PMDA ክᩏຬߩჇຬߦኻߔࠆᦼᓙޔ ᔨ

10.4. PMDAክᩏຬߩჇຬߦኻߔࠆᦼᓙޔ ᔨ

y ฎ޿ㆊ෰ߩ੐଀߿⚻㛎ߦ࿕ၫߖߕޔ⑼ቇ⊛ߥ⼏⺰ߦਥ⌒ࠍ⟎߈ޔክᩏ╬ࠍㅴ߼ߡ޿ߚߛ߈ߚ޿ޕ y ߢ߈ࠆߛߌᣧᦼߦታ〣ߢ⢻ജࠍ⊒ើߢ߈ࠆੱ᧚⢒ᚑࠍ߅㗿޿ߒߚ޿ޕ

y ክᩏ࠴࡯ࡓࠍჇ߿ߒߡ߽⚻㛎ࠍߟߺޔ⢻ജߩ޽ࠆክᩏᓎޔਥછ߇޿ߥ޿ߣክᩏᦼ㑆⍴❗ߦ⚿߮ߟ߆ߥ

޿ޕᣧᕆߦੱ᧚⢒ᚑࠍㅴ߼ߡ޿ߚߛ߈ߚ޿ޕ

y ⏕߆ߦੱຬࠍჇ߿ߒޔ࠴࡯ࡓᢙࠍჇ߿ߔߎߣߪ㊀ⷐߛ߇ޔߘࠇߛߌߢߪ໧㗴ߪ⸃᳿ߖߕޔᦨ߽㊀ⷐߥ ὐߪᛚ⹺ⷐઙࠍḩߚߔ߆ุ߆ߩ್ᢿࠍㄦㅦ߆ߟᱜ⏕ߦⴕ߃ࠆ⚻㛎޽ࠆክᩏຬߩሽ࿷߆ߣᕁ߁ޕ߽ߜࠈ ࠎޔᐔဋ⊛ߦክᩏߩ⾰߇਄߇ࠆߎߣ߇ℂᗐߢ޽ࠆߩߢޔ᰷☨ߩክᩏ࡟ࡌ࡞ߦഠࠄߥ޿ᢎ⢒೙ᐲߩలታ ߇ਇนᰳߣᕁ߁ޕ

y Ⴧຬߦߪᦼᓙߔࠆ߇ޔᢎ⢒૕೙ߩ᭴▽ߦߟ޿ߡ߽ᤚ㕖੹ᓟߣ߽ᬌ⸛ߒߡ߶ߒ޿ޕ

y ߎߎ1㨪2ᐕߢ⋧ᒰᢙߩክᩏຬ߇Ⴧຬߐࠇߡ޿ࠆ߇ޔᧄ⾰⊛ߥክᩏࠍⴕ߃ࠆੱ᧚ߪ⢒ߞߡ޿ߥ޿ශ⽎

ࠍฃߌࠆޕߘࠇ⋧ᔕߩᤨ㑆ࠍⷐߔࠆߎߣߪℂ⸃ߢ߈ࠆ߇ޔᢎ⢒㨯⸠✵ߩㆊ⒟ߢክᩏߦᧄ⾰⊛ߦᔅⷐߥ

ⷰὐߢ⷗ࠄࠇࠆᢎ⢒ࠍߒߡ޿ߚߛ߈ߚ޿ޕ߹ߚ↳⺧⠪ߣߩࠦࡒࡘ࠾ࠤ࡯࡚ࠪࡦ߽㊀ⷐߥⷐ⚛ߣ⠨߃ࠆ ߩߢޔኾ㐷ᕈߩߺߦ஍ࠆߎߣߥߊߘߩὐߩᢎ⢒߽Ꮧᦸߔࠆޕߘࠇ߇ክᩏߩ⾰ߩะ਄ߣክᩏࠬࡇ࡯࠼ߩ ᡷༀߦߟߥ߇ࠆߣ⠨߃ࠆޕ

y ⧯޿ᜂᒰቭߩ⢻ജ޽ࠆ޿ߪ⡯ᬺੱߣߒߡߩ࡟ࡌ࡞ߣࡃ࡜ࡦࠬߦߟ޿ߡ ᔨ߇ᱷࠆߩߢޔ⚵❱ߣߒߡߩ ᢎ⢒ߦᎿᄦࠍᦸ߻ޕ

y ৻⇟ߩ ᔨὐߪޔᣂછ⠪ߩ⎇ୃࠍߤߩࠃ߁ߦㅴ߼ࠆ߆ߢ޽ࠆޕ

y ክᩏㇱߩੱຬ߇ᕆჇߒߡ޿ࠆ߇ޔᣂੱߣᕁࠊࠇࠆᜂᒰ⠪ߩਛߦߪડᬺߣߩࠦࡒࡘ࠾ࠤ࡯࡚ࠪࡦߩߣࠅ ᣇޔኻੱኻᔕ߇ਇㆡಾߥੱ߇޿ࠆޕᣧᕆߥᡷༀࠍᦸ߻㧔৻ᣇߢ੹ᓟߩࠬࠤࠫࡘ࡯࡞ࠍ᣿⏕ߦ␜ߒޔല

₸⊛ߥኻᔕࠍขࠆᜂᒰ⠪߽૗ੱ߆ߪ⷗ฃߌࠄࠇࠆࠃ߁ߦߥߞߚ㧕ޕ

y ክᩏຬ߇ᧂ⚻㛎߿⚻㛎߇ᵻ޿ߚ߼ߦࠃࠆ↳⺧⠪ߣߩࡒࠬࠦࡒࡘ࠾ࠤ࡯࡚ࠪࡦ߿ክᩏߩᷙੂ߇⿠߈ߥ

޿ࠃ߁ޔᢎ⢒࡮⎇ୃ࡮OJTߩలታࠍ߅㗿޿ߒߚ޿ޕ

y ᛚ⹺ክᩏߦ߅޿ߡᶏᄖⷙ೙ᒰዪߣߩㅪ៤߇ᔅⷐߣߐࠇߥ߇ࠄޔኻᔕߢ߈ࠆੱ᧚߇ዋߥ޿ߩߢߪߥ޿߆ ߣᕁࠊࠇࠆޕ

㧨ੱ᧚ࡑࡀࠫࡔࡦ࠻㧪

y ৻ᤨᦼߦᄙ㊂ߩჇຬࠍⴕ߁ߎߣߦࠃࠅޔክᩏ࡟ࡌ࡞ߩૐਅޔክᩏߩㆃᑧࠍ᜗ߊߎߣ߇ߥ޿ࠃ߁ㆡಾߥ ࡑࡀࠫࡔࡦ࠻ߣᢎ⢒ޔክᩏၮḰߩဋ৻ൻࠍᔀᐩߒߡ޿ߚߛ߈ߚ޿ޕ

y න⚐ߦੱຬࠍᕆჇߐߖߡ߽਎ઍ㑆ߩਇဋⴧ߇↢ߓޔ⚵❱ో૕ߣߒߡߩࡃ࡜ࡦࠬ߇ᖡߊߥࠆߣᕁ߁ޕߒ ߚ߇ߞߡޔክᩏ࠴࡯ࡓޔክᩏㇱߣ޿ߞߚ⚵❱න૏ߢჇ߿ߔߣ޿߁⠨߃ࠍᜬߞߡޔㇱ㐳ࠢ࡜ࠬޔክᩏᓎ

ࠢ࡜ࠬ╬ޔࡃ࡜ࡦࠬࠃߊੱຬࠍჇ߿ߒߡ޿ߊߴ߈ߛߣᕁ߁ޕ

y ᣂⷙណ↪ߩክᩏຬߦኻߔࠆOJTࡊࡠࠣ࡜ࡓߣߒߡޔ㧔ೋ࿁㧕ᴦ㛎⸘↹ዯޔᴦ㛎⋧⺣ޔᛚ⹺ክᩏߩ㗅ߦ

ᬺോ߇ਈ߃ࠄࠇࠆߣ⡞ߊޕ2008ᐕ4 ᦬ߦ౏⴫ߐࠇߚޟᣂක⮎ຠᛚ⹺ክᩏታോߦଥࠆክᩏຬߩߚ߼ߩ

⇐ᗧ੐㗄ޠߦߪޔ⧯ᚻክᩏຬߩ⚻㛎ਇ⿷ࠍ⵬޿ޔน⢻ߥ㒢ࠅክᩏᒰዪߩࡐ࡚ࠫࠪࡦߦ৻⽾ᕈࠍᜬߚߖ ࠆ⁓޿߇޽ࠆߣᕁࠊࠇࠆޕߒ߆ߒߥ߇ࠄޔOJTࡊࡠࠣ࡜ࡓߩᲧセ⊛ೋᦼߦഀࠅᝄࠄࠇࠆᴦ㛎⋧⺣ߩౝ

ኈߪޔᣂ⮎㐿⊒ߩ๮ㆇࠍᏀฝߒ߆ߨߥ޿ߚ߼ޔᔅߕߒ߽⚻㛎߇චಽߣߪ޿߃ߥ޿⧯ᚻߩክᩏᜂᒰߩਇ චಽߥℂ⸃ߦၮߠ޿ߚᗧ⷗߇PMDA ߩ⷗⸃ߦᔅⷐએ਄ߦ෻ᤋߐࠇࠆߎߣߩߥ޿ࠃ߁ޔክᩏᓎ࡟ࡌ࡞

ߩᔨ౉ࠅߥ࠴ࠚ࠶ࠢࠍ߅㗿޿ߒߚ޿ޕ

y ຠ⋡ߩ․ᓽޔㆊ෰ߩ⚻✲╬ߩ⢛᥊ࠍℂ⸃ߒޔߘߩᤨޘߦᔕߓߚㆡಾߥክᩏࠍⴕ߁ߚ߼ߦߪࡑ࠾ࡘࠕ࡞

ߦᓥߞߚ↹৻⊛ߥኻᔕߢߪਇචಽߢ޽ࠅޔ޽ࠆ⒟ᐲክᩏ⚻㛎ࠍⓍ߻ᔅⷐ߇޽ࠆߣ⠨߃ࠄࠇࠆޕߒߚ߇

ࠃ߁ޔᾖળ╬ߦవ┙ߞߡᔅߕ޽ࠆ⒟ᐲߩ⚻㛎⠪߇ߘߩᔅⷐᕈࠍ⏕⹺ߔࠆࠃ߁߅㗿޿ߒߚ޿ޕ

y ੱຬࠍჇᒝߔࠆߩߪ⾥ᚑߢ޽ࠆ߇ޔ⾰㧔⚻㛎߿⾗ᩰⷐઙ㧕ࠍࠃࠅ⠨ᘦߒߡޔ⎇ୃࠍචಽⴕ޿ޔ࡝࠰࡯

ࠬࡑࡀ࡯ࠫࡔࡦ࠻ࠍ߈ߜࠎߣⴕ߃ࠆ૕೙ࠍᢛ߃ߡ޿ߚߛ߈ߚ޿ޕ 㧨ੱ᧚੤ᵹ㧪

y ડᬺ಴り⠪߇ᄙߊណ↪ߐࠇޔ߹ߚ޿ߕࠇߪPMDA಴り⠪߇ડᬺߦណ↪ߐࠇࠆߎߣߢޔPMDAߣડᬺ

ߩߘࠇߙࠇߩ┙႐ߦߟ޿ߡߩ⋧੕ℂ⸃߇ㅴ߻ߎߣࠍᦼᓙߔࠆޕ

y ⵾⮎ડᬺ╬ߩ↥ᬺ⇇߆ࠄੱຬࠍ൐㓸ߒޔ೙㒢ߥߊPMDA ክᩏຬߦዞߌࠆࠃ߁ߦߔࠆޕ߹ߚޔ෻ኻߦ PMDAክᩏቭ߇ડᬺ߳⇣േߔࠆ╬ߩ੤ᵹ߇ᔅⷐޕ

y ડᬺ಴り⠪ࠍ߽ߞߣⓍᭂ⊛ߦណ↪ߔࠇ߫ࠃ޿ߣᕁ߁ޕPMDA ߩ⃻ⴕߩዞᬺⷙೣߢߪޔ೑⋉⋧෻ࠍ߅ ߘࠇࠆ޽߹ࠅડᬺ಴り⠪߳ߩ㐷ᚭ߇㐽ߑߐࠇߡ޿ࠆ߇ޔ߅੕޿ߦቇ߱ᯏળࠍᄬߞߡ޿ࠆޕ೑⋉⋧෻ߦ

