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DrugAdministrationLawofthePeople'sRepublicofChina--------------------------------------------------------------------------------OrderofthePresidentofthePeople'sRepublicofChina(No.45)TheDrugAdministrationLawofthePeople’sRepublicofChina,revisedatthe20thMeetingoftheStandingCommitteeoftheNinthNationalPeople’sCongressonFebruary28,2001,isherebypromulgatedandshallgointoeffectasofDecember1,2001.JiangZeminPresidentofthePeople’sRepublicofChinaFebruary28,2001DRUGADMINISTRATIONLAWOFTHEPEOPLE’SREPUBLICOFCHINA(Adoptedatthe7thMeetingoftheStandingCommitteeoftheSixthNationalPeople'sCongressonSeptember20,1984,revisedatthe20thMeetingoftheStandingCommitteeoftheNinthNationalPeople'sCongressonFebruary28,2001)ChapterIGeneralProvisionsArticle1ThisLawisenactedtostrengthendrugadministration,toensuredrugqualityandsafetyforhumanbeings,toprotectthehealthofpeopleandtheirlegitimaterightsandinterestsintheuseofdrugs.Article2Allinstitutionsandindividualsengagedinresearch,production,distribution,use,ordrugadministrationinthePeople’sRepublicofChinashallabidebythisLaw.Article3TheStatedevelopsbothmodernandtraditionalmedicinestogivefullplaytotheirroleinpreventionandtreatmentofdiseasesandinmaintenanceofhealth.TheStateprotectstheresourcesofnaturalcrudedrugsandencouragesthecultivationofChinesecrudedrugs.Article4TheStateencouragesresearchanddevelopmentofnewdrugsandprotectsthelegitimaterightsandinterestsofcitizens,legalbodiesandotherinstitutionsengagedinthisfieldofendeavor.Article5ThedrugregulatorydepartmentundertheStateCouncilshallberesponsiblefordrugadministrationnationwide.TherelevantdepartmentsundertheStateCouncilshallberesponsiblefortherelatedadministrativeworkwithinthelimitsoftheirduties.Thedrugregulatorydepartmentsofthepeople’sgovernmentsofprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernmentshallberesponsiblefordrugregulationintheiradministrativeareas.Therelevantdepartmentsofthesaidpeople’sgovernmentsshallberesponsiblefortherelatedregulatoryworkwithinthelimitsoftheirduties.ThedrugregulatorydepartmentundertheStateCouncilshallcooperatewiththecompetentdepartmentsforcomprehensiveeconomicadministrationundertheStateCouncilinimplementingpharmaceuticaldevelopmentprogramsandpoliciesformulatedbytheStateforthepharmaceuticalindustry.Article6Thedrugtestinginstitutesestablishedordesignatedbydrugregulatorydepartmentsshallundertaketheresponsibilityfordrugtestingrequiredforconductingdrugreviewandapprovalandcontrollingdrugqualityinaccordancewithlaw.ChapterIIControloverDrugManufacturersArticle7Theestablishmentofadrugmanufacturershallbesubjecttoapprovalbythelocaldrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentandbegrantedtheDrugManufacturingCertificate,and,withthecertificate,themanufacturershallberegisteredwiththeadministrativedepartmentforindustryandcommerce.Noonemaymanufacturerdrugswithoutthecertificate.ThevalidtermandthescopeofmanufacturingshallbeindicatedintheDrugManufacturingCertificate.Forrenewalofthecertificateonexpiration,reexaminationisrequired.Whengivingapprovaltotheestablishmentofanewmanufacturer,thedrugregulatorydepartmentshallseetoitthat,apartfromtherequirementsspecifiedbytheprovisionsinArticle8ofthisLawthatshouldbemet,thepharmaceuticaldevelopmentprogramsandpoliciesformulatedbytheStateforthepharmaceuticalindustryareconformedtoandpreventduplicateconstruction.Article8Adrugmanufacturertobeestablishedshallmeetthefollowingrequirements:(1)havinglegallyqualifiedpharmaceuticalandengineeringprofessionals,andthenecessarytechnicalworkers;(2)havingthepremises,facilities,andhygienicenvironmentrequiredfordrugmanufacturing;(3)havingtheinstitutionsandpersonnelcapableofqualitycontrolandtestingfordrugstobeproducedandthenecessaryinstrumentsandequipment;and(4)havingrulesandregulationstoensurethequalityofdrugs.Article9DrugmanufacturersshallconductproductionaccordingtotheGoodManufacturingPracticeforPharmaceuticalProducts(GMP)formulatedbythedrugregulatorydepartmentundertheStateCouncilonthebasisofthisLaw.ThedrugregulatorydepartmentshallinspectadrugmanufacturerastoitscompliancewiththeGMPrequirementsandissueacertificatetothemanufacturerpassingtheinspection.ThespecificmeasuresandscheduleforimplementingtheGMPshallbeformulatedbythedrugregulatorydepartmentundertheStateCouncil.Article10WiththeexceptionoftheprocessingofpreparedslicesofChinesecrudedrugs,adrugshallbeproducedinconformitywiththeNationalDrugStandardandwiththeproductionprocessesapprovedbythedrugregulatorydepartmentundertheStateCouncil,andtheproductionrecordsshallbecompleteandaccurate.Whendrugmanufacturersmakeanychangeintheproductionprocessthatmayaffectthedrugquality,theyshallsubmitthematterforexaminationandapprovaltotheoriginalapprovalauthority.PreparedslicesofChinesecrudedrugsshallbeprocessedinconformitywiththenationaldrugstandards.Thosenotcoveredbythenationaldrugstandardsshallbeproducedaccordingtotheprocessingproceduresformulatedbythedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregions,ormuni