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1、ChapterIIIDrugClinicalTrialsArticle30 Anydrugclinicaltrial,includingbioequivalencestudy,shallbeapprovedbytheStateFoodandDrugAdministration,andshallbeincompliancewiththeGoodClinicalPractice.Drugregulatorydepartmentshallsuperviseandinspecttheapprovedclinicaltrials.Article31 Clinicaltrialsshallbec
2、onductedfornewdrugregistrationapplications.Asforgenericdrugregistrationapplicationsandsupplementaryapplications,clinicaltrialsshallbeconductedinaccordancewiththerequirementsintheAnnexoftheProvisions.AclinicaltrialconsistsofphasesI,II,IIIandIV.PhaseIClinicalTrial:initialclinicalpharmacologyandsa
3、fetyevaluationstudiesinhumans.Thesestudiesaredesignedtoobservetolerabilityofhumanstoandpharmacokineticsofanewdrug,inordertoprovidebasisforestablishingtheadministrationregimen.PhaseIIClinicalTrial:preliminaryevaluationoftherapeuticeffectivenessofadrug.Thepurposesaretopreliminarilyevaluatethether
4、apeuticeffectivenessandsafetyofthedrugforparticularindication(s)inpatients,andprovideevidencefordesignofPhaseIIIclinicaltrialandsettlementofadministrativedoseregimen.Accordingtospecifictrialobjectives,thisphaseoftrialmaybedesignedinvariousforms,includingtherandomizedblindcontrolledclinicaltrial
5、.PhaseIIIClinicalTrial:confirmationoftherapeuticeffectivenessofadrug.Thepurposesaretofurtherverifydrugtherapeuticeffectivenessandsafetyoneligiblepatientswithtargetindication(s),toevaluateoverallbenefit-riskrelationshipsofthedrug,andtoultimatelyprovidesufficientevidenceforthereviewofdrugregistra
6、tionapplication.Thestudy,ingeneral,shallbearandomizedblindcontrolledtrialwithanadequatesamplesize.PhaseIVClinicalTrial:anewdrugpost-marketingstudy.Thepurposesaretoassesstherapeuticeffectivenessandadversereactionswhenadrugiswidelyused,toevaluateoverallbenefit-riskrelationshipsofthedrugwhenusedam
7、onggeneralpopulationorspecificgroups,andtoadjusttheadministrationdose,etc.Bioequivalencestudyreferstoahumanstudy,whichappliesbioavailabilitystudymethodswithpharmacokineticparametersasindicatorstocompareactiveingredientabsorptionra
