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:(GMP)20GMP,,,,,GMP,,,20,,,GMP()(100061):,,(WHO)(US2FDA)(EU)(JAP)(ICH)/(PIC/S)GMP,GMP,GMP,GMPGMP,GMP,,;,,:GMP;;;:R95:A:100227777(2008)1020843203ContrastResearchReportofDomesticandForeignDrugGMP(1)StateFoodAndDrugAdministrationCenterForCertificationOfDrug(Beijing100061)ABSTRACTAccordingtodeploymentofSFDA,StateFoodAndDrugAdministrationCenterforCertificationofDrugandtherelevantunitsandexperts,translatedthedrugGMPregulationsandrelatedinformationofWHO,FDA,EU,Japan,ICH,drugsinspectiontreaty/PlanningOrganization(PIC/S)andothercountriesandorganizations.BythebackgroundofChinesedrugGMP,wecomparedonthemanagementsystemandthespecificcontentofGMP.KEYWORDSdrugGMP;international;domestic;contrastresearch1GMPGMP,,,1963GMP1969(WHO)GMP,GMP1985207201,[1]1988203217GMP;1993234820082210GMP(1992),GMP19944,199411,,,GMP1995207211,,1995210201()GMP1998208219,(SDA),GMP1999201201,GMP,GMP1999206218,GMP(1998),1999208201[2]1999204221,GMP,20021220059GMP[324]GMP,GMP,GMP,GMP199812,GMP;200012,GMP;200212,GMP2004206230,GMP,GMP20042072012004210226,:200620120120072012012008201201GMP200512,44007200GMPGMP:(1)GMP2001212201,[5];2002209215,[6]GMP,GMP,GMP,GMP,GMPGMP()225,33;GMP(2)GMPGMPGMP,GMP19992005,18GMP,1600,,,4469GMPGMP,GMP(WHO)(FDA)(EU),GMPGMP(3)GMPGMPGMP,,GMP44820082210,GMP(4),GMP,,,GMP,,,,,,GMP,GMP,,,GMP,,GMP,,,GMP,,,,():[1][S]1,19841[2][S]19,19981[3]1[Z]1[2002]442,20021[4]1[Z]1[2005]437,20051[5][S]145,20011[6][S]1360,20021[2008]518():,:,:()(199670),12;()(1997280);()(2001130);()(2001478);()()(2002259);()()(2003119)(16),:X(CT)(PET)(SPECT)X60,54820082210