2014食藥署中文年報電子書

27 / 132

27
Food and Drug Administration
ୋ ௝z ᖹۜ၍ଣz 3
ྡ3-1cᖹۜ͛ն඄ಂ
ᖹۜၾɓছऊ൬ۜʔΝdҹᗫɛ͏Ԓ᜗਄ੰʿ͛նτΌd᙮׵৷၍ܓՓପุd̀
඲՟੻ʕ̯ሊ͛˴၍ዚᗫࣨ೯ʘᖹۜ஢̙ᗇʑঐɪ̹னਯd੽ᖹۜج ஝ࠈࡌၾ਷ყટ
ࠐeᄲݟ ᔊʷၾ၍ଣɓʩʷe๕᎘Ⴁிၾ၍ଣeݴ ஷၾۜሯ္಻eʔجᖹ ՟يᇕʿ၍
Փᖹۜ၍ଣdᎇࣛ౛છԨ੶ʷᖹۜτΌ္಻ዚՓdᆽڭ ͏଺͜ᖹτΌf
ܔͭҁ዆ᖹۜ͛ն඄ಂdܼ̍ɪ̹ۃ ʿɪ̹ ܝʘ၍ଣd଄ႊᖹۜɪ̹ۃ ਿᓾ޼
Ӻeڢᑗґ༊᜕eᑗґ༊᜕eᎴԄႡிචݬ ˸ʿɪ̹ܝ Դ͜eΫ㉿ʿܵᚃҷഛഃච
ݬf މᆽ ڭ ᖹۜۜሯʿᐕࣖd˸ɪ̹ݟۃ᜕೮াᄲݟஷ͜Ҧஔ˖΁eᖹۜᅵۜᏨ᜕e
΢ධᖹۜᎴԄ஝ᇍ€GXPഃᇆݟՓ ܓd˸ʿɪ̹ܝ ʘᖹۜۜሯτΌ္಻ԣᚐၣЪ
ุd˸༺Όࠦᖹۜ͛ն඄ಂࠅӋʘͦᅺ€ྡ3-1f
ୋɓືcᖹۜج஝ᅺ๟ʿପۜᄲ ݟ
ତر
਷ყج ஝࿁ɪ̹ܝ ᖹۜʘۜሯࠅ Ӌ஼ϋ౤৷dˈՉ݊ɪ̹ܝ ᜊһ೮াʘ၍ଣdʿ
ࠦ࿁อጳۨ࿒ᖹۜ௔ᚃɪ̹€Էνj୚ߤ eਿΪط ᐕପۜdϾ਷lz޴ᗫج ஝ᕍνd
ΪϤ͉໇ܵᚃᏨൖࡌ͍ʿ޼ࠈᖹ ي޴ᗫ၍ଣ஝ᇍd̤ਞϽ਷ყගᖹۜ၍ଣᒈැʿ০࿁
ࠬᎈ༰৷e؂͜࿁൥Ոतମ׌ʘᖹۜ၍ଣdࠈ ֛ᖹۜݟ ᜕೮া၍ଣՓܓ Ԩ௔ᚃᄣࡌ ᖹ
݁၍ଣج ஝˸ᆽڭ ᖹۜۜሯɓߧ ׌ၾϞࣖ׌f
CTD
GLP
GCP
GPvP
GMP
jCommon Technical Document ( ஷ͜Ҧஔ׌˖΁ )
jGood Laboratory Practice ( ᎴԄྼ᜕܃዁Ъ஝ᇍ )
jGood Clinical Practice ( ᖹۜᎴԄᑗґ༊᜕๟ ۆ )
jGood Pharmacovigilance Practice ( ᖹۜᎴԄτΌ္ൖ஝ᇍ )
jGood Manufacturing Practice ( ᎴԄᖹۜႡி஝ᇍ )
ᄲݟ
ᇆݟ
Ꮸ᜕
ਿᓾ޼Ӻ ڢᑗґ༊᜕ ᑗґ༊᜕ ͡ሗ஢̙ ͛ପႡி ɪ̹ݴஷ
CTD τΌeϞࣖeۜሯ
GLPeGCP GPvP
GMP
Ꮸ᜕ ʱؓ