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ProvisionsofDrugRegistration

（ThemeasureofDrugRegistrationisapprovedbyStateAdministrationforMarketRegulationinOrderNo.27onJanuary22，）

Chapter1：GeneralPrinciples

Article1：Forthepurposesofstandardizingdrugregulationbehaviorsandensuringthesafety，effectivenessandqualitycontrolofthedrugs,theprovisionsisenactedaccordingto《TheDrugAdministrationLawofPeople’sRepublicofChina》（hereinaftercalled“TheDrugAdministration”），《Lawofthepeople’sRepublicofChinaonTraditionalChineseMedicine》，《VaccineAdministrationLawofthePeople’sRepublicofChina》（hereinaftercalled“VaccineAdministrationLaw”），《LawofthePeople’sRepublicofChinaonAdministrativePermission》，《RegulationsforImplementationoftheDrugAdministration》andotherlawsandadministrativeregulations.

Article2:Theprovisionsisapplicabletotheactivitiesofdrugresearch，registrationandsupervisionandadministrationforthepurposesoflaunchingthedrugwithintheterritoryofthePeople’sRepublicofChina.

Article3:DrugRegistrationreferstotheapplicantsofDrugRegistration（hereinaftercalled“Applicant”）submittingthefilesofdrugclinicaltrials，drugmarketingauthorization，re-registrationandsupplementaryapplicationsaccordingtothelegalproceduresandrelatedrequirements.Theadministrationdecideswhethertoapprovesuchtheapplicationaccordingtoreviewthesafety,effectivenessandqualitycontrolbasedonlawsandregulationsandexistingscientificcognition.

TheapplicantisMarketingAuthorizationHolder（hereinaftercalled“MAH”）afterachievingthemarketeddruglicense.

Article4：DrugregistrationisdividedintoTraditionalChineseMedicine，ChemicalMedicineandBiologicalproductsforclassifiedmanagement

TraditionalChinesemedicineregistrationisclassifiedaccordingtoinnovativetraditionalChinesemedicine,ModifiedtraditionalChineseMedicine,