中英对照放射性药品管理办法(2022修订).docx

MeasuresfortheAdministrationofRadiopharmaceuticals(2022Revision)DocumentNumber：OrderNo.752of(heStateCouncilofthePeople'sRepublicofChinaAreaofLaw:PharmaceuticalAdministration1.evelofAuthority：AdministrativeRegulationsIssuingAuthority：StateCouncilDateIssued：03-29-2022EffectiveDale：05-01-2022Status:Effective2017-2022AnnotationVersion2011-2017AnnotationVersion1989-2011AnnotationVersionMeasuresfortheAdministrationofRadiopharmaceuticals(PromulgatedbyOrderNo.25ofIheSlateCouncilofIhePeople'sRepublicofChinaonJanuary13,1989;revisedforthefirsttimeinaccordancewiththeDecisionoftheStateCouncilonAbolishingandAmendingSomeAdministrationRegulationsonJanuary8,2011;revisedforthesecondtimeinaccordancewiththeDecisionoftheStateCounciltoAmendandRepealCertainAdministrativeRegulationsonMarch1,2017;andrevisedforthethirdtimeinaccordancewiththeDecisionoftheStateCounciltoAmendandRepealCertainAdministrativeRegulationsonMarch29,2022)Chapter I GeneralProvisionsArticle1TheseMeasuresareformulatedtostrengthenthecontrolofradiopharmaceuticalsinaccordancewiththeMedicinalProductAdministrationLawofthePeople'sRepublicofChina(hereinafterreferredtoastheMedicinal放射性药品管理办法（1989年1月13日中华人民共和国国务院令第25号发布根据2011年1月8日国务院关于废止和修改部分行政法规的决定第一次修订根据2017年3月1日国务院关于修改和废止部分行政法规的决定第二次修订根据2022年3月29日国务院关于修改和废止部分行政法规的决定第三次修订）第一章总则第一条为了加强放射性药品的管理，根据中华人民共和国药品管理法（以下称药品管理法）的规定，制定本办法。ProductAdministrationLaw).Article2"Radiopharmaceuticals"refertoanyformsofradionuclideortheirtaggeddrugsthatareusedforclinicaldiagnosisorinradiotherapy.Article3AllentitiesorindividualsinthePeople'sRepublicofChinaarerequiredtoabidebytheseMeasureswhentheyareengagedinresearchwork,production,distribution,transportation,consumption,examination,supervisionandadministrationworkrelatedtoradiopharmaceuticals.Article4ThemedicinalproductregulatorydepartmentoftheStateCouncilshallberesponsibleforthenationalsupervisionandadministrationofradiopharmaceuticals.Theadministrativedepartmentofscience,technologyandindustryfornationaldefenseoftheStateCouncilshallberesponsiblefortherelevantadministrationofradiopharmaceuticalsaccordingtoitsfunctions.TheenvironmentalprotectiondepartmentoftheStateCouncilshallberesponsibleforthesupervisionandadministrationoftheradiationsafetyandprotectioninrelationtoradiopharmaceuticals.Chapter II ExaminationandApprovalfortheDevelopmentandClinicalResearchofNewRadiopharmaceuticalsArticle5Thedevelopmentofanewkindofradiopharmaceuticalincludestheresearchworkinitstechnologicalprocess,qualityrequirements,preclinical-pharmacologicalstudyandclinicalstudy;Theresearchentity,第二条放射性药品是指用于临床诊断或者治疗的放射性核素制剂或者其标记药物。第三条凡在中华人民共和国领域内进行放射性药品的研究、生产、经营、运输、使用、检验、监督管理的单位和个人都必须遵守本办法。第四条国务院药品监督管理部门负责全国放射性药品监督管理工作。国务院国防科技工业主管部门依据职责负责与放射性药品有关的管理工作。国务院环境保护主管部门负责与放射性药品有关的辐射安全与防护的监督管理工作。第二章放射性新药的研制、临床研究和审批第五条放射性新药的研制内容，包括工艺路线、质量标准、临床前药理及临床研究。研制单位在制订新药工艺路线的同时，必须研究该药的理化性能、纯度（包括核素纯度）及检验方法、药理、毒理、动物药代动力学、whendesigningthetechnologicalprocessforanewdrug,muststudythephysicalandchemicalproperties,purity(includingpurenessofradionuclide),testingmethod,pharmacology,toxicity,nucleinanimaldynamics,radio-specificactivity,dosage,pharmaceuticalformsandstabilityofthatradiopharmaceutical.Furthermore,theresearchentitymustmakeastudyofradioimmunityanalysiscontainerwithrespecttoitsscalability,range,specificity,accuracy,precisionandstability.TheCIaSSifiCatiOnofnewradiopharmaceuticalsshallbehandledaccordingtotheprovisionsissuedbythemedicinalproductregulatorydepartmentoftheSlateCouncilondrugregistration.Article6Beforetheclinicaltestorvalidationofnewradiopharmaceuticalsdevelopedbytheresearchentity,anapplicationshallbefiledwiththemedicinalproductregulatorydepartmentoftheStaleCouncil,withmaterialsandspecimenssubmittedasrequired,andclinicalstudyshallbeconductedatthedrugclinicaltestinstitutiondesignatedbythemedicinalproductregulatorydepartmentoftheStateCouncilafteritapprovestheapplication.Article7Aftercompletionofclinicalstudyofanewlydevelopedradiopharmaceutical,theresearchentitymustsubmitanapplicationtothemedicinalproductregulatorydepartmentoftheStateCouncilforexaminationandapproval.Thelattershallconsulttheadministrativedepartmentofscience,technologyandindustryfornationaldefenseofthe放射性比活度、剂量、剂型、稳定性等。研制单位对放射免疫分析药盒必须进行可测限度、范围、特异性、准确度、精密度、稳定性等方法学的研究。放射性新药的分类，按国务院药品监督管理部门有关药品注册的规定办理。第六条研制单位研制的放射性新药，在进行临床试验或者验证前，应当向国务院药品监督管理部门提出申请，按规定报送资料及样品，经国务院药品监督管理部门审批同意后，在国务院药品监督管理部门指定的药物临床试验机构进行临床研究。第七条研制单位在放射性新药临床研究结束后，向国务院药品监督管理部门提出申请，经国务院药品监督管理部门审核批准，发给新药证书。国务院药品监督管理部门在审核批准时，应当征求国务院国防科技工业主管部门的意见。StateCouncilbeforegrantingaNewDrugPermit.Article8Beforeanewlydevelopedradiopharmaceuticalisputtoproduction,theproductionentityortheresearchentitythatholdsapermitfortheproductionofradiopharmaceuticalsmustsubmitanapplicationtogetherwithacopyofNewDrugPermitandspecimentothemedicinalproductregulatorydepartmentoftheStateCouncil.Afterexaminationandverification,themedicinalproductregulatorydepartmentoftheStaleCouncilshallissuethemapprovalnumber.Chapter III TheProductio