㈩ᘦߒߥ߇ࠄ߽ޔડᬺ಴り⠪߇ߘߩ⢻ജࠍሽಽߦPMDAߢ⊒ើߢ߈ޔߘߩ⚿ᨐ߇ႎࠊࠇࠆࠃ߁ߥ㧔⃻

ⴕ࡞࡯࡞ߢߪ৻ቯᦼ㑆ߪਥછߦߥࠇߥ޿㧕઀⚵ߺ૞ࠅࠍᣧᕆߦㅴ߼ࠆᔅⷐ߇޽ࠆߣᕁ߁ޕ

y ක≮⃻႐߿⵾⮎ળ␠ߩ┙႐ߢߩ⒳ޘߩ೙㒢ࠍℂ⸃ߒߥ޿ߢᗧ⷗ࠍㅀߴࠆੱ߇⋧ᄌࠊࠄߕᄙ޿ࠃ߁ߦ ᕁࠊࠇࠆޕ․ߦޔᲧセ⊛⧯޿ੱߪߘߩࠃ߁ߥ⚻㛎ࠍⓍ߹ߕߦ᧍਄ߢߩߺ⼏⺰ߔࠆߎߣߦߥࠆޕᴦ㛎ࠍ ⴕ߁⃻႐ࠍ⚻㛎ߒߚੱ߿ޔ⵾⮎ળ␠ߢ㐿⊒ᬺോߦᓥ੐ߒߚ⚻㛎ߩ޽ࠆੱ߇Ⴧ߃ߡ޿ߊߎߣࠍᦼᓙߔࠆޕ y Ⴧຬߐࠇߚክᩏຬߩ߶ߣࠎߤ߇ᣂත⠪╬ߩ⚻㛎ߩᵻ޿ੱ᧚ߢ޽ࠆߚ߼ޔክᩏຬߣߒߡᵴべߢ߈ࠆ߹ߢ

ߦᤨ㑆߇߆߆ߞߡ޿ࠆߩ߇⃻⁁ߢ޽ࠆޕකቇ⇇߿↥ᬺ⇇ߣߩੱ᧚੤ᵹࠍᵴ⊒ߦⴕ޿ޔ⚻㛎⼾ንߥੱ᧚ ࠍណ↪ߢ߈ࠆࠃ߁ߦߔࠆߚ߼ߦޔ೙ᐲ߿ᓙㆄ㕙ߩలታࠍᦼᓙߔࠆޕ

y Ⴧຬߔࠆߛߌߢክᩏ߇ࠬࡓ࡯ࠬߦㅴⴕߔࠆߣߪᕁ߃ߥ޿ޕክᩏᜂᒰቭߩࠬࠠ࡞ߦࠃߞߡޔ↳⺧⠪஥ߣ ߩࠦࡒࡘ࠾ࠤ࡯࡚ࠪࡦ⢻ജ߿ᾖળ੐㗄ߩౝኈߩ࡟ࡌ࡞߇⇣ߥࠅޔክᩏߩㅴⴕᐲ߇Ꮐฝߐࠇࠆߣᕁࠊࠇ ࠆޕ⥃ᐥ⹜㛎ታᣉߦ㑐ߔࠆታോ߿㐿⊒⮎੐ߦ㑐ߔࠆታോ޽ࠆ޿ߪක⮎ຠߩࡑ࡯ࠤ࠹ࠖࡦࠣߦߟ޿ߡߩ

⚻㛎߇߶ߣࠎߤߥ޿߹߹ߦPMDA ߩክᩏຬߣߥߞߡޔᧄᒰߦ౏ᐔߥ┙႐ߢߩክᩏ߇ߢ߈ࠆߩߢ޽ࠈ ߁߆ޕ⚻㛎ߩߥ޿ክᩏຬ୥⵬ߪ৻ቯᦼ㑆ޔ⵾⮎ડᬺߢߩታ⠌ࠍ⟵ോઃߌࠆ╬ߩࡠ࡯࠹࡯࡚ࠪࡦࠍ⸳ߌ ߡߪߤ߁߆ޕჇຬߩߺߦ⌕⋡ߖߕޔੱ੐೙ᐲ߽ᡷༀߔߴ߈ὐ߇ߥ޿߆⷗⋥ߔߴ߈ߢ޽ࠆޕߚߛߒޔߎ ߩࠃ߁ߥੱ᧚⢒ᚑߦ㑐ߒߡߪޔᢙᐕߩᦼ㑆߇ᔅⷐߢ޽ࠅޔPMDA ᄖㇱ߆ࠄߪ⷗߃ߦߊ޿ߩߢޔ⋡ᮡ

ࠍ᣿⏕ߦឝߍߚ਄ߢޔቯᦼ⊛ߦㅴ᝞ࠍႎ๔ߒߡ޿ߚߛ߈ߚ޿ޕ

y ክᩏຬ㧔ᣂੱࠍ฽߻㧕ߣડᬺ㐿⊒ᜂᒰ⠪ߣ㐿⊒࡮ክᩏߦଥࠆ⼏⺰ࠍ⋥ធળߞߡߔࠆᯏળࠍ⸳ߌޔ߅੕

޿ߩⅣႺߩℂ⸃ࠍᷓ߼ߡ޿ߚߛ߈ߚ޿ޕ

y ክᩏຬో૕ߩ࡟ࡌ࡞ࠕ࠶ࡊ㧔࡟ࡌ࡞ဋ╬ൻ㧕߇ᔅⷐߛߣᕁࠊࠇࠆޕߘߩ⸃᳿ߩߚ߼ߦߪડᬺ஥ߣߩⓍ

ᭂ⊛ߥീᒝળ╬ߩ㐿௅߽น⢻ߛߣ⠨߃ࠆޕᤚ㕖৻ೞ߽ᣧ޿ࡏ࠻ࡓࠕ࠶ࡊࠍ߅㗿޿ߒߚ޿ޕ 㧨ክᩏߩ⾰㧪

y ክᩏຬ߇Ⴧຬߐࠇޔክᩏ߇ᣧߊߥࠆߎߣߪ᱑ㄫߒߚ޿ޕߒ߆ߒޔ⚻㛎ߩዋߥ޿ክᩏຬ߇Ⴧ߃ࠆߎߣߦ ࠃࠅೋᱠ⊛ߥᾖળ੐㗄ߩჇടޔክᩏ࠴࡯ࡓ㑆ߩ߫ࠄߟ߈߇ᄢ߈ߊߥࠆ╬ߩ ᔨ߇޽ࠆޕክᩏቭߩ⾰ߩ ะ਄ߦߪోജࠍ᜼ߍߡขࠅ⚵ࠎߢ޿ߚߛ߈ߚ޿ޕ

y એ೨ޔክᩏຬ߇Ⴧຬߐࠇߚ㓙ߦޔᾖળ੐㗄ߩ⾰߇ૐਅߒߚߎߣ߇޽ߞߚ㧔ᣣᧄ⮎ዪᣇߩ⸥タࠍ⍮ࠄߥ

޿╬㧕ޕჇຬߔࠆ႐วߦߪޔਇᔅⷐߥᾖળ੐㗄߇⊒಴ߐࠇࠆߎߣ╬߇ߥ޿ࠃ߁ޔ࠻࡟࡯࠾ࡦࠣߣฦㇱ ߩ⚻㛎⠪ߦࠃࠆ⋙〈࡮ᜰዉࠍᔀᐩߒߡ߶ߒ޿ޕ

y ૕೙߇ᢛߞߚᲑ㓏ߢޔ㊀▫ߩ㓈ࠍߟߟߊࠃ߁ߥᧄ⾰ߦଥࠊࠄߥ޿ࠃ߁ߥߎߣࠍ⚦߆ߊᜰ៰ߔࠆᣇะߦ ⴕ߆ߥ޿ࠃ߁ߦߒߡ߶ߒ޿ޕ

y ᐕޘክᩏຬߩჇຬࠍ࿑ࠅޔᣧᦼߦክᩏߩࠬࡇ࡯࠼ࠍ਄ߍߡ޿ߊߩߪ⾥ᚑߛ߇ޔ࡝࠰࡯ࠬߦ૛⵨߇ߢ߈ ߚߎߣߦࠃߞߡክᩏߩࡂ࡯࠼࡞ࠍ㜞ߊߒߚࠅޔࠃࠅ⹦⚦ߥ࠺࡯࠲ࠍⷐ᳞ߔࠆࠃ߁ߥᣇะߦჇ߃ߚክᩏ

ੱຬࠍ૶߁ߩߢߪߥߊޔᏱߦክᩏߩല₸ࠍ᳞߼ߡ߶ߒ޿ޕ߻ߒࠈޔ⃻࿷ߩᬺ⇇ౣ✬ߩേ߈߿⚻ᷣ⁁ᴫ ࠍ⠨߃ࠆߣ੹ᓟ↳⺧⠪஥ߩ࡝࠰࡯ࠬߪᐕޘ❗ዊߐࠇߡ޿ߊᣇะߢ޽ࠆޕ

y ክᩏߩല₸ൻߩߚ߼ᾖળ࿁ᢙߪᷫࠄߒޔ㧔ᾖળ㧙࿁╵ࠍ㧕2㨪3࿁ߩ߿ࠅߣࠅߢቢੌߒߡ߶ߒ޿ޕ y ክᩏᜂᒰቭߩ୘ੱ⊛ߥ⥝๧ޔክᩏߩᧄ⾰એᄖߩᾖળ㧔ࠦ࡯࠼⇟ภޔ⸥タᣇᴺޔ஻⠨ᰣ╬㧕߇ᄙߊޔክ

