药品英文网店

NEWSLETTER)З哦рЗNATIONALMEDICALPRODUCTS2019.
Volume7PublishedbyChinaCenterforFoodandDrugInternationalExchangeServier(Tianjin)PharmaceuticalCo.
,Ltd.
GeneralOfficeoftheStateCouncilIssuedtheOpinionsonEstablishingaTeamofProfessionalized&SpecializedDrugInspectorsRecently,theGeneralOfficeoftheStateCouncilissuedtheOpinionsonEstablishingaTeamofProfessionalized&SpecializedDrugInspectors(hereinafterreferredtoasOpinions).
TheOpinionsdefinesprofessional&specializedinspectorsofdrugs(incl.
medicaldevicesandcosmetics)asthosewhoaccreditedbythedrugregulatoryauthoritiestoconductcomplianceverificationandriskassessmentonplacesandactivitieswheretheadministrativecounterpartsengageindrugR&Dandproduction,etc.
Theinspectorsconstituteanimportantsupportingforceforstrengtheningdrugsupervisionandensuringdrugsafety.
Pertheprofessionalizationorientationandprofessional&technicalrequirements,bytheendof2020,thedrugregulatoryauthoritiesoftheStateCouncilandtheprovinciallevelsshallhavebasicallycompletedtheconstructionofasystemofprofessional&specializeddruginspectors.
Onthisbasis,itwilltakeanotherthreetofiveyearstobuildandfurtherimproveapoliticallyandprofessionallyqualified,honestandefficientprofessional&specializeddruginspectorteamsystemwithfull-timeinspectorsasthemainstayandpart-timeinspectorsasasupplement,basicallysatisfyingtherequirementsfordrugadministration.
TheOpinionsproposesfivepolicymeasures.
1.
Improvetheinstitutionsandmechanismsofdruginspection.
Professional&specializedteamsofdruginspectorsshallbeconstructedatthenationalandprovinciallevelswithreinforcedinstitutionconstruction,clarifieddivisionofpowers,refinedinspectionrequirements,andamelioratedcoordinationmechanismforinspections.
2.
Ensurethestaffingofinspectors.
Reasonablydeterminethesizeoftheteam,standardizethestaffingmanagement,innovatetheinspectormanagementmechanism,andenrichtheinspectorteamthroughmultiplechannels.
3.
Strengthenthemanagementoftheinspectors.
Professionalized&specializeddruginspectorsshallbesubjecttohierarchicalclassificationmanagementwithstrictjobaccessandemploymentconditions,andscientificandreasonablemechanismsforassessment&evaluation,promotionanddemotion.
4.
Continuouslyimprovetheabilityandqualityofinspectors.
Strengtheninspectorbusinesstraining,encourageself-improvement,andinnovatehigh-qualityinspectortrainingmode.
5.
Establishanincentiveandrestraintmechanism.
Broadentheprofessionaldevelopmentspaceofinspectors,improvethepolicyforinspectorstoparticipateintheevaluationofcorrespondingprofessionaltitles,establishaguaranteemechanismforremuneration,andstrengthendisciplineandsupervision.
(July19,2019)国务院办公厅印发《关于建立职业化专业化药品检查员队伍的意见》近日,国务院办公厅印发《关于建立职业化专业化药品检查员队伍的意见》(以下简称《意见》).
《意见》提出,职业化专业化药品(含医疗器械、化妆品)检查员是指经药品监管部门认定,依法对管理相对人从事药品研制、生产等场所、活动进行合规确认和风险研判的人员,是加强药品监管、保障药品安全的重要支撑力量.
要坚持职业化方向和专业性、技术性要求,到2020年底,国务院药品监管部门和省级药品监管部门基本完成职业化专业化药品检查员队伍制度体系建设.
在此基础上,再用三到五年时间,构建起基本满足药品监管要求的职业化专业化药品检查员队伍体系,进一步完善以专职检查员为主体、兼职检查员为补充,政治过硬、素质优良、业务精湛、廉洁高效的检查员队伍.
