚿ᨐߪޔડᬺ ߇㐿⊒ᚢ⇛ࠍ┙᩺ߔࠆ㓙ߩࡌࡦ࠴ࡑࠢߣߒߡ߽↪ߐࠇߡࠆޕ ᧄⓂߢߪޔ2008 ᐕߦ࿖ౝߢᛚߐࠇߚ 78 ຠ⋡ߩ࠺࠲ࠍട߃ߚᣂක⮎ຠߩ⥃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࿃ሶߦߟߡႎ๔ߔࠆޕ
╙2┨ ⎇ⓥߩ⇛ 2.1. ኻ⽎ຠ⋡ ᒰ⎇ⓥᚲߩ࠺࠲ࡌࠬߦജߐࠇߡࠆ 1996 ᐕએ㒠ߦ࿖ౝߢᛚߐࠇߚᣂක⮎ຠߩ߁ߜޔ৻ቯߩ ⺞ᩏ㗄⋡߇ឥߞߡࠆ 2000㨪2008 ᐕߩ 486 ຠ⋡ࠍኻ⽎ߣߒߚ㧔 1㧕ޕᣂක⮎ຠߪޔ⁛┙ⴕᴺੱක⮎ ຠක≮ᯏེ✚วᯏ᭴㧔એਅޔPMDA㧕ߩࡎࡓࡍࠫ8ߦឝタߐࠇߡࠆᣂലᚑಽක⮎ຠ㧔એਅޔ NME㧕ޔᣂක≮↪㈩วޔᣂᛩਈ⚻〝ක⮎ຠޔᣂല⢻ක⮎ຠޔᣂဳක⮎ຠޔᣂ↪㊂ක⮎ຠ╬ߣߒޔ2000 㨪2004 ᐕߪක⮎ຠㇱળߦߡክ⼏ߐࠇߚຠ⋡ޔ2005㨪2008 ᐕߪක⮎ຠㇱળߦߡክ⼏߅ࠃ߮ႎ๔ߐࠇߚຠ ⋡ࠍኻ⽎ߣߒߚޕㇱળክ⼏ຠ⋡ߪᛚᓟߦౣክᩏᦼ㑆߇⸳ቯߐࠇޔ↪ᚑ❣⺞ᩏ╬ߦၮߠߊౣ⹏ଔ߇ታ ᣉߐࠇࠆޕ৻ᣇޔㇱળႎ๔ຠ⋡ߪㇱળክ⼏ຠ⋡ࠃࠅᣂⷙᕈ߇⋧ኻ⊛ߦૐߊޔౣክᩏᦼ㑆߇ᣂߚߦ⸳ቯߐ ࠇߥޕຠ⋡ߪክᩏႎ๔ᦠߏߣߦࠞ࠙ࡦ࠻ߒޔ૬↪⮎‛≮ᴺ╬ߦߡⶄᢙᚑಽ߇ᛚߐࠇߚ߽ߩߪ 1 ߟߩ ຠ⋡ߣߒߡ㓸⸘ߒߚޕ 1 ࠕࡦࠤ࠻⺞ᩏߩኻ⽎㧔2000㨪2008 ᐕ㧕 ㇱળಽ 2000 2001 2002 2003 2004 2005 2006 2007 2008 ว⸘ ㇱળክ⼏ຠ⋡ 67 39 43 29 28 32 54 59 55 406 ㇱળႎ๔ຠ⋡ - - - 15 18 24 23 80 ว⸘ 67 39 43 29 28 47 72 83 78 486 2.2. ⺞ᩏᣇᴺ 2008ᐕ 1㨪12 ߦᛚߐࠇߚ 78 ຠ⋡㧔ㇱળክ⼏ 55 ຠ⋡ޔㇱળႎ๔ 23 ຠ⋡㧕ߦ㑐ߒߡߪޔ2009 ᐕ 2 㨪3 ߦ↳⺧ડᬺߦኻߒߡࠕࡦࠤ࠻⺞ᩏࠍታᣉߒޔ77 ຠ⋡㧔98.7㧑㧕ߦߟߡ࿁╵ࠍᓧߚޕࠕࡦࠤ ࠻ߪ 2 ㇱ᭴ᚑߣߒޔ⺞ᩏ I ߦߡ↳⺧ડᬺ߅ࠃ߮ຠ⋡ߩዻᕈޔᴦ㛎⸘↹ዯឭᣣ߿ᾖળ㗄ᚻᣣ╬ߩ 㕖ᖱႎࠍ⥃ᐥ㐿⊒ᦼ㑆߅ࠃ߮ክᩏᦼ㑆ߦ㑐ߔࠆ⚦ߥ࠺࠲ࠍ㓸ߒߚޕ⺞ᩏ II ߢߪ↳⺧ડ ᬺ߆ࠄߺߚ PMDA ߅ࠃ߮↳⺧⠪⥄りߩࡄࡈࠜࡑࡦࠬ⹏ଔࠍଐ㗬ߒߚޕ߹ߚޔPMDA ߩ⚵❱߅ࠃ߮ᯏ ⢻ޔክᩏຬߩჇຬޔክᩏࡊࡠࠬޔ೨⹏ଔ⋧⺣ᐲߦ㑐ߔࠆ↳⺧ડᬺߩⷐᦸ߿ᗧࠍ㓸ߒߚ㧔╙ 10 ┨ࠍෳᾖ㧕ޕ ⶄᢙߩડᬺ߇↳⺧ߦ㑐ࠊߞߚห㐿⊒ຠ╬ߪޔഃ⮎ࠝࠫࡦߩડᬺߦ⺞ᩏ I ߩ࿁╵ࠍଐ㗬ߒޔห 㐿⊒ડᬺࠃࠅࠝࠫࡦડᬺ߇࿁╵ߔࠆߎߣߩᛚ⻌ࠍᓧߚޕ⺞ᩏ II ߪࠝࠫࡦડᬺ߅ࠃ߮ห㐿⊒ડᬺ ߩਔ⠪ߦㅍઃߒޔᛚຠ⋡ᢙߦ㑐ࠊࠄߕޔડᬺߏߣߦ 1 ߟߩ࿁╵ࠍଐ㗬ߒߚޕ 㓸ߒߚේ࠺࠲ߩᯏኒᕈߪޔ⮎ડᬺߦዻߐߥᒰ⎇ⓥᚲኾછߩࠨ࠴ࠕࠪࠬ࠲ࡦ࠻߇ડᬺฬ߅ ࠃ߮ຠ⋡ฬࠍࡑࠬࠢߔࠆߎߣߦࠃߞߡᜬߒߚޕ߹ߚޔክᩏႎ๔ᦠ߿⮎ോႎ╬ߩᖱႎ߽㓸ߒޔ ࿁╵߇ᓧࠄࠇߥ߆ߞߚຠ⋡߿⺞ᩏ㗄⋡ߩ࠺࠲ࠍ৻ㇱቢߒߚޕ ↳⺧ࠍขࠅਅߍߚߣផ᷹ߐࠇࠆຠ⋡ߦ㑐ߒߡ߽ޔห᭽ߩࠕࡦࠤ࠻⺞ᩏࠍቯᦼ⊛ߦⴕߞߡࠆ߇ޔ ല࿁╵߇ᓧࠄࠇߚຠ⋡ᢙ߇߹ߛዋߥߚޔᧄⓂߩ⸃ᨆኻ⽎ߦߡߥޕᓟޔචಽߥࠨࡦࡊ࡞߇ 㓸Ⓧߐࠇߚᤨὐߢ⸃ᨆߔࠆߎߣࠍ⸘↹ߒߡࠆޕ
2.3. ⸃ᨆᣇᴺ
ᮡḰ⊛ߥ⛔⸘⸃ᨆ࠰ࡈ࠻ Stata/IC 10.1 for Windows㧔Stata Corp LP, College Station, TX, USA㧕ࠍ↪ߒޔ
એਅߩ 3 ߟߩᦼ㑆ߩ⚻ᤨ⊛ផ⒖ࠍ⸃ᨆߒߚޕክᩏᦼ㑆ߦ㑐ߒߡߪޔPMDA8ޔ☨࿖ߩ Food and Drug
Administration㧔એਅޔFDA㧕9ޔEU ߩ European Medicines Agency㧔એਅޔEMEA㧕10ߩᖱႎࠃࠅ▚ ߒߚ୯߽Ყセߒߚޕ߹ߚޔ3 ߟߩᦼ㑆ࠍⵍ⺑ᄌᢙޔᛚຠ⋡ߦ㑐ㅪߔࠆ․ᕈࠍ⺑ᄌᢙߣߒߚ࿁Ꮻಽ ᨆߦࠃߞߡޔฦᦼ㑆ߣ㑐ଥߔࠆ࿃ሶࠍផ⸘ߒߚޕ y ⥃ᐥ㐿⊒ᦼ㑆㧦ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚ↳⺧ᣣ ડᬺ߇࿖ౝߦ߅ߌࠆᦨೋߩ⥃ᐥ⹜㛎ߩೋ࿁ᴦ㛎⸘↹ዯࠍⷙᒰዪߦឭߒߚᣣ߆ࠄޔᛚ↳⺧ᦠࠍ ⷙᒰዪߦឭߒߚᣣ߹ߢߩᦼ㑆 y ክᩏᦼ㑆㧦ᛚ↳⺧ᣣ㨪ᛚᣣ ડᬺ߇ᛚ↳⺧ᦠࠍⷙᒰዪߦឭߒߚᣣ߆ࠄޔⷙᒰዪ߇ᛚᦠࠍઃߒߚᣣ߹ߢߩᦼ㑆 y 㐿⊒ᦼ㑆㧦ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚᣣ ⥃ᐥ㐿⊒ᦼ㑆ߣክᩏᦼ㑆ࠍว▚ߒߚᦼ㑆 ᦼ㑆߇⪺ߒߊ㐳ຠ⋡߿․ߦࠃࠅ⍴ຠ⋡߇ሽߔࠆߎߣ߆ࠄޔਥߚࠆၮᧄ⛔⸘㊂ߪਛᄩ୯ߣߒޔ ࠨࡦࡊ࡞ᢙ㧔N㧕ޔᐔဋ୯ޔᮡḰᏅ㧔SD㧕ࠍ૬⸥ߒߚޕ߹ߚޔᄙߊߩ⸃ᨆ⚿ᨐߪޔ࠺࠲ߩಽᏓ߇ࠊ ߆ࠆࠃ߁▫߭ߍ࿑ߢ␜ߒߚ㧔࿑ 1㧕ޕ▫߭ߍ࿑ߩ▫ߩਛᄩߩ✢ߪਛᄩ୯㧔50%㧕ޔ▫ߩਅ┵ޔ┵ߩ✢ߪ ߘࠇߙࠇ╙ 1 ྾ಽὐ㧔25%㧕ޔ╙ 3 ྾ಽὐ㧔75%㧕ࠍ␜ߒߡࠆޕߔߥࠊߜޔ100 ߩࠨࡦࡊ࡞߇ ߞߚ႐วޔ25 ⇟⋡ߩࠨࡦࡊ࡞ߩ୯߇╙ 1 ྾ಽὐޔ50 ⇟⋡߇ਛᄩ୯ޔ75 ⇟⋡߇╙ 3 ྾ಽὐߣߥࠆޕ ▫ߩਅߩㄭធ୯㧔߭ߍ㧕ߪ▫ߩ㜞ߐ㧔╙ 1 ྾ಽὐ㨪╙ 3 ྾ಽὐߩ㐳ߐ㧕ߩ 1.5 એౝߢਛᄩ୯߆ ࠄᦨ߽㔌ࠇߡࠆࠨࡦࡊ࡞ࠍ␜ߒߡࠆޕㄭធ୯ᄖߦࠆᄖࠇ୯ߪὐߣߒߡ␜ߐࠇࠆޕ ࿑ 1 ▫߭ߍ࿑ ታ㓙䈱ಽᏓ ᐳᮡ ਛᄩ୯䋨50%䋩 ╙1྾ಽὐ䋨25%䋩 ╙3྾ಽὐ䋨75%䋩 䋨0%䋩 䋨100%䋩 ᄖ䉏୯ ਅㄭធ୯ ㄭធ୯ ᦼ㑆
࿑ 2 ߦޔ2000㨪2008 ᐕߩᛚຠ⋡ߦ߅ߌࠆᛚᐕ߅ࠃ߮↳⺧ᐕߩಽᏓࠍ␜ߒߚޕฦᦼ㑆ߩᐕᰴផ⒖ ߪᛚᐕߢ␜ߒޔ৻ㇱߩ⸃ᨆߢ↳⺧ᐕߩ⚿ᨐࠍㆮ 1 ߦᷝઃߒߚޕᛚᐕߦࠃࠆ⸃ᨆߪޔᛚᒰᤨߩ ᛚክᩏ߅ࠃ߮ߘࠇએ೨ߩ⥃ᐥ㐿⊒ߩ⁁ᴫࠍߒߡࠆ߇ޔክᩏᦼ㑆ߩ㐳ຠ⋡߇ᄙ႐วߪ⥃ᐥ㐿⊒ ߿↳⺧ࠍⴕߞߚᤨᦼߣᛚᐕߩᤨᏅ߇ᄢ߈ߊޔ⸃ᨆ⚿ᨐ߇ᒰᤨߩ⁁ᴫࠍᤋߒߡߥน⢻ᕈ߇ࠆޕ ߎࠇߦኻߒߡޔ↳⺧ᐕߩ⸃ᨆߪ↳⺧ᐕ೨ᓟߩ⥃ᐥ㐿⊒߿ᛚክᩏߩ⁁ᴫࠍ␜ߒߡ߅ࠅޔ․ቯߩᤨᦼߦ ዉߐࠇߚ╷߿ክᩏߩᄌൻ╬ࠍ⹏ଔߔࠆߩߦㆡߒߡࠆޕߘߩ㕙ޔ⺞ᩏᤨὐߢᛚߐࠇߡߥ ຠ⋡ߪ⸃ᨆኻ⽎ߣߥࠄߥߚޔ↳⺧ᐕ߇ᦨㄭߢࠆ߶ߤຠ⋡ᢙ߇ᷫዋߒߡክᩏᦼ㑆ߩ⍴ຠ⋡߇⋧ ኻ⊛ߦᄙߊߥࠅޔኻߦ↳⺧ᐕ߇ㆊߢࠆ߶ߤ 2000 ᐕએ㒠ߦᛚߐࠇߚຠ⋡ߩክᩏᦼ㑆߇㐳ߊߥࠆޕ ࿑ 2 2000㨪2008 ᛚຠ⋡ߩᛚᐕޔ↳⺧ᐕ 0 20 40 60 80 Fr eq ue nc y 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Approval Year 0 20 40 60 80 Fr eq ue nc y 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 NDA Year↳⺧ᐕ ᛚᐕ ຠ⋡ ᢙ ຠ⋡ ᢙ
╙3┨ ᛚຠ⋡ߩౝ⸶ 2000㨪2008 ᐕߦ࿖ౝߢᛚߐࠇߚᣂක⮎ຠ 486 ຠ⋡ߩ↳⺧ಽޔክᩏಽ╬ࠍ 2ޔ⮎ലಽ㘃ࠍ 3 ߦ␜ߒߚޕ↳⺧ಽ߇ⶄᢙࠆຠ⋡ߪޔߩಽߦߚޕክᩏಽߪޔㅢᏱክᩏຠ⋡߅ࠃ߮ㄦㅦಣ ℂຠ⋡ࠍޟㅢᏱክᩏຠ⋡ޠޔᏗዋ∔∛↪ක⮎ຠ㧔HIV ࠍ㒰ߊ㧕ޔHIV ᗵᨴ∝ᴦ≮⮎ޔᏗዋ∔∛એᄖߩఝవ ክᩏຠ⋡ޔㆡᔕᄖ↪ޔ᛫߇ࠎ૬↪≮ᴺࠍޟఝవክᩏຠ⋡ޠߣߒߡ㓸⸘ߒߚޕ⮎ലಽ㘃ߪ⮎ോႎ╬ ߢ↪ࠄࠇߡࠆ 21 ಽ㘃ߢ␜ߒߚޕ 2008ᐕߩᛚຠ⋡ᢙߪ 78 ߢࠅޔߎߩ 3 ᐕ㑆ᄢ߈ߥᄌേߪߥޕ↳⺧ಽޔክᩏಽߦ߽⋡┙ߞߚ ᄌൻߪߥߊޔ2008 ᐕߦᛚߐࠇߚ NME ߪ 34 ຠ⋡㧔43.6%㧕ޔఝవ⊛ߦክᩏߐࠇߚ߽ߩߪ 35 ຠ⋡㧔44.9%㧕 ߢߞߚޕ߹ߚޔ2000㨪2008 ᐕߩ 9 ᐕ㑆ߩ߶߷ਛ㑆ߦߚࠆ 2004 ᐕ 4 ߩ PMDA ⸳┙એ㒠ߦ↳⺧ߐࠇ ߚᛚຠ⋡ߪᐕޘჇടߒߡ߅ࠅޔ2008 ᐕߦߪ 76 ຠ⋡㧔97.4%㧕߇ 2004 ᐕ 4 એ㒠ߦ↳⺧ߐࠇߚ߽ߩߢ ߞߚޕ2008 ᐕߦᛚߐࠇߚ 78 ຠ⋡ߩ߁ߜޔࡃࠗࠝක⮎ຠޔ⥄␠㐿⊒ຠߪߘࠇߙࠇ 12 ຠ⋡㧔15.4%㧕ޔ 49ຠ⋡㧔62.8%㧕ߢࠅޔᄖ⾗♽ડᬺߦࠃࠆ↳⺧ߪ 40 ຠ⋡㧔51.3%㧕*1ߢߞߚޕ⮎ലಽ㘃ߢߪޔ2008 ᐕߩᛚຠ⋡ߪઍ⻢ᕈක⮎ຠ㧔18 ຠ⋡ޔ23.1%㧕ޔᓴⅣེቭ↪⮎㧔9 ຠ⋡ޔ11.5%㧕ޔ᛫ᖡᕈ⣲≌⮎㧔9 ຠ ⋡ޔ11.5%㧕߇ᄙ߆ߞߚޕ 2 ⸃ᨆኻ⽎ߩౝ⸶ ຠ⋡․ᕈ 2000 2001 2002 2003 2004 2005 2006 2007 2008 ว⸘ ↳⺧ ᣂലᚑಽක⮎ຠ䋨NME䋩 40 22 24 15 16 21 23 35 34 230 ಽ (%) (59.7) (56.4) (55.8) (51.7) (57.1) (44.7) (31.9) (42.2) (43.6) (47.3) ᣂක≮↪㈩ว 1 0 0 0 2 1 1 3 5 13 ᣂᛩਈ⚻〝ක⮎ຠ 4 6 3 1 5 3 8 4 4 38 ᣂല⢻ක⮎ຠ 21 9 10 8 5 19 26 28 26 152 ᣂဳක⮎ຠ 0 2 5 0 0 2 7 4 2 22 ᣂ↪㊂ක⮎ຠ 1 0 1 5 0 1 4 8 6 26 㘃ૃಣᣇක≮↪㈩ว 0 0 0 0 0 0 2 1 1 4 ߘߩઁߩක⮎ຠ 0 0 0 0 0 0 1 0 0 1 ክᩏ ㅢᏱክᩏຠ⋡ 51 25 29 24 17 23 42 52 40 303 ಽ ㄦㅦಣℂຠ⋡ 0 2 1 1 0 4 5 3 3 19 Ꮧዋ∔∛↪ක⮎ຠ䋨㒰HIV䋩 9 7 8 2 3 7 10 13 16 75 HIVᗵᨴ∝ᴦ≮⮎ 2 1 0 1 3 2 1 2 3 15 Ꮧዋ∔∛એᄖ䈱ఝవክᩏຠ⋡ 5 4 5 1 3 5 4 9 11 47 ㆡᔕᄖ↪ 0 0 0 0 1 6 10 4 5 26 ᛫䈏䉖૬↪≮ᴺ 0 0 0 0 1 0 0 0 0 1 ఝవክᩏຠ⋡ 16 12 13 4 11 20 25 28 35 164 (%) (23.9) (30.8) (30.2) (13.8) (39.3) (42.6) (34.7) (33.7) (44.9) (33.7) PMDA⸳┙ᓟ䋨2004ᐕ4એ㒠䋩↳⺧ 0 0 0 0 4 12 42 70 76 204 (%) (0.0) (0.0) (0.0) (0.0) (14.3) (25.5) (58.3) (84.3) (97.4) (42.0) 䊋䉟䉥ක⮎ຠ 8 8 2 3 2 9 10 13 12 67 (%) (11.9) (20.5) (4.7) (10.3) (7.1) (19.2) (13.9) (15.7) (15.4) (13.8) 䉥䊥䉳䊮 ⥄␠ຠ 51 26 30 21 19 29 59 61 49 345 (%) (76.1) (66.7) (69.8) (72.4) (67.9) (61.7) (81.9) (73.5) (62.8) (71.0) ዉຠ 14 10 11 7 7 17 12 21 29 128 ਇ 2 3 2 1 2 1 1 1 0 13 ડᬺ ᄖ⾗♽ 26 22 18 18 16 20 41 46 40 247 ࿖☋ (%) (38.8) (56.4) (41.9) (62.1) (57.1) (42.6) (56.9) (55.4) (51.3) (50.8) ว⸘ 67 39 43 29 28 47 72 83 78 486
