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 TheProduction,Sales,ImportandExportofRadiopharmaceuticalsArticle 9 Thestateshall,asneeded,makerationaldistributionofmanufacturersofradiopharmaceuticals.Article 10 Fortheformationofaradiopharmaceuticalproductionordistributionenterprise,theconditionsprescribedintheMedicinalProductAdministrationLawshallhemet,theprovisionsandstandardsissuedbythestateonthesecurityandprotectionofradioisotopesshallbecompliedwith,andtheapprovalIbrmalitiesforenvironmentalimpactassessmentdocumentsshallbeundergone.Fortheformationofaradiopharmaceuticalproductionenterprise,themedicinalproductregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentwheretheenterpriseislocatedshallissueaPermitforaRadiopharmaceuticalProductionEnterpriseafterthedepartmentofscience,technologyandindustryfornational第八条放射性新药投入生产，需由生产单位或者取得放射性药品生产许可证的研制单位，凭新药证书（副本）向国务院药品监督管理部门提出生产该药的申请，并提供样品，由国务院药品监督管理部门审核发给批准文号。第三章放射性药品的生产、经营和进出口第九条国家根据需要，对放射性药品的生产企业实行合理布局。第十条开办放射性药品生产、经营企业，必须具备药品管理法规定的条件，符合国家有关放射性同位素安全和防护的规定与标准，并履行环境影响评价文件的审批手续；开办放射性药品生产企业，经所在省、自治区、直辖市国防科技工业主管部门审查同意，所在省、自治区、直辖市药品监督管理部门审核批准后，由所在省、自治区、直辖市药品监督管理部门发给放射性药品生产企业许可证：开办放射性药品经营企业，经所在省、自治区、直辖市药品监督管理部门审核并征求所在省、自治区、直辖市国防科技工业主管部门意见后批准的，由所在省、自治区、直辖市药品监督管理部门发给放射性药品经营企业许可证。无许可证的生产、经营企业，一律不准生产、销售放射性药品。defenseoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentwheretheenterpriseislocatedconductsexaminationandgrantsconsentandthemedicinalproductregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentwheretheenterpriseislocatedconductsverificationandgrantsapproval.Fortheformationofaradiopharmaceuticaldistributionenterprise,themedicinalproductregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentwheretheenteriseislocatedshallissueaPermitforaRadiopharmaceuticalDistributionEnterpriseafterthemedicinalproductregulatorydepartmentoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentwheretheenterpriseislocatedconductsverificationandgrantsapprovaluponconsultationwiththedepartmentofscience,technologyandindustryfornationaldefenseoftheprovince,autonomousregion,ormunicipalitydirectlyundertheCentralGovernmentwheretheenterpriseislocated.Aproductionordistributionenterprisewithoutsuchapermitmaynotproduceorsellradiopharmaceuticals.第一条放射性药品生产企业许可证、放 射性药品经营企业许可证的有效期为5年，期满前6个 月，放射性药品生产、经营企业应当分别向原发证的药品 监督管理部门重新提出申请，按第十条审批程序批准后， 换发新证。Article 11 Thetermofvalidityof"PermitforaRadiopharmaceuticalsProductionEnterprise"and"PermitforaRadiopharmaceuticalsDistributionEnterprise"isfiveyears.Ifneeded,theenterprisesengagedintheproductionorsaleofradiopharmaceuticalsshallmakeanewapplicationsixmonthsbeforetheexpirationtothemedicinalproductregulatorydepartmentwhichshall,inaccordancewithArticle1()oftheseMeasures,issuethemanewpermit.第十二条放射性药品生产企业生产已有国家标准 的放射性药品，必须经国务院药品监督管理部门征求国务 院国防科技工业主管部门意见后审核批准，并发给批准文 号。凡是改变国务院药品监督管理部门已批准的生产工艺 路线和药品标准的，生产单位必须按原报批程序提出补充 申请，经国务院药品监督管理部门批准后方能生产。Article 12 TheproductionofradiopharmaceuticalsforwhichtherearenationalstandardsbyaradiopharmaceuticalsproductionenterpriseshallbesubjecttotheapprovalofthemedicinalproductregulatorydepartmentoftheStateCouncilafterconsultationwiththeadministrativedepartmentofscience,technologyandindustryfornationaldefenseoftheStateCouncil,anduponapproval,anapprovalnumbershallbeissued.WheretheproductionprocessroutesandpharmaceuticalstandardsthathavebeenapprovedbythemedicinalproductregulatorydepartmentoftheStaleCouncilarechanged,aproductionentityshallfileasupplementalapplicationaccordingtotheoriginalapprovalprocedures,andmayconductproductiononlyafterapprovalbythemedicinalproductregulatorydepartmentoftheStateCouncil.