【中英文对照版】药物临床试验机构监督检查办法(试行).docx

国家药监局关于发布药物临 床试验机构监督检查办法（试 行）的通告（国家药品监督管理局通告 2023年第56号）为进一步加强对药物临床试验 机构的管理，规范药物临床试 验机构监督检查工作，国家药 监局组织制定了药物临床试 验机构监督检查办法（试 行），现予发布。药物临床试验机构监督检查办法(试行)MeasuresfortheSupervisionandInspectionofDrugClinicalTrialInstitutions(forTrialImplementation)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通告2023年第56号公布日期：2023.11.03施行日期：2024.03.01效力位阶：部门规范性文件法规类别：药品管理IssuingAuthority：StateDrugSupervision&AdministrationBureau(replaced)DocumentNumber：AnnouncementNo.562023oftheNationalMedicalProductsAdministrationDateIssued：11-03-2023EffectiveDate：03-01-20241.evelofAuthority：DepartmentalRegUlatOryDocumentsAreaofLaw:PharmaceuticalAdministrationAnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheMeasuresfortheSupervisionandInspectionofDrugClinicalTrialInstitutions(forTrialImplementation)(AnnouncementNo.562023oftheNationalMedicalProductsAdministration)Tofurtherstrengthentheadministrationofclinicaldrugtrialinstitutionsandregulatethesupervisionandinspectionofdrugclinicaltrialinstitutions,theNationalMedicalProductsAdministrationhasorganizedthedevelopmentoftheMeasuresfortheSupervisionandInspectionofDrugClinicalTrialInstitutions(forTrialImplementation),whichareherebyissued.ThisAnnouncementshallcomeintoforceon本通告自2024年3月1日起March152024.实施。特此通告。Annex:MeasuresfortheSupervisionandInspectionofDrugClinicalTrialInstitutions(forTrialImplementation)附件：药物临床试验机构监督检查办法（试行）NationalMedicalProductsAdministration国家药监局November3,20232023年11月3日Annex附件MeasuresfortheSupervisionandInspectionofDrugClinicalTrialInstitutions(forTrialImplementation)药物临床试验机构监督检查办法（试行）ChapterIGeneralProvisions第一章总则Article1TheseMeasuresaredevelopedinaccordancewiththePharmaceuticalAdministrationLawofthePeople'sRepublicofChina,theVaccineAdministrationLawofthePeople'sRepublicofChina,theMeasuresfortheAdministrationofDrugRegistration,theProvisionsontheAdministrationofDrugClinicalTrialInstitutions,andtheGoodClinicalPracticeforDrugs(uGCP)toregulatethesupervisionandinspectionofdrugclinicaltrialinstitutionsandstrengthentheadministrationofdrugclinicaltrials.第一条为规范药物临床试验机构监督检查工作，加强药物临床试验管理，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以及药品注册管理办法药物临床试验机构管理规定药物临床试验质量管理规范（以下简称GCP）等，制定本办法。Article2TheseMeasuresshallapplytodrugregulatoryauthorities*inspectionandhandlingoftherecordationofdrugclinicaltrialinstitutions(utrialinstitutions)andthecomplianceofdrug第二条药品监督管理部门对药物临床试验机构（以下简称试验机构）备案及开展以药品注册为目的的药物临床试 验活动遵守相关法律法规、执 行GCP等情况实施检查、处置 等，适用本办法。第三条 国家药品监督管 理局（以下简称国家局）负责 制定试验机构监督检查制度， 指导省级药品监督管理部门 （以下简称省级局）开展试验 机构监督检查，根据需要组织 对试验机构进行监督检查。国 家局食品药品审核查验中心 （以下简称国家局核查中心） 负责建立国家检查员库并实施 检查员培训与管理，负责实施 国家局组织开展的试验机构检 查、药品注册核查；推进试验 机构备案管理信息化及监督检 查工作信息化建设；对省级药 品检查机构质量管理体系进行 评估，对各省检查工作进行技 术指导。第四条省级局负责本行 政区域内试验机构的监督检查 以及国家局交办的有关事项， 建立试验机构监督检查工作制 度和机制，配备与本省试验机 构检查工作相匹配的省级检查 员队伍；推进监督检查工作信 息化建设；组织对本行政区域 内试验机构开展日常监督检 查、有因检查、其他检查等， 监督试验机构符合法定要求； 对本行政区域内试验机构涉嫌clinicaltrialactivitiescarriedoutforthepurposeofdrugregistrationwithrelevantlawsandregulations,theimplementationoftheGCP,andothercircumstances.Article3TheNationalMedicalProductsAdministration(uNMPAn)shallberesponsiblefordevelopingtherulesforthesupervisionandinspectionoftrialinstitutions,guidingprovincialdrugregulatoryauthorities("provincialauthoties)tocarryoutthesupervisionandinspectionoftrialinstitutions,andorganizingthesupervisionandinspectionoftrialinstitutionsasneeded.TheCenterforFoodandDrugInspectionofNMPA(mCFD,)shallberesponsibleforestablishinganationaldatabaseofinspectorsandconductinginspectortrainingandmanagementandcarryingouttheinspectionoftrialinstitutionsanddrugregistrationinspectionorganizedbytheNMPA;promotingtheinformationtechnologydevelopmentoftherecordationadministrationoftrialinstitutionsandthesupervisionandinspectionwork;assessingthequalitymanagementsystemsofprovincialdruginspectioninstitutionsandprovidingtechnicalguidancefortheinspectionworkofallprovinces.Article4ProvincialauthoritiesshallberesponsibleforthesupervisionandinspectionoftrialinstitutionswithintheirrespectiveadministrativeregionsandrelevantmattersassignedbytheNMPA,establishingaworkingsystemandmechanismforthesupervisionandinspectionoftrialinstitutions,assigningaprovincialteamofinspectorsmatchingtheinspectionoftrialinstitutionsintheirrespectiveprovinces;promotingtheinformationtechnologydevelopmentofthesupervisionandinspectionwork;organizingtheroutinesupervisionandinspection,for-causeinspection,andotherinspectionoftrialinstitutionswithintheirrespectiveadministrativeregions,违法违规行为依法进行处置。第五条药品监督管理部 门设置的药品检查机构依法开 展试验机构检查，药品检验、 审评等机构根据试验机构检查 工作需要提供技术支撑。supervisingtrialinstitutions'compliancewithstatutoryrequirements;andlegallypunishinganysuspectedviolationoflaworregulationcommittedbytrialinstitutionswithintheirrespectiveadministrativeregions.Article5Adruginspectioninstitutionsetupbythedrugregulatorydepartmentshallcarryoutinspectionsoftrialinstitutionsinaccordancewiththelaw,anddrugtesting,evaluation,andotherrelevantin