ᩏߩല₸ൻࠍᅹߍߡ޿ࠆߩߢߪߥ޿߆ޕ

y ᣂߒ޿ክᩏຬ߆ࠄߪޔߎࠇ߹ߢߣߪ㆑ߞߚᾖળ߇ᄙߊߐࠇࠆޕએ೨߆ࠄ޿ࠆੱ߆ࠄߪᜰ␜ߐࠇߥ޿ౝ

ኈߢ޽ࠆߎߣ߆ࠄޔPMDAߩ⛔৻⷗⸃ߢߪߥ޿ߣ⠨߃ࠄࠇࠆޕክᩏຬߦࠃࠆᏅ⇣ࠍᷫࠄߖߥ޿߆ޕ

଀㧕቟ቯᕈ⹜㛎ߦ߅޿ߡోࡐࠗࡦ࠻ߦ߅ߌࠆోࡠ࠶࠻ߩ࠴ࡖ࡯࠻ࠍឭ಴ߔࠆߎߣࠍⷐ᳞㧦↳⺧ᷝઃ⾗

ᢱߦߪઍ⴫⊛ߥ࠴ࡖ࡯࠻ࠍᷝઃߒޔㆡวᕈᦠ㕙⺞ᩏᤨߦߔߴߡߩ࠴ࡖ࡯࠻ࠍឭ಴ߒߡ޿ࠆޕ

y ੱᢙࠍჇ߿ߔߩߪ޿޿߇ޔᦨㄭߩᾖળ੐㗄ߪ⚻㛎ߩዋߥߐߦ⿠࿃ߔࠆ࡟ࡌ࡞ߩૐ޿߽ߩ߇ᄙ޿ࠃ߁ߦ ᕁ߁㧔⵾ຠߩ․ᕈߪήⷞߒߡࠟࠗ࠼࡜ࠗࡦߤ߅ࠅߩ⹜㛎ᚑ❣ࠍ᳞߼ߚࠅޔ⾗ᢱߦ⸥タ߇޽ࠆߦ߽㑐ࠊ ࠄߕᾖળࠍ಴ߔ╬㧕ޕ࠴࡯ࡓߦࠃࠅᾖળ੐㗄ߩᢙ߿⾰ߦᄢ߈ߊ⋧㆑߇↢ߓߡ޿ࠆࠃ߁ߦᕁ߃ࠆߩߢޔ

⛔৻ߒߚ⷗⸃ߢ಴ߖࠆࠃ߁ߥ࠻࡟࡯࠾ࡦࠣ߿ၮḰࠍ⸳ߌߡ߶ߒ޿ޕ

y Ⴧຬߦࠃࠆክᩏᦼ㑆ߩ⍴❗ߣ޿߁ὐߦߪᦼᓙࠍߔࠆߣߎࠈߢ޽ࠆޕߒ߆ߒߥ߇ࠄޔჇຬߩ⚿ᨐޔㅒߦ

୘ޘߩ᭽ޘߥᗧ⷗߇಴ߐࠇޔߘߩ෼ᜪߦᤨ㑆ࠍⷐߒߚࠅޔ޽ࠆ޿ߪ෼ᜪߖߕߦ↳⺧⠪஥ߦߘߩ߹߹ᾖ ળ੐㗄╬ߢ␜ߐࠇߚࠅߔࠆߎߣ߇ߥ޿ߩ߆ ᔨߔࠆߣߎࠈߢ޽ࠆޕჇຬߔࠇ߫ߔࠆ߶ߤޔ୘೎ߩ↳⺧

ຠ⋡ߏߣߦPMDAߣߒߡߩᣇ㊎࡮ࡐࠗࡦ࠻ࠍ߈ߞߜࠅቯ߼ߡክᩏࠍߒߡ߽ࠄ޿ߚ޿ߣ⠨߃ࠆޕ y Ⴧຬߩߚ߼ޔᜂᒰቭߦࠃߞߡክᩏ╬ߦ㆑޿߇಴ߥ޿ࠃ߁PMDAౝߢߩᣇ㊎ࠍ⛔৻ߒߡ߶ߒ޿ޕ y ክᩏຬ㑆ߩክᩏ࡟ࡌ࡞ߦᏅ߇಴ߥ޿ࠃ߁ߦߒߡ߶ߒ޿㧔ᢎ⢒ߩᦝߥࠆలታࠍᦸ߻㧕ޕ

y ੱ߇Ⴧ߃ߡ߽ޔPMDA ో૕ߩ⷗⸃߿ᣇะᕈߦ߫ࠄߟ߈߇ߥߊޔ޽ࠆ৻ቯ▸࿐ౝߦ⚊߹ࠆࠃ߁ߦ⇐ᗧ

޿ߚߛ߈ߚ޿ޕ

y ੱ߇Ⴧ߃ࠆߎߣߦࠃࠅክᩏၮḰ㧔್ᢿ㧕߇ࡃ࡜ࡃ࡜ߦߥࠆߎߣ߇ ᔨߐࠇࠆޕ

y ᜂᒰቭߩ㑆ߢᜰ៰੐㗄ߦߟ޿ߡਇᢛว߇ߥ޿ࠃ߁ߦߒߡ߶ߒ޿㧔Aᜂᒰቭߪᜰ៰ߒߥ޿߽ߩࠍޔઁຠ

⋡ߩBᜂᒰቭߢߪᜰ៰ߔࠆ╬ߩਇᢛว㧕ޕ

y ᜂᒰ⠪㧔ክᩏㇱ㧕ߦࠃߞߡޔડᬺߦኻߔࠆኻᔕ࡮ⷐ᳞ᐲว޿߇⇣ߥࠆޕክᩏㇱ㑆ߢ⋡✢วࠊߖ߽ߒߡ

޿ߚߛ߈ߚ޿ޕ

¾ ੐଀1㧦ኻ㕙ഥ⸒ߩ㓙ߦޔኻ㕙ഥ⸒ᒰᣣ߹ߢߩ࠲ࠗࡓ࡜ࠗࡦࠍᢎ߃ߡߊࠇࠆᜂᒰㇱߣᢎ߃ߥ޿ᜂ ᒰㇱ߇޽ࠆޕ

¾ ੐଀2㧦CTD 2.7.6㗄ߦኻߔࠆㆊ೾ߥⷐ᳞㧔଀㧦⹜㛎⚿ᨐࠍᮮᢿ⊛ߦߺࠆߚ߼ߩ⸥タᢛ஻ߩⷐ᳞

߿ޔ✚᜝ႎ๔ᦠߩ⸥タ▸࿐ࠍ⿥߃ࠆㅊട⸃ᨆߩⷐ᳞╬㧕ࠍߔࠆᜂᒰㇱ߇޽ࠆޕ

¾ ੐଀3㧦CTDߩୃᱜ▎ᚲߦࡑ࡯ࠞ࡯ࠍᣉߒߚ਄ޔୃᱜℂ↱ࠍ⸥ߒߚ็߈಴ߒࠍⷐ᳞ߐࠇࠆ႐ว߇

޽ࠆޕ y

y ⽼ᄁฬߩㆡಾᕈߦߟ޿ߡ↳⺧೨ߢߪ޽ߞߚ߇PMDAߦ⋧⺣ߒߚߣߎࠈޔPMDA஥߆ࠄෘ↢ഭ௛⋭ߦ

Ⓧᭂ⊛ߦ⋧⺣ߒߡ߽ࠄ޿ޔߘߩ⚿ᨐክᩏߩᣧ޿Ბ㓏ߢ⽼ᄁฬߩ⷗⋥ߒࠍ࿑ࠆߎߣ߇ߢ߈ޔ㕖Ᏹߦഥ߆ ߞߚ੐଀߇޽ߞߚޕ

㧨ߘߩઁో⥸㧪

y ੱຬߩჇടߦࠃࠅޔክᩏ࠴࡯ࡓࠍჇടߐߖࠆߎߣ߇น⢻ߥ⁁ᴫߦߥߞߚߣߪᕁ߁߇ޔ⃻࿷ߩክᩏᣇᴺ

߿ክᩏ࠴࡯ࡓߩ޽ࠅᣇ╬ࠍᛮᧄ⊛ߦᄌᦝߒߥ޿ߣ޿ߟ߹ߢߚߞߡ߽࠼࡜࠶ࠣ࡜ࠣߪ⸃ᶖߐࠇߥ޿ߣ

⠨߃ࠆޕ

y ክᩏຬჇຬߩߚ߼ߦክᩏᚻᢙᢱ߇਄߇ߞߚ߇ޔክᩏ߇ㅦߊߥߞߚታᗵ߇ߥ޿ޕ⚿ᨐ߇ߔߋߦߪ಴ߡߎ ߥ޿ߎߣߪℂ⸃ߢ߈ࠆ߇ޔ⃻⁁ߩክᩏߦኻߔࠆᆫ൓ߩ߹߹ߢޔㄭ޿዁᧪ክᩏᦼ㑆߇⍴ߊߥࠆߣߪᕁ߃ ߥ޿ޕPMDA ߣߒߡߪౕ૕⊛ߦ૗߇ߤ߁ߥࠇ߫ክᩏ߇ㅦߊߥࠆߩ߆ࠍ᣿⏕ߦߒޔߘࠇߦߟ޿ߡᬺ⇇

ߣ⼏⺰ߔࠆ႐ࠍ⸳ߌߡ߶ߒ޿ޕ

y ⃻࿷ߩ PMDAክᩏຬߩᬺോ㊂ߣ⛎ਈ᳓Ḱ㧔⍮ࠄߥ޿߇㧕߇ޔ਎㑆ߩ৻⥸Ᏹ⼂߆ࠄߺࠆߣޔߟࠅ޽ߞ ߡ޿ࠆߣߪᕁ߃ߥ޿ޕ⛎ਈ᳓Ḱࠍ਄ߍࠆ߆ޔㅦ߿߆ߦჇຬߒߡഭ௛ᤨ㑆ࠍਅߍࠆ߆ߒߡޔᬺോⅣႺࠍ ᡷༀߒߥ޿ߣޔ⦟޿ੱ᧚ߪ㓸߹ࠄߥ޿ߩߢߪߥ޿߆ޕ

y PMDA ߪᣂ⮎ክᩏ૕೙ߩ᜛లᒝൻߣߒߡክᩏኾ㐷ຬࠍჇຬߒޔᣂ⮎ክᩏ࡮ᴦ㛎⋧⺣ߩ૕೙ᢛ஻ߔࠆ ߎߣࠍ᜼ߍߡ߅ࠅޔ2008ᐕ4᦬ߦߪ80ฬჇຬߒߡ޿ࠆ߇ޔක⮎ຠ╬ߩክᩏߦ㑐ਈߒߚ⚻㛎ߩਲߒ޿