第十三条放射性药品生产、经营企业，必须配备 与生产、经营放射性药品相适应的专业技术人员，具有安 全、防护和废气、废物、废水处理等设施，并建立严格的 质量管理制度。Article 13 Theproductionanddistributionenterprisesofradiopharmaceuticalsarerequiredtoemploytechnicalpersonnelwhoarequalifiedfortheworkandtohavesafetyandprotectionfacilitiesaswellaswastegas,liquidandmaterialdisposalfacilities.Theymustalsohaveastrictqualitycontrolsystem.第十四条放射性药品生产、经营企业，必须建立 质量检验机构，严格实行生产全过程的质量控制和检验。 产品出厂前，须经质量检验。符合国家药品标准的产品方 可出厂，不符合标准的产品一律不准出厂。Article 14 Theproductionanddistributionenterprisesofradiopharmaceuticalsarerequiredtosetupqualityinspectionoffices.Theentireprocessofpluctionmustbepulunderstrictqualifycontrolandinspection.Allradiopharmaceuticalsaresubjecttoqualitytesting.OnlytheproductsthatmeettheStatepharmaceuticalstandardshallbeallowedtobeshippedoutfromthefactories.ProductsthatarenotuptothestandardarenotallowedoutofIhefactory.Drugswithshorthalf-liferadionuclideapprovedbythemedicinalproductregulatorydepartmentoftheStateCouncilmayleavefactorieswhileundergoinginspection,butwhenthequalityIhereofisfoundfailingtomeetthepharmaceuticalstandardsofthestate,theproductionenterpriseshallimmediatelystopproducingandsellingthedrugs,immediatelynotifytheusingentitiesofstoppingusingthedrugs,andconcurrentlyreporttothemedicinalproductregulatorydepartment,healthadministrativedepartment,andadministrativedepartmentofscience,technologyandindustr),fornationaldefenseoftheStaleCouncil.Article 15 Theproductionanddistributionentitiesofradiopharmaceuticalsandmedicalentitiesshall,respectivelybasedonthePermitforaRadiopharmaceuticalsProductionEnterprise,thePermitforaRadiopharmaceuticalsDistributionEnterprise,andthePermitfortheUseofRadiopharmaceuticalsissuedbythemedicinalproductregulatorydepartmentsoftheprovinces,autonomousregions,andmunicipalitiesdirectlyundertheCentralGovernment,purchaseandsellradiopharmaceuticals.Article 16 ThevarietiesofimportedradiopharmaceuticalsmustmeetthepharmaceuticalstandardsorothermedicinalrequirementsofChina,andregistrationcertificatesforimporteddrugsshallbeobtainedinaccordancewiththeMedicinalProductAdministrationLaw.Theimportandexportformalitiesshallbeundergoneforimportedandexportedradiopharmaceuticalsinaccordancewiththeprovisionsissuedbythestateonforeigntradeandthe经国务院药品监督管理部门审核批准的含有短半衰期放射性核素的药品，可以边检验边出厂，但发现质量不符合国家药品标准时，该药品的生产企业应当立即停止生产、销售，并立即通知使用单位停止使用，同时报告国务院药品监督管理、卫生行政、国防科技工业主管部门。第十五条放射性药品的生产、经营单位和医疗单位凭省、自治区、直辖市药品监督管理部门发给的放射性药品生产企业许可证、放射性药品经营企业许可证，医疗单位凭省、自治区、直辖市药品监督管理部门发给的放射性药品使用许可证，开展放射性药品的购销活动。第十六条进口的放射性药品品种，必须符合我国的药品标准或者其他药用要求，并依照药品管理法的规定取得进口药品注册证书。进出口放射性药品，应当按照国家有关对外贸易、放射性同位素安全和防护的规定，办理进出口手续。securityandprotectionofradioisotopes.第十七条进口放射性药品，必须经国务院药品监督管理部门指定的药品检验机构抽样检验；检验合格的， 方准进口。Article 17 RadiopharmaceulicalstobeimportedmustbesubjecttothesamplinginspectionbythepharmaceuticalinspectionandtestinginstitutionsdesignatedbythemedicinalproductregulatorydepartmentoftheStateCouncil;andonlythosepassingtheinspectionmaybeimported.对于经国务院药品监督管理部门审核批准的含有短半衰期 放射性核素的药品，在保证安全使用的情况下，可以采取 边进口检验，边投入使用的办法。