《意见》提出了五方面政策措施.
一是完善药品检查体制机制.
构建国家、省两级职业化专业化药品检查员队伍,强化检查机构建设,明确检查事权划分,落实检查要求,完善检查工作协调机制.
二是落实检查员配置.
合理确定队伍规模,规范检查员编制管理,创新检查员管理机制,多渠道充实检查员队伍.
三是加强检查员队伍管理.
职业化专业化药品检查员实行分级分类管理,确立严格的岗位准入和任职条件,建立科学合理的考核评价与职级升降机制.
四是不断提升检查员能力素质.
强化检查员业务培训,鼓励检查员提升能力水平,创新高素质检查员培养模式.
五是建立激励约束机制.
拓宽检查员职业发展空间,完善检查员参加相应职称评审的政策,建立检查员薪酬待遇保障机制,强化纪律约束和监督.
(2019-07-19)2NATIONALMEDICALPRODUCTSNEWSLETTER国家药品监督管理局发布《关于仿制药质量和疗效一致性评价工作中药品标准执行有关事宜的公告》NMPAIssuedtheAnnouncementonIssuesPertainingtotheImplementationofDrugStandardsintheConsistencyEvaluationoftheQualityandEfficacyofGenericDrugs为推进仿制药质量和疗效一致性评价工作,明确仿制药注册标准和《中华人民共和国药典》等国家药品标准的关系,2019年8月2日,国家药品监督管理局发布了《关于仿制药质量和疗效一致性评价工作中药品标准执行有关事宜的公告》.
(2019-08-02)Topromotetheconsistencyevaluationofthequalityandefficacyofgenericdrugs,andclarifytherelationshipbetweentheregistrationstandardsofgenericdrugsandthenationaldrugstandardssuchasthePharmacopoeiaofthePeople'sRepublicofChina,onAugust2,2019,NMPAissuedtheAnnouncementonIssuesPertainingtotheImplementationofDrugStandardsintheConsistencyEvaluationoftheQualityandEfficacyofGenericDrugs.
(August2,2019)根据《国务院办公厅关于做好证明事项清理工作的通知》(国办发〔2018〕47号)要求,为进一步减证便民、优化服务,2019年7月24日,国家药品监督管理局发布《关于取消16项证明事项的公告(第二批)》,自发布之日起,所列证明事项停止执行.
(2019-07-24)为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号),原食品药品监管总局发布了《关于调整原料药、药用辅料和药包材审评审批事项的公告》(2017年第146号),2019年7月16日,国家药品监督管理局发布《关于进一步完善药品关联审评审批和监管工作有关事宜的公告》,就原料药、药用辅料、直接接触药品的包装材料和容器(以下简称原辅包)与药品制剂关联审评审批和监管有关事宜进行了进一步明确.
一、总体要求(一)原辅包的使用必须符合药用要求,主要是指原辅包的质量、安全及功能应该满足药品制剂的需要.
原辅包与药品制剂国家药品监督管理局发布《关于取消16项证明事项的公告(第二批)》国家药品监督管理局发布《关于进一步完善药品关联审评审批和监管工作有关事宜的公告》NMPAIssuedtheAnnouncementonCancellationof16CertificationItems(SecondBatch)NMPAIssuedtheAnnouncementonIssuesConcerningtheFurtherImprovementofDrug-relatedAssociatedReview&ApprovalandSupervisionAspertheNoticeoftheGeneralOfficeoftheStateCouncilonEffectiveClearanceofCertificationItems(theStateCouncilGeneralAspertheOpinionsoftheGeneralOfficeoftheCPCCentralCommitteeandtheGeneralOfficeoftheStateCouncilonDeepeningtheReformofReview&ApprovalSystemtoEncourageInnovationinDrugsandMedicalDevices(GeneralOffice[2017]No.
42),andtheAnnouncementonAdjustingtheReview&ApprovalItemsofAPIs,PharmaceuticalExcipientsandPackagingMaterials(AnnouncementNo.