80 ฬࠍክᩏᦼ㑆⍴❗ߦነਈߢ߈ࠆ߹ߢᢎ⢒⸠✵߇ߢ߈ߡ޿ࠆߣߪ߹ߛ⸒߃ߥ޿⁁ᴫߢ޽ࠆޕ⃻⁁ߢ ߪ᰷☨ߣᲧߴክᩏᦼ㑆ߪ1ᐕ㐳޿ߣ⸒ࠊࠇߡ߅ࠅޔޟክᩏᦼ㑆ߩ⍴❗ޠ߇ᕆോߢ޽ࠆޕߘߩ⸃᳿╷ߣ ߒߡޔԘޟᣂක⮎ຠክᩏᬺോߦ㑐ࠊࠆክᩏຬߩߚ߼ߩ⇐ᗧ੐㗄ޠߦ㑐ߒߡክᩏኾ㐷ຬߦ๟⍮ᔀᐩߒޔ ߐࠄߦߪ㗔ၞߏߣߩޟ୘೎⇐ᗧ੐㗄ޠࠍㅊടߒߡክᩏၮḰࠍࠃࠅ᣿⏕ൻߔࠆߎߣޔԙ੐೨⹏ଔ⋧⺣೙

ᐲࠍ⸳⟎ߒޔᴦ㛎⋧⺣೙ᐲ᜛లߦࠃࠅᣂ⮎ᛚ⹺ክᩏߩല₸ൻࠍⴕ߁ߎߣޔԚᜂᒰߔࠆክᩏኾ㐷㗔ၞߩ ක♽ክᩏኾ㐷ຬࠍᄖㇱ߆ࠄዉ౉ߒޔᣧᦼߦක≮⃻႐ߩኾ㐷⍮⼂ࠍ〯߹߃ߚ್ᢿ߇น⢻ߥክᩏ࠴࡯ࡓࠍ

᭴▽ߔࠆߎߣߩ3ὐ߇ᔅⷐߣ⠨߃ࠆޕ

వⴕ⎇ⓥ

ᧄ⎇ⓥߪޔએਅߩవⴕ⎇ⓥߩ⺞ᩏ㗄⋡ޔ⸃ᨆᣇᴺ߅ࠃ߮⚿ᨐߦၮߠ޿ߡ߅ࠅޔ2007ᐕ߹ߢߩ࠺࡯࠲ࡌ

࡯ࠬߦ2008ᐕߩᛚ⹺ຠ⋡ߩ࠺࡯࠲ࠍㅊടߒߡ⸃ᨆࠍታᣉߒߚޕ⪺⠪ߩᚲዻߪ⎇ⓥᒰᤨߩ߽ߩࠍ⸥ߒߚޕ

1) ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩᛚ⹺ክᩏᦼ㑆

ක⮎↥ᬺ᡽╷⎇ⓥᚲ࡝ࠨ࡯࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 14㧔2003ᐕ12᦬㧕 ዊ㊁ ବ੺㧔㊄ᴛᄢቇ⮎ቇㇱ ഥᢎ᝼㧕

቟Ⓧ ❱ⴡ㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕 ศጟ ⍮㉿㧔㊄ᴛᄢቇ⮎ቇㇱ㧕

↰᧛ ᶈม㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ೨ਥછ⎇ⓥຬ㧕

2) ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩᛚ⹺ክᩏᦼ㑆㧙2003ᐕᛚ⹺ขᓧຠ⋡ߦ㑐ߔࠆ⺞ᩏ㧙 ක⮎↥ᬺ᡽╷⎇ⓥᚲ࡝ࠨ࡯࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 24㧔2004ᐕ11᦬㧕 ዊ㊁ ବ੺㧔㊄ᴛᄢቇ⮎ቇㇱ ഥᢎ᝼㧕

቟Ⓧ ❱ⴡ㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕

3) ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩᛚ⹺ክᩏᦼ㑆ߣ⥃ᐥ㐿⊒ᦼ㑆㧙2004ᐕᛚ⹺ขᓧຠ⋡ߦ㑐ߔࠆ⺞ᩏ㧙 ක⮎↥ᬺ᡽╷⎇ⓥᚲ࡝ࠨ࡯࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 30㧔2005ᐕ8᦬㧕

቟Ⓧ ❱ⴡ㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕

4) ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩᛚ⹺ክᩏᦼ㑆㧔1996ᐕ㨪2005ᐕᛚ⹺ຠ⋡㧕 ක⮎↥ᬺ᡽╷⎇ⓥᚲ࡝ࠨ࡯࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 35㧔2006ᐕ12᦬㧕

቟↰ ㇌┨㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕

5) ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩᛚ⹺ክᩏᦼ㑆㧙2007ᐕᐲ⺞ᩏ㧙

ක⮎↥ᬺ᡽╷⎇ⓥᚲ࡝ࠨ࡯࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 37㧔2007ᐕ12᦬㧕

቟↰ ㇌┨㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕

ዊ㊁ ବ੺㧔᧲੩ᄢቇᄢቇ㒮⮎ቇ♽⎇ⓥ⑼ ක⮎ຠ⹏ଔ⑼ቇ⻠ᐳ ಎᢎ᝼㧕

6) ᣣᧄߦ߅ߌࠆᣂක⮎ຠߩ㐿⊒ᦼ㑆㧙⥃ᐥ㐿⊒ᦼ㑆ߣᛚ⹺ክᩏᦼ㑆㧙 ක⮎↥ᬺ᡽╷⎇ⓥᚲ࡝ࠨ࡯࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 42㧔2008ᐕ9᦬㧕

቟↰ ㇌┨㧔ක⮎↥ᬺ᡽╷⎇ⓥᚲ ਥછ⎇ⓥຬ㧕

ዊ㊁ ବ੺㧔᧲੩ᄢቇᄢቇ㒮⮎ቇ♽⎇ⓥ⑼ ක⮎ຠ⹏ଔ⑼ቇ⻠ᐳ ಎᢎ᝼㧕

ෳ⠨ᢥ₂

1 ᢥㇱ⑼ቇ⋭ޔෘ↢ഭ௛⋭ޔ⚻ᷣ↥ᬺ⋭. ޟ㕟ᣂ⊛ක⮎ຠ࡮ක≮ᯏེഃ಴ߩߚ߼ߩ5߆ᐕᚢ⇛ޠ㧔2007 ᐕ4᦬26ᣣ㧕: http://www.mhlw.go.jp/houdou/2007/04/h0427-3.html. Accessed on October 13, 2009.

2 ෘ↢ഭ௛⋭. ޟ᦭ലߢ቟ోߥක⮎ຠࠍㄦㅦߦឭଏߔࠆߚ߼ߩᬌ⸛ળႎ๔ᦠޠ㧔2007ᐕ7᦬27ᣣ㧕:

http://www.mhlw.go.jp/shingi/2007/07/s0730-10.html. Accessed on October 13, 2009.

3 ⁛┙ⴕ᡽ᴺੱක⮎ຠක≮ᯏེ✚วᯏ᭴. ޟᐔᚑ20੐ᬺᐕᐲ ᬺോႎ๔ޠ㧔2009ᐕ7᦬14ᣣ㧕:

http://www.pmda.go.jp/guide/outline/report/report_20.html. Accessed on October 13, 2009.

4 ක⮎↥ᬺ᡽╷⎇ⓥᚲ. ޟᣣᧄߦ߅ߌࠆᣂක⮎ຠߩ㐿⊒ᦼ㑆㧙⥃ᐥ㐿⊒ᦼ㑆ߣᛚ⹺ክᩏᦼ㑆㧙ޠ࡝ࠨ࡯

࠴ࡍ࡯ࡄ࡯࡮ࠪ࡝࡯࠭No. 42㧔2008㧕: http://www.jpma.or.jp/opir/research/article42.html. Accessed on October 13, 2009.

5 ක⮎↥ᬺ᡽╷⎇ⓥᚲ. ޟᣣᧄߦ߅ߌࠆᣂක⮎ຠߩክᩏᦼ㑆㧙2008ᐕᛚ⹺ຠ⋡㧙ޠ᡽╷⎇࠾ࡘ࡯ࠬNo.

27㧔2009ᐕ3᦬㧕: http://www.jpma.or.jp/opir/news/index.html. Accessed on October 13, 2009.

6 ක⮎↥ᬺ᡽╷⎇ⓥᚲ. ޟᣣᧄߦ߅ߌࠆᣂක⮎ຠߩ⥃ᐥ㐿⊒ߩേะޠ᡽╷⎇࠾ࡘ࡯ࠬNo. 28㧔2009ᐕ8

᦬㧕: http://www.jpma.or.jp/opir/news/index.html. Accessed on October 13, 2009.

7 Ishibashi T. Trends in Clinical Development and Review Times of New Drugs in Japan: 2009 Update. Slides presented at: 45th Drug Information Association Annual Meeting; 2009 Jun 21-25;San Diego, CA.

8 ⁛┙ⴕ᡽ᴺੱක⮎ຠක≮ᯏེ✚วᯏ᭴ ᛚ⹺ᖱႎ: http://www.info.pmda.go.jp/info/syounin_index.html.

Accessed on October 13, 2009.

9 Food and Drug Administration (FDA). Drug and Biologic Approval Reports:

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiol ogicApprovalReports/default.htm. Accessed on October 13, 2009.

10 European Medicines Agency (EMEA) Annual Reports: http://www.emea.europa.eu/htms/general/direct/ar.htm.

Accessed on October 13, 2009.

11 ෘ↢⋭. ޟᄖ࿖⥃ᐥ࠺࡯࠲ࠍฃߌ౉ࠇࠆ㓙ߦ⠨ᘦߔߴ߈᳃ᣖ⊛ⷐ࿃ߦߟ޿ߡޠ㧔ක⮎ክ╙672ภޔ1998 ᐕ8᦬11ᣣ㧕: http://www.pmda.go.jp/ich/e/e5_98_8_11.pdf. Accessed on October 13, 2009.

12 ⁛┙ⴕ᡽ᴺੱක⮎ຠක≮ᯏེ✚วᯏ᭴. ޟᐔᚑ19ᐕᐲ ╙1࿁ክᩏ࡮቟ోᬺോᆔຬળ⾗ᢱޠ㧔2007ᐕ 6᦬8ᣣ㧕: http://www.pmda.go.jp/guide/hyougikai/19/h190608gijishidai.html. Accessed on October 13, 2009.

13 ⁛┙ⴕ᡽ᴺੱක⮎ຠක≮ᯏེ✚วᯏ᭴. ޟᣂක⮎ຠߦଥࠆᜂᒰಽ㊁ߩᄌᦝߦߟ޿ߡޠ㧔⮎ᯏ⊒╙

1128010ภޔ2008ᐕ11᦬28ᣣ㧕: http://www.pmda.go.jp/operations/notice/2008/file/1128010.pdf. Accessed on October 13, 2009.