3 ⸃ᨆኻ⽎ߩ⮎ലಽ㘃 ⮎ലಽ㘃 2000 2001 2002 2003 2004 2005 2006 2007 2008 ว⸘ ਛᨔ⚻♽↪⮎ 8 1 0 2 1 1 5 5 3 26 (%) (11.9) (2.6) (0.0) (6.9) (3.6) (2.1) (6.9) (6.0) (3.9) (5.4) ⸃ᾲ㎾∩ᶖἻ⮎ 2 0 1 0 0 2 0 2 0 7 (%) (3.0) (0.0) (2.3) (0.0) (0.0) (4.3) (0.0) (2.4) (0.0) (1.4) ᧃ᪳⚻♽↪⮎ 2 2 0 0 0 1 0 2 2 9 (%) (3.0) (5.1) (0.0) (0.0) (0.0) (2.1) (0.0) (2.4) (2.6) (1.9) ⌒⑼⡊㥦⑼↪⮎ 6 1 1 2 1 1 3 2 4 21 (%) (9.0) (2.6) (2.3) (6.9) (3.6) (2.1) (4.2) (2.4) (5.1) (4.3) ᛫ࠕ࡞ࠡ↪⮎ 6 2 1 0 0 1 1 2 1 14 (%) (9.0) (5.1) (2.3) (0.0) (0.0) (2.1) (1.4) (2.4) (1.3) (2.9) ᓴⅣེቭ↪⮎ 5 2 7 6 1 3 4 6 9 43 (%) (7.5) (5.1) (16.3) (20.7) (3.6) (6.4) (5.6) (7.2) (11.5) (8.9) ๆེቭ↪⮎ 0 2 1 0 1 1 1 4 0 10 (%) (0.0) (5.1) (2.3) (0.0) (3.6) (2.1) (1.4) (4.8) (0.0) (2.1) ᶖൻེቭ↪⮎ 3 1 2 0 1 1 0 4 3 15 (%) (4.5) (2.6) (4.7) (0.0) (3.6) (2.1) (0.0) (4.8) (3.9) (3.1) ᶖൻᕈẩ≌↪⮎ 3 1 2 1 0 0 2 0 0 9 (%) (4.5) (2.6) (4.7) (3.5) (0.0) (0.0) (2.8) (0.0) (0.0) (1.9) ࡎ࡞ࡕࡦ 1 2 3 2 2 4 6 6 7 33 (%) (1.5) (5.1) (7.0) (6.9) (7.1) (8.5) (8.3) (7.2) (9.0) (6.8) ᴲዩ↢ᱺེቭ↪⮎ 0 0 0 0 2 0 4 4 0 10 (%) (0.0) (0.0) (0.0) (0.0) (7.1) (0.0) (5.6) (4.8) (0.0) (2.1) ᄖ⊹↪⮎ 2 2 2 1 0 1 2 0 2 12 (%) (3.0) (5.1) (4.7) (3.5) (0.0) (2.1) (2.8) (0.0) (2.6) (2.5) ઍ⻢ᕈක⮎ຠ 8 7 3 5 5 7 11 14 18 78 (%) (11.9) (18.0) (7.0) (17.2) (17.9) (14.9) (15.3) (16.9) (23.1) (16.1) ᛫ᖡᕈ⣲≌⮎ 4 5 4 4 3 7 7 9 9 52 (%) (6.0) (12.8) (9.3) (13.8) (10.7) (14.9) (9.7) (10.8) (11.5) (10.7) ᕈක⮎ຠ 0 0 0 0 1 1 0 1 0 3 (%) (0.0) (0.0) (0.0) (0.0) (3.6) (2.1) (0.0) (1.2) (0.0) (0.6) ᛫↢‛⾰ 2 3 3 2 2 3 3 3 4 25 (%) (3.0) (7.7) (7.0) (6.9) (7.1) (6.4) (4.2) (3.6) (5.1) (5.1) ൻቇ≮ᴺ 6 3 5 2 5 6 11 6 6 50 (%) (9.0) (7.7) (11.6) (6.9) (17.9) (12.8) (15.3) (7.2) (7.7) (10.3) ↢‛ቇ⊛ 6 2 2 1 0 3 7 4 6 31 (%) (9.0) (5.1) (4.7) (3.5) (0.0) (6.4) (9.7) (4.8) (7.7) (6.4) 㚟⯻⮎ 0 1 1 0 0 0 1 0 0 3 (%) (0.0) (2.6) (2.3) (0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.6) X✢ㅧᓇ䊶⸻ᢿ⮎ 2 1 3 0 1 1 2 2 1 13 (%) (3.0) (2.6) (7.0) (0.0) (3.6) (2.1) (2.8) (2.4) (1.3) (2.7) 䈠䈱ઁ 1 1 2 1 0 2 2 2 3 14 (%) (1.5) (2.6) (4.7) (3.5) (0.0) (4.3) (2.8) (2.4) (3.9) (2.9) ਇ 0 0 0 0 2 1 0 5 0 8 (%) (0.0) (0.0) (0.0) (0.0) (7.1) (2.1) (0.0) (6.0) (0.0) (1.7) ว⸘ 67 39 43 29 28 47 72 83 78 486 ᵈ㧦⮎ോႎ╬ߢ↪ࠄࠇߡࠆ⸥ 21 ಽ㘃ߢ␜ߒߚ
╙4┨ ᣂක⮎ຠߩ⥃ᐥ㐿⊒ᦼ㑆 4.1. ⥃ᐥ㐿⊒ᦼ㑆㧔ೋ࿁ᴦ㛎⸘↹ዯឭᣣ㨪ᛚ↳⺧ᣣ㧕ߩផ⒖ 2000㨪2008 ᐕߦᛚߐࠇߚ 486 ຠ⋡ߩ߁ߜޔ࿖ౝߢታᣉߐࠇߚ⥃ᐥ⹜㛎ߦ㑐ߔࠆ࠺࠲߇ᓧࠄࠇߚ 342ຠ⋡㧔70.4%㧕ࠍ⥃ᐥ㐿⊒ᦼ㑆ߩ⸃ᨆኻ⽎ߣߒߚޕᱷࠅ 144 ຠ⋡ߩ߁ߜޔ30 ຠ⋡ߪ࿖ౝߢ⥃ᐥ⹜㛎 ࠍታᣉߒߡ߅ࠄߕޔ114 ຠ⋡ߪ࠺࠲߇৻ㇱᰳ᷹ߒߡߚߚޔ⸃ᨆ߆ࠄ㒰ᄖߒߚޕ⥃ᐥ㐿⊒ᦼ㑆ߩᛚ ᐕߩផ⒖ࠍ࿑ 3ޔ 4 ߦ␜ߒߚޕ߹ߚޔ↳⺧ᐕߩផ⒖ࠍㆮ 1 ߦ࿑ 40ޔ 41 ߣߒߡᷝઃߒߚޕ 2000㨪2008 ᐕߩ 9 ᐕ㑆ߦ߅ߌࠆᣂක⮎ຠోߩ⥃ᐥ㐿⊒ᦼ㑆ߩਛᄩ୯ߪ 59.5 ࡨ㧔5.0 ᐕ㧕ߢࠅޔ NMEߢ 70.8 ࡨ㧔5.9 ᐕ㧕ޔNME એᄖߩຠ⋡ߢ 40.0 ࡨ㧔3.3 ᐕ㧕ߢߞߚޕో⥸⊛ߦ⥃ᐥ㐿⊒ᦼ㑆ߪ ⍴❗ะߦࠆ߽ߩߩޔߘߩ߫ࠄߟ߈ߪᄢ߈߆ߞߚޕߎࠇߪ Phase 1㨪3 ⹜㛎ࠍߔߴߡ࿖ౝߢⴕ߁㐿⊒߆ ࠄޔᄖ࿖⥃ᐥ࠺࠲ࠍᦨᄢ㒢ߦᵴ↪ߒߡ࿖ౝߢߪ৻ㇱߩ⥃ᐥ⹜㛎ߩߺታᣉߔࠆࠤࠬ߹ߢޔ㐿⊒ᚢ⇛߇ ᄙ᭽ൻߒߡࠆߎߣߦࠃࠆߣផኤߐࠇࠆޕ ࿑ 3 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖ 0 50 10 0 15 0 20 0 25 0 1 s t CT P N t o N D A ( m o n th s ) 2000 2001 2002 2003 2004 2005 2006 2007 2008 79.6 74.5 64.1 56.0 63.6 54.2 60.9 52.4 ਛᄩ୯ 44.6 ೋ࿁ ᴦ㛎⸘↹ ዯ䌾↳⺧ 䋨 ᢙ 䋩 ᛚᐕ ో 0 50 10 0 15 0 20 0 25 0 2000 20012002200320042005200620072008 200020012002200320042005200620072008 NME non-NME 1 s t CTPN t o N D A ( mon th s) ೋ࿁ᴦ 㛎⸘↹ዯ䌾↳ ⺧䋨 ᢙ 䋩 ᛚᐕ NMEએᄖ 79.666.9 66.8 68.8 88.8 69.2 66.1 61.3 82.4 88.1 27.6 35.9 41.5 35.7 54.1 42.3 ਛᄩ୯ 32.1 78.4 ᵈ㧦Ꮐߩࠣࡈߩὐ✢ߪోߩਛᄩ୯ 59.5 ࡨ 4 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖ ో NME NMEએᄖ ᛚᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD 2000 43 79.6 77.9 34.6 33 79.6 78.3 29.2 10 82.4 76.7 50.6 2001 24 74.5 77.3 32.0 17 66.9 69.7 29.8 7 88.1 95.9 31.5 2002 26 64.1 62.3 30.9 22 66.8 68.2 29.9 4 27.6 29.5 6.0 2003 24 56.0 62.2 34.9 14 68.8 67.7 18.8 10 35.9 54.4 49.9 2004 17 63.6 64.3 30.8 11 88.8 74.9 32.1 6 41.5 44.7 16.1 2005 34 54.2 65.8 42.7 16 69.2 71.6 36.0 18 35.7 60.7 48.3 2006 51 60.9 70.6 53.9 19 66.1 75.0 50.0 32 54.1 68.0 56.6 2007 63 52.4 59.0 36.2 28 61.3 70.5 40.5 35 42.3 49.7 29.9 2008 60 44.6 66.6 52.7 27 78.4 91.4 57.1 33 32.1 46.4 39.1 ว⸘ 342 59.5 67.1 42.1 187 70.8 75.1 38.7 155 40.0 57.5 44.1
4.2. ↳⺧ಽޔክᩏಽޔ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆 ↳⺧ಽߩ⥃ᐥ㐿⊒ᦼ㑆ࠍ࿑ 4ޔ 5 ߦ␜ߒߚޕNME ߩਛᄩ୯߇ 70.8 ࡨߢߞߚߩߦኻߒߡޔ NMEએᄖߩຠ⋡ߪޔਛᄩ୯߇ᄢ߈㗅ߦᣂᛩਈ⚻〝 47.1 ࡨޔᣂല⢻ 42.3 ࡨޔᣂဳ 38.6 ࡨޔᣂ ක≮↪㈩ว 36.9 ࡨޔᣂ↪㊂ 25.3 ࡨޔ㘃ૃಣᣇක≮↪㈩ว 21.6 ࡨߣޔߕࠇߩ↳⺧ಽߢ߽ ⥃ᐥ㐿⊒ߦ 20 ࡨએߩᦼ㑆ࠍⷐߒߚޕክᩏಽߦߺࠆߣޔᛚ↳⺧ᤨߦᏗዋ∔∛↪ක⮎ຠ㧔49.5 ࡨ㧕߹ߚߪᏗዋ∔∛એᄖߩఝవክᩏຠ⋡㧔51.7 ࡨ㧕ߦᜰቯߐࠇߚ NME ߩਛᄩ୯ߪޔㅢᏱክᩏຠ⋡ 㧔79.0 ࡨ㧕߅ࠃ߮ㄦㅦಣℂຠ⋡㧔68.9 ࡨ㧕ߦᲧߴߡዊߐߊޔߘߩᏅ߽ᄢ߈߆ߞߚ㧔࿑ 5ޔ 6㧕ޕ ৻ᣇޔNME એᄖߩຠ⋡ߢߪޔㆡᔕᄖ↪㧔17.0 ࡨޔN=1㧕ޔㄦㅦಣℂຠ⋡㧔28.5 ࡨ㧕ޔᏗዋ∔∛↪ක ⮎ຠ㧔33.9 ࡨ㧕ޔᏗዋ∔∛એᄖߩఝవክᩏຠ⋡㧔35.1 ࡨ㧕ޔㅢᏱክᩏຠ⋡㧔42.3 ࡨ㧕ߩ㗅ߦਛᄩ୯ ߇ዊߐߊޔክᩏಽ㑆ߩᏅߪዊߐ߆ߞߚޕ ࿑ 4 ↳⺧ಽߩ⥃ᐥ㐿⊒ᦼ㑆 0 50 100 150 200 250 1st CTPN to NDA (months) similar composition dosage formulation indication route combination NME ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧䋨ᢙ䋩 ᣂක≮↪㈩ว ᣂᛩਈ⚻〝ක⮎ຠ ᣂലᚑಽක⮎ຠ䋨NME䋩 ᣂല⢻ක⮎ຠ ᣂဳක⮎ຠ ᣂ↪㊂ක⮎ຠ 㘃ૃಣᣇක≮↪㈩ว ਛᄩ୯ 70.8 36.9 47.1 42.3 38.6 25.3 21.6 ᵈ㧦ὐ✢ߪోߩਛᄩ୯ 59.5 ࡨ 5 ↳⺧ಽߩ⥃ᐥ㐿⊒ᦼ㑆 ↳⺧ಽ N ਛᄩ୯ ᐔဋ୯ SD ᣂലᚑಽක⮎ຠ 187 70.8 75.1 38.7 ᣂක≮↪㈩ว 10 36.9 56.3 42.1 ᣂᛩਈ⚻〝ක⮎ຠ 22 47.1 64.8 51.9 ᣂല⢻ක⮎ຠ 86 42.3 60.1 43.7 ᣂဳක⮎ຠ 18 38.6 57.9 42.1 ᣂ↪㊂ක⮎ຠ 15 25.3 40.5 40.8 㘃ૃಣᣇක≮↪㈩ว 4 21.6 24.9 14.5 ว⸘ 342 59.5 67.1 42.1
