【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,andotherrelevantinstitutionsshallprovidetechnicalsupportasrequiredfortheinspectionoftrialinstitutions.第六条试验机构和研究 者应当切实履行药物临床试验 相关责任，授权其他人员承担 临床试验有关工作时，应当建 立相应管理程序，并采取措施 实施质量管理，加强相关信息 化建设。研究者应当监督所有 授权人员依法依规开展临床试 验，执行试验方案、履行工作 职责，保护受试者的权益和安 全，保障试验数据和结果真 实、准确、完整、可靠。Article6Atrialinstitutionanditsresearchersshalleffectivelyfulfilltheirresponsibilitiesrelatingtodrugclinicaltrials,andshall,whenauthorizingotherpersonneltoundertakeclinicaltrial-relatedwork,establishcorrespondingmanagementprocedures,takemeasurestocarryoutqualitymanagementandstrengthentherelevantinformationtechnologydevelopment.Researchersshallsuperviseallauthorizedpersonnelincarryingoutclinicaltrialsinaccordancewiththeapplicablelawsandregulations,implementtrialplans,performtheirworkduties,protecttherightsandinterestsandsafetyofhumansubjects,andguaranteetheveracity,accuracy,completeness,andreliabilityoftrialdataandresults.第七条根据检查性质和 目的，对试验机构开展的检查 分为日常监督检查、有因检 查、其他检查。不同类型检查 可以结合进行。Article7Accordingtothenatureandpurposesofinspections,theinspectionsoftrialinstitutionsareclassifiedintoroutinesupervisionandinspection,for-causeinspection,andotherinspections.Differenttypesofinspectionsmaybeconductedincombination.（一）日常监督检查是按照年 度检查计划，对试验机构遵守 有关法律法规、执行GCP情(1) Routinesupervisionandinspectionmeansthesupervisionandinspectionconductedinaccordancewithannualinspectionplansontrialinstitutions*compliancewithrelevantlawsandregulations,implementationoftheGCP,andrectificationofproblemsfoundinpreviousinspections,amongothers.Routinesupervisionandinspectionshallbecarriedoutbasedonrisksandinlightoftheconditionsofclinicaltrialprojectsunderresearchbytrialinstitutions.Forthefirstsupervisionandinspectionafterrecordation,emphasisshallbeplacedonverifyingtherecordationconditionsoftrialinstitutionsortrial况、既往检查发现问题的整改 情况等开展的监督检查。日常 监督检查应当基于风险，结合 试验机构在研临床试验项目情 况开展。对于备案后首次监督 检查，重点核实试验机构或者 试验专业的备案条件。specialties.(2) For-causeinspectionmeansatargetedinspectionofspecificissuesofatrialinstitutionthatmayhavequalityandsafetyrisksorcluestomajorproblemsofsuspectedviolationsoflawsandregulations,suchascomplaintsandreports.Inthefor-causeinspection,adruginspectioninstitutionmaydirectlyentertheinspectionsitetoconductinspectionsonpossibleproblemswithoutpriornoticetotheinspectedinstitution.（二）有因检查是对试验机构 可能存在质量安全风险的具体 问题或者投诉举报等涉嫌违法 违规重要问题线索的针对性检 查。有因检查可以不提前通知 被检查机构，直接进入检查现 场，针对可能存在的问题开展 检查。（三）其他检查是除上述二种 类型检查之外的检查，如专项 检查、监督抽查等。Chapter Il StaffDrug Inspection Institutions and Their第二章药品检查机构和人员(3) Otherinspectionsmeansinspectionsotherthantheaforesaidtwotypesofinspections,suchasspecialinspectionandsupervisionandrandominspection.第八条药品检查机构应 当建立检查质量管理体系，完 善检查工作程序，明确检查标 准和原则，保障检查工作质 量；加强检查记录与相关文件 档案管理；定期回顾分析检查 工作情况，持续改进试验机构 检查工作。Article8Adruginspectioninstitutionshallestablishaninspectionqualitymanagementsystem,improveinspectionworkprocedures,specifyinspectionstandardsandprinciples,andguaranteetheinspectionworkquality;strengthenthemanagementofinspectionrecordsandrelevantdocumentsandarchives,regularlyconductretrospectiveanalysisoftheinspectionwork,andcontinuouslyimprovetheinspectionoftrialinstitutions.第九条药品检查机构按 照检查计划组织实施检查任 务。试验机构日常监督检查年 度计划由省级局结合本行政区 域内试验机构和试验活动的具 体情况组织制定；检查可以基 于风险选择重点内容，聚焦重 点领域、关键环节。