进口检验单位发现药品 质量不符合要求时，应当立即通知使用单位停止使用，并 报告国务院药品监督管理、卫生行政、国防科技工业主管 部门。Drugswithshorthalf-liferadionuclideapprovedbythemedicinalproductregulatorydepartmentoftheStateCouncilmaybeusedwhileundergoingimportinspection,providedthattheirsafeuseisensured.Importinspectionentitiesshall,immediatelyaflerfindingthatdrugqualityfailstosatisfytheprescribedrequirements,notifytheusingentitiesofstoppingusingthedrugsandreportittothemedicinalproductregulatorydepartment,healthadministrativedepartment,andadministrativedepartmentofscience,technologyandindustryfornationaldefenseoftheStateCouncil.第四章放射性药品的包装和运输ChapterIVThePackagingandShipmentofRadiopharmaceuticals第十八条放射性药品的包装必须安全实用，符合 放射性药品质量要求，具有与放射性剂量相适应的防护装 置。包装必须分内包装和外包装两部分，外包装必须贴有 商标、标签、说明书和放射性药品标志，内包装必须贴有 标签。Article18Thepackagingofradiopharmaceuticalsmustbesafeandreliable,anduptothestandardsforthequalityrequirementsofradiopharmaceuticals.Theremustbeprotectiondevicesthatwillmatchdifferentradiodosages.Thepackagingisrequiredtoconsistofpackingandinnerpackaging.Theremustbetrademark,label,specificationsandmarkerofradiopharmaceuticalsonthepackingandalabelontheinnerpackaging.Onthelabeltheremustbenameofthedrug,radio-specificactivityandpacking.Thespecificationsmustindicatethenameoftheproductionentity,approvalnumber,batchnumber,maincomposition,dateofmanufacture,half-lifeofradionuclide,indications,administration,dosage,contraindication,expirydateandprecautionsinadditiontonameofthedrug,radio-specificactivityandpacking.Article19Theshipmentofradiopharmaceuticalsshallbehandledinaccordancewiththerulesformulatedbythestatetransportationandpostaldepartments.Noentityorpersonshallbeallowedtocarryalongradiopharmaceuticalsonanymeansofpublictransportation.ChapterVtheUseofRadiopharmaceuticalsArticle20Ifamedicalentitydesirestosetuparadiologicdepartmentoraradioisotopedepartment,itisrequiredtoemploytechnicalpersonnelwhoarequaliedfortherapeuticworkaftertechnicalnuclearmedicinetraining.Withoutpriortechnicaltrainingnopersonnelshallbeallowedtoengageintheuseofradiopharmaceuticals.Article 21 Medicalentitiesmustuseradiopharmaceuticalsinaccordancewiththeprovisionsissuedbythestateonthesecurityandprotectionofradioisotopes.Themedicinalproductregulatorydepartmentsoftheprovinces,autonomousregions,标签必须注明药品品名、放射性比活度、装量。说明书除注明前款内容外，还须注明生产单位、批准文号、批号、主要成份、出厂日期、放射性核素半衰期、适应症、用法、用量、禁忌症、有效期和注意事项等。第十九条放射性药品的运输，按国家运输、邮政等部门制订的有关规定执行。严禁任何单位和个人随身携带放射性药品乘坐公共交通运输工具。第五章放射性药品的使用第二十条医疗单位设置核医学科、室（同位素室），必须配备与其医疗任务相适应的并经核医学技术培训的技术人员。非核医学专业技术人员未经培训，不得从事放射性药品使用工作。第二H一条医疗单位使用放射性药品，必须符合国家有关放射性同位素安全和防护的规定。所在地的省、自治区、直辖市药品监督管理部门，应当根据医疗单位核医疗技术人员的水平、设备条件，核发相应等级的放射 性药品使用许可证，无许可证的医疗单位不得临床使用 放射性药品。放射性药品使用许可证有效期为5年，期满前6个 月，医疗单位应当向原发证的行政部门重新提出申请，经 审核批准后，换发新证。第二十二条医疗单位配制、使用放射性制剂，应当符合药品管理法及其实施条例的相关规定。第二十三条 持有放射性药品使用许可证的医 疗单位，必须负责对使用的放射性药品进行临床质量检 验，收集药品不良反应等项工作，并定期向所在地药品监 督管理、卫生行政部门报告。由省、自治区、直辖市药品 监督管理、卫生行政部门汇总后分别报国务院药品监督管 理、卫生行政部门。andmunicipalitiesdirectlyundertheCentralGovernmentwheretheyarerespectivelylocatedshall,accordingtothecompetenceofthenuclearmedicinetechniciansandtheequipmentconditionsofthemedicalentities,issuethePennitfortheUseofRadiopharmaceuticalsatthecorrespondinglevel,andnomedicalentitywithoutthepermitshalluseradiopharmaceuticalsforclinicalpurpose.ThetermofvalidityofaPermitfortheUseofRadiopharmaceuticalsis5years.Ifneeded,themedicalentitymust