࿑ 5 ክᩏಽߩ⥃ᐥ㐿⊒ᦼ㑆 0 50 100 150 200 250 0 50 100 150 200 250 off label priority ex-orphan orphan accelerated standard NME non-NME 1st CTPN to NDA (months) NMEએᄖ ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧䋨ᢙ䋩 ㅢᏱክᩏຠ⋡ ㄦㅦಣℂຠ⋡ Ꮧዋ∔∛↪ක⮎ຠ 䋨HIV䉕㒰䈒䋩 Ꮧዋ∔∛એᄖ䈱 ఝవክᩏຠ⋡ ㆡᔕᄖ↪ ఝవ ክᩏ ຠ⋡ 42.3 28.5 33.9 35.1 17.0 ਛᄩ୯ 79.0 68.9 49.5 51.7 6 ክᩏಽߩ⥃ᐥ㐿⊒ᦼ㑆 ో NME NMEએᄖ ክᩏಽ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ㅢᏱክᩏຠ⋡ 242 67.2 73.1 42.9 130 79.0 83.2 37.8 112 42.3 61.4 45.6 ㄦㅦಣℂຠ⋡ 13 39.2 56.0 48.1 5 68.9 80.0 56.5 8 28.5 41.1 38.3 Ꮧዋ∔∛↪ක⮎ຠ㧔㒰HIV㧕 50 46.1 53.9 38.2 30 49.5 57.7 36.3 20 33.9 48.2 41.2 Ꮧዋ∔∛એᄖߩఝవክᩏຠ⋡ 36 49.3 51.0 29.9 22 51.7 50.3 24.7 14 35.1 52.0 37.6 ㆡᔕᄖ↪ 1 17.0 17.0 - 0 - - - 1 17.0 17.0 -ว⸘ 342 59.5 67.1 42.1 187 70.8 75.1 38.7 155 40.0 57.5 44.1 NMEࠍኻ⽎ߦޔ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆ࠍ⸃ᨆߒߚޕ࿑ 6 ߦߪ 5 ຠ⋡એࠆ⮎ലಽ㘃ࠍ␜ߒޔ 5ຠ⋡ᧂḩ߅ࠃ߮ਇߩ߽ߩߪޟߘߩઁޠߦ߹ߣߚޕ 7 ߦߪޔߔߴߡߩ⮎ലಽ㘃ߩ⚿ᨐࠍ␜ߒߚޕ NME߇ 5 ຠ⋡એࠆ⮎ലಽ㘃ߢߪޔਛᨔ⚻♽↪⮎㧔85.8 ࡨ㧕ޔᓴⅣེቭ↪⮎㧔85.4 ࡨ㧕ޔ᛫ࠕ ࡞ࠡ↪⮎㧔78.4 ࡨ㧕ߩ㗅ߦਛᄩ୯߇ᄢ߈߆ߞߚޕਛᄩ୯߇ዊߐ߆ߞߚߩߪޔ᛫ᖡᕈ⣲≌⮎㧔48.2 ࡨ㧕ޔ⌒⑼⡊㥦⑼↪⮎㧔50.7 ࡨ㧕ޔ↢‛ቇ⊛㧔ࡢࠢ࠴ࡦޔⴊᶧ╬㧦59.5 ࡨ㧕ߢࠅޔᦨ ߽ᦼ㑆ߩ㐳ਛᨔ⚻♽↪⮎ߩ⥃ᐥ㐿⊒ᦼ㑆ߪ᛫ᖡᕈ⣲≌⮎ߩ 1.8 ߢߞߚ㧔࿑ 6㧕ޕ৻ᣇޔNME એ ᄖ߇ 5 ຠ⋡એࠆ⮎ലಽ㘃ߢߪޔ᛫ࠕ࡞ࠡ↪⮎㧔67.7 ࡨ㧕ޔ↢‛ቇ⊛㧔62.6 ࡨ㧕ޔᓴⅣེ ቭ↪⮎㧔61.1 ࡨ㧕ߩ㗅ߦਛᄩ୯߇ᄢ߈ߊޔ↢‛ቇ⊛ߪ NME એᄖߩຠ⋡ߩਛᄩ୯߇ NME ࠃࠅᄢ ߈߆ߞߚ㧔 7㧕ޕ
࿑ 6 ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆㧔NME㧕
0 50 100 150 200
1st CTPN to NDA (months) others
X-ray & diagnostics biologics chemotherapy antiinfectives antineoplastics metabolism integumentary genitourinary hormones cardiovascular allergy sensory organs CNS ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧䋨ᢙ䋩 ਛᨔ⚻ ᛫䉝䊧䊦䉩䊷 ᓴⅣེ 䊖䊦䊝䊮 ᴲዩ↢ᱺེ ᄖ⊹↪ ઍ⻢ᕈ ᛫ᖡᕈ⣲≌ ᛫↢‛⾰ ൻቇ≮ᴺ ↢‛ቇ⊛ ㅧᓇ䊶⸻ᢿ⮎ 䈠䈱ઁ ⌒⑼䊶⡊㥦⑼ ਛᄩ୯ 85.8 50.7 78.4 85.4 66.2 75.9 69.6 78.2 48.2 69.5 73.9 59.5 66.2 59.0 ᵈ㧦5 ຠ⋡એࠆ⮎ലಽ㘃ࠍ␜ߒޔ5 ຠ⋡ᧂḩ߅ࠃ߮ਇߩ߽ߩߪޟߘߩઁޠߦ߹ߣߚ㧧 ὐ✢ߪ NME ోߩਛᄩ୯ 70.8 ࡨ 7 ⮎ലಽ㘃ߩ⥃ᐥ㐿⊒ᦼ㑆 ో NME NMEએᄖ ⮎ലಽ㘃 N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ਛᨔ⚻♽↪⮎ 24 84.1 98.0 50.3 17 85.8 106.4 45.9 7 43.7 77.6 58.4 ⸃ᾲ㎾∩ᶖἻ⮎ 2 93.4 93.4 8.3 2 93.4 93.4 8.3 0 - - -ᧃ᪳⚻♽↪⮎ 6 76.0 77.0 48.4 2 118.1 118.1 56.2 4 58.3 56.5 34.1 ⌒⑼⡊㥦⑼↪⮎ 16 48.8 64.1 40.0 11 50.7 68.5 41.7 5 41.3 54.4 38.7 ᛫ࠕ࡞ࠡ↪⮎ 11 78.4 66.1 34.5 5 78.4 62.6 26.4 6 67.7 69.1 42.4 ᓴⅣེቭ↪⮎ 32 81.8 81.5 37.7 20 85.4 90.1 30.2 12 61.1 67.1 45.5 ๆེቭ↪⮎ 7 32.6 49.0 45.6 2 55.9 55.9 3.8 5 20.7 46.2 55.5 ᶖൻེቭ↪⮎ 13 46.9 56.7 34.8 4 74.0 76.7 49.1 9 40.7 47.8 25.0 ᶖൻᕈẩ≌↪⮎ 4 191.9 170.0 74.7 1 67.4 67.4 - 3 221.7 204.2 36.7 ࡎ࡞ࡕࡦ 24 66.1 72.8 45.2 10 66.2 77.5 38.1 14 52.1 69.5 50.8 ᴲዩ↢ᱺེቭ↪⮎ 9 59.2 61.4 29.9 6 75.9 72.7 27.5 3 34.4 38.7 23.0 ᄖ⊹↪⮎ 9 69.2 60.2 19.1 5 69.6 64.2 12.8 4 57.9 55.3 26.5 ઍ⻢ᕈක⮎ຠ 49 57.5 64.1 42.3 23 78.2 81.9 43.8 26 35.9 48.4 34.6 ᛫ᖡᕈ⣲≌⮎ 39 46.5 54.8 35.5 22 48.2 52.7 33.1 17 41.7 57.6 39.3 ᕈක⮎ຠ 3 44.2 39.4 8.9 3 44.2 39.4 8.9 0 - - -᛫↢‛⾰ 14 54.4 59.5 32.2 8 73.9 78.3 26.7 6 28.6 34.6 19.6 ൻቇ≮ᴺ 29 58.8 65.5 45.6 16 69.5 81.9 44.5 13 36.5 45.4 39.6 ↢‛ቇ⊛ 23 60.9 63.3 38.0 15 59.5 59.1 35.8 8 62.6 71.2 43.1 㚟⯻⮎ 1 36.7 36.7 - 1 36.7 36.7 - 0 - - -X✢ㅧᓇ⸻ᢿ⮎ 9 62.8 64.5 29.2 5 66.2 76.9 29.1 4 45.3 49.1 23.9 ߘߩઁ 12 34.6 42.2 23.8 5 59.5 65.0 19.4 7 24.5 25.9 6.5 ਇ 6 42.4 47.3 28.1 4 46.3 50.5 34.5 2 40.9 40.9 16.3 ว⸘ 342 59.5 67.1 42.1 187 70.8 75.1 38.7 155 40.0 57.5 44.1
4.3. ਥߥࡑࠗ࡞ࠬ࠻ࡦ߆ࠄ↳⺧߹ߢߩᦼ㑆 2006㨪2008 ᐕߩᛚຠ⋡ࠍኻ⽎ߦޔ⥃ᐥ㐿⊒ᦼ㑆ࠍޟೋ࿁ᴦ㛎⸘↹ዯឭᣣޠޔޟᦨೋߩᖚ⠪ኻ⽎⹜㛎 ߩ㐿ᆎᣣޠޔޟ↪㊂ᔕ⹜㛎ߩ㐿ᆎᣣޠޔޟᲧセᬌ⸽⹜㛎ߩ㐿ᆎᣣޠޔޟ↳⺧ޠߩ 5 ߟߩࡑࠗ࡞ࠬ࠻ࡦߢಾ ࠅޔฦᤨὐ߆ࠄ↳⺧߹ߢߩᦼ㑆ࠍ⸃ᨆߒߚ㧔࿑ 7ޔ 8㧕ޕNME એᄖߩຠ⋡ߢߪޔㅊട↳⺧ߩౝኈࠍ⋡ ⊛ߦታᣉߒߚ⥃ᐥ⹜㛎ߩᴦ㛎⸘↹ዯឭᣣ߿㐿ᆎᣣࠍ↪ߚޕ ࿑ 7 ਥߥࡑࠗ࡞ࠬ࠻ࡦ߆ࠄ↳⺧߹ߢߩᦼ㑆㧔2006㨪2008 ᐕᛚຠ⋡㧕 0 50 100 150 200 250 Time (months)
initial CTPN to NDA 1st patient study to NDA
1st dose response study to NDA 1st confirmatory study to NDA
ᦼ㑆䋨ᢙ䋩 ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧ ᖚ⠪ኻ⽎⹜㛎䌾↳⺧ Ყセᬌ⸽⹜㛎䌾↳⺧ ↪㊂ᔕ⹜㛎䌾↳⺧ 26.4 46.0 43.7 ਛᄩ୯ 52.3 ో 0 50 100 150 200 250 0 50 100 150 200 250 NME non-NME
initial CTPN to NDA 1st patient study to NDA
1st dose response study to NDA 1st confirmatory study to NDA
Time (months) 31.8 48.3 53.7 ਛᄩ୯ 66.3 24.7 40.1 33.1 39.3 NMEએᄖ ᦼ㑆䋨ᢙ䋩 ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧ ᖚ⠪ኻ⽎⹜㛎䌾↳⺧ Ყセᬌ⸽⹜㛎䌾↳⺧ ↪㊂ᔕ⹜㛎䌾↳⺧ 8 ਥߥࡑࠗ࡞ࠬ࠻ࡦ߆ࠄ↳⺧߹ߢߩᦼ㑆㧔2006㨪2008 ᐕᛚຠ⋡㧕 ో NME NMEએᄖ 䊙䉟䊦䉴䊃䊮 N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧ 174 52.3 65.0 47.7 74 66.3 79.3 49.7 100 39.3 54.5 43.5 ᖚ⠪ኻ⽎⹜㛎䌾↳⺧ 120 43.7 59.0 43.6 60 53.7 70.2 49.0 60 33.1 47.8 34.2 ↪㊂ᔕ⹜㛎䌾↳⺧ 91 46.0 61.2 39.9 51 48.3 66.8 44.2 40 40.1 54.1 32.7 Ყセᬌ⸽⹜㛎䌾↳⺧ 129 26.4 33.7 26.4 51 31.8 41.5 35.6 78 24.7 28.5 16.3 ޟೋ࿁ᴦ㛎⸘↹ዯ㨪↳⺧ޠߩਛᄩ୯ߪޔNME ߣߘࠇએᄖߢߘࠇߙࠇ 66.3 ࡨޔ39.3 ࡨߢࠅޔߘ ߩᏅߪ 27.0 ࡨߢߞߚޕਔ⠪ߩᏅߪ㐿⊒ᓟᦼ߶ߤዊߐߊޔޟᲧセᬌ⸽⹜㛎㨪↳⺧ޠߪ NME ߢ 31.8 ࡨ ޔNME એᄖߩຠ⋡ߢ 24.7 ࡨߢࠅޔߘߩᏅߪ 7.1 ࡨߢߞߚޕNME ߢߪᄙߊߩ႐วޔೋ࿁ᴦ㛎 ⸘↹ዯ߆ࠄ↳⺧߹ߢߩᦼ㑆ޔߔߥࠊߜ Phase 1㨪3 ࠍㅢߒߡⶄᢙߩ⥃ᐥ⹜㛎ࠍⴕ߁ߩߦኻߒߡޔNME એ ᄖߩຠ⋡ߢߪㅊട↳⺧ߔࠆౝኈߦᔕߓߡታᣉߔࠆ⹜㛎ߩ⒳㘃߿ᢙ߇⇣ߥࠆޕߒߚ߇ߞߡޔNME એᄖߩ ຠ⋡ߢ Phase 1 ⹜㛎ߩߺታᣉߒߚࠤࠬ╬ࠍޟೋ࿁ᴦ㛎⸘↹ዯ㨪↳⺧ޠߢߪਔ⠪ߩᏅߪᄢ߈ߊޔ↪ ㊂ᔕ⹜㛎߿Ყセᬌ⸽⹜㛎ࠍታᣉߒߚ NME એᄖߩຠ⋡ࠍ㐿⊒ᓟᦼߩᦼ㑆ߢߪߘߩᏅߪዊߐߊߥࠆ ߣ⠨߃ࠄࠇࠆޕ