⵬ㆮ1㧦↳⺧ᐕ೎ߩ⸃ᨆ⚿ᨐ

⥃ᐥ㐿⊒ᦼ㑆㧔࿑ 40ޔ⴫ 41㧕ޔክᩏᦼ㑆㧔࿑ 41ޔ⴫ 42㧕ޔ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆㧔⴫

43㧕ޔክᩏࡊࡠ࠮ࠬߦⷐߒߚᦼ㑆㧔⴫ 44㧕ޔㆡวᕈᦠ㕙⺞ᩏߦⷐߒߚᦼ㑆㧔⴫ 45㧕߅ࠃ߮࿖ౝGCP⺞ ᩏߦⷐߒߚᦼ㑆㧔⴫ 46㧕ߩ↳⺧ᐕ೎ߩផ⒖ࠍ␜ߒߚޕ1996ᐕએ೨ߦ↳⺧ߐࠇߚຠ⋡ߪ1996ᐕߦ߹ߣ߼

ߚޕ

࿑ 40 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖㧔↳⺧ᐕ೎㧕

0501001502002501st CTPN to NDA (months)

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧䋨᦬ᢙ䋩

↳⺧ᐕ 65.3

85.8

79.4

85.4 72.1

63.6

41.2 55.4

ਛᄩ୯ 13.0 53.4

31.6 41.0

71.6

ో૕

050100150200250

1996 19971998

19992000 20012002

20032004 20052006

2007 1996 19971998

19992000 20012002

20032004 20052006

20072008

NME non-NME

1st CTPN to NDA (months)ೋ࿁ᴦ㛎⸘↹ዯ䌾↳⺧䋨᦬ᢙ䋩

↳⺧ᐕ

NMEએᄖ

73.3 118.3

93.4

33.4 55.4

43.4

ਛᄩ୯ 13.0 35.0

42.3 71.4

88.1 51.7

31.0 64.8

80.3 67.4

58.0 81.2

64.9 68.9 66.3 90.3

79.1

75.4

34.7

ᵈ㧦Ꮐ஥ߩࠣ࡜ࡈߩὐ✢ߪో૕ߩਛᄩ୯

59.5

ࡨ᦬

⴫ 41 ⥃ᐥ㐿⊒ᦼ㑆ߩផ⒖㧔↳⺧ᐕ೎㧕

ో૕ NME NMEએᄖ

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD 䌾1996 16 65.3 61.6 16.3 15 64.8 60.9 16.5 1 73.3 73.3

-1997 16 85.8 91.3 36.4 12 80.3 83.8 31.7 4 118.3 113.6 45.4 1998 12 79.4 74.9 28.6 9 79.1 78.9 19.9 3 88.1 62.7 51.1 1999 24 85.4 85.2 35.4 18 90.3 89.9 31.5 6 71.4 71.2 45.4 2000 23 71.6 71.6 30.5 18 67.4 65.1 23.5 5 93.4 94.9 43.4 2001 30 41.0 50.6 30.9 17 58.0 56.2 26.1 13 33.4 43.4 36.0 2002 30 72.1 74.3 34.3 22 81.2 74.6 27.8 8 55.4 73.4 50.4 2003 32 63.6 69.1 44.2 12 75.4 85.3 47.6 20 51.7 59.4 40.1 2004 44 41.2 68.7 55.2 17 68.9 88.0 48.3 27 35.0 56.5 56.6 2005 40 53.4 59.2 44.6 16 64.9 77.3 57.1 24 43.4 47.2 29.5 2006 53 55.4 71.4 47.9 25 66.3 82.0 50.9 28 42.3 62.0 43.8 2007 20 31.6 38.1 30.6 6 34.7 38.2 30.6 14 31.0 38.1 31.8

2008 2 13.0 13.0 13.3 0 - - - 2 13.0 13.0 13.3

ว⸘ 342 59.5 67.1 42.1 187 70.8 75.1 38.7 155 40.0 57.5 44.1

࿑ 41 ክᩏᦼ㑆ߩផ⒖㧔↳⺧ᐕ೎㧕

050100150NDA to Approval (months)

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

ᛚ⹺↳⺧䌾ᛚ⹺䋨᦬ᢙ䋩

↳⺧ᐕ 60.5

39.6 27.719.2

23.5 26.2

19.9 18.6

ਛᄩ୯ 2.9 19.5

12.6 15.818.1

ో૕

050100150

1996 19971998

19992000 20012002

20032004 20052006

20072008 1996 19981999

20002001 20022003

20042005 20062007

2008

Standard Review Priority Review

NDA to Approval (months)ᛚ⹺↳⺧䌾ᛚ⹺䋨᦬ᢙ䋩

↳⺧ᐕ

ఝవክᩏຠ⋡

ㅢᏱክᩏຠ⋡

59.4

29.6 9.1

21.9

15.8 ਛᄩ୯ 2.3 14.6 15.9 12.7

12.4 25.3

11.6 60.5

39.6

16.7 20.1

23.7

21.9 25.1

19.3 22.8

26.1 28.5

13.8 5.0

ᵈ㧦Ꮐ஥ߩࠣ࡜ࡈߩὐ✢ߪో૕ߩਛᄩ୯

20.6

ࡨ᦬

⴫ 42 ክᩏᦼ㑆ߩផ⒖㧔↳⺧ᐕ೎㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD 䌾1996 29 60.5 69.1 24.6 27 60.5 69.8 25.0 2 59.4 59.4 23.4

1997 22 39.6 46.0 20.2 22 39.6 46.0 20.2 0 - -

-1998 15 27.7 32.9 19.6 13 26.1 33.4 21.1 2 29.6 29.6 1.9 1999 42 19.2 21.7 11.8 27 22.8 25.9 12.1 15 12.4 14.1 6.4 2000 36 15.8 20.3 16.1 24 16.7 24.1 18.3 12 12.7 12.6 4.9 2001 38 18.1 20.4 12.6 28 20.1 23.3 12.2 10 9.1 12.3 10.4 2002 40 23.5 29.3 15.8 31 23.7 28.9 14.4 9 21.9 30.4 21.0 2003 49 26.2 28.9 12.2 31 28.5 29.8 11.9 18 25.3 27.4 13.0 2004 60 19.9 21.8 10.3 37 25.1 26.5 8.3 23 14.6 14.2 8.5 2005 46 19.5 19.0 6.4 26 21.9 22.4 4.9 20 15.8 14.5 5.3 2006 70 18.6 18.0 6.9 42 19.3 19.7 6.1 28 15.9 15.5 7.4 2007 33 12.6 12.3 4.7 11 13.8 14.0 5.5 22 11.6 11.5 4.1

2008 6 2.9 3.5 2.1 3 5.0 4.4 2.9 3 2.3 2.6 0.7

ว⸘ 486 20.6 25.5 18.4 322 23.5 29.9 19.6 164 15.1 16.7 11.7

⴫ 43 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆㧔↳⺧ᐕ೎㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD

↳⺧䌾ೋ࿁㕙⺣

䌾1996 27 6.7 12.3 22.7 25 6.9 13.0 23.5 2 2.7 2.7 1.2

1997 20 5.2 5.2 1.4 20 5.2 5.2 1.4 0 - -

-1998 14 2.6 8.3 19.4 12 2.6 8.4 20.9 2 7.3 7.3 7.9

1999 36 2.0 3.6 5.2 24 2.2 4.3 5.8 12 1.4 2.1 3.7

2000 31 1.9 1.8 0.6 22 1.9 1.9 0.6 9 1.6 1.7 0.6

2001 34 2.2 2.3 2.0 25 2.3 2.6 1.6 9 2.0 1.3 2.6

2002 30 2.5 3.3 4.8 26 2.6 3.5 5.1 4 1.6 1.6 0.6

2003 41 2.9 4.8 7.7 25 3.0 5.5 9.6 16 2.7 3.5 2.7

2004 50 2.7 2.3 3.2 34 2.8 2.9 1.5 16 2.0 1.0 5.1

2005 38 2.4 2.7 2.3 22 2.7 3.4 1.6 16 2.0 1.7 2.8

2006 62 2.7 2.7 2.0 39 2.7 3.0 2.0 23 2.3 2.1 1.9

2007 28 2.6 2.7 1.5 10 2.6 2.5 0.8 18 2.6 2.9 1.8

2008 5 -4.0 -2.1 3.7 2 1.9 1.9 0.4 3 -5.0 -4.8 0.7

ว⸘ 416 2.6 3.7 8.0 286 2.7 4.5 9.3 130 2.1 2.0 3.2

↳⺧㨪ኾ㐷ද⼏

䌾1996 16 72.2 74.2 27.3 15 71.8 74.3 28.2 1 72.5 72.5

-1997 15 35.6 43.8 21.4 15 35.6 43.8 21.4 0 - -

-1998 12 22.2 29.0 20.5 11 21.7 28.9 21.5 1 29.1 29.1 -1999 33 15.7 17.5 12.4 23 16.9 21.2 12.7 10 8.8 8.9 6.2 2000 30 10.7 14.3 13.4 21 12.7 16.6 15.5 9 10.2 9.0 2.6 2001 36 12.8 15.6 12.5 27 15.1 18.8 12.8 9 4.3 6.3 4.4 2002 36 19.9 25.1 14.3 29 19.3 24.2 13.2 7 22.6 28.6 19.0 2003 40 21.8 24.3 12.7 26 22.5 25.4 12.5 14 20.9 22.2 13.1 2004 54 16.9 19.3 9.9 37 22.0 23.1 8.3 17 11.5 11.0 8.0 2005 44 16.5 16.0 6.2 25 19.3 19.4 4.4 19 12.3 11.5 5.2 2006 63 15.7 15.8 6.4 39 16.9 17.1 6.1 24 14.1 13.6 6.3

2007 30 9.6 9.7 5.1 11 10.5 11.4 5.4 19 9.2 8.6 4.7

2008 5 0.0 0.9 2.3 2 2.5 2.5 3.6 3 -0.1 -0.2 0.3

ว⸘ 414 16.7 20.9 17.6 281 19.3 24.7 18.8 133 11.7 13.0 11.1

↳⺧㨪ක⮎ຠㇱળ

䌾1996 28 59.0 67.4 24.7 26 59.0 68.2 25.1 2 58.0 58.0 24.1

1997 22 38.1 44.3 19.8 22 38.1 44.3 19.8 0 - -

-1998 15 26.3 31.3 19.2 13 24.6 31.7 20.7 2 28.5 28.5 2.4 1999 42 17.7 19.5 12.1 27 20.9 24.2 12.0 15 10.2 11.0 6.3 2000 36 13.9 18.6 15.9 24 15.3 22.4 18.2 12 11.1 10.9 4.3 2001 36 16.1 18.4 12.3 28 17.5 21.2 12.3 8 7.4 8.4 4.6 2002 40 20.6 27.0 15.7 31 20.9 26.5 14.2 9 20.1 28.6 21.1 2003 49 24.5 27.1 12.1 31 26.2 27.9 11.7 18 23.3 25.9 13.1 2004 60 18.2 20.0 9.9 37 23.1 24.5 8.0 23 13.3 12.7 8.2 2005 46 17.3 17.2 6.1 26 20.1 20.7 4.4 20 13.4 12.6 5.0 2006 69 16.8 16.5 6.7 41 17.5 18.2 5.9 28 14.6 13.9 7.1

2007 33 10.2 10.8 4.6 11 11.9 12.6 5.4 22 9.8 9.8 4.0

2008 6 1.5 2.6 2.0 3 4.2 3.8 2.4 3 1.4 1.4 0.2

ว⸘ 482 19.0 23.6 18.2 320 21.6 28.0 19.4 162 13.1 14.9 11.6

⴫ 43 ↳⺧߆ࠄਥߥࡑࠗ࡞ࠬ࠻ࡦ߹ߢߩᦼ㑆㧔↳⺧ᐕ೎㧕㧔⛯߈㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD

