Page 62 - 2019食藥署年報(中文版)

ϓ؈ࣖू؈ࣖू
ϓ

ீཀԘ஺ਗࡰၾྠඟΥЪd͉໇ʿࣛ˲ϓ̌ᆽႩۜሯʔୌΥ஝ᇍʘᖹۜj

ɓe׵Ӎվᗳᖹۜԫ΁ʕd͉໇΋׵਷ყ೯ତՉ˼Valsartanࡡࣘᖹ͵ўϞ

NDMAdԨਗ਼ܔᙄᏨ᜕˙جʮක׵֜˙ၣ१ʿᆄݲᖹۜۜሯၾሊ͛ڭ਄҅

€European Directorate for the Quality of Medicines, EDQMʘ֜˙ᖹ

ۜ၍Փྼ᜕܃€OMCLsၣഖ̻ၽd͵ਗ਼Ꮸ᜕ഐ؈ʱйʱԮЇEDQMʿᒵ

਷࠮ۜᖹۜτΌ௅€Ministry of Food and Drug Safety, MFDSd΍Νމ

ΌଢᖹۜτΌҪᗫf͉໇ԨࠅӋႡኒᅀ࿁׵Ӎվᗳᖹۜʘࡡࣘᖹ඲஼ҭᏨ
᜕d͊Ꮸ̈NDMAʿNDEA֐੻ԶႡிԴ͜dԨॶɝGMPᇆݟࠠᓃd˸ᆽ

ڭุ٫ໝྼੂБd࢝ତၪᚐ਷ɛ͜ᖹτΌӔːf

ɚeீཀ˴ਗ̋੶ࠬᎈછ၍ዚՓd͉໇˴ਗݟᐏ2ҭݴชޥߴପ̮ۜᝈʔୌΥʕ

ശᖹՊၾႡிᅀϓۜᏨ᜕஝ࣸdʔʚ܆ᇙ׳Бdϓ̌ڜ˟518,405ኒପۜݴ

ɝҢ਷dڭღ਷ɛޥߴટ၇τΌf͉໇͵˴ਗਗ਼ମ੬ৃࢹஷٝ਷̮޴ᗫఊ
Зਖ਼࢕dԨஷజЇᆄຑ֜˙ᖹۜ၍Փྼ᜕܃€Official Medicines Control

Laboratories, OMCLs˸ʿᆄݲᐼ᜗֜˙ᖹۜ၍Փྼ᜕܃ၣഖ€General

(XURSHDQ 2I¿FLDO 0HGLFLQHV &RQWURO /DERUDWRU\ 1HWZRUN *(21d˸

лᔷٝ΢਷ሊ͛˴၍ዚᗫdጐ฽࢝ତҢ਷࿁਷ყ̹ఙᖹۜτΌʘࠠൖd΍Ν

މޥߴʘۜሯҪᗫf̤މᒒеᗳЧઋҖ೯͛d͉໇ʊਗ਼͛يᖹۜޥߴ̮ᝈᏨ

ݟॶɝᏨ᜕܆ᇙЪุʘפᅵݴ೻dԨխᝫႡிุ٫Ꮠ̋੶І˴၍ଣd΍Νၪ

ᚐ͏଺͜ᖹτΌf

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