4.4. ᄖ࿖⥃ᐥ࠺࠲ߩ↪ ᄖ࿖⥃ᐥ࠺࠲ߩ࿖ౝᛚ↳⺧߳ߩ↪⁁ᴫࠍ࿑ 8 ߦ␜ߒߚޕᄖ࿖⥃ᐥ࠺࠲ࠍᣣᧄએᄖߩ࿖ߢታᣉ ߐࠇߚ Phase 2㨪3 ⹜㛎ߩᚑ❣ߣቯ⟵ߒޔᣂක⮎ຠߩലᕈ߅ࠃ߮ోᕈߩᩮߣߒߡᛚ↳⺧ᦠߦᷝઃ ߒߚ߽ߩࠍޟ⹏ଔ⾗ᢱޠޔᛚክᩏߩෳ⠨⾗ᢱߣߒߡឭߒߚ߽ߩࠍޟෳ⠨⾗ᢱޠߦಽ㘃ߒߚޕ ᄖ࿖⥃ᐥ࠺࠲ߩฃߌࠇߦ㑐ߔࠆ ICH E5 ࠟࠗ࠼ࠗࡦ11⊒ⴕߩ 2 ᐕᓟߦߚࠆ 2000 ᐕߪޔᄖ࿖ Phase 2㨪3 ⹜㛎ᚑ❣ࠍ⹏ଔ⾗ᢱߣߒߡᛚ↳⺧ᦠߦᷝઃߒߡߚຠ⋡ߩഀว߇ NMEޔߘࠇએᄖߣ߽ߦ 10㨪15%⒟ᐲߢߞߚޕ2001 ᐕએ㒠ޔ߹ߕ NME એᄖߩຠ⋡ߢ↪߇Ⴧ߃ޔߘߩᓟ NME ߢ߽Ⴧടߒޔ ㄭᐕߢߪ NME ߩඨᢙએߩᛚ↳⺧ߦ㓙ߒߡᄖ࿖⥃ᐥ࠺࠲߇⹏ଔ⾗ᢱߣߒߡ↪ߐࠇߡࠆޕ߹ߚޔ ෳ⠨⾗ᢱࠍࠆߣ 2006 ᐕએ㒠ߪ NME ߩ 70%એޔNME એᄖߩຠ⋡ߩ 60%એߢᄖ࿖⥃ᐥ࠺࠲߇ ↪ߐࠇߡ߅ࠅޔ࿖ౝᛚ↳⺧ߩᩮ⾗ᢱߣߒߡߩᄖ࿖⥃ᐥ࠺࠲ߩ↪߇ቯ⌕ߒߡࠆߣ߃ࠆޕ 9 ߦޔᄖ࿖⥃ᐥ࠺࠲ߩ↪ߣ⥃ᐥ㐿⊒ᦼ㑆ߩ㑐ଥࠍ␜ߒߚޕNME ߢߪޔᄖ࿖⥃ᐥ࠺࠲ࠍᷝઃ ߒߥ߆ߞߚຠ⋡ߣᷝઃߒߚຠ⋡ߩ⥃ᐥ㐿⊒ᦼ㑆ߩਛᄩ୯ߪߘࠇߙࠇ 75.9 ࡨߣ 59.2 ࡨޔᐔဋ୯ߪ 82.6 ࡨߣ 64.9 ࡨߢࠅޔᷝઃߒߚຠ⋡ߢᗧߦ⍴߆ߞߚ㧔t ᬌቯޔp < 0.01㧕ޕNME એᄖߩຠ⋡ߢ߽ᄖ࿖ ⥃ᐥ࠺࠲ࠍ↪ߒߚຠ⋡ߪ↪ߒߥ߆ߞߚຠ⋡ߦᲧߴߡਛᄩ୯ޔᐔဋ୯ߣ߽ߦ⍴߆ߞߚ߇ޔߘߩᏅߪ ⛔⸘⊛ߦᗧߢߪߥ߆ߞߚޕ ࿑ 8 ᄖ࿖ Phase 2㨪3 ⹜㛎࠺࠲ߩ↪ 15.2 42.4 33.3 9.1 17.6 41.2 17.6 23.5 45.5 31.8 18.2 4.5 35.7 50.0 7.1 7.1 45.5 18.2 36.4 37.5 25.0 31.3 6.3 42.1 36.8 15.8 5.3 53.6 32.1 14.3 55.6 29.6 14.8 0 20 40 60 80 10 0 U s e o f F o re ig n P2 -3 St ud ie s 2000 2001 2002 2003 2004 2005 2006 2007 2008
evaluation⹏ଔ⾗ᢱ referenceෳ⠨⾗ᢱ did not submit or no dataᷝઃ䈞䈝䇮ᄖ࿖䊂䊷䉺䈭䈚 unknownਇ
䋨ᛚᐕ䋩 ᄖ࿖ P2 䌾 3 ⹜㛎䊂 䊷 䉺 䈱 ↪䋨 % 䋩 NME 10.0 20.0 50.0 20.0 42.9 42.9 14.3 50.0 25.0 25.0 40.0 60.0 16.7 16.7 50.0 16.7 38.9 27.8 33.3 37.5 25.0 37.5 31.4 31.4 34.3 2.9 21.2 39.4 33.3 6.1 0 20 40 60 80 10 0 U s e o f F o re ig n P2 -3 St ud ie s 2000 2001 2002 2003 2004 2005 2006 2007 2008
evaluation⹏ଔ⾗ᢱ referenceෳ⠨⾗ᢱ did not submit or no dataᷝઃ䈞䈝䇮ᄖ࿖䊂䊷䉺䈭䈚 unknownਇ
ᄖ࿖ P2 䌾 3 ⹜ 㛎 䊂 䊷 䉺 䈱 ↪䋨 % 䋩 䋨ᛚᐕ䋩 NMEએᄖ 9 ᄖ࿖⥃ᐥ࠺࠲ߩ↪ߣ⥃ᐥ㐿⊒ᦼ㑆 ᄖ࿖䊂䊷䉺 ో NME NMEએᄖ 䈱↪ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD 䈭䈚 205 65.7 72.0 44.2 104 75.9 82.6 39.0 101 42.2 61.2 46.7 䈅䉍 120 49.5 58.7 37.7 72 59.2 64.9 36.8 48 34.9 49.4 37.6 ਇ 17 79.1 67.4 38.5 11 79.1 72.0 35.8 6 55.3 59.0 45.3 ว⸘ 342 59.5 67.1 42.1 187 70.8 75.1 38.7 155 40.0 57.5 44.1 ᵈ㧦ᄖ࿖ P2㨪3 ⹜㛎ᚑ❣ࠍ⹏ଔ⾗ᢱߣߒߚ႐วࠍޟࠅޠߣߒߚ
4.5. ኻ㕙ഥ⸒ߩ↪ ⥃ᐥ㐿⊒ᦼ㑆ਛߦ↳⺧⠪߇ PMDA ߩኻ㕙ഥ⸒㧔ᴦ㛎⋧⺣㧕ࠍ↪ߒߚ࿁ᢙߣߘߩౝ⸶ࠍ⸃ᨆߒߚޕડ ᬺߪ⸘↹ߒߡࠆ⥃ᐥ⹜㛎ߩ୶ℂᕈ߿⑼ቇᕈޔᛚ↳⺧ߩⷐઙ╬ߦߟߡޔPMDA ࠃࠅᜰዉഥ⸒ࠍᓧ ࠆߚߦኻ㕙ഥ⸒ࠍ↳ߒㄟߎߣ߇ߢ߈ޔߘߩౝኈߪᢥᦠൻߐࠇޔᛚ↳⺧ᦠߦᷝઃߐࠇࠆޕ ࿑ 9 ߪኻ㕙ഥ⸒ߩ࿁ᢙߩಽᏓޔ࿑ 10 ߅ࠃ߮ 10 ߪኻ㕙ഥ⸒ߩᐔဋ࿁ᢙ㧔ࠣࡈ㧕ߣฦ⋧⺣ಽ ߩታᣉ₸㧔᛬ࠇ✢ࠣࡈ㧕ߩផ⒖ࠍ␜ߒߚ߽ߩߢࠆޕNME ߣߘࠇએᄖߩຠ⋡ߢኻ㕙ഥ⸒ߩ࿁ᢙߩಽ Ꮣߦᄢ߈ߥ㆑ߪߥߊޔ⚂ 4 ಽߩ 1 ߩຠ⋡ߢኻ㕙ഥ⸒߇ 1 ࿁߽ታᣉߐࠇߥ߆ߞߚ㕙ޔ߅ࠃߘඨᢙߩຠ ⋡ߢ 2 ࿁એታᣉߐࠇߡߚ㧔࿑ 9㧕ޕᛚᐕߦߺࠆߣޔNME ߢߪ 2004 ᐕߩ 3.6 ࿁ࠍࡇࠢߦኻ㕙ഥ ⸒ߩᐔဋ࿁ᢙߪᷫዋߒߡ߅ࠅޔ2008 ᐕߦᛚߐࠇߚຠ⋡ߢߪ 2.4 ࿁ߢߞߚ㧔࿑ 10ޔ 10㧕ޕฦ⋧⺣ ಽߩታᣉ₸ߪᛚᐕߦࠃߞߡჇᷫߪࠆ߇ޔ2008 ᐕߦᛚߐࠇߚ NME ߢߪ╙ 1 ⋧⹜㛎㐿ᆎ೨⋧⺣߇ 22%ޔ╙ 2 ⋧⹜㛎⚳ੌᓟ⋧⺣߇ 33%ޔ↳⺧೨⋧⺣߇ 63%ߢࠅޔోࠍㅢߓߡ↳⺧೨⋧⺣ߩታᣉ₸߇㜞 ߆ߞߚޕ৻ᣇޔNME એᄖߩຠ⋡ߢߪޔ2005 ᐕ߆ࠄㇱળႎ๔ຠ⋡ࠍ⸃ᨆኻ⽎ߦട߃ߚᓇ㗀ߢ╙ 1 ⋧⹜㛎 㐿ᆎ೨⋧⺣ߩታᣉ₸߇ૐਅߒߚน⢻ᕈߪࠆ߽ߩߩޔኻ㕙ഥ⸒ߩ࿁ᢙߪ 2004 ᐕߩ 2.2 ࿁߆ࠄ߶߷ᮮ߫ ߢࠅޔNME ߦᲧߴߡ࿁ᢙ߅ࠃ߮ታᣉ₸ߩᄌേ߇ዊߐޕ ࿑ 9 ኻ㕙ഥ⸒ߩ࿁ᢙߩಽᏓ 51 37 41 35 13 10 27.3% 19.8% 21.9% 18.7% 7.0% 5.3% 37 41 39 20 12 6 23.9% 26.5% 25.2% 12.9% 7.7% 3.9% NME non-NME 0 1 2 3 4 5 or more NMEએᄖ 5࿁એ
࿑ 10 ኻ㕙ഥ⸒ߩ࿁ᢙߣታᣉ₸ߩផ⒖ 1. 0 0. 8 0. 6 0. 4 0. 2 0. 0 % o f N D As w ith C o n s u lta ti o n s 0 1 2 3 4 N u m b er of C o n s u lta ti o n s 2000 2001 2002 2003 2004 2005 2006 2007 2008 Approval Year
frequency pre-P1 post-P2 pre-NDA others
ኻ㕙ഥ⸒䈱࿁ ᢙ ฦ⋧⺣ಽ 䈱ታᣉ₸ ᛚᐕ ᐔဋ࿁ᢙ ╙1⋧೨ ╙2⋧ᓟ ↳⺧೨ 䈠䈱ઁ NME 1. 0 0. 8 0. 6 0. 4 0. 2 0. 0 % o f N D As w ith C o n s u lta ti o n s 0 1 2 3 4 N u m b er of C o n s u lta ti o n s 2000 2001 2002 2003 2004 2005 2006 2007 2008 Approval Year
frequency pre-P1 post-P2 pre-NDA others
ኻ 㕙ഥ⸒䈱࿁ᢙ ฦ⋧⺣ಽ䈱 ታᣉ₸ ᛚᐕ ╙1⋧೨ ╙2⋧ᓟ ↳⺧೨ 䈠䈱ઁ NMEએᄖ ᐔဋ࿁ᢙ ᵈ㧦ࠣࡈߪኻ㕙ഥ⸒ߩᐔဋ࿁ᢙ㧔Ꮐ⋡⋓㧕ޔ᛬ࠇ✢ࠣࡈߪฦ⋧⺣ಽߩታᣉ₸㧔ฝ⋡⋓㧕ࠍ␜ߒߡࠆ㧧ޟߘߩઁߩ ⋧⺣ޠߦߪޔ೨ᦼ╙ 2 ⋧⹜㛎㐿ᆎ೨⋧⺣ޔᓟᦼ╙ 2 ⋧⹜㛎㐿ᆎ೨⋧⺣ޔᚻ⛯⋧⺣ޔ↢‛ቇ⊛ห╬ᕈ⹜㛎╬⋧⺣ޔຠ⾰ ⋧⺣ޔోᕈ⋧⺣ޔㅊട⋧⺣ࠍߚ 10 ኻ㕙ഥ⸒ߩ࿁ᢙߣታᣉ₸ߩផ⒖ ฦ⋧⺣ಽ䈱ታᣉ₸ ࿁ᢙ ╙1⋧㐿ᆎ೨ ╙2⋧⚳ੌᓟ ↳⺧೨ 䈠䈱ઁ ᛚᐕ N ᐔဋ୯ SD ᐔဋ୯ SD ᐔဋ୯ SD ᐔဋ୯ SD ᐔဋ୯ SD NME 2000 33 0.3 0.7 0.00 0.00 0.06 0.24 0.09 0.29 0.18 0.39 2001 17 1.1 0.8 0.06 0.24 0.06 0.24 0.71 0.47 0.24 0.44 2002 22 1.1 1.2 0.09 0.29 0.23 0.43 0.55 0.51 0.23 0.43 2003 14 1.9 1.0 0.00 0.00 0.43 0.51 0.71 0.47 0.71 0.47 2004 11 3.6 2.3 0.27 0.47 0.55 0.52 0.91 0.30 0.64 0.50 2005 16 3.3 3.2 0.13 0.34 0.44 0.51 0.75 0.45 0.69 0.48 2006 19 2.1 1.2 0.21 0.42 0.47 0.51 0.53 0.51 0.53 0.51 2007 28 2.5 1.7 0.36 0.49 0.46 0.51 0.54 0.51 0.57 0.50 2008 27 2.4 1.4 0.22 0.42 0.33 0.48 0.63 0.49 0.70 0.47 ว⸘ 187 1.8 1.8 0.15 0.36 0.31 0.46 0.54 0.50 0.47 0.50 NMEએᄖ 2000 10 0.2 0.6 0.00 0.00 0.10 0.32 0.00 0.00 0.10 0.32 2001 7 0.9 1.1 0.00 0.00 0.00 0.00 0.43 0.53 0.43 0.53 2002 4 1.5 1.3 0.50 0.58 0.25 0.50 0.50 0.58 0.25 0.50 2003 10 1.1 0.9 0.30 0.48 0.20 0.42 0.20 0.42 0.40 0.52 2004 6 2.2 1.7 0.50 0.55 0.50 0.55 0.50 0.55 0.33 0.52 2005 18 2.1 1.6 0.06 0.24 0.33 0.49 0.44 0.51 0.61 0.50 2006 32 1.9 1.5 0.09 0.30 0.53 0.51 0.47 0.51 0.47 0.51 2007 35 1.9 1.4 0.17 0.38 0.51 0.51 0.37 0.49 0.43 0.50 2008 33 1.6 1.3 0.03 0.17 0.55 0.51 0.33 0.48 0.48 0.51 ว⸘ 155 1.7 1.4 0.12 0.33 0.43 0.50 0.37 0.48 0.44 0.50