146of2017)issuedbytheformerCFDA,onJuly16,2019,NMPAissuedtheAnnouncementonIssuesConcerningtheFurtherImprovementofDrug-relatedAssociatedReview&ApprovalandSupervision,tofurtherclarifytheadministrativedetailsforassociatedreview&approvalandsupervisionofOffice[2018]No.
47),tofurtherreduceredundantcertificationfortheconvenienceofthepeopleandserviceoptimization,NMPAissuedonJuly24,2019theAnnouncementonCancellationof16CertificationItems(SecondBatch),thelistedcertificationitemsshallbesuspendedfromthedateofpromulgation.
(July24,2019)APIs,pharmaceuticalexcipients,packagingmaterialsandcontainersindirectcontactwithpharmaceuticals(hereinafterreferredtoasAEP:APIs+excipients+packaging)withdrugs/preparations.
I.
Overallrequirements(1)TheuseofAEPmustcomplywiththemedicinalrequirements,mainlyreferringtothequality,safetyandfunctionofAEPshouldmeettheneedsofthepharmaceuticalpreparation.
Thereview&approvalofAEPanddrug/preparationassociatedregistrationshallberegisteredontheregistrationplatformbyAEPregistrant,andthedrug/preparationregistrationapplicantshallassociatethedatawiththeVolumeVII20193关联审评审批由原辅包登记人在登记平台上登记,药品制剂注册申请人提交注册申请时与平台登记资料进行关联;因特殊原因无法在平台登记的原辅包,也可在药品制剂注册申请时,由药品制剂注册申请人一并提供原辅包研究资料.
(二)原辅包登记人负责维护登记平台的登记信息,并对登记资料的真实性和完整性负责.
境内原辅包供应商作为原辅包登记人应当对所持有的产品自行登记.
境外原辅包供应商可由常驻中国代表机构或委托中国代理机构进行登记,登记资料应当为中文,境外原辅包供应商和代理机构共同对登记资料的真实性和完整性负责.
(三)药品制剂注册申请人申报药品注册申请时,需提供原辅包登记号和原辅包登记人的使用授权书.
(四)药品制剂注册申请人或药品上市许可持有人对药品质量承担主体责任,根据药品注册管理和上市后生产管理的有关要求,对原辅包供应商质量管理体系进行审计,保证符合药用要求.
(五)监管部门对原辅包登记人提交的技术资料负有保密责任,对登记平台的技术信息保密,登记平台只公开登记品种的登记状态标识(A或I)、登记号、品种名称、企业名称(代理机构名称)、企业生产地址、原药品批准文号(如有),原批准证明文件有效期(如有),产品来源、规格、更新日期和其他必要的信息.
二、产品登记管理(六)原辅包登记人按照登记资料技术要求在平台登记,获得登记号.
其中,原料药在登记前应取得相应生产范围的《药品生产许可证》,并按照原食品药品监管总局《关于发布化学药品新注册分类申报资料要求(试行)的通告》(2016年第80号)要求进行登记;药用辅料和药包材登记按照本公告1、2的资料要求进行登记.
登记资料技术要求根据产业发展和科学技术进步不断完善,由国家药品监督管理局药品审评中心(以下简称药审中心)适时更新公布.
(七)药品制剂注册申请与已登记原辅包进行关联,药品制剂获得批准时,即表明其关联的原辅包通过了技术审评,登记平台标识为"A";未通过技术审评或尚未与制剂注册进行关联的标识为"I".
(八)除国家公布禁止使用、淘汰或者注销的原辅包外,符合以下情形的原辅包由药审中心将相关信息转入登记平台并给予登记号,登记状态标识为"A":1.
批准证明文件有效期届满日不早于platformregistrationdatawhensubmittingtheregistrationapplication;forAEPsthatcannotberegisteredontheplatformforspecialreasons,itisalsopossiblefordrug/preparationregistrationapplicantstoprovidetheAEPresearchdossierstogetherwiththeapplicationfordrug/preparationregistration.
(2)AEPregistrantisresponsibleformaintainingtheregistrationinformationoftheregistrationplatform,andfortheauthenticityandcompletenessoftheregistrationinformation.
