【中英文对照版】药品上市许可持有人落实药品质量安全主体责任监督管理规定

药品上市许可持有人落实药品质量安全主体责任监督管理规定ProvisionsontheSupervisionandAdministrationoftheFulfillmentofMedicinalProductQualityandSafetyResponsibilitiesbyHoldersofMarketingAuthorizationforMedicinalProducts制定机关国家药品监督管理局已变更发文字号国家药品监督管理局公告2022年第126号公布日期

2022.

12.29施行日期

2023.

03.01效力位阶部门规范性文件法规类别卫生综合规定IssuingAuthority StateDrugSupervisionAdministrationBureaureplacedDocumentNumberAnnouncementNo.126

[2022]oftheNationalMedicalProductsAdministrationDateIssued12-29-2022EffectiveDate03-01-2023LevelofAuthority:DepartmentalRegulatoryDocumentsAreaofLaw:GeneralProvisionsonHealthandSanitationAnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheProvisionsontheSupervisionandAdministrationoftheFulfillmentofMedicinalProductQualityandSafetyResponsibilitiesbyHoldersofMarketingAuthorizationforMedicinalProductsAnnouncementNo.126

[2022]oftheNationalMedicalProductsAdministrationForthepurposesoffulfillingthequalityresponsibilitiesofholdersofmarketingauthorizationformedicinalproductsinaccordancewiththeMedicinalProductAdministrationLawofthePeoplesRepublicofChinaandotherlawsandregulationstheNationalMedicalProductsAdministrationhasdevelopedtheProvisionsontheSupervisionandAdministrationoftheFulfillmentofMedicinalProductQualityandSafetyResponsibilitiesbyHoldersofMarketingrawmaterialsinactiveingredientsandpackagingmaterialsandcontainersimmediatelyincontactwithmedicinalproductsamongotherstoensurethatrawmaterialsinactiveingredientsandpackagingmaterialsandcontainersimmediatelyincontactwithmedicinalproductsamongotherssatisfytherequirementsformedicinaluseandcomplywiththequalitymanagementnormsdevelopedbythemedicinalproductregulatorydepartmentoftheStateCouncilandrelevantrequirementsofcorrespondingassociatedevaluationandapprovalamongothersandtherequirementsoflawsandregulations.Article14HoldersshallinaccordancewithrelevantprovisionsonmedicinalproductregulationandtherequirementsoftheGMPformedicinalproductsamongothersestablishthesystemsofpostmarketingchangecontrolofmedicinalproductsanddevelopandimplementtheinternalchangeclassificationprincipleslistsofchangesworkingproceduresandriskmanagementrequirements;andshallinlightofproductcharacteristicsdeterminethemanagementcategoriesofchangesaftersufficientresearchassessmentandnecessaryverificationandimplementandspecifytheminannualreportsafterapprovalandrecordation.Incaseofauthorizedmanufacturerelevantresearchassessmentandnecessaryverificationshallbeconductedjointlywiththeauthorizedmanufacturers.Article15Medicinalproductmanufacturersshallestablishrulesandproceduresforthereleaseofexfactorymedicinalproductsspecifythestandardsandconditionsforex-factoryreleaseexaminetheresultsofmedicinalproductqualityinspectionkeyproductionrecordsanddeviationcontrolandconductqualityinspectiononmedicinalproducts.Theex-factoryproductsthatmeettherelevantstandardsandconditionsmaybereleasedonlyuponsignatureofqualifiedpersons.Holdersshallperformtheresponsibilitiesforthereleaseofmedicinalproductstobeplacedonthemarketdeveloptherulesandproceduresforthereleaseofmedicinalproductstobeplacedonthemarketexaminetherulesandproceduresforthereleaseofex-factorymedicinalproductsdevelopedbytheauthorizedmanufacturersclarifythestandardsforthereleaseofmedicinalproductstobeplacedonthemarketandexaminetheresultsoftestingofanddocumentsonthereleaseofexfactorymedicinalproductsreleasedbymedicinalproductmanufacturersandmayreleasethosemeetingrelevantprovisionsonlyuponsignatureofqualifiedpersons.Whennecessaryholdersmayexaminetheproductionrecordsinspectionrecordsanddeviationinvestigationamongothersofmedicinalproductsoftheauthorizedparties.Article16Incaseofauthorizedmanufactureofmedicinalproductsaholdershallassessthequalityassuranceandriskmanagementcapabilitiesoftheauthorizedpartyandenterintoaqualityagreementandanagreementontheauthorizedmanufactureasrequired;shallperformtheobligationssuchasassessmentandapprovalofmaterialsupplierschangemanagementverificationreleaseofmedicinalproductstobeplacedonthemarketandannualreporting;andshallsupervisetheperformanceofobligationsundertheagreementsconductregulatoron-siteexaminationofthequalitymanagementsystemoftheauthorizedpartyandensuretheeffectiveconnectionbetweenqualitymanagementsystemsofbothpartiesandthecontinuouscomplianceofthemanufactureprocesswiththestatutoryrequirements.Aholdershallnottransferthroughthequalityagreementtheobligationsandresponsibilitieswhichshouldbeperformedbytheholderinaccordancewiththelaw.ManufacturersofthemedicinalproductsmanufactureduponauthorizationshallstrictlyimplementqualityagreementsorganizethemanufactureofthemedicinalproductsmanufactureduponauthorizationinaccordancewiththeGMPformedicinalproductsactivelysupportandaccepttheexaminationbyholdersandtakecorrectiveandpreventivemeasuresagainstallthedefectsfoundintheexaminationtoimplementrectifications.Article17HoldersshallensurethatthestorageandtransportationofmedicinalproductsmeettherequirementsoftheGSPformedicinalproductsamongothers.WheremedicinalproductsarestoredtransportedorsolduponauthorizationholdersshallassessthequalityassuranceandriskmanagementcapabilitiesoftheauthorizedpartiesenterintoauthorizationagreementsandqualityagreementswiththeauthorizedpartiesinaccordancewithrelevantprovisionsandexamineonaregularbasisthestorageandtransportationmanagementoftheauthorizedpartiestoensurethecomplianceofthestorageandtransportationprocesswiththeGSPformedicinalproductsandtherequirementsformedicinalproductstorgeconditions.TheenterprisesauthorizedtostoreandtransportmedicinalproductsshallconductstorageandtransportationactivitiesinaccordancewiththerequirementsoftheGSPformedicinalproductsfulfilltheirobligationsundertheagreementsandassumethecorrespondinglegalliabilities.Article18Holdersshallestablishandimplementtheirmedicinalproducttraceabilityrulesinaccordancewiththelawestablishbythemselvesorauthorizethirdpartiestoestablishinformationtechnology-baseddrugtraceabilitysystemsasrequiredassignmedicinalproducttraceabilitymarkstothesalespackagingunitsatalllevelsofmedicinalproductsprovidetraceabilityinformationtodownstreamdistributorsandusingentitiesofmedicinalproductsrecordandpreservethemedicinalproductinformationinthewholeprocessinatimelyandaccuratemannerandrealizethetraceabilityofmedicinalproductsandprovidetraceabilitydatatomedicinalproductregulatorydepartmentsasrequired.Article19Holdersshallestablishandimprovetheirmedicinalproductrecallrulesinaccordancewiththerelevantprovisionsonmedicinalproductrecall.Whereanyqualityproblemorotherhiddensafetyriskwithamedicinalproductisfoundtherecallshallbeinitiatedinaccordancewiththerelevantprovisionsandtherelevantenterpriseorusingentityshallbenotifiedinatimelymannerandtheinvestigationandassessmentreporttherecallplanandtherecallnoticeshallbesubmittedtothelocalprovincialmedicinalproductregulatorydepartmentforrecordation.IfthemedicinalproductrecalledneedstobedestroyeditshallbedestroyedinUponcompletionoftherecallthemedicinalproductrecallanddispositioninformationshallbereportedtothelocalprovincialmedicinalproductregulatorydepartmentandhealthdepartmentinatimelymannerinaccordancewithrelevantprovisions.Article20HoldersshallestablishpharmacovigilancesystemsestablishspecialpharmacovigilancedepartmentsconductpharmacovigilanceworkinaccordancewiththerequirementsoftheGVPformedicinalproductsamongothersandmonitoridentifyassessandcontroladversereactionstomedicinalproductsandotherharmfulreactionsassociatedwiththeuseofmedicinalproductssoastominimizemedicinalproductsafetyrisks.Article21Holdersshalldeveloppost-marketingriskmanagementplanstaketheinitiativetoconductpost-marketingstudiesandbasedonthepostmarketingstudiesonthesafetyefficacyandqualitycontrollabilityofmedicinalproductsamongothersconductpost-marketingevaluationonaregularbasistocomprehensivelyanalyzeandassessthebenefitsandrisksofmedicinalproducts.Accordingtotheevaluationresultsqualityimprovementorriskpreventionandcontrolmeasuressuchasrevisingpackageleafletsimprovingqualitystandardsimprovingprocessprescriptionssuspendingmanufactureorsalesrecallingmedicinalproductsapplyingforcancellationofmedicinalproductapprovalcertificationdocumentsshallbetakeninaccordancewiththelaw.Withrespecttoamedicinalproductconditionallyapprovedholdersshalltakecorrespondingriskmanagementmeasuresandcompleterelevantstudiesasrequiredwithintheprescribedtimelimits.Article22Holdersshalldevelopdispositionplansformedicinalproductsafetyeventsandorganizetrainingsandemergencyresponsedrillsonaregularbasis.Incaseofanymajorsafetyincidentrelatedtothequalityofmedicinalproductstheholdershallimmediatelytakeeffectivemeasurestodisposeoftherelevantmedicinalproductsandtheirrawmaterialsandinactiveingredientsandpackagingmaterialsandcontainersimmediatelyincontactwithmedicinalproductsandrelevantproductionlinesamongotherstopreventanyaggravationofharm.Article23Aholdershallestablishthereportingrulesforcreasingthemanufactureofmedicinalproductsinshortage.Wherethemanufactureofanymedicinalproductsincludedinthenationallistofmedicinalproductsinshortagesubjecttoproductionsuspensionreportingisceasedtheholdershallreporttothelocalprovincialmedicinalproductregulatorydepartmentsixmonthsbeforetheimplementationoftheplannedproductionsuspensionandreporttolocalprovincialmedicinalproductregulatorydepartmentwithinthreedaysintheeventofunexpectedproductionsuspension.IfnecessaryitshallbereporttotheNationalMedicalProductsAdministration.Article24Holdersshallhavethecapabilitiesofpaymentofdamagesasrequiredbylawestablishrelevantmanagementproceduresandrulesforpaymentofdamagesandimplementthefirstreceivercompensationliabilitysystems.Thecapabilitiesofpaymentofdamagesshallbecommensuratewiththedegreeofrisksmarketscalecompensationstandardsforpersonalinjuriesandotherfactors.Holdersshallhavetherelevantcertificatesonthecapabilitiesofpaymentofdamagesorcorrespondingcommercialinsurancepurchasecontractsamongothers.ChapterIVQualityManagementMechanismsforHoldersArticle25QualitymanagementpersonnelshallsupervisetheimplementationoftherequirementsoftheGMPformedicinalproductsamongothersintheprocessofthemanufactureandinspectionofeachbatchofmedicinalproductsorganizetheinvestigationofdeviationsarisingandtakecontrolmeasuresagainstpotentialqualityrisksinatimelymanner;personsinchargeofqualityshallensurethecompletionofexaminationofproductionrecordsandinspectionrecordsbeforethereleaseofeachbatchofmedicinalproductsensuretheexaminationandapprovalofchangesrelatedtoqualityasrequiredandensurethatallmajordeviationsandinspectionresultsbeyondlimitshavebeeninvestigatedandhandledinatimelymanner.Article26Personsinchargeofqualityshallorganizeonaregularbasistheretrospectiveanalysisonproductionmanagementandqualitymanagementamongothersinconsiderationofproductrisksconductresearchandjudgmentonrepetitiverisksandemergingrisksatleastonceaquarterinprincipledevelopcorrectiveandpreventivemeasuresandcontinuouslyimprovequalitymanagementsystems.Personsinchargeofenterprisesshalllistentothequalitymanagementworkreportingbypersonsinchargeofqualityonaregularbasisfullylistentotheopinionsandsuggestionsofthepersonsinchargeofqualityonthepreventionandcontrolofmedicinalproductqualityrisksandprovidenecessaryconditionsandresourcesfortheimplementationofqualityriskpreventionandcontrol.Article27Holdersshallestablishtheannualreportingsystems.Personsinchargeofenterprisesshalldesignatespecializedbodiesorpersonneltoberesponsiblefortheannualreportingtoensurethattheinformationintheannualreportsonmedicinalproductsistrueaccuratecompleteandtraceableandcomplieswiththerequirementsoflawsregulationsandrelevantprovisions.Reportwritersshallsummarizetheinformationonthemanufactureandsalespost-marketingresearchandriskmanagementamongothersofmedicinalproductsinthepreviouscalendaryeartoformannualreportsbasedontheannualreporttemplatesdevelopedbytheNationalMedicalProductsAdministrationandsubmitthereportstothelocalprovincialmedicinalproductregulatorydepartmentuponapprovalbythelegalrepresentativesorpersonsinchargeoftheenterprisesorpersonsauthorizedtherebyinwriting.理部门报告Article28Holdersshallconductself-inspectionorinternalauditonaregularbasistomonitortheimplementationoftheGMPformedicinalproductstheGSPformedicinalproductsandtheGVPamongothers.Plansandrecordsshallbemadeforself-inspectionorinternalauditandself-inspectionreportsshallbeformedafterthecompletionoftheself-inspectionwiththecontentincludingatleastthebasicinformationontheself-inspectiontheconclusionoftheevaluationandthesuggestionsoncorrectiveandpreventivemeasures.Article29Holdersshallestablishtrainingmanagementrulesdeveloptrainingprogramsorplansandconductpre-employmenttrainingsandcontinuingtrainingsofallpersonnelengagingintheresearchanddevelopmentmanagementproductionmanagementqualitymanagementsalesmanagementandpharmacovigilanceofandpostmarketingstudiesonmedicinalproducts.Thecontentsoftrainingsshallincludeatleastrelevantregulationsandcorrespondingpostresponsibilitiesandskills.Holdersshallpreservetrainingrecordsandassesstheeffectivenessoftrainingsonaregularbasis.SupervisionandAdministrationArticle30Provincialmedicinalproductregulatorydepartmentsshallstrengthenthesupervisoryinspectionsofholderswithintheirrespectiveadministrativeregionsaccordingtotheirdutiesinaccordancewiththelawlistthefulfillmentofmedicinalproductqualityandsafetyresponsibilitiesbyholdersastheobjectofsupervisoryinspectionsandputemphasisontheinspectionoftheperformanceofdutiesbykeypersonnelandrelevantqualitymanagementpersonnelandtheoperationofqualitymanagementsystemsamongothers.Article31Provincialmedicinalproductregulatorydepartmentsshallaccordingtotheactualneedsofmedicinalproductregulationdeveloptheplansforthesampletestingofmedicinalproductqualityandspecifytheobjectivesandkeypointsofsampletesting;andmayorganizethesampletestingofthequalityofrawmaterialsrelevantinactiveingredientsandpackagingmaterialsandcontainersimmediatelyincontactwithmedicinalproducts.Article32Holdersshallsupportthesupervisoryinspectionsandsampletestingconductedbymedicinalproductregulatorydepartmentsandtheextendedinspectionsconductedbytherelevantpartiesandarenotallowedtorefuseorevadesupervisoryinspectionsinterferewithobstructorrefusesampletestingforgedestroyorconcealrelevantevidentiarymaterialsorusewithoutpermissionitemsplacedundersealorimpounded.AuthorizationforMedicinalProductswhichare实施herebyissuedandshallcomeintoforceonMarch