╙5┨ ᣂක⮎ຠߩክᩏᦼ㑆 5.1. ክᩏᦼ㑆㧔ᛚ↳⺧ᣣ㨪ᛚᣣ㧕ߩផ⒖ 2000㨪2008 ᐕߦᛚߐࠇߚ 486 ຠ⋡ࠍኻ⽎ߦޔክᩏᦼ㑆ߩផ⒖ࠍᛚᐕߦ⸃ᨆߒߚ㧔࿑ 11ޔ 11㧕ޕ ߹ߚޔ↳⺧ᐕߩផ⒖ࠍㆮ 1 ߦ࿑ 41ޔ 42 ߣߒߡᷝઃߒߚޕ 2004ᐕ 4 ߩ PMDA ⸳┙ᤨߦክᩏ߇৻ᤨ⊛ߦṛߞߚߚޔ2005 ᐕߦክᩏᦼ㑆ߪ৻ᣤ㐳ߊߥߞߚ߇ޔ ߘߩᓟߪ⍴ߊߥߞߡ߅ࠅޔ2008 ᐕߩክᩏᦼ㑆ߩਛᄩ୯ߪ 19.0 ࡨ㧔1.6 ᐕ㧕ߣ 4 ᐕ߱ࠅߦ 20 ࡨࠍਅ ࿁ࠅޔSD ߽ 11.0 ࡨߣዊߐ߆ߞߚޕክᩏᦼ㑆ߩ⍴❗ߦട߃ޔ߫ࠄߟ߈߇ዊߐߊߥߞߚߩߪޔPMDA ⸳ ┙એ㒠ߦ↳⺧ߐࠇߚᛚຠ⋡߇Ⴧടߒ㧔 2㧕ޔክᩏᦼ㑆߇⪺ߒߊ㐳߽ߩ߇ᷫዋߒߚߎߣߦࠃࠆߣ⠨ ߃ࠄࠇࠆޕክᩏಽߦߺࠆߣޔ2008 ᐕߩㅢᏱክᩏຠ⋡ߩክᩏᦼ㑆ߪ 21.9 ࡨ㧔1.8 ᐕ㧕ߢࠅޔห᭽ ߦ߫ࠄߟ߈߇ዊߐ߆ߞߚޕ৻ᣇޔఝవክᩏຠ⋡ߪ 15.6 ࡨ㧔1.3 ᐕ㧕ߢࠅޔߎߩ 3 ᐕ㑆߹ࠅᄌേߒ ߡߥޕ ࿑ 11 ክᩏᦼ㑆ߩផ⒖ 0 50 10 0 15 0 N D A to A p p ro v al ( m o n th s ) 2000 2001 2002 2003 2004 2005 2006 2007 2008 ᛚ ↳⺧ 䌾ᛚ 䋨 ᢙ 䋩 ᛚᐕ 28.3 16.8 17.7 19.1 18.3 24.0 22.8 20.0 ਛᄩ୯ 19.0 ో 0 50 10 0 15 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2000 2001 2002 2003 2004 2005 2006 2007 2008
Standard Review Priority Review
N D A t o Ap p ro v a l (m o n th s) 34.9 22.8 21.0 20.5 22.1 26.1 28.6 22.4 21.9 12.2 9.014.38.27.8 20.7 17.0 14.3 ਛᄩ୯ 15.6 ᛚ ↳⺧ 䌾ᛚ 䋨 ᢙ 䋩 ᛚᐕ ఝవክᩏຠ⋡ ㅢᏱክᩏຠ⋡ ᵈ㧦Ꮐߩࠣࡈߩὐ✢ߪోߩਛᄩ୯ 20.6 ࡨ 11 ክᩏᦼ㑆ߩផ⒖ ో ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡ ᛚᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD 2000 67 28.3 31.9 20.1 51 34.9 36.9 19.7 16 12.2 15.8 10.8 2001 39 16.8 26.1 21.4 27 22.8 30.7 20.9 12 9.0 15.7 19.6 2002 43 17.7 25.2 19.0 30 21.0 29.8 20.9 13 14.3 14.6 5.9 2003 29 19.1 23.2 17.3 25 20.5 25.4 17.4 4 8.2 9.0 7.0 2004 28 18.3 19.4 18.2 17 22.1 25.8 20.3 11 7.8 9.4 7.8 2005 47 24.0 25.4 13.1 27 26.1 29.7 13.9 20 20.7 19.7 9.5 2006 72 22.8 29.1 20.1 47 28.6 34.2 21.9 25 17.0 19.6 11.4 2007 83 20.0 25.1 20.7 55 22.4 28.9 22.7 28 14.3 17.7 13.5 2008 78 19.0 20.0 11.0 43 21.9 22.4 10.4 35 15.6 17.0 11.1 ว⸘ 486 20.6 25.5 18.4 322 23.5 29.9 19.6 164 15.1 16.7 11.7
߇ࠎ૬↪≮ᴺ㧕߅ࠃ߮ㄦㅦಣℂຠ⋡ߩክᩏᦼ㑆ߪޔㅢᏱክᩏຠ⋡ߦᲧߴߡ⏕߆ߦ⍴ߊޔ߫ࠄߟ߈߽ዊ
ߐ߆ߞߚ㧔࿑ 13ޔ 13㧕ޕ
࿑ 12 ↳⺧ಽߩክᩏᦼ㑆
0 50 100 150
NDA to Approval (months) other similar composition dosage formulation indication route combination NME ᛚ↳⺧䌾ᛚ䋨ᢙ䋩 ᣂක≮↪㈩ว ᣂᛩਈ⚻〝ක⮎ຠ ᣂലᚑಽක⮎ຠ䋨NME䋩 ᣂല⢻ක⮎ຠ ᣂဳක⮎ຠ ᣂ↪㊂ක⮎ຠ 㘃ૃಣᣇක≮↪㈩ว 䈠䈱ઁ 7.7 12.0 ਛᄩ୯ 21.9 19.6 24.3 18.8 23.2 18.7 ో 0 50 100 150 0 50 100 150 other similar composition dosage formulation indication route combination NME
Standard Review Priority Review
NDA to Approval (months)
ఝవክᩏຠ⋡ ㅢᏱክᩏຠ⋡ ᛚ↳⺧䌾ᛚ䋨ᢙ䋩 ᣂක≮↪㈩ว ᣂᛩਈ⚻〝ක⮎ຠ ᣂലᚑಽක⮎ຠ䋨NME䋩 ᣂല⢻ක⮎ຠ ᣂဳක⮎ຠ ᣂ↪㊂ක⮎ຠ 㘃ૃಣᣇක≮↪㈩ว 䈠䈱ઁ 26.1 22.6 24.9 21.7 24.6 19.1 7.7 12.0 ਛᄩ୯ 14.2 2.3 21.9 14.8 3.6 15.4 ᵈ㧦Ꮐߩࠣࡈߩὐ✢ߪోߩਛᄩ୯ 20.6 ࡨ 12 ↳⺧ಽߩክᩏᦼ㑆 ో ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡ ↳⺧ಽ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ᣂലᚑಽක⮎ຠ 230 21.9 28.3 22.0 153 26.1 34.8 23.2 77 14.2 15.4 11.3 ᣂක≮↪㈩ว 13 19.6 22.5 10.2 12 22.6 24.2 8.6 1 2.3 2.3 -ᣂᛩਈ⚻〝ක⮎ຠ 38 24.3 29.6 18.1 27 24.9 30.6 18.0 11 21.9 27.2 18.9 ᣂല⢻ක⮎ຠ 152 18.8 22.0 13.6 84 21.7 25.7 14.9 68 14.8 17.4 10.1 ᣂဳක⮎ຠ 22 23.2 23.9 11.7 20 24.6 25.9 10.2 2 3.6 3.6 3.1 ᣂ↪㊂ක⮎ຠ 26 18.7 20.2 12.4 21 19.1 21.8 12.9 5 15.4 13.7 7.7 㘃ૃಣᣇක≮↪㈩ว 4 12.0 13.2 3.0 4 12.0 13.2 3.0 0 - - -䈠䈱ઁ 1 7.7 7.7 - 1 7.7 7.7 - 0 - - -ว⸘ 486 20.6 25.5 18.4 322 23.5 29.9 19.6 164 15.1 16.7 11.7 ࿑ 13 ክᩏಽߩክᩏᦼ㑆 0 50 100 150
NDA to Approval (months) cancer combo off label priority ex-orphan HIV orphan accelerated standard ᛚ↳⺧䌾ᛚ䋨ᢙ䋩 ㅢᏱክᩏຠ⋡ ㄦㅦಣℂຠ⋡ Ꮧዋ∔∛↪ක⮎ຠ 䋨HIV䉕㒰䈒䋩 HIVᗵᨴ∝ᴦ≮⮎ Ꮧዋ∔∛એᄖ䈱 ఝవክᩏຠ⋡ ㆡᔕᄖ↪ ᛫䈏䉖૬↪≮ᴺ ఝవ ክᩏ ຠ⋡ ਛᄩ୯ 24.0 16.0 16.1 2.3 12.7 19.1 4.0 ో 0 50 100 150 0 50 100 150 cancer combo off label priority ex-orphan HIV orphan accelerated standard NME non-NME
NDA to Approval (months)
NMEએᄖ ᛚ↳⺧䌾ᛚ䋨ᢙ䋩 ㅢᏱክᩏຠ⋡ ㄦㅦಣℂຠ⋡ Ꮧዋ∔∛↪ක⮎ຠ 䋨HIV䉕㒰䈒䋩 HIVᗵᨴ∝ᴦ≮⮎ Ꮧዋ∔∛એᄖ䈱 ఝవክᩏຠ⋡ ㆡᔕᄖ↪ ᛫䈏䉖૬↪≮ᴺ ਛᄩ୯ 22.6 12.6 14.3 2.3 13.2 19.1 4.0 26.1 23.0 17.8 2.3 12.6 ᵈ㧦Ꮐߩࠣࡈߩὐ✢ߪోߩਛᄩ୯ 20.6 ࡨ
13 ክᩏಽߩክᩏᦼ㑆 ో NME NMEએᄖ ክᩏಽ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ㅢᏱክᩏຠ⋡ 303 24.0 30.7 19.7 148 26.1 35.1 23.4 155 22.6 26.5 14.3 ㄦㅦಣℂຠ⋡ 19 16.0 17.4 12.1 5 23.0 25.9 11.9 14 12.6 14.4 11.0 Ꮧዋ∔∛↪ක⮎ຠ㧔㒰HIV㧕 75 16.1 19.6 13.0 42 17.8 20.2 12.4 33 14.3 18.8 13.9 HIVᗵᨴ∝ᴦ≮⮎ 15 2.3 2.3 0.5 11 2.3 2.3 0.5 4 2.3 2.3 0.4 Ꮧዋ∔∛એᄖߩఝవክᩏຠ⋡ 47 12.7 13.5 5.3 24 12.6 13.0 4.8 23 13.2 14.0 5.9 ㆡᔕᄖ↪ 26 19.1 23.1 11.2 0 - - - 26 19.1 23.1 11.2 ᛫߇ࠎ૬↪≮ᴺ 1 4.0 4.0 - 0 - - - 1 4.0 4.0 -ว⸘ 486 20.6 25.5 18.4 230 21.9 28.3 22.0 256 19.4 22.9 14.1 ⮎ലಽ㘃ߩክᩏᦼ㑆ࠍ࿑ 14 ߦ␜ߒߚޕክᩏಽߦ㑐ࠊࠄߕޔోߢ 5 ຠ⋡એࠆ⮎ലಽ㘃ࠍ ␜ߒޔ5 ຠ⋡ᧂḩ߅ࠃ߮ਇߩ߽ߩߪޟߘߩઁޠߦ߹ߣߚޕ 14 ߦߪޔߔߴߡߩ⮎ലಽ㘃ߩ⚿ᨐࠍ ␜ߒߚޕㅢᏱክᩏຠ⋡ߢߪൻቇ≮ᴺ㧔18.3 ࡨ㧕ޔ᛫↢‛⾰㧔19.8 ࡨ㧕ޔ᛫ᖡᕈ⣲≌⮎㧔20.9 ࡨ㧕 ߩ㗅ߦክᩏᦼ㑆ߩਛᄩ୯߇ዊߐߊޔ⸃ᾲ㎾∩ᶖἻ㧔48.6 ࡨ㧕ޔ⌒⑼⡊㥦⑼↪⮎㧔32.7 ࡨ㧕ޔ᛫ࠕ ࡞ࠡ↪⮎㧔31.4 ࡨ㧕ߩ㗅ߦክᩏᦼ㑆߇㐳߆ߞߚޕ৻ᣇޔఝవክᩏຠ⋡ߢߪ HIV ᗵᨴ∝ᴦ≮⮎ࠍ ൻቇ≮ᴺ㧔3.1 ࡨ㧕ޔᓴⅣེቭ↪⮎㧔12.8 ࡨ㧕ޔਛᨔ⚻↪⮎㧔14.6 ࡨ㧕ߩ㗅ߦዊߐߊޔๆེ ቭ↪⮎㧔48.5 ࡨ㧕ޔ↢‛ቇ⊛㧔22.3 ࡨ㧕ޔ⌒⑼⡊㥦⑼↪⮎㧔20.8 ࡨ㧕ߩ㗅ߦᄢ߈ߊޔߘߩ㗅 ᐨߪㅢᏱክᩏຠ⋡ߣߪ⇣ߥߞߡߚޕ ࿑ 14 ⮎ലಽ㘃ߩክᩏᦼ㑆 0 50 100 150
NDA to Approval (months) others