Article9Adruginspectioninstitutionshallorganizeandimplementinspectiontasksaccordingtotheinspectionplan.Theannualplanforroutinesupervisionandinspectionoftrialinstitutionsshallbemadebytheprovincialauthorityinlightofthespecificcircumstancesoftrialinstitutionsandtrialactivitieswithinitsadministrativeregion.Thefocusofinspectionmaybeselectedbasedonrisksandtheinspectionshallfocusonkeyfieldsandcriticallinks.对试验机构、试验专业或者研 究者存在以下情形的，应当纳 入检查重点或者提高检查频 次：Anytrialinstitution,trialspecialty,orresearcherthatfallsunderanyofthefollowingcircumstancesshallbetakenasthefocusofinspectionorbesubjecttoinspectionwithincreasedfrequency:（一）既往存在严重不合规问 题的；(1) Itorhehasseriousnon-complianceproblemsinthepast.（二）研究者同期承担临床试 验项目较多、研究者管理能力 或者研究人员数量相对不足等 可能影响试验质量的；(2) Theresearcherundertakesalargenumberofclinicaltrialprojectsatthesametimeorlacksmanagementabilityorthenumberofresearchersisinsufficient,amongothers,whichmayaffectthetrialquality.（三）投诉举报或者其他线索 提示存在质量安全风险的。(3) Therearecomplaints,reports,orothercluesindicatingtheexistenceofqualityandsafetyrisks.第十条检查人员应当具 备相应的检查资质和能力；应 当严格遵守法律法规、廉政纪 律和工作要求，不得向被检查 机构提出与检查无关的要求； 在检查前应当接受廉政教育， 签署承诺书和无利益冲突声 明；与被检查机构存在利益关 系或者有其他可能影响检查结Article10Inspectorsshallhavecorrespondinginspectionqualificationandability;strictlyabidebylawsandregulations,integritydisciplinesandworkrequirements,andshallnotraiserequirementsirrelevanttoinspectiontotheinspectedinstitution.Theyshallreceiveintegrityeducationbeforetheinspectionandsignaletterofcommitmentandastatementonnoconflictsofinterest;andvoluntarilymakestatementsandwithdrawfromtheinspectioniftheyhaveanyinterestintheinspectedinstitution果公正性的情况时，应当主动 声明并回避。orfallunderanyothercircumstancewhichmayaffecttheimpartialityofinspectionresults.第十一条检查人员应当 严格遵守保密规定并签署保密 协议，严格管理涉密资料，严 防泄密事件发生。不得泄露检 查相关信息及被检查机构技术 或者商业秘密等信息。Article11Inspectorsshallstrictlyabidebytheprovisionsonconfidentialityandsignconfidentialityagreements,strictlymanageconfidentialmaterials,andstrictlypreventtheleakageofconfidentialmaterials.Theyshallnotdivulgeanyinformationrelatingtotheinspectionortechnicalortradesecretsoftheinspectedinstitution.第三章检查程序ChapterIIIInspectionProcedures第十二条实施检查前， 药品检查机构应当根据检查任 务制定具体检查方案，明确检 查内容、检查时间和检查方式 等。检查方式以现场检查为 主，可视情况开展远程检查。Article12Beforeaninspection,adruginspectioninstitutionshallmakeaspecificinspectionplanaccordingtoinspectiontasks,specifyingtheinspectioncontent,time,andmethods,amongothers.Themethodofon-siteinspectionshallbemainlyadoptedforinspection,andremoteinspectionmaybeconductedasthecasemaybe.第十三条药品检查机构 组建检查组实施检查。检查组 一般由2名以上检查员组成， 实行组长负责制。必要时可以 增加相关领域专家参加检查工 作。检查人员应当提前熟悉检 查方案以及检查相关资料。第十四条确定检查时间 后，药品检查机构原则上在检 查前5至7个工作日通知被检 查机构，有因检查除外。国家 局核查中心实施的试验机构检 查，应当同时通知被检查机构 所在地省级局。省级局应当选Article13Adruginspectioninstitutionshallsetupaninspectionteamtoconductinspections.Theinspectionteamshallgenerallyconsistoftwoormoreinspectorsandbesubjecttotheteamleaderresponsibilitysystem.Ifnecessary,expertsinrelevantfieldsmaybeincreasedtoparticipateintheinspection.Inspectorsshallbefamiliarwiththeinspectionplanandinspection-relatedmaterialsinadvance.Article14Aftertheinspectiontimeisdetermined,adruginspectioninstitutionshall,inprinciple,notifytheinspectedinstitutionfivetosevenworkingdaysbeforetheinspection,exceptforthefor-causeinspection.FortheinspectionofatrialinstitutioncarriedoutbytheCFDI5theprovincialauthorityattheplacewheretheinspectedinstitutionislocatedshallbenotifiedatthesametime.Theprovincial派1名药品监督管理人员作为 观察员协助检查工作，并将检 查发现的问题等及时报告省级 局。