12023.特此公告Annex:ProvisionsontheSupervisionandAdministrationoftheFulfillmentofMedicinalProductQualityandSafetyResponsibilitiesbyHoldersofMarketingAuthorizationforMedicinalProducts附件《药品上市许可持有人落实药品质量安全主体责任监督管理规定》NationalMedicalProductsAdministration国家药监局December2920222022年12月29日Annex附件ProvisionsontheSupervisionandAdministrationoftheFulfillmentofMedicinalProductQualityandSafetyResponsibilitiesbyHoldersofMarketingAuthorizationforMedicinalProducts药品上市许可持有人落实药品质量安全主体责任监督管理规定ChapterIGeneralProvisions第一章总则Article1Forthepurposeoffulfillingthequalityandsafetyresponsibilitiesofholdersofmarketingauthorizationformedicinalproductshereinafterreferredtoas“holders，theseProvisionsaredevelopedinaccordancewiththeMedicinalProductAdministrationLawofthePeoplesRepublicofChinatheVaccineAdministrationLawofthe第一条为落实药品上市许可持有人（以下简称持有人）的质量安全主体责任，根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《药品注Whereanyincompliancewiththeprovisionsisfounduponasupervisoryinspectionorsampletestingthemedicinalproductregulatorydepartmentshalltakemeasuressuchascreasingproductionsaleuseorimporttocontrolrisks;andwhoeverissuspectedofcommittinganyillegalconductoracrimeshallbelegallyinvestigatedandpunishedorbetransferredtothejudicialorganinatimelymanner.Article33Provincialmedicinalproductregulatorydepartmentsshallestablishcreditfilesonmedicinalproductsafetyforholdersmanufacturersofmedicinalproductswithintheirrespectiveadministrativeregionsinaccordancewiththelawandpublicizerelevantinformationinatimelymannerasrequiredstrengthentheanalysisandutilizationofcreditfiledataandconductriskresearchandjudgmentonaregularbasis.SupplementalProvisionsWheretherearespecialprovisionsonnarcoticdrugspsychotropicsubstancespoisonoussubstancesformedicaluseandpharmaceuticalprecursorchemicalsradiopharmaceuticalsvaccinesandotherbiologicalproductstraditionalChinesemedicinaldecoctionpiecesortraditionalChinesemedicineformulagranulesamongotherssuchprovisionsshallprevail.TheseProvisionsshallcomeintoforceon第三十五条本规定自March

12023.2023年3月1日起施行PeoplesRepublicofChinatheMeasuresfortheAdministrationofMedicinalProductRegistrationtheMeasuresfortheSupervisionandAdministrationofManufactureofMedicinalProductsandthegoodmanufacturingpractices“GMP”formedicinalproductsthegoodsupplypractices“GSP”formedicinalproductsandthegoodpharmacovigilancepracticesGVPamongothers.Article2TheseProvisionsshallapplytoholderslegalfulfillmentofmedicinalproductqualityandsafetyresponsibilitiesandthesupervisionandadministrationthereofwithintheterritoryofthePeoplesRepublicofChina.Article3HoldersshallcomplywiththeMedicinalProductAdministrationLawofthePeoplesRepublicofChinaandotherrelevantlawsandregulationsandestablishandimprovethequalitymanagementsystemsformedicinalproductsaccordingtotherequirementsofthegoodlaboratorypracticefornonclinicallaboratorystudiesformedicinalproductsthegoodclinicalpracticeformedicinalproductstheGMPformedicinalproductstheGSPformedicinalproductsandtheGVPamongothersestablishandimprovemedicinalproductqualitymanagementsystemsandberesponsibleforthesafetyefficacyandqualitycontrollabilityofmedicinalproductsinthewholeprocessofresearchdevelopmentmanufacturedistributionanduseofmedicinalproductsinaccordancewiththelaw.ChapterIIDutiesandRequirementsofKeyPositionsofHoldersArticle4Holdersshallestablishmanagementdepartmentswithclearresponsibilitiesbestaffedwithmanagementpersonnelcommensuratewiththescalesofthemanufactureanddistributionofmedicinalproductsclarifythedutiesofnonclinicallaboratorystudiesclinicaltrialsproductionandsalepost-marketingstudiesandsurveillanceandreportingofadversereactionsamongothersandmeettherequirementsofrelevantqualitymanagementnorms.Holdersshallindependentlyestablishqualitymanagementdepartmentsperformthewhole-processqualitymanagementdutiesparticipateinallactivitiesrelatedtoqualityandberesponsibleforexaminingalldocumentsrelatedtoqualitymanagement.Article5Thepersonsinchargeprimarypersonsinchargeofenterprisespersonsinchargeofproductionmanagementhereinafterreferredtoas“personsinchargeofproduction，personsinchargeofqualitymanagementhereinafterreferredtoas“personsinchargeofqualityqualifiedpersonsandotherpersonnelatkeypositionsofholdersincludingmanufacturersofmedicinalproductsshallbefull-timepersonneloftheenterprisesandmeettherelevantrequirementsoftherelevantqualitymanagementnorms.Insuchanenterprisethepersoninchargeofqualitymanagementandthepersoninchargeofproductionmanagementshallnotbethesameperson.Withrespecttothemanufactureandqualitymanagementofspecificvarietiesofmedicinalproductsholdersshallspecifythedirectlyresponsibleexecutivesinchargeandotherliablepersons.Article6Thelegalrepresentativesandpersonsinchargeprimarypersonsinchargeofenterprisesshallbefullyresponsibleforthequalityofmedicinalproducts.Personsinchargeofenterprisesshallbefullyresponsiblefortheroutineadministrationofenterprisesandfulfillthewhole-processqualitymanagementresponsibilities;beresponsibleforemployingspecialpersonsinchargeofqualityandprovidingnecessaryconditionsandresourcestoensurequalitymanagementdepartmentsindependentperformanceofduties;beresponsibleforappointingspecialqualifiedpersonstoensuretheindependentperformanceoftheresponsibilitiesofreleasingmedicinalproductstobeplacedonthemarket;beresponsiblefordisposingofmajorsafetyincidentsrelatedtomedicinalproductqualitytoensurethatrisksarecontrolledinatimelymanner;beresponsiblefortheestablishmentoftrainingandassessmentrulesforproductionmanagementandqualitymanagement;andberesponsibleforemployingorappointingpersonsinchargeofpharmacovigilance.Personsinchargeofenterprisesshallhaveworkexperienceinthefieldsrelatedtopharmaceuticalsandbefamiliarwiththerelevantlawsregulationsandrulesonthesupervisionandadministrationofmedicinalproducts.Article7Personsinchargeofproductionshallbemainlyresponsibleforthemanagementofmanufactureofmedicinalproductstoensuretheorganizationofmanufactureandstorageofmedicinalproductsaccordingtotheapprovedtechnologicalprocesses;ensurethatfactorypremisesfacilitiesandequipmentareingoodoperatingconditionsandcompletenecessaryvalidationworktoensurethequalityofmedicinalproductsmanufactured;andensuretheeffectiveoperationofproductionmanagementtrainingrulesandconductthetrainingsandassessmentsofallpersonnelinmedicinalproductmanufacturemanagement.Personsinchargeofproductionshallhavepharmacyorrelevantprofessionalbackgroundshavediplomasatorabovetheundergraduatelevelintermediateprofessionalortechnicaltitlesoraboveorthequalificationsoflicensedpharmacistshavethreeyearsormoreofpracticalexperienceinmedicinalproductmanufactureandqualitymanagementincludingatleastoneyearofexperienceinmedicinalproductmanufacturemanagementandbefamiliarwithrelevantlawsregulationsandrulesonmedicinalproductmanufacturemanagement.Article8Personsinchargeofqualityshallberesponsibleformedicinalproductqualitymanagementestablishqualitycontrolandqualityassurancesystemssupervisetheimplementationofrelevantqualitymanagementnormsandensuretheeffectiveoperationofqualitymanagementsystems;ensurethatproductionprocesscontrolandmedicinalproductqualitycontrolcomplywiththerequirementsofrelevantregulationsandstandards;ensuretheauthenticityaccuracycompletenessandtraceabilityofdataandrecordsonmedicinalproductmanufactureandinspectionsamongothers;andensuretheeffectiveoperationofqualitymanagementtrainingrulesandconducttrainingandassessmentofallpersonnelinmedicinalproductqualitymanagement.Personsinchargeofqualityshallhavepharmacyorrelevantprofessionalbackgroundshavediplomasatorabovetheundergraduatelevelintermediateprofessionalortechnicaltitlesoraboveorthequalificationsoflicensedpharmacistshavefiveyearsormoreofpracticalexperienceinmedicinalproductmanufactureandqualitymanagementincludingatleastoneyearofexperienceinmedicinalproductqualitymanagementandbefamiliarwithrelevantlawsregulationsandrulesonmedicinalproductqualitymanagement.Article9Qualifiedpersonsshallindependentlyperformthedutiesofreleaseofmedicinalproductsandensurethatthemanufactureandinspectionofeachbatchofreleasedmedicinalproductsareinlinewithrelevantlawsandregulationsmedicinalproductregistrationmanagementrequirementsandqualitystandards.Productsshallnotbereleasedwithoutthesignatureofandapprovalbyqualifiedpersons.Qualifiedpersonsshallhavepharmacyorrelevantprofessionalbackgroundshavediplomasatorabovetheundergraduatelevelintermediateprofessionalortechnicaltitlesoraboveorthequalificationsoflicensedpharmacistshavefiveyearsormoreofpracticalexperienceinmedicinalproductmanufactureandqualitymanagementhavetheexperienceinengaginginmedicinalproductproductionprocesscontrolandqualityinspectionandbefamiliarwithrelevantlawsregulationsandrulesonmedicinalproductregulation.度Aholdermayappointmultiplequalifiedpersonsaccordingtothescaleoftheenterprisetocoverthedutiesofreleaseofalltheproductsoftheenterprise.Thedutiesofallqualifiedpersonsshallbeclearlydividedandmaynotbeoverlapped.Whenaqualifiedpersonisnotondutyforsomereasonuponapprovalbythelegalrepresentativeorpersoninchargeoftheenterprisehisorherdutiesmaybetemporarilytransferredtoanyotherqualifiedpersonorapersonwiththerelevantqualificationandthescopeofpoweranditemstransferredandtheperiodoftransfershallbespecifiedinwriting.Duringtheperiodoftransfertheoriginalqualifiedpersonshallstillassumethecorrespondingresponsibilities.Article10PersonsinchargeofpharmacovigilanceshallberesponsiblefortheestablishmentoperationandcontinuousimprovementofpharmacovigilancesystemstoensurethatthepharmacovigilancesystemscomplywithrelevantlawsandregulationsandtherequirementsoftheGVP.Apersoninchargeofpharmacovigilanceshallbeanexecutiveholdingacertainpositionhavethemedicalpharmacyepidemiologyoranyotherrelevantprofessionalbackgroundadiplomaatorabovetheundergraduateleveloranintermediateprofessionalortechnicaltitleoraboveandthreeyearsormoreofpharmacovigilance-relatedworkexperiencebefamiliarwithChina*srelevantlawsandregulationsandtechnicalguidingprinciplesonpharmacovigilanceandpossessknowledgeandskillsrelatedtopharmacovigilancemanagement.ChapterIIIQualityManagementRequirementsforHoldersArticle11HoldersshallestablishthequalitymanagementsystemscoveringthewholeprocessofmedicinalproductmanufactureandmanufacturemedicinalproductsaccordingtonationalmedicinalproductstandardsandthequalitystandardsandmanufacturingprocessesreviewedandapprovedbymedicinalproductregulatorydepartmentstoensurethecontinuingcomplianceofthewholeprocessofmanufactureofmedicinalproductionswiththerequirementsoftheGMPformedicinalproducts.Holdersshallestablishandimprovemedicinalproductqualitymanagementsystemscoveringthewholelifecycleofnonclinicallaboratorystudiesclinicaltrialsmanufactureanddistributionpost-marketingstudiesandsurveillanceandreportingofadversereactionsamongothers;andshallestablishthequalityobjectivesthatmeetmedicinalproductqualitymanagementrequirementsandcontinuouslyimprovequalitymanagementsystemstoensurethatallthemedicinalproductsmanufacturedareinlinewiththeintendedpurposesandregistrationrequirements.Holdersshallexaminethesuppliersof。