X-ray & diagnostics biologics chemotherapy antiinfectives antineoplastics metabolism integumentary genitourinary hormones GI ulcer gastrointestinal respiratory cardiovascular allergy sensory organs peripheral NS analgestics CNS ਛᨔ⚻ ᛫䉝䊧䊦䉩䊷 ᓴⅣེ 䊖䊦䊝䊮 ᴲዩ↢ᱺེ ᄖ⊹↪ ઍ⻢ᕈ ᛫ᖡᕈ⣲≌ ᛫↢‛⾰ ൻቇ≮ᴺ ↢‛ቇ⊛ ㅧᓇ䊶⸻ᢿ⮎ 䈠䈱ઁ ⌒⑼䊶⡊㥦⑼ ⸃ᾲ㎾∩ᶖἻ ᧃ᪳⚻ ๆེ ᶖൻེ ᶖൻᕈẩ≌ ᛚ↳⺧䌾ᛚ䋨ᢙ䋩 20.5 22.5 21.3 23.0 25.1 19.7 18.3 18.0 10.9 23.0 28.6 19.0 44.8 24.8 26.1 31.4 20.9 25.5 ਛᄩ୯ 27.7 ో 0 50 100 150 0 50 100 150 others X-ray & diagnostics biologics chemotherapy antiinfectives antineoplastics metabolism integumentary genitourinary hormones GI ulcer gastrointestinal respiratory cardiovascular allergy sensory organs peripheral NS analgestics CNS
Standard Review Priority Review
NDA to Approval (months)
ఝవክᩏຠ⋡ ㅢᏱክᩏຠ⋡ ਛᨔ⚻ ᛫䉝䊧䊦䉩䊷 ᓴⅣེ 䊖䊦䊝䊮 ᴲዩ↢ᱺེ ᄖ⊹↪ ઍ⻢ᕈ ᛫ᖡᕈ⣲≌ ᛫↢‛⾰ ൻቇ≮ᴺ ↢‛ቇ⊛ ㅧᓇ䊶⸻ᢿ⮎ 䈠䈱ઁ ⌒⑼䊶⡊㥦⑼ ᛚ↳⺧䌾ᛚ䋨ᢙ䋩 ⸃ᾲ㎾∩ᶖἻ ᧃ᪳⚻ ๆེ ᶖൻེ ᶖൻᕈẩ≌ ਛᄩ୯ 14.6 21.0 27.1 20.9 24.0 25.1 23.0 20.9 19.8 18.3 23.3 28.6 23.7 48.6 26.2 32.7 31.4 22.5 23.2 28.5 20.5 19.2 29.2 16.7 15.6 16.1 16.6 3.1 22.3 15.2 18.9 16.0 20.8 12.8 48.5 ᵈ㧦ోߢ 5 ຠ⋡એࠆ⮎ലಽ㘃ࠍ␜ߒޔ5 ຠ⋡ᧂḩ߅ࠃ߮ਇߩ߽ߩߪޟߘߩઁޠߦ߹ߣߚ㧧 Ꮐߩࠣࡈߩὐ✢ߪోߩਛᄩ୯ 20.6 ࡨ
14 ⮎ലಽ㘃ߩክᩏᦼ㑆 ో ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡ ⮎ലಽ㘃 N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ਛᨔ⚻♽↪⮎ 26 27.7 35.5 27.0 23 28.5 38.0 27.8 3 14.6 16.5 4.7 ⸃ᾲ㎾∩ᶖἻ⮎ 7 44.8 34.7 20.0 4 48.6 50.0 5.6 3 18.9 14.3 8.0 ᧃ᪳⚻♽↪⮎ 9 24.8 22.4 7.7 5 26.2 26.9 4.4 4 16.0 16.6 7.4 ⌒⑼⡊㥦⑼↪⮎ 21 26.1 32.6 19.6 17 32.7 35.4 20.8 4 20.8 20.8 5.0 ᛫ࠕ࡞ࠡ↪⮎ 14 31.4 31.5 13.5 14 31.4 31.5 13.5 0 - - -ᓴⅣེቭ↪⮎ 43 20.9 28.0 16.9 33 22.5 31.9 17.4 10 12.8 15.3 4.6 ๆེቭ↪⮎ 10 25.5 35.4 25.5 9 23.2 34.0 26.6 1 48.5 48.5 -ᶖൻེቭ↪⮎ 15 20.5 22.4 8.5 10 21.0 22.1 6.6 5 20.5 23.0 12.4 ᶖൻᕈẩ≌↪⮎ 9 22.5 28.5 17.2 8 27.1 29.7 18.0 1 19.2 19.2 -ࡎ࡞ࡕࡦ 33 21.3 27.7 16.3 28 20.9 27.1 16.9 5 29.2 31.4 13.1 ᴲዩ↢ᱺེቭ↪⮎ 10 23.0 26.3 10.7 9 24.0 27.4 10.8 1 16.7 16.7 -ᄖ⊹↪⮎ 12 25.1 34.6 20.7 12 25.1 34.6 20.7 0 - - -ઍ⻢ᕈක⮎ຠ 78 19.7 23.2 14.4 48 23.0 26.2 15.4 30 15.6 18.3 11.3 ᛫ᖡᕈ⣲≌⮎ 52 18.3 20.5 13.3 21 20.9 25.3 13.2 31 16.1 17.2 12.5 ᕈක⮎ຠ 3 101.9 100.4 35.8 3 101.9 100.4 35.8 0 - - -᛫↢‛⾰ 25 18.0 19.6 13.4 18 19.8 21.7 14.9 7 16.6 14.1 6.2 ൻቇ≮ᴺ 50 10.9 14.9 15.6 22 18.3 25.3 18.1 28 3.1 6.8 5.7 ↢‛ቇ⊛ 31 23.0 26.4 22.1 11 23.3 32.5 30.8 20 22.3 23.0 15.5 㚟⯻⮎ 3 16.3 16.2 1.0 0 - - - 3 16.3 16.2 1.0 X✢ㅧᓇ⸻ᢿ⮎ 13 28.6 30.8 13.6 13 28.6 30.8 13.6 0 - - -ߘߩઁ 14 22.9 26.2 14.4 12 22.9 27.0 15.5 2 22.0 22.0 4.0 ਇ 8 11.6 12.5 5.7 2 17.0 17.0 7.7 6 9.8 11.0 4.8 ว⸘ 486 20.6 25.5 18.4 322 23.5 29.9 19.6 164 15.1 16.7 11.7 5.3. ↳⺧⠪ߩ್ᢿߦࠃࠆޟክᩏㆃᑧޠߩή ክᩏᦼ㑆߇ㄭᐕ⍴❗ߒߡࠆߎߣࠍ↳⺧⠪ߪታᗵߢ߈ߡࠆߩߢࠈ߁߆ޕ࿑ 15 ߪ↳⺧⠪ߩ್ᢿߦ ࠃࠆޟክᩏㆃᑧޠߩήߩផ⒖ࠍ␜ߒߡࠆޕޟክᩏㆃᑧޠࠍޟㆊߩຠ⋡ߣᲧセߒߡࠄ߆ߦㆃᑧߒ ߡࠆߣᕁࠊࠇࠆ߽ߩޠߣቯ⟵ߒޔડᬺᜂᒰ⠪ߩਥⷰ⊛್ᢿߦၮߠߊ࿁╵ࠍଐ㗬ߒߚޕ2008 ᐕߦ↳⺧⠪ ߇ޟክᩏㆃᑧࠅޠߣ್ᢿߒߚ߽ߩߪޔ࿁╵߇ᓧࠄࠇߚ 77 ຠ⋡ߩ߁ߜ 25 ຠ⋡㧔32.5㧑㧕ߢࠅޔᧄ⺞ ᩏ㗄⋡ࠍ⸳ቯߒߚ 2005 ᐕએ㒠ᷫዋߒߡߚޕᧄ⚿ᨐ߆ࠄޔ↳⺧⠪߽ክᩏᦼ㑆߇ㄭᐕ⍴ߊߥߞߡࠆߣ ⼂ߒߡࠆߎߣ߇ુ߃ࠆޕ৻ᣇߢޔޟክᩏㆃᑧޠߩήߪㆊߣߩᲧセߦၮߠߊ್ᢿߢࠅޔᧄ⚿ᨐ ߇ޔክᩏ߇ṛࠅߥߊㅴࠎߢࠆߣߩ್ᢿࠍᗧߒߡࠆࠊߌߢߪߥޕ ࿑ 15 ↳⺧⠪ߩ್ᢿߦࠃࠆޟክᩏㆃᑧޠߩή㧔2005㨪2008 ᐕᛚຠ⋡㧕 55.8 44.2 51.5 48.5 48.1 51.9 32.5 67.5 0 20 40 60 80 10 0 D e la y in R e vi ew 2005 2006 2007 2008 no delay delayed ክᩏㆃᑧ 䈱ή䋨 % 䋩 ᛚᐕ ㆃᑧ䈭䈚 ㆃᑧ䈅䉍 ో 61.5 38.5 59.1 40.9 50.0 50.0 39.5 60.5 47.1 52.9 37.5 62.5 44.0 56.0 23.5 76.5 0 20 40 60 80 10 0 2005 2006 2007 2008 2005 2006 2007 2008
Standard Review Priority Review
no delay delayed De la y i n Re v ie w ክ ᩏㆃᑧ 䈱 ή䋨 % 䋩 ᛚᐕ ㆃᑧ䈭䈚 ㆃᑧ䈅䉍 ఝవክᩏຠ⋡ ㅢᏱክᩏຠ⋡
5.4. ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆ߣ⋡ᮡ㆐ᚑ₸ ክᩏᦼ㑆ࠍⴕߣ↳⺧⠪ߩᜬߜᤨ㑆㧔࠲ࠗࡓࠢࡠ࠶ࠢ㧕ߦಽߌߡޔ࿑ 16ޔ 15 ߦ␜ߒߚޕ↳⺧⠪ ߩᜬߜᤨ㑆ߪޔࠕࡦࠤ࠻⺞ᩏߦߡല࿁╵߇ᓧࠄࠇߚຠ⋡ߦߟߡ㓸⸘ߒߚޕⴕߩᜬߜᤨ㑆ߪޔޟክ ᩏᦼ㑆㧙↳⺧⠪ߩᜬߜᤨ㑆ޠߦࠃߞߡ▚ߒߚޕ2008 ᐕߩᛚຠ⋡ߦ߅ߌࠆⴕߩᜬߜᤨ㑆ߩਛᄩ୯ߪޔ ోޔㅢᏱክᩏຠ⋡ޔఝవክᩏຠ⋡ߢߘࠇߙࠇ 9.4 ࡨޔ11.9 ࡨޔ7.1 ࡨߢߞߚߩߦኻߒߡޔ↳⺧ ⠪ߩᜬߜᤨ㑆ߪߘࠇߙࠇ 7.3 ࡨޔ7.8 ࡨޔ6.0 ࡨߢߞߚޕ2005 ᐕߦ৻ᣤᑧ㐳ߒߚᜬߜᤨ㑆ߪޔⴕ ޔ↳⺧⠪ߩᣇߢߘߩᓟ⍴❗ะߦߞߚޕ ࿑ 16 ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆㧔ਛᄩ୯㧕 13.9 12.5 10.5 7.6 11.1 7.3 10.9 7.3 11.2 5.6 13.4 9.1 13.4 9.5 11.3 8.5 9.4 7.3 0 5 10 15 20 P ro c e s s T ime ( m on th s) 2000 2001 2002 2003 2004 2005 2006 2007 2008
Regulatory Authority Applicant
ᜬ䈤ᤨ㑆 䋨 ᢙ䋩 ⴕ ᛚᐕ ↳⺧⠪ ో 15.7 16.5 11.1 9.1 12.2 8.0 11.3 7.8 12.6 7.4 15.4 10.7 15.1 10.0 14.5 8.8 11.9 7.8 7.5 4.5 3.3 6.3 8.7 5.0 4.4 3.8 4.7 3.2 9.0 8.0 10.0 6.5 7.5 7.07.1 6.0 0 5 10 15 20 2000 2001 2002 2003 2004 2005 2006 2007 2008 2000 2001 2002 2003 2004 2005 2006 2007 2008
Standard Review Priority Review
Regulatory Authority Applicant
Pr o c ess T ime ( m on th s ) ᜬ䈤ᤨ㑆 䋨 ᢙ䋩 ᛚᐕ ఝవክᩏຠ⋡ ㅢᏱክᩏຠ⋡ ⴕ ↳⺧⠪