↳⺧䌾⮎੐ಽ⑼ળ

䌾1996 27 59.6 69.0 25.4 25 59.6 69.8 25.8 2 58.4 58.4 23.9

1997 19 39.5 46.6 20.8 19 39.5 46.6 20.8 0 - -

-1998 14 27.6 33.6 19.8 12 25.5 34.0 21.5 2 31.0 31.0 0.2 1999 39 20.6 22.2 11.7 25 22.7 26.3 11.8 14 14.3 14.8 6.8 2000 31 15.1 19.3 15.3 21 16.5 22.6 17.6 10 12.0 12.5 3.9 2001 37 16.9 19.0 12.5 28 19.2 22.4 12.4 9 6.3 8.6 4.5 2002 39 22.5 28.1 16.0 31 23.0 27.9 14.4 8 19.1 29.0 22.4 2003 41 25.3 27.3 12.2 28 29.8 29.7 12.2 13 24.0 22.1 10.8 2004 45 21.7 22.3 11.0 32 26.6 26.5 8.5 13 7.2 11.9 9.8 2005 31 18.8 18.5 7.2 15 22.4 23.8 4.2 16 14.8 13.5 5.6 2006 47 17.9 17.9 6.8 28 18.5 19.6 6.3 19 17.6 15.5 6.9 2007 22 11.8 11.6 4.2 6 12.5 12.6 5.5 16 11.3 11.2 3.8

2008 3 2.1 2.4 0.7 0 - - - 3 2.1 2.4 0.7

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⹺

䌾1996 29 60.5 69.1 24.6 27 60.5 69.8 25.0 2 59.4 59.4 23.4

1997 22 39.6 46.0 20.2 22 39.6 46.0 20.2 0 - -

-1998 15 27.7 32.9 19.6 13 26.1 33.4 21.1 2 29.6 29.6 1.9 1999 42 19.2 21.7 11.8 27 22.8 25.9 12.1 15 12.4 14.1 6.4 2000 36 15.8 20.3 16.1 24 16.7 24.1 18.3 12 12.7 12.6 4.9 2001 38 18.1 20.4 12.6 28 20.1 23.3 12.2 10 9.1 12.3 10.4 2002 40 23.5 29.3 15.8 31 23.7 28.9 14.4 9 21.9 30.4 21.0 2003 49 26.2 28.9 12.2 31 28.5 29.8 11.9 18 25.3 27.4 13.0 2004 60 19.9 21.8 10.3 37 25.1 26.5 8.3 23 14.6 14.2 8.5 2005 46 19.5 19.0 6.4 26 21.9 22.4 4.9 20 15.8 14.5 5.3 2006 70 18.6 18.0 6.9 42 19.3 19.7 6.1 28 15.9 15.5 7.4 2007 33 12.6 12.3 4.7 11 13.8 14.0 5.5 22 11.6 11.5 4.1

2008 6 2.9 3.5 2.1 3 5.0 4.4 2.9 3 2.3 2.6 0.7

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

䌾1996 26 66.8 73.6 24.8 25 64.0 73.5 25.3 1 77.8 77.8

-1997 17 42.6 44.5 12.6 17 42.6 44.5 12.6 0 - -

-1998 13 29.6 35.4 20.9 12 27.5 35.9 21.8 1 30.1 30.1 -1999 29 22.6 24.6 13.8 21 25.0 28.9 13.5 8 13.9 13.4 6.1 2000 24 19.3 22.5 14.6 18 19.3 24.4 16.3 6 18.0 16.8 5.3 2001 29 18.8 20.0 11.2 21 21.4 23.5 10.7 8 8.2 10.7 5.8 2002 31 27.8 32.3 15.8 23 27.8 31.6 13.6 8 31.1 34.1 21.8 2003 26 27.9 31.7 11.9 16 34.6 34.1 10.7 10 26.8 27.7 13.3

2004 36 26.3 24.8 11.3 27 30.0 29.7 6.8 9 9.4 9.9 8.8

2005 27 20.8 20.9 8.3 14 26.2 25.8 6.2 13 17.8 15.5 6.9 2006 42 21.6 20.3 7.7 24 22.3 22.6 5.8 18 19.0 17.1 9.0 2007 17 14.6 14.2 5.1 6 15.4 15.1 5.2 11 14.5 13.6 5.3

2008 3 3.1 3.1 0.3 0 - - - 3 3.1 3.1 0.3

ว⸘ 320 23.8 29.2 20.1 224 27.5 34.1 20.6 96 16.2 17.8 13.5

⴫ 44 ክᩏࡊࡠ࠮ࠬߦⷐߒߚᦼ㑆㧔↳⺧ᐕ೎㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD

↳⺧䌾ೋ࿁㕙⺣

䌾1996 27 6.7 12.3 22.7 25 6.9 13.0 23.5 2 2.7 2.7 1.2

1997 20 5.2 5.2 1.4 20 5.2 5.2 1.4 0 - -

-1998 14 2.6 8.3 19.4 12 2.6 8.4 20.9 2 7.3 7.3 7.9

1999 36 2.0 3.6 5.2 24 2.2 4.3 5.8 12 1.4 2.1 3.7

2000 31 1.9 1.8 0.6 22 1.9 1.9 0.6 9 1.6 1.7 0.6

2001 34 2.2 2.3 2.0 25 2.3 2.6 1.6 9 2.0 1.3 2.6

2002 30 2.5 3.3 4.8 26 2.6 3.5 5.1 4 1.6 1.6 0.6

2003 41 2.9 4.8 7.7 25 3.0 5.5 9.6 16 2.7 3.5 2.7

2004 50 2.7 2.3 3.2 34 2.8 2.9 1.5 16 2.0 1.0 5.1

2005 38 2.4 2.7 2.3 22 2.7 3.4 1.6 16 2.0 1.7 2.8

2006 62 2.7 2.7 2.0 39 2.7 3.0 2.0 23 2.3 2.1 1.9

2007 28 2.6 2.7 1.5 10 2.6 2.5 0.8 18 2.6 2.9 1.8

2008 5 -4.0 -2.1 3.7 2 1.9 1.9 0.4 3 -5.0 -4.8 0.7

ว⸘ 416 2.6 3.7 8.0 286 2.7 4.5 9.3 130 2.1 2.0 3.2

ೋ࿁㕙⺣䌾ኾ㐷ද⼏

䌾1996 15 57.1 60.7 25.7 14 51.8 60.0 26.5 1 70.7 70.7

-1997 13 31.7 38.6 22.9 13 31.7 38.6 22.9 0 - -

-1998 11 17.2 19.6 5.5 10 18.6 20.0 5.6 1 16.2 16.2

-1999 27 12.4 14.2 12.9 20 13.4 17.8 12.8 7 1.7 3.9 6.2

2000 29 9.0 12.7 13.5 21 10.8 14.8 15.4 8 8.2 7.3 2.5

2001 32 10.7 13.5 13.0 24 11.6 16.2 14.0 8 5.4 5.4 3.3 2002 28 17.8 21.7 14.3 25 18.2 21.3 12.6 3 10.9 25.0 28.7 2003 37 18.4 20.2 11.8 23 19.3 21.1 11.4 14 16.4 18.7 12.6 2004 49 15.3 18.2 8.4 34 20.0 21.1 7.2 15 9.8 11.6 7.5

2005 37 13.0 13.6 5.4 21 15.8 16.6 4.7 16 9.7 9.7 3.5

2006 60 13.2 13.3 5.6 38 14.3 14.3 5.5 22 12.0 11.6 5.4

2007 27 7.0 7.4 4.6 10 8.3 9.6 4.8 17 5.2 6.1 4.1

2008 4 4.4 4.2 1.0 1 2.9 2.9 - 3 4.8 4.6 0.6

ว⸘ 369 13.8 17.8 15.6 254 16.2 20.9 16.5 115 9.0 10.9 10.3 ኾ㐷ද⼏䌾ක⮎ຠㇱળ

䌾1996 16 3.2 4.0 3.0 15 3.5 4.1 3.1 1 2.5 2.5

-1997 15 3.7 6.7 9.1 15 3.7 6.7 9.1 0 - -

-1998 12 3.1 4.8 6.2 11 3.3 5.2 6.4 1 1.0 1.0

-1999 33 2.0 3.2 6.0 23 2.0 4.1 5.3 10 1.7 1.1 7.3

2000 30 2.5 4.2 5.2 21 2.9 4.6 6.1 9 2.5 3.0 2.0

2001 35 2.2 2.5 1.8 27 2.5 2.7 1.9 8 1.5 1.7 0.6

2002 36 2.0 3.9 5.9 29 1.9 3.5 5.3 7 2.1 5.4 8.0

2003 40 1.2 1.6 1.3 26 1.3 1.7 1.4 14 1.1 1.6 1.1

2004 54 1.2 1.7 1.8 37 1.1 1.4 0.9 17 1.7 2.3 2.8

2005 44 1.1 1.2 0.6 25 1.1 1.3 0.7 19 1.1 1.2 0.5

2006 63 1.1 1.2 0.7 39 1.1 1.2 0.8 24 1.1 1.2 0.6

2007 30 1.0 1.6 2.2 11 1.0 1.2 0.7 19 1.1 1.8 2.7

2008 5 1.3 1.4 0.4 2 1.1 1.1 0.2 3 1.3 1.6 0.4

ว⸘ 413 1.4 2.5 3.9 281 1.6 2.7 4.2 132 1.3 1.9 3.2

⴫ 44 ክᩏࡊࡠ࠮ࠬߦⷐߒߚᦼ㑆㧔↳⺧ᐕ೎㧕㧔⛯߈㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD ක⮎ຠㇱળ䌾⮎੐ಽ⑼ળ

䌾1996 27 0.8 1.2 1.2 25 0.8 1.3 1.2 2 0.4 0.4 0.3

1997 19 0.9 1.5 1.3 19 0.9 1.5 1.3 0 - -

-1998 14 1.3 1.8 1.3 12 1.3 1.7 1.2 2 2.5 2.5 2.6

1999 39 1.2 2.5 3.5 25 1.1 1.6 1.2 14 1.4 4.0 5.4

2000 31 0.9 0.9 0.5 21 0.9 1.1 0.5 10 0.5 0.6 0.5

2001 36 0.8 1.1 0.8 28 0.8 1.2 0.9 8 0.7 0.7 0.3

2002 39 1.4 1.3 0.7 31 1.5 1.4 0.7 8 0.9 1.0 0.4

2003 41 1.0 1.1 0.5 28 1.0 1.2 0.5 13 0.9 1.0 0.5

2004 45 1.1 1.4 0.6 32 1.1 1.4 0.5 13 1.6 1.6 0.6

2005 31 1.1 1.5 0.6 15 1.7 1.6 0.6 16 1.0 1.4 0.7

2006 47 1.1 1.4 0.6 28 1.1 1.4 0.6 19 1.1 1.3 0.6

2007 22 1.1 1.3 0.5 6 1.3 1.4 0.5 16 1.1 1.2 0.5

2008 3 0.7 1.0 0.5 0 - - - 3 0.7 1.0 0.5

ว⸘ 394 1.1 1.4 1.4 270 1.1 1.4 0.9 124 1.1 1.5 2.1

⮎੐ಽ⑼ળ䌾ᛚ⹺

䌾1996 27 0.6 0.4 1.2 25 0.6 0.3 1.3 2 1.0 1.0 0.5

1997 19 0.6 0.3 1.2 19 0.6 0.3 1.2 0 - -

-1998 14 0.1 -0.2 1.3 12 0.4 0.0 1.2 2 -1.4 -1.4 2.1

1999 39 0.2 -0.2 1.4 25 0.6 0.1 1.1 14 -0.1 -0.7 1.7

2000 31 0.8 0.8 0.7 21 0.8 0.7 0.4 10 0.7 1.1 1.1

2001 37 0.8 0.9 0.5 28 0.8 0.9 0.6 9 0.8 0.7 0.4

2002 39 0.9 1.0 0.3 31 0.9 1.0 0.3 8 0.9 0.9 0.3

2003 41 0.9 0.9 0.2 28 0.9 0.9 0.2 13 0.8 0.8 0.2

2004 45 0.9 0.8 0.5 32 0.9 0.9 0.2 13 0.7 0.3 0.8

2005 31 1.0 0.9 0.2 15 1.0 0.9 0.2 16 1.0 0.9 0.3

2006 47 0.8 0.8 0.3 28 0.9 0.8 0.2 19 0.8 0.8 0.4

2007 22 0.5 0.5 0.5 6 0.4 0.4 0.5 16 0.6 0.5 0.5

2008 3 0.2 0.2 0.0 0 - - - 3 0.2 0.2 0.0

ว⸘ 395 0.8 0.6 0.8 270 0.8 0.7 0.8 125 0.8 0.5 1.0 ᛚ⹺䌾⮎ଔ෼タ

䌾1996 26 1.9 2.2 0.8 25 1.9 2.3 0.8 1 1.9 1.9

-1997 17 1.9 2.1 0.5 17 1.9 2.1 0.5 0 - -

-1998 13 1.8 1.9 0.4 12 1.8 1.9 0.4 1 1.8 1.8

-1999 29 1.9 3.3 4.7 21 1.9 3.8 5.5 8 1.8 1.9 0.5

2000 24 2.2 2.4 0.7 18 2.2 2.4 0.8 6 1.9 2.4 0.7

2001 29 1.9 2.2 1.6 21 1.9 2.2 1.6 8 1.2 2.0 1.9

2002 31 1.9 2.4 1.2 23 1.9 2.2 1.1 8 1.9 2.7 1.7

2003 26 1.7 2.6 1.9 16 1.8 3.0 2.2 10 1.7 2.0 1.3

2004 36 1.7 1.7 0.7 27 1.7 1.8 0.5 9 0.6 1.2 1.2

2005 27 1.7 2.1 1.0 14 1.9 2.4 0.9 13 1.6 1.6 0.9

2006 42 1.9 2.0 0.8 24 1.9 2.1 0.5 18 1.8 1.8 1.0

2007 17 1.9 1.6 2.3 6 1.9 1.5 3.9 11 1.9 1.7 0.9

2008 3 0.7 0.5 0.4 0 - - - 3 0.7 0.5 0.4

ว⸘ 320 1.9 2.2 1.9 224 1.9 2.3 2.1 96 1.7 1.8 1.2

⴫ 45 ㆡวᕈᦠ㕙⺞ᩏߦⷐߒߚᦼ㑆㧔↳⺧ᐕ೎㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD

↳⺧㨪ㆡวᕈᦠ㕙⺞ᩏ㐿ᆎᣣ

䌾1996 3 106.1 100.2 13.0 3 106.1 100.2 13.0 0 - -

-1997 11 6.6 14.8 28.4 11 6.6 14.8 28.4 0 - -

-1998 15 4.1 11.3 19.9 13 4.1 10.7 20.9 2 15.1 15.1 16.2

1999 38 2.3 3.6 4.7 24 3.0 4.8 5.7 14 1.5 1.7 0.7

2000 30 2.4 2.7 1.2 20 3.0 3.1 1.3 10 2.0 1.9 0.6

2001 37 3.1 3.5 1.7 28 3.8 4.0 1.5 9 1.5 1.8 0.9

2002 34 4.0 5.7 6.4 27 4.4 6.5 6.9 7 2.3 2.5 0.8

2003 38 3.8 5.0 8.2 27 4.1 6.1 9.5 11 2.6 2.4 1.2

2004 52 4.9 5.1 2.6 37 5.7 6.1 2.2 15 2.8 2.5 1.8

2005 43 7.6 7.2 3.8 26 9.8 9.7 2.4 17 3.4 3.4 1.9

2006 61 8.2 7.3 2.9 40 8.5 8.6 1.9 21 5.0 4.8 3.0

2007 25 5.9 5.9 2.8 8 7.6 7.6 1.6 17 5.3 5.1 2.9

2008 5 0.3 0.8 1.5 2 2.0 2.0 2.1 3 0.1 0.0 0.3

ว⸘ 392 4.4 6.5 11.2 266 5.2 8.0 13.2 126 2.6 3.3 3.1 ㆡวᕈᦠ㕙⺞ᩏ㐿ᆎᣣ㨪⚳ੌᣣ

䌾1996 3 0.1 0.1 0.0 3 0.1 0.1 0.0 0 - -

-1997 11 0.4 0.6 0.5 11 0.4 0.6 0.5 0 - -

-1998 15 0.4 0.4 0.2 13 0.4 0.4 0.2 2 0.3 0.3 0.3

1999 38 0.2 0.3 0.4 24 0.3 0.5 0.5 14 0.1 0.1 0.1

2000 30 0.2 0.3 0.3 20 0.2 0.3 0.3 10 0.1 0.1 0.1

2001 37 0.3 0.3 0.4 28 0.3 0.3 0.4 9 0.1 0.3 0.5

2002 34 0.2 1.3 6.0 27 0.1 0.3 0.4 7 0.2 5.2 13.1

2003 38 0.1 0.2 0.2 27 0.1 0.2 0.2 11 0.0 0.1 0.1

2004 49 0.1 0.1 0.1 35 0.1 0.1 0.1 14 0.0 0.0 0.1

2005 43 0.0 0.1 0.1 26 0.0 0.1 0.1 17 0.0 0.1 0.1

2006 61 0.0 0.0 3.5 40 0.0 -0.5 3.8 21 0.0 0.9 2.8

2007 25 0.0 0.1 0.1 8 0.0 0.0 0.0 17 0.0 0.1 0.2

2008 5 0.0 0.0 0.0 2 0.0 0.0 0.0 3 0.0 0.0 0.0

ว⸘ 389 0.1 0.3 2.3 264 0.1 0.1 1.5 125 0.0 0.5 3.3 ㆡวᕈᦠ㕙⺞ᩏ⚳ੌᣣ䌾⚿ᨐㅢ⍮ᣣ

䌾1996 3 4.1 6.0 6.4 3 4.1 6.0 6.4 0 - -

-1997 8 2.3 2.4 0.9 8 2.3 2.4 0.9 0 - -

-1998 14 0.9 1.2 0.8 12 0.9 1.1 0.7 2 2.2 2.2 0.4

1999 31 0.9 1.1 0.8 22 1.1 1.2 0.8 9 0.7 0.8 0.6

2000 25 1.3 1.7 1.9 18 1.5 1.9 2.2 7 1.1 1.2 0.5

2001 34 1.6 1.6 0.6 27 1.7 1.7 0.6 7 1.3 1.2 0.6

2002 30 1.7 3.2 5.5 25 1.8 3.5 6.0 5 1.6 1.6 0.2

2003 38 1.3 2.1 2.6 27 1.3 2.1 2.8 11 1.1 2.0 2.2

2004 47 2.5 3.7 3.3 33 3.0 4.4 3.4 14 1.1 1.9 2.4

2005 42 2.1 2.5 2.1 25 2.7 2.8 1.9 17 1.3 2.1 2.4

2006 60 1.8 2.4 3.4 40 2.0 2.8 4.0 20 1.4 1.5 1.4

2007 23 0.9 1.1 1.0 8 0.8 1.1 0.8 15 0.9 1.1 1.1

2008 2 0.6 0.6 0.3 1 0.9 0.9 - 1 0.4 0.4

-ว⸘ 357 1.6 2.3 2.9 249 1.7 2.6 3.2 108 1.1 1.6 1.7

↳⺧㨪ㆡวᕈᦠ㕙⺞ᩏ⚿ᨐㅢ⍮ᣣ

䌾1996 3 113.3 106.2 17.7 3 113.3 106.2 17.7 0 - -