authorityshallappointonedrugregulatoryofficerasanobservertoassistintheinspectionandpromptlyreporttheproblemsfoundintheinspectiontotheprovincialauthority.第十五条检查组开始现 场检查时，应当召开首次会议 （有因检查可除外），向被检 查机构出示并宣读检查通知， 确认检查范围，告知检查纪 律、廉政纪律、注意事项以及 被检查机构享有的权利和应当 履行的义务Q被检查机构应当积极配合检查 组工作，安排研究者、其他熟 悉业务的相关人员协助检查组 工作，及时提供相关资料，并 保证所提供的资料、数据及相 关情况真实、准确、完整、可 靠，不得拒绝、逃避、拖延或 者阻碍检查。Article15Whenstartinganon-siteinspection,aninspectionteamshallconveneapreliminarymeeting(exceptforthefor-causeinspection)topresentandreadouttheinspectionnoticetotheinspectedinstitution,confirmthescopeoftheinspection,andinformtheinspectedinstitutionoftheinspectiondiscipline,integritydiscipline,mattersrequiringattention,aswellastherightsenjoyedbyandobligationstobefulfilledbytheinspectedinstitution.Theinspectedinstitutionshallactivelycooperatewiththeinspectionteaminitswork,arrangeresearchersandotherrelevantpersonnelwhoarefamiliarwiththebusinesstoassisttheinspectionteam,providerelevantmaterialsinatimelymanner,andensurethatthematerials,data,andtherelevantinformationprovidedaretrue,accurate,complete,andreliable,andshallnotrefuse,evade,delay,orobstructtheinspection.第十六条检查组应当根 据检查方案实施检查。检查过 程中检查方案需变更的，应当 报告检查派出机构同意后实 施。Article16Theinspectionteamshallconducttheinspectioninaccordancewiththeinspectionplan.Ifitisnecessarytochangetheinspectionplaninthecourseoftheinspection,suchchangeshallbereportedtothedispatchedinstitutionforinspectionforapprovalbeforeimplementation.第十七条检查组应当详 细记录检查时间、地点、内 容、发现的问题等，并根据实 际情况对发现的问题留存相关 证据。Article17Theinspectionteamshallkeepdetailedrecordsoftheinspectiontime,place,content,andproblemsdiscovered,amongothers,andretaintherelevantevidencefortheproblemsdiscoveredinlightoftheactualcircumstances.第十八条检查组应当对 现场检查情况进行汇总分析， 客观、公平、公正地对检查发 现的缺陷进行风险评估和分 级；检查组评估认为存在质量 安全风险的，应当要求被检查 机构及时控制风险，必要时报 告检查派出机构采取进一步风 险控制措施。Article18Theinspectionteamshallsummarizeandanalyzetheon-siteinspectioninformationandconductriskassessmentandgradingofthedeficienciesdiscoveredintheinspectioninanobjective,fair,andimpartialmanner.Iftheinspectionteamdeemsuponassessmentthattherearequalityandsafetyrisks,itshallrequiretheinspectedinstitutiontopromptlycontrolrisks,andwhennecessary,reporttothedispatchedinstitutionforinspectiontotakefurtherriskcontrolmeasures.第十九条现场检查结束 时，检查组应当召开末次会 议，向被检查机构通报现场检 查情况。被检查机构对现场检 查情况有异议的，可以陈述申 辩，检查组应当如实记录，并Article19Uponthecompletionoftheon-siteinspection,theinspectionteamshallconveneafinalmeetingtonotifytheinspectedinstitutionoftheon-siteinspectioninformation.Iftheinspectedinstitutionraisesanyobjectiontotheon-siteinspection,itmaymakestatementsandarguments.Theinspectionteamshallmaketruthfulrecordsanddeterminethedeficienciesdiscovered结合陈述申辩的内容确定发现 的缺陷，形成缺陷项目清单。 缺陷项目清单由检查组成员、 被检查机构负责人、观察员（如适用）签字确认，加盖被 检查机构公章，各执一份。inlightofthestatementsandargumentsandformalistofdeficiencyitems.Thelistofdeficiencyitemsshallbesignedbythemembersoftheinspectionteam,thepersoninchargeoftheinspectedinstitutionandtheobserver(ifapplicable)forconfirmation,theofficialsealoftheinspectedinstitutionshallbeaffixed,andeachpartyshallholdonecopyrespectively.检查组完成现场检查后，除取 证资料外，应当退还被检查机 构提供的其他资料。Aftercompletingtheon-siteinspection,theinspectionteamshallreturnthematerialsprovidedbytheinspectedinstitution,exceptforthematerialsforobtainingevidence.第二十条现场检查结束 后，检查组应当撰写现场检查 报告，列明发现的缺陷项目与 缺陷分级、现场检查结论及处 理建议，并由检查组全体人员 签字确认。Article 20 Afterthecompletionof