15 ⴕߣ↳⺧⠪ߩᜬߜᤨ㑆 ⴕ ↳⺧⠪ ✚ᦼ㑆 ᛚᐕ N ਛᄩ୯ ᐔဋ୯ SD ਛᄩ୯ ᐔဋ୯ SD ਛᄩ୯ ᐔဋ୯ SD ో 2000 55 13.9 15.3 8.6 12.5 16.9 15.4 30.4 32.2 20.3 2001 35 10.5 12.8 10.7 7.6 14.0 16.7 16.8 26.8 22.5 2002 40 11.1 13.2 8.7 7.3 11.7 13.0 17.7 24.9 18.9 2003 27 10.9 12.1 7.3 7.3 8.8 6.6 18.6 20.9 12.8 2004 27 11.2 13.3 15.3 5.6 6.6 4.7 18.5 19.9 18.3 2005 42 13.4 15.0 11.3 9.1 11.0 7.3 24.5 26.0 13.7 2006 63 13.4 16.3 11.2 9.5 11.9 11.1 22.6 28.2 18.2 2007 75 11.3 14.1 15.4 8.5 11.5 13.0 20.2 25.6 21.1 2008 74 9.4 10.6 5.8 7.3 9.3 9.1 18.9 19.9 11.3 ว⸘ 438 11.2 13.7 11.0 8.2 11.6 11.9 20.7 25.3 18.1 ㅢᏱክᩏຠ⋡ 2000 43 15.7 17.0 8.3 16.5 19.7 15.9 34.9 36.7 19.9 2001 24 11.1 16.5 10.8 9.1 15.3 16.3 22.5 31.9 21.8 2002 29 12.2 14.9 9.5 8.0 13.9 14.5 20.7 28.9 20.6 2003 23 11.3 13.4 7.0 7.8 9.5 6.8 19.5 23.0 12.5 2004 17 12.6 17.0 17.9 7.4 8.8 4.4 22.1 25.8 20.3 2005 26 15.4 17.5 12.9 10.7 12.2 7.7 26.0 29.7 14.2 2006 43 15.1 18.7 11.9 10.0 14.0 12.6 28.0 32.7 19.7 2007 52 14.5 17.0 17.5 8.8 12.1 14.2 22.6 29.1 23.1 2008 42 11.9 12.7 5.6 7.8 9.8 9.5 22.5 22.5 10.5 ว⸘ 299 13.6 16.2 11.9 9.3 13.2 12.9 23.3 29.4 19.1 ఝవክᩏຠ⋡ 2000 12 7.5 9.4 7.0 4.5 6.6 6.9 11.9 16.0 11.8 2001 11 3.3 4.6 3.5 6.3 11.1 18.1 8.7 15.7 20.5 2002 11 8.7 8.7 3.3 5.0 6.0 4.0 14.3 14.6 6.4 2003 4 4.4 4.2 3.5 3.8 4.8 3.7 8.2 9.0 7.0 2004 10 4.7 7.0 5.9 3.2 3.0 2.3 7.9 10.0 8.0 2005 16 9.0 10.9 6.5 8.0 9.0 6.4 23.1 19.9 10.5 2006 20 10.0 11.1 7.5 6.5 7.6 4.6 17.1 18.6 9.2 2007 23 7.5 7.4 5.0 7.0 10.2 10.0 15.5 17.6 12.7 2008 32 7.1 7.9 5.0 6.0 8.6 8.6 15.3 16.5 11.5 ว⸘ 139 7.5 8.4 5.8 5.8 8.1 8.6 14.6 16.4 11.7 ᵈ㧦ᜬߜᤨ㑆ߦߟߡല࿁╵߇ᓧࠄࠇߚຠ⋡ࠍኻ⽎ߣߒߡࠆߚޔ ✚ᦼ㑆ߩ୯ߪ࿑ 11ޔ 11 ߣߪ⇣ߥࠆ ᐭߩޟ㕟ᣂ⊛ක⮎ຠක≮ᯏེഃߩߚߩ 5 ࡨᐕᚢ⇛ޠ1ࠍฃߌߡޔPMDA ߪᣂක⮎ຠߩክᩏᦼ 㑆ࠍᲑ㓏⊛ߦ⍴❗ߒޔ2011 ᐕᐲߦߪ 2004 ᐕ 4 એ㒠ߦ↳⺧ߐࠇߚຠ⋡ߩክᩏᦼ㑆ߩਛᄩ୯ࠍㅢᏱክᩏ ຠ⋡ߢ 12 ࡨޔఝవክᩏຠ⋡ߢ 9 ࡨߣߔࠆ⋡ᮡࠍឝߍߡࠆ㧔 16ޔ⚦ߪㆮ 2 ࠍෳᾖ㧕3,12ޕ㓸 ⸘ᦼ㑆߇ᧄ⎇ⓥߢߪᥲᐕޔPMDA ߩ⋡ᮡ୯߅ࠃ߮ᬺോႎ๔ߢߪᐕᐲߣ߁㆑ߪࠆ߽ߩߩޔ2008 ᐕߩ ᛚຠ⋡ߦ߅ߌࠆᜬߜᤨ㑆ࠍ 2008 ᐕᐲߩ⋡ᮡ୯㧔ㅢᏱክᩏຠ⋡㧦ⴕ 13 ࡨޔ↳⺧⠪ 8 ࡨޔఝవክ ᩏຠ⋡㧦ⴕ 6 ࡨޔ↳⺧⠪ 6 ࡨ㧕ߣᲧセߔࠆߣޔㅢᏱክᩏຠ⋡ߢߪⴕ㧔11.9 ࡨ㧕߅ࠃ߮↳⺧⠪ 㧔7.8 ࡨ㧕ޔఝవክᩏຠ⋡ߢߪ↳⺧⠪㧔6.0 ࡨ㧕߇ߘࠇߙࠇ⋡ᮡ୯ࠍ㆐ᚑߒߡߚޕ 16 PMDA ߩክᩏᦼ㑆ߩ⋡ᮡ୯㧔ਛᄩ୯㧕 ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡ ᐕᐲ ✚ᦼ㑆 ⴕ ↳⺧⠪ ✚ᦼ㑆 ⴕ ↳⺧⠪ 2007 21 13 8 12 6 6 2008 20 13 8 12 6 6 2009 19 12 7 11 6 5 2010 16 11 5 10 6 4 2011 12 9 3 9 6 3
࿑ 17 ߪⴕߣ↳⺧⠪ߩᜬߜᤨ㑆ߩಽᏓ㧔ᮮゲ㧦ⴕޔ❑ゲ㧦↳⺧⠪㧕ߣޔ2008 ᐕᐲߩ⋡ᮡ୯ࠍ㆐ᚑ ߒߚຠ⋡ᢙߣഀวࠍ␜ߒߡࠆޕ࠺࠲߇ᓧࠄࠇߚㅢᏱክᩏ 42 ຠ⋡ߩ߁ߜⴕޔ↳⺧⠪ߩᣇ߇⋡ᮡ ᦼ㑆એౝߦክᩏ߅ࠃ߮ኻᔕࠍ⚳ੌߒߚ߽ߩߪ 11 ຠ⋡㧔26.2%㧕ޔⴕߩߺ㆐ᚑߪ 12 ຠ⋡㧔28.6%㧕ޔ↳ ⺧⠪ߩߺ㆐ᚑߪ 11 ຠ⋡㧔26.2%㧕ޔᣇᧂ㆐ᚑߪ 8 ຠ⋡㧔19.1%㧕ߢߞߚޕ߹ߚޔఝవክᩏߐࠇߚ 32 ຠ⋡ߢߪޔ⋡ᮡᦼ㑆ߦኻߒߡᣇ㆐ᚑ߇ 9 ຠ⋡㧔28.1%㧕ޔⴕߩߺ㆐ᚑ߇ 5 ຠ⋡㧔15.6%㧕ޔ↳⺧⠪ߩ ߺ㆐ᚑ߇ 9 ຠ⋡㧔28.1%㧕ޔᣇᧂ㆐ᚑ߇ 9 ຠ⋡㧔28.1%㧕ߢߞߚޕ↳⺧⠪ߪㅢᏱክᩏຠ⋡ޔఝవክᩏ ຠ⋡ߣ߽ߦ⋡ᮡ୯ࠍ㆐ᚑߒߚഀว߇ 50%ࠍ߃ߡ߅ࠅޔᜬߜᤨ㑆ߩਛᄩ୯ߪ⋡ᮡ୯એౝߢߞߚޕ৻ᣇޔ ⴕߩ⋡ᮡ㆐ᚑ₸ߪㅢᏱክᩏຠ⋡ߢ 54.8%ޔఝవክᩏຠ⋡ߢ 43.8%ߢࠅޔఝవክᩏຠ⋡ߢ⋡ᮡᧂ㆐ᚑ ߢߞߚޕ ࿑ 17 2008 ᐕᛚຠ⋡ߩᜬߜᤨ㑆ߩಽᏓߣ⋡ᮡ㆐ᚑ₸ 13 months 8 months n=12 (28.6%) n=8 (19.1%) n=11 (26.2%) n=11 (26.2%) 0 10 20 30 40 50 60 A p pl ic a n ts' P ro c e ss T ime (m on th s ) 0 5 10 15 20 25
Regulatory Authority's Process Time (months)
↳⺧ ⠪䈱 ᜬ䈤 ᤨ㑆 䋨 ᢙ䋩 ⴕ䈱ᜬ䈤ᤨ㑆䋨ᢙ䋩 13䊰 8䊰 ㅢᏱክᩏຠ⋡ 6 months 6 months n=5 (15.6%) n=9 (28.1%) n=9 (28.1%) n=9 (28.1%) 0 10 20 30 40 50 60 A p pl ic a n ts' P ro c e ss T ime (m on th s ) 0 5 10 15 20 25
Regulatory Authority's Process Time (months)
↳⺧ ⠪䈱 ᜬ䈤 ᤨ㑆䋨 ᢙ 䋩 ⴕ䈱ᜬ䈤ᤨ㑆䋨ᢙ䋩 6䊰 6䊰 ఝవክᩏຠ⋡ ⴕ ↳⺧⠪ ҇13ࡨ >13ࡨ ว⸘ ҇8ࡨ 11 (26.2%) 11 (26.2%) 22 (52.4%) >8ࡨ 12 (28.6%) 8 (19.1%) 20 (47.6%) ว⸘ 23 (54.8%) 19 (45.2%) 42 (100%) ⴕ ↳⺧⠪ ҇6ࡨ >6ࡨ ว⸘ ҇6ࡨ 9 (28.1%) 9 (28.1%) 18 (56.3%) >6ࡨ 5 (15.6 %) 9 (28.1%) 14 (43.8 %) ว⸘ 14 (43.8%) 18 (56.3%) 32 (100%) ᰴߦޔޟ㕟ᣂ⊛ක⮎ຠක≮ᯏེഃߩߚߩ 5 ࡨᐕᚢ⇛ޠ1ߩᦨ⚳ᐕߦߚࠆ 2011 ᐕᐲߩ⋡ᮡ୯ߣ 2008ᐕߩታ❣ࠍᲧセߒߚ㧔࿑ 18㧕ޕ2008 ᐕߩㅢᏱክᩏຠ⋡ߩ߁ߜޔ2011 ᐕᐲߩ⋡ᮡ୯ߢࠆⴕ 9 ࡨ ޔ↳⺧⠪ 3 ࡨߩਔᣇࠍḩߚߒߡߚ߽ߩߪࠊߕ߆ 4 ຠ⋡㧔9.5%㧕ߢࠅޔ30 ຠ⋡㧔71.4%㧕߇ᣇ ᧂ㆐ᚑߢߞߚޕห᭽ߦⴕ 6 ࡨޔ↳⺧⠪ 3 ࡨߩਔᣇࠍ㆐ᚑߒߡߚఝవክᩏຠ⋡ߪ 3 ຠ⋡㧔9.4%㧕 ߩߺߢޔඨᢙએ߇ᣇᧂ㆐ᚑߢߞߚޕ3 ᐕᓟߩ⋡ᮡ୯ߢࠆㅢᏱክᩏຠ⋡ 12 ࡨ㧔ⴕ 9 ࡨޔ↳ ⺧⠪ 3 ࡨ㧕ޔఝవክᩏຠ⋡ 9 ࡨ㧔ⴕ 6 ࡨޔ↳⺧⠪ 3 ࡨ㧕ߣ 2008 ᐕߩታ❣㧔 15㧕ߩ㑆ߦߪޔ ㅢᏱክᩏຠ⋡ߢ 10.5 ࡨ㧔ⴕ 2.9 ࡨޔ↳⺧⠪ 4.8 ࡨ㧕ޔఝవክᩏຠ⋡ߢ 6.3 ࡨ㧔ⴕ 1.1 ࡨޔ ↳⺧⠪ 3.0 ࡨ㧕ߩᏅ߇ሽߒޔනߩ㆑ࠍၒࠆߎߣߪኈᤃߢߪߥޕ
࿑ 18 2008 ᐕᛚຠ⋡ߩ 2011 ᐕᐲ⋡ᮡ୯ߩ㆐ᚑ₸ 9 months 3 months n=6 (14.3%) n=30 (71.4%) n=4 (9.5%) n=2 (4.8%) 0 10 20 30 40 50 60 A p pl ic a n ts' P ro c e ss T ime (m on th s ) 0 5 10 15 20 25
Regulatory Authority's Process Time (months)
↳⺧ ⠪䈱 ᜬ䈤ᤨ㑆 䋨 ᢙ䋩 ⴕ䈱ᜬ䈤ᤨ㑆䋨ᢙ䋩 9䊰 䊰 ㅢᏱክᩏຠ⋡ 6 months 3 months n=11 (34.4%) n=18 (56.3%) n=3 (9.4%) n=0 (0%) 0 10 20 30 40 50 60 A p pl ic a n ts' P ro c e ss T ime (m on th s ) 0 5 10 15 20 25
Regulatory Authority's Process Time (months)
↳⺧ ⠪䈱 ᜬ䈤 ᤨ㑆 䋨 ᢙ䋩 ⴕ䈱ᜬ䈤ᤨ㑆䋨ᢙ䋩 6䊰 3䊰 ఝవክᩏຠ⋡ ⴕ ↳⺧⠪ ҇9ࡨ >9ࡨ ว⸘ ҇3ࡨ 4 (9.5%) 2 (4.8%) 6 (14.3%) >3ࡨ 6 (14.3%) 30 (71.4%) 36 (85.7%) ว⸘ 10 (23.8%) 32 (76.2%) 42 (100%) ⴕ ↳⺧⠪ ҇6ࡨ >6ࡨ ว⸘ 㻡3䊰 3 (9.4%) 0 (0%) 3 (9.4%) >3䊰 11 (34.4%) 18 (56.3%) 29 (90.6%) ว⸘ 14 (43.8%) 18 (56.3%) 32 (100%) 5.5. ክᩏࡊࡠࠬߩ⚦ 5.5.1. 2000㨪2008 ᐕߩᛚຠ⋡ 2000㨪2008 ᐕߩᛚຠ⋡ࠍኻ⽎ߦޔክᩏᦼ㑆ࠍޟ↳⺧ޠޔޟೋ࿁㕙⺣ޠޔޟኾ㐷ද⼏ޠޔޟක⮎ຠㇱળޠޔ ޟ⮎ಽ⑼ળޠޔޟᛚޠޔߥࠄ߮ߦᛚᓟߩޟ⮎ଔタޠࠍട߃ߚ 7 ߟߩࡑࠗ࡞ࠬ࠻ࡦߢಾࠅޔ↳⺧ ߆ࠄฦࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆ࠍ࿑ 19ޔ 17 ߦ␜ߒߚޕ߹ߚޔ↳⺧ᐕߩ୯ࠍㆮ 1 ߦ 43 ߣߒߡ ᷝઃߒߚޕޟ↳⺧㨪ೋ࿁㕙⺣ޠߩਛᄩ୯ߪㅢᏱክᩏຠ⋡ 2.7 ࡨޔఝవክᩏຠ⋡ 2.1 ࡨߢࠅޔߘߩᏅ ߪ 0.6 ࡨߣዊߐ߆ߞߚ߇ޔޟ↳⺧㨪ኾ㐷ද⼏ޠߪㅢᏱክᩏຠ⋡ 19.3 ࡨޔఝవክᩏຠ⋡ 11.7 ࡨߣਔ ⠪ߩᏅߪ 7.6 ࡨ߹ߢ߇ࠅޔ↳⺧߆ࠄක⮎ຠㇱળޔ⮎ಽ⑼ળޔᛚޔ⮎ଔタ߹ߢߩᦼ㑆ࠍㅢߓߡ ߘߩᏅߪ 8.4㨪11.3 ࡨߩ▸࿐ߦߞߚޕ ࿑ 19 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆 -20 0 20 40 60 80 100 120 140 -20 0 20 40 60 80 100 120 140
Standard Review Priority Review
NDA to 1st Interview Mtg NDA to Expert Mtg
NDA to COD NDA to PAC
NDA to Approval NDA to Price Listing
Time (months) ఝవክᩏຠ⋡ ㅢᏱክᩏຠ⋡ ᦼ㑆䋨ᢙ䋩 ↳⺧䌾ೋ࿁㕙⺣ ↳⺧䌾ක⮎ຠㇱળ ↳⺧䌾ᛚ ↳⺧䌾ኾ㐷ද⼏ ↳⺧䌾⮎ಽ⑼ળ ↳⺧䌾⮎ଔタ ਛᄩ୯ 2.1 11.7 13.1 14.0 15.1 16.2 2.7 19.3 21.6 24.6 23.5 27.5
