Regulations-for-Implementation-of-the-Drug-Adminis

RegulationsforImplementationoftheDrugAdministrationLawofthePeople'sRepublicofChinaDecreeoftheStateCouncilofthePeople’sRepublicofChinaNo.360TheRegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChinaareherebypromulgatedandshallgointoeffectasofSeptember15,2002.Premier:ZhuRongjiAugust4,2002RegulationsforImplementationoftheDrugAdministrationLawofthePeople’sRepublicofChinaChapterIGeneralProvisionsArticle1TheRegulationsareformulatedinaccordancewiththeDrugAdministrationLawofthePeople’sRepublicofChina(hereinafterreferredtoastheDrugAdministrationlaw).Article2ThedrugregulatorydepartmentundertheStateCouncilshallestablishanationaldrugtestinginstitute.Thedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentmayestablishdrugtestinginstituteswithinitsrespectiveadministrativearea.Theplanfortheestablishmentoflocaldrugtestinginstitutesshallbeproposedbythedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionandmunicipalitydirectlyundertheCentralGovernmentandsubmittedtothepeople’sgovernmentoftheprovince,autonomousregionandmunicipalitydirectlyundertheCentralGovernmentforapproval.ThedrugregulatorydepartmentundertheStateCouncilandthedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentmay,whennecessary,designateanytestinginstitutefulfillingtherequirementsfordrugtestingtoundertakedrugtesting.ChapterIIControloverDrugManufacturersArticle3ADrugManufacturingCertificateshallbeacquiredforestablishmentofadrugmanufactureraccordingtothefollowingprocedures:(1)Theapplicantshallsubmitanapplicationtothedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,wherethemanufacturingsiteistobelocated.Thedrugregulatorydepartmentofthepeople’sgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentshall,within30workingdaysfromthedateitreceivestheapplication,makeareviewaccordingtothepharmaceuticalindustrydevelopmentprogramsandpoliciesissuedbytheStateandmakeadecisiononapprovalordisapproval.(2)Aftercompletionofestablishmentoftheplannedmanufacturer,theapplicantshallapplytotheoriginalapprovingdepartmentforacceptanceinspection.Theoriginalapprovingdepartmentshall,within30workingdaysfromthedateitreceivestheapplication,arrangeanacceptanceinspectionaccordingtotherequirementsfortheestablishmentofsuchmanufacturerssetforthinArticle8oftheDrugAdministrationLaw;aDrugManufacturingCertificateshallbeissuedtotheapplicantiftheinspectionispassed.Theapplicantshall,byholdingtheDrugManufacturingCertificate,registerwiththeadministrativedepartmentforindustryandcommerceinaccordancewithlaw.Article4AnydrugmanufacturerthatintendstoaltertheapproveditemsintheDrugManufacturingCertificateshall,30dayspriortoalterationofanyapproveditems,applytotheoriginalcertificate-issuingauthorityforregistrationofalteration;noapproveditemsmaybealteredwithoutapproval.Theoriginalcertificate-issuingauthorityshallmakeadecisionwithin15workingdaysfromthedateitreceivestheapplication.Theapplicationshall,byholdingtheDrugManufacturingCertificatewithaltereditems,registerthealterationwiththeadministrativedepartmentforindustryandcommerceinaccordancewithlaw.Article5Thedrugregulatorydepartmentofthepeople’sgovernmentatorabovetheprovinciallevelshallorganizeinspectionsofdrugmanufacturersinaccordancewiththeGoodManufacturingPracticeforPharmaceuticalProducts(GMP)andthemeasuresandscheduleforimplementingtheGMPformulatedbythedrugregulatorydepartmentundertheStateCouncil,andissueacertificatetothemanufacturerthatcomplieswiththeGMP.ForthemanufacturerproducinginjectionsorradioactivepharmaceuticalsandforthatproducingbiologicalproductsspecifiedbythedrugregulatorydepartmentundertheStateCouncil,theinspectionofwhichshallbeconductedbythedrugregulatorydepartmentundertheStateCouncil.TheformatofGMPcertificateshallbeuniformlyprovidedforbythedrugregulatorydepartmentundertheStateCouncil.Article6Anynewly-establisheddrugmanufacturerormanufacturerwithnewly–builtdrugmanufacturingworkshopsornewly-addeddosageformsforproductionshall,within30daysfromthedateitobtainstheapprovaldocumentsformanufacturingdrugorfromthedateitsformalproductionisapproved,applytothedrugregulatorydepartmentforGMPcertificationasrequired.Thedrugregulatorydepartmentacceptingtheapplicationshall,withinsixmonthsfromthedateitreceivestheapplication,organizeinspectionsastothecompliancewiththeGMPrequirementsbytheapplyingmanufacturer.Acertificateshallbeissuedtothemanufactureriftheinspectionispassed.Article7ThedrugregulatorydepartmentundertheStateCouncilshallsetupadatabaseofGMPinspectors.AGMPinspectorshallbequalifiedasrequiredbythedrugregulatorydepartmentundertheStateCouncil.AGMPinspectionshallbeconductedbyateamofinspectorsrandomlyselectedfromthedatabaseofGMPinspectorsaccordingtotheprovisionsofthedrugregulatorydepartmentundertheStateCouncil.Article8ThevalidtermofaDrugManufacturingCertificateisfiveyears.