-1997 8 10.2 21.2 32.8 8 10.2 21.2 32.8 0 - -

-1998 14 5.9 13.4 21.1 12 5.5 12.7 22.3 2 17.6 17.6 16.3

1999 32 3.8 5.4 5.4 23 4.4 6.5 6.1 9 2.7 2.6 1.1

2000 25 3.8 4.7 2.6 18 4.3 5.3 2.9 7 3.1 3.3 1.0

2001 34 4.7 5.2 1.9 27 5.2 5.8 1.6 7 3.0 3.0 1.1

2002 30 6.3 9.7 9.1 25 6.5 9.5 7.5 5 4.2 11.1 16.1

2003 38 6.0 7.2 8.4 27 6.2 8.3 9.6 11 4.3 4.6 2.6

2004 48 8.2 9.0 5.3 34 9.9 11.0 4.7 14 4.1 4.3 3.3

2005 42 10.2 9.8 4.3 25 12.8 12.6 2.4 17 6.2 5.6 2.9

2006 60 9.9 9.6 3.9 40 11.0 10.8 2.8 20 7.1 7.2 4.8

2007 23 7.2 7.1 2.7 8 8.8 8.7 1.9 15 6.8 6.3 2.8

2008 2 2.3 2.3 3.0 1 4.4 4.4 - 1 0.2 0.2

-ว⸘ 359 6.9 9.2 12.4 251 8.3 10.8 14.1 108 4.4 5.6 5.3

⴫ 46 ࿖ౝGCP⺞ᩏߦⷐߒߚᦼ㑆㧔↳⺧ᐕ೎㧕

ో૕ ㅢᏱክᩏຠ⋡ ఝవክᩏຠ⋡

↳⺧ᐕ N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD N ਛᄩ୯ ᐔဋ୯ SD

↳⺧䌾࿖ౝGCP⺞ᩏ㐿ᆎᣣ

䌾1996 22 16.0 33.9 36.6 21 16.0 32.8 37.1 1 58.0 58.0

-1997 18 7.8 14.6 22.9 18 7.8 14.6 22.9 0 - -

-1998 14 6.8 13.7 21.0 12 6.8 13.6 22.2 2 14.3 14.3 17.1

1999 37 3.7 5.5 6.3 24 4.2 6.5 7.3 13 2.6 3.7 3.4

2000 29 3.4 4.8 7.6 19 3.6 5.8 9.4 10 2.8 3.1 0.8

2001 34 3.4 3.6 1.1 27 3.7 3.9 1.0 7 2.8 2.5 0.7

2002 32 6.2 7.7 7.3 26 6.2 8.4 7.9 6 5.4 5.1 1.8

2003 35 7.1 8.7 8.7 26 7.4 10.0 9.5 9 6.7 5.0 4.1

2004 46 9.7 8.0 10.0 36 10.7 10.6 3.7 10 3.2 -1.3 17.8

2005 38 11.2 10.4 4.4 25 13.2 13.0 2.8 13 5.5 5.5 2.2

2006 53 12.3 11.0 4.0 38 13.3 12.4 3.6 15 7.4 7.5 2.5

2007 21 8.0 8.2 3.1 7 11.2 11.3 1.9 14 7.0 6.6 2.2

2008 2 2.3 2.3 2.7 2 2.3 2.3 2.7 0 - -

-ว⸘ 381 6.8 9.8 13.9 281 8.1 11.5 15.0 100 5.3 5.2 8.6

࿖ౝGCP⺞ᩏ㐿ᆎᣣ䌾⚳ੌᣣ

䌾1996 22 0.1 -0.4 2.6 21 0.1 -0.4 2.6 1 0.4 0.4

-1997 17 0.3 0.3 0.3 17 0.3 0.3 0.3 0 - -

-1998 14 0.3 0.3 0.1 12 0.3 0.3 0.1 2 0.3 0.3 0.0

1999 37 0.2 0.3 0.6 24 0.3 0.3 0.1 13 0.2 0.5 1.0

2000 29 0.2 0.2 0.2 19 0.3 0.3 0.2 10 0.1 0.1 0.1

2001 34 0.3 0.3 0.2 27 0.3 0.4 0.2 7 0.2 0.2 0.1

2002 32 0.5 1.7 6.2 26 0.5 0.6 1.0 6 0.3 6.1 14.2

2003 34 0.3 0.4 0.2 25 0.4 0.4 0.2 9 0.3 0.3 0.0

2004 45 0.3 0.4 0.4 35 0.4 0.5 0.4 10 0.1 0.1 0.1

2005 38 0.4 0.4 0.2 25 0.5 0.5 0.2 13 0.3 0.3 0.1

2006 53 0.4 0.5 0.3 38 0.4 0.5 0.4 15 0.4 0.4 0.2

2007 21 0.3 0.3 0.2 7 0.3 0.3 0.2 14 0.2 0.3 0.2

2008 2 0.2 0.2 0.1 2 0.2 0.2 0.1 0 - -

-ว⸘ 378 0.3 0.4 1.9 278 0.3 0.4 0.8 100 0.3 0.6 3.5

࿖ౝGCP⺞ᩏ⚳ੌᣣ䌾⚿ᨐㅢ⍮ᣣ

䌾1996 17 8.0 9.0 5.3 16 7.9 8.5 5.0 1 17.3 17.3

-1997 17 6.6 9.3 7.2 17 6.6 9.3 7.2 0 - -

-1998 11 9.8 9.0 3.8 10 10.3 9.5 3.5 1 3.4 3.4

-1999 31 7.8 9.0 6.6 21 9.4 10.8 7.2 10 4.6 5.2 2.3

2000 25 8.1 9.8 9.6 17 9.4 11.0 11.2 8 6.6 7.1 4.3

2001 34 6.2 6.8 4.5 27 7.6 7.7 4.6 7 3.9 3.4 2.2

2002 30 4.2 6.0 5.3 24 4.6 6.9 5.6 6 2.0 2.4 1.5

2003 34 5.4 5.7 4.0 25 5.5 5.8 4.0 9 3.3 5.2 4.3

2004 43 4.0 4.3 1.8 33 4.1 4.5 1.8 10 3.8 3.8 1.7

2005 37 3.0 3.0 1.4 24 2.7 2.8 1.4 13 3.1 3.4 1.2

2006 53 1.4 1.5 0.8 38 1.4 1.5 0.8 15 1.5 1.6 0.5

2007 18 1.4 1.5 0.9 7 1.8 1.5 0.7 11 1.2 1.5 1.1

2008 2 0.7 0.7 0.3 2 0.7 0.7 0.3 0 - -

-ว⸘ 352 4.0 5.5 5.4 261 4.7 6.2 5.8 91 3.0 3.7 3.1

↳⺧䌾࿖ౝGCP⺞ᩏ⚿ᨐㅢ⍮ᣣ

䌾1996 17 26.7 48.7 38.6 16 26.5 47.0 39.2 1 75.7 75.7

-1997 18 16.5 24.5 23.4 18 16.5 24.5 23.4 0 - -

-1998 11 19.1 25.3 21.9 10 18.8 24.8 23.1 1 30.1 30.1

-1999 31 12.6 14.0 7.9 21 14.2 16.5 8.2 10 8.3 8.5 2.7

2000 25 12.7 15.0 12.3 17 13.8 17.3 14.2 8 9.4 10.1 4.4

2001 34 9.5 10.8 5.0 27 12.1 11.9 4.8 7 5.6 6.2 2.7

2002 30 11.0 15.6 10.3 24 12.4 16.1 8.9 6 8.3 13.5 15.5

⵬ㆮ2㧦ᧄ⎇ⓥ⚿ᨐߣPMDAᬺോႎ๔ߩᲧセ

ᧄ⎇ⓥߣPMDA߇Ფᐕ⊒ⴕߒߡ޿ࠆᬺോႎ๔ߩ㆑޿ߣߒߡޔᧄ⎇ⓥߢߪᥲᐕ㧔1᦬㨪12᦬㧕ߢ㓸⸘ߒ ߡ޿ࠆߩߦኻߒߡޔPMDAߩ⋡ᮡ୯߅ࠃ߮ᬺോႎ๔ߢߪᐕᐲ㧔4᦬㨪⠉3᦬㧕ࠍ↪޿ߡ޿ࠆὐ߇޽ࠆޕ

߹ߚޔᧄ⎇ⓥߢߪߔߴߡߩᛚ⹺ຠ⋡ࠍ⸃ᨆኻ⽎ߣߒޔ⋡⊛ߦᔕߓߡPMDAߦ↳⺧ߐࠇߚຠ⋡ߩ⚿ᨐࠍ␜

ߒߡ޿ࠆߩߦኻߒߡޔᬺോႎ๔ߢߪ2004ᐕ4᦬એ㒠ߦ↳⺧ߐࠇߚຠ⋡ࠍਥߚࠆ⸃ᨆኻ⽎ߣߒߡ޿ࠆޕ ߐࠄߦޔᧄ⎇ⓥߢߪክᩏᦼ㑆ߩ⹦⚦ࠍࠕࡦࠤ࡯࠻⺞ᩏߦߡ↳⺧ડᬺࠃࠅ෼㓸ߒߡ߅ࠅޔᰳ᷹߿᦭ല࿁╵

߇ᓧࠄࠇߥ߆ߞߚຠ⋡߿⺞ᩏ㗄⋡߇ሽ࿷ߔࠆޕ৻ᣇޔᬺോႎ๔ߢߪPMDA߇଻᦭ߒߡ޿ࠆోຠ⋡ߩ࠺࡯

࠲ࠍ㓸⸘ߒߡ޿ࠆߣផኤߐࠇࠆޕਔ⠪ߢ౒ㅢߒߡ޿ࠆὐߪޔᦼ㑆ࠍ␜ߔ⛔⸘㊂ߣߒߡ᦬ᢙߩਛᄩ୯ࠍ↪

޿ߡ޿ࠆߎߣ߇޽ࠆޕ

᡽ᐭ߇2007ᐕ4᦬ߦ⊒ⴕߒߚޟ㕟ᣂ⊛ක⮎ຠ࡮ක≮ᯏེഃ಴ߩߚ߼ߩ5ࡨᐕᚢ⇛ޠ¹ࠍฃߌߡޔPMDA ߪᣂක⮎ຠߩክᩏᦼ㑆ࠍᲑ㓏⊛ߦ⍴❗ߒޔ2011ᐕᐲߦߪ2004ᐕ4᦬એ㒠ߦ↳⺧ߐࠇߚຠ⋡ߩክᩏᦼ㑆 ߩਛᄩ୯ࠍㅢᏱክᩏຠ⋡ߢ12ࡨ᦬ޔఝవክᩏຠ⋡ߢ9ࡨ᦬ߣߔࠆ⋡ᮡࠍឝߍߡ޿ࠆ^3,12ޕ߹ߚޔክᩏᦼ 㑆ࠍⴕ᡽ߣ↳⺧⠪ߩᜬߜᤨ㑆ߦಽߌޔᐕᐲߏߣߦ⋡ᮡ୯ࠍ⸳ቯߒߡ޿ࠆ㧔⴫ 47㧕ޕߐࠄߦޔਛᦼ⋡ᮡߣ ߒߡޔᣂක⮎ຠో૕߅ࠃ߮ㅢᏱክᩏຠ⋡ߢߪ2004㨪2007ᐕᐲߦ70%ߩຠ⋡ޔ2008ᐕᐲߦ80%ߩຠ⋡ߢ ⴕ᡽஥ߩᜬߜᤨ㑆ࠍ12ࡨ᦬એౝߣߒޔఝవክᩏຠ⋡ߢߪ2008ᐕᐲߦ50%ߩຠ⋡ߢ6ࡨ᦬એౝߣߔࠆߎ ߣࠍ⋡ᜰߒߡ޿ࠆޕ

⴫ 47 PMDAߩክᩏᦼ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

ᵈ㧦⴫ 16 ࠍౣឝ

⴫ 48ߦ2008ᐕᐲߩᬺോႎ๔³߅ࠃ߮ᧄ⎇ⓥ⚿ᨐࠍਗߴߡ␜ߒߚޕฦࠞ࡜ࡓฝ஥ߩޟ%ޠߪޔⴕ᡽ߩ ᜬߜᤨ㑆߇ᣂක⮎ຠో૕߅ࠃ߮ㅢᏱክᩏຠ⋡ߢߪ12ࡨ᦬એౝޔఝవክᩏຠ⋡ߢߪ6ࡨ᦬એౝߢ޽ߞߚ

ഀวࠍ␜ߒߡ߅ࠅޔ㕍ሼߪ⋡ᮡ㆐ᚑޔ⿒ሼߪ⋡ᮡᧂ㆐ᚑࠍ⴫ߒߡ޿ࠆޕ߹ߚޔ✚ክᩏᦼ㑆߅ࠃ߮ⴕ᡽ߣ

↳⺧⠪ߩᜬߜᤨ㑆ߩਛᄩ୯ࠍ⴫ 49ߦ␜ߒߚޕᐕᐲߣᥲᐕޔࠨࡦࡊ࡞ᢙߩ㆑޿ߪ޽ࠆ߽ߩߩޔ2004ᐕ4

᦬એ㒠ߦPMDAߦ↳⺧ߐࠇߚຠ⋡ޔߔߴߡߩᛚ⹺ຠ⋡ࠍ໧ࠊߕޔ✚ክᩏᦼ㑆߅ࠃ߮ᜬߜᤨ㑆ߩ⚻ᤨ⊛ផ

⒖ߪޔਔ⠪ߢ᭎ߨ৻⥌ߒߡ޿ߚޕ

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