17 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆 ో ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡ ᛚᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ↳⺧䌾ೋ࿁㕙⺣ 2000 59 3.9 5.3 8.8 46 4.5 5.9 9.6 13 1.7 3.1 4.6 2001 35 2.0 2.4 2.3 25 2.3 3.1 2.0 10 1.6 0.9 2.2 2002 39 2.2 3.9 4.8 28 2.2 4.6 5.4 11 2.0 1.9 0.6 2003 25 2.3 2.3 1.4 21 2.5 2.6 1.0 4 1.3 0.6 2.0 2004 18 2.5 3.4 3.5 13 2.6 3.9 3.6 5 2.0 2.2 3.4 2005 37 2.7 2.6 2.3 22 2.7 2.8 0.9 15 2.7 2.4 3.6 2006 59 2.5 4.2 10.4 41 2.8 5.4 11.9 18 2.2 1.5 4.8 2007 70 2.6 4.2 12.8 48 2.7 5.2 15.4 22 2.1 2.0 2.1 2008 74 2.8 3.4 6.0 42 2.8 4.3 7.5 32 2.8 2.3 2.6 ว⸘ 416 2.6 3.7 8.0 286 2.7 4.5 9.3 130 2.1 2.0 3.2 ↳⺧䌾ኾ㐷ද⼏ 2000 37 16.3 23.1 18.6 28 23.4 27.3 18.9 9 8.2 9.9 9.1 2001 35 13.3 22.1 21.7 23 19.8 27.1 21.5 12 6.0 12.6 19.4 2002 37 13.6 21.0 18.4 28 17.1 24.7 19.8 9 10.3 9.7 3.0 2003 28 14.4 17.0 15.0 24 14.9 18.8 15.3 4 5.1 5.8 5.8 2004 25 15.1 16.3 17.9 17 15.9 20.9 19.7 8 4.8 6.7 7.6 2005 40 20.6 21.6 13.7 26 21.2 25.1 14.6 14 15.3 15.2 9.1 2006 63 18.8 24.7 19.2 42 23.3 29.4 21.1 21 12.3 15.1 9.1 2007 73 18.2 22.9 20.8 51 19.4 26.1 22.9 22 13.1 15.6 12.5 2008 76 16.2 16.9 10.7 42 20.0 19.8 9.9 34 12.6 13.3 10.6 ว⸘ 414 16.7 20.9 17.6 281 19.3 24.7 18.8 133 11.7 13.0 11.1 ↳⺧䌾ක⮎ຠㇱળ 2000 66 26.0 29.4 19.9 50 32.9 34.7 19.2 16 9.9 12.9 10.9 2001 39 15.5 24.7 21.4 27 20.9 29.2 21.0 12 8.0 14.6 19.7 2002 42 15.8 23.8 19.0 30 19.4 28.0 20.8 12 12.6 13.3 5.3 2003 29 17.1 21.0 17.0 25 17.7 23.2 17.2 4 6.2 7.2 6.4 2004 28 15.8 17.2 18.0 17 19.7 23.3 20.4 11 5.7 7.8 7.4 2005 46 22.6 23.6 12.9 27 24.1 27.9 13.9 19 18.1 17.4 8.3 2006 71 21.0 27.5 19.8 46 26.5 32.7 21.5 25 15.9 17.9 11.3 2007 83 19.0 23.3 20.4 55 20.9 27.1 22.4 28 13.4 16.0 13.5 2008 78 17.0 18.2 10.8 43 20.3 20.6 10.1 35 14.0 15.3 11.1 ว⸘ 482 19.0 23.6 18.2 320 21.6 28.0 19.4 162 13.1 14.9 11.6 ↳⺧䌾⮎ಽ⑼ળ 2000 60 29.2 32.0 19.5 45 35.7 36.8 19.5 15 14.7 17.5 10.6 2001 35 20.1 26.6 22.4 24 23.3 31.8 21.6 11 8.0 15.2 20.5 2002 41 16.9 23.8 18.7 29 19.8 28.0 20.6 12 13.0 13.5 6.1 2003 29 17.9 22.2 17.2 25 19.4 24.5 17.4 4 7.5 8.4 6.8 2004 28 17.3 18.5 18.0 17 20.5 24.6 20.3 11 7.1 9.2 7.2 2005 32 24.9 25.7 13.3 21 26.6 29.5 13.7 11 23.4 18.4 9.2 2006 54 27.8 32.1 21.3 40 29.8 36.5 22.2 14 15.2 19.4 11.7 2007 61 20.4 26.1 23.0 40 25.9 31.7 25.6 21 14.5 15.4 11.1 2008 55 19.2 20.8 11.8 29 24.3 24.6 10.1 26 14.8 16.7 12.4 ว⸘ 395 20.9 26.0 19.3 270 24.6 30.8 20.3 125 14.0 15.7 11.7 ↳⺧䌾ᛚ 2000 67 28.3 31.9 20.1 51 34.9 36.9 19.7 16 12.2 15.8 10.8 2001 39 16.8 26.1 21.4 27 22.8 30.7 20.9 12 9.0 15.7 19.6 2002 43 17.7 25.2 19.0 30 21.0 29.8 20.9 13 14.3 14.6 5.9 2003 29 19.1 23.2 17.3 25 20.5 25.4 17.4 4 8.2 9.0 7.0 2004 28 18.3 19.4 18.2 17 22.1 25.8 20.3 11 7.8 9.4 7.8 2005 47 24.0 25.4 13.1 27 26.1 29.7 13.9 20 20.7 19.7 9.5 2006 72 22.8 29.1 20.1 47 28.6 34.2 21.9 25 17.0 19.6 11.4 2007 83 20.0 25.1 20.7 55 22.4 28.9 22.7 28 14.3 17.7 13.5 2008 78 19.0 20.0 11.0 43 21.9 22.4 10.4 35 15.6 17.0 11.1 ว⸘ 486 20.6 25.5 18.4 322 23.5 29.9 19.6 164 15.1 16.7 11.7 ↳⺧䌾⮎ଔタ 2000 51 35.0 36.8 21.4 44 37.3 40.4 20.5 7 13.6 13.8 8.4
ฦࡊࡠࠬߩਛᄩ୯ࠍᛚᐕߦⓍߺߍߚࠣࡈࠍ࿑ 20 ߦ␜ߒߚޕ߹ߚޔᛚᐕߩⷐ⚂⛔⸘㊂ ࠍ 18ޔ↳⺧ᐕߩ୯ࠍㆮ 1 ߩ 44 ߦ␜ߒߚޕ↳⺧߆ࠄ⮎ଔタߦ⥋ࠆࡊࡠࠬࠍ⚥Ⓧߒߚᦼ㑆ߪޔ ክᩏᦼ㑆ߣห᭽ߦ PMDA ⸳┙ᓟߦ৻ᣤ㐳ߊߥߞߚᓟޔ2007 ᐕޔ2008 ᐕߦ߆ߌߡ⍴ߊߥߞߚޕ2008 ᐕߩ ㅢᏱክᩏຠ⋡ߦ߅ߌࠆฦࡊࡠࠬߩਛᄩ୯ߪޟ↳⺧㨪ೋ࿁㕙⺣ޠ߇ 2.8 ࡨޔޟೋ࿁㕙⺣㨪ኾ㐷ද⼏ޠ߇ 16.0ࡨޔޟኾ㐷ද⼏㨪ක⮎ຠㇱળޠ߇ 1.1 ࡨޔޟක⮎ຠㇱળ㨪⮎ಽ⑼ળޠ߇ 1.2 ࡨޔޟ⮎ಽ⑼ળ 㨪ᛚޠ߇ 0.8 ࡨޔޟᛚ㨪⮎ଔタޠ߇ 1.9 ࡨߢߞߚޕ2000㨪2008 ᐕࠍㅢߓߡޟೋ࿁㕙⺣㨪ኾ㐷 ද⼏ޠ߇ోߩ⚂ 3 ಽߩ 2 ࠍභߡ߅ࠅޔᧄᦼ㑆ߣ⚥Ⓧߒߚᦼ㑆ߩჇᷫߪㅪേߒߡߚޕޟኾ㐷ද⼏㨪 ක⮎ຠㇱળޠߪ 2005 ᐕએ㒠ޔ⍴❗ߒߡ߅ࠅޔߘߩઁߩᦼ㑆ߪ 9 ᐕ㑆ߣㅢߓߡ߶߷ห᭽ߢߞߚޕ 2008ᐕߩఝవክᩏຠ⋡ߢߪޟ↳⺧㨪ೋ࿁㕙⺣ޠ߇ 2.8 ࡨޔޟೋ࿁㕙⺣㨪ኾ㐷ද⼏ޠ߇ 9.5 ࡨޔޟኾ 㐷ද⼏㨪ක⮎ຠㇱળޠ߇ 1.1 ࡨޔޟක⮎ຠㇱળ㨪⮎ಽ⑼ળޠ߇ 1.1 ࡨޔޟ⮎ಽ⑼ળ㨪ᛚޠ߇ 0.9 ࡨޔޟᛚ㨪⮎ଔタޠ߇ 1.9 ࡨߢࠅޔޟೋ࿁㕙⺣㨪ኾ㐷ද⼏ޠએᄖߪㅢᏱክᩏຠ⋡ߣห᭽ߩ୯ߢ ߞߚޕߒߚ߇ߞߡޔㅢᏱክᩏຠ⋡߅ࠃ߮ఝవክᩏຠ⋡ߩክᩏᦼ㑆ߩᏅߪޔਥߦޟೋ࿁㕙⺣㨪ኾ㐷ද⼏ޠ ߢ↢ߓߡࠆߣ߃ࠆޕ߹ߚޔޟ↳⺧㨪ೋ࿁㕙⺣ޠ߅ࠃ߮ޟೋ࿁㕙⺣㨪ኾ㐷ද⼏ޠߩ߫ࠄߟ߈ߪޔߘߩ ઁߩᦼ㑆ߦᲧߒߡㅢᏱክᩏຠ⋡ޔఝవክᩏຠ⋡ߣ߽ߦᄢ߈߆ߞߚޕߘߎߢޔᰴߩ 5.5.2 㗄ߦߡޟ↳⺧㨪 ೋ࿁㕙⺣㨪ኾ㐷ද⼏ޠߩࡊࡠࠬࠍߐࠄߦ⚦߆ߊಽߌߡᬌ⸛ߒߚޕ ࿑ 20 ክᩏࡊࡠࠬߦⷐߒߚᦼ㑆㧔ਛᄩ୯㧕 4.5 22.0 3.2 1.0 0.1 1.8 2.3 16.7 3.6 0.9 0.6 2.2 2.2 12.6 2.3 0.8 0.8 1.9 2.5 12.2 2.8 1.1 0.8 1.9 2.6 12.8 2.1 1.0 1.1 2.1 2.7 18.2 1.5 1.1 0.9 1.9 2.8 19.7 1.3 1.1 0.9 1.7 2.7 16.7 1.1 1.3 0.9 1.7 2.8 16.0 1.1 1.2 0.8 1.9 0 10 20 30 Ti m e ( m on th s ) 2000 2001 2002 2003 2004 2005 2006 2007 2008
NDA to 1st Interview Mtg 1st Interview Mtg to Expert Mtg
Expert Mtg to COD COD to PAC
PAC to Approval Approval to Price Listing
ᦼ㑆 䋨 ᢙ䋩 ㅢᏱክᩏຠ⋡ ↳⺧䌾ೋ࿁㕙⺣ ኾ㐷ද⼏䌾ක⮎ຠㇱળ ⮎ಽ⑼ળ䌾ᛚ ೋ࿁㕙⺣䌾ኾ㐷ද⼏ ක⮎ຠㇱળ䌾⮎ಽ⑼ળ ᛚ䌾⮎ଔタ 䋨ᛚᐕ䋩 1.7 1.7 1.4 1.6 -0.4 1.7 1.6 4.7 2.2 0.6 0.5 1.9 2.0 8.0 2.7 0.7 1.1 3.3 1.3 4.2 1.1 1.3 0.7 1.9 2.0 3.2 1.7 1.1 0.7 1.0 2.7 10.3 1.2 0.7 0.8 1.7 2.2 13.2 1.3 1.1 1.0 1.7 2.1 10.1 1.1 1.1 0.9 1.6 2.8 9.5 1.1 1.1 0.9 1.9 0 10 20 30 Ti m e ( m on th s ) 2000 2001 2002 2003 2004 2005 2006 2007 2008
NDA to 1st Interview Mtg 1st Interview Mtg to Expert Mtg
Expert Mtg to COD COD to PAC
PAC to Approval Approval to Price Listing
ఝవክᩏຠ⋡ ᦼ㑆 䋨 ᢙ䋩 ↳⺧䌾ೋ࿁㕙⺣ ኾ㐷ද⼏䌾ක⮎ຠㇱળ ⮎ಽ⑼ળ䌾ᛚ ೋ࿁㕙⺣䌾ኾ㐷ද⼏ ක⮎ຠㇱળ䌾⮎ಽ⑼ળ ᛚ䌾⮎ଔタ 䋨ᛚᐕ䋩 -0.4 ᵈ㧦ೋ࿁㕙⺣ߥߒߩ႐วޔೋ࿁㕙⺣ߪೋ࿁ᾖળ㗄ᚻࠍઍ↪ߒߚ