AEPsupplier,asAEPregistrant,shallregistertheproductvoluntarily.
TheoverseasAEPsuppliersmayberegisteredbytheirresidentrepresentativeofficesinChina,orentrustedChineseagencies.
TheregistrationinformationshallbeinChinese,andtheoverseasAEPsupplierandagencyshallbejointlyresponsiblefortheauthenticityandcompletenessoftheregistrationinformation.
(3)Whenapplyingforregistrationofadrug/preparation,theapplicantmustprovidetheAEPregistrationnumberandtheauthorizationletterofAEPregistrant.
(4)Theapplicantfordrug/preparationregistrationortheMarketingAuthorizationHolderbearstheprincipalresponsibilityfordrugquality.
Accordingtotherelevantrequirementsfordrugregistrationandpost-marketingproductionmanagement,thequalitymanagementsystemofAEPsuppliershallbeauditedtoensurecompliancewiththerequirementsofdruguse.
(5)TheregulatorydepartmentshallberesponsiblefortheconfidentialityofthetechnicalinformationsubmittedbyAEPregistrant,aswellasthetechnicalinformationoftheregistrationplatform.
Theregistrationplatformshalldiscloseonlytheregisteredvariety'sregistrationstatusindicator(AorI),registrationnumber,varietyname,company/agencyname,productionaddress,theoriginaldrugapprovalnumber(ifany),thevalidityperiodoftheoriginalapprovaldocument(ifany),productsource,specification,updatedateandothernecessaryinformation.
II.
Productregistrationmanagement(6)AEPregistrantshallregisterontheplatformperthetechnicalrequirementsoftheregistrationdossiers,andobtaintheregistrationnumber.
APIsshould,priortoregistration,obtaintheDrugManufacturingCertificatewithinthecorrespondingproductionscope,andregisterinaccordancewiththeAnnouncementonPromulgatingtheRequirementsforApplicationDossiersofChemicalsinNewRegistrationClassifications(Interim)(CFDAAnnouncementNo.
80of2016);pharmaceuticalexcipientsandpharmaceuticalpackagingmaterialsshallberegisteredperthedatarequirementsofAnnex1andAnnex2ofthisAnnouncement.
Thetechnicalrequirementsforregistrationdossiersshallbecontinuouslyimprovedaccordingtoindustrialdevelopmentandscientificandtechnologicalprogress,andupdatedandannouncedinduecoursebyCDEofNMPA(hereinafterreferredtoasCDE).
(7)Theapplicationforregistrationofthedrug/preparationshallbeassociatedwiththeregisteredAEP.
Wherethedrug/preparationisapproved,itindicatesthatitsassociatedAEPhasalsopassedthetechnicalreview,andmarkedasAontheregistrationplatform;wherethetechnicalreviewfailedortheassociationisunestablished,theidentifiershallbeI.
(8)ExceptforAEPsphasedout,cancelled,orprohibitedbythestatefrombeingused,AEPthatmeetsthefollowingconditionsshallbetransferredtotheregistrationplatformbyCDEandtheregistrationnumbershallbegiven,andtheregistrationstatusshallbemarkedasA:1.
APIswithanexpirationdateoftheapproval/proofdocumentnoearlierthanNovember27,2017;2.
APIsthathavebeenacceptedand4NATIONALMEDICALPRODUCTSNEWSLETTER2017年11月27日的原料药;2.
已受理并完成审评审批的原料药,含省局按照国食药监注〔2013〕38号文审评的原料药技术转让申请;3.
已受理并完成审评的药用辅料和药包材;4.
曾获得批准证明文件的药用辅料;5.
批准证明文件有效期届满日不早于2016年8月10日的药包材.
转入登记平台的原辅包登记人应按照本公告登记资料要求在登记平台补充提交研究资料,完善登记信息,同时提交资料一致性承诺书(承诺登记平台提交的技术资料与注册批准技术资料一致).
(九)仿制或进口境内已上市药品制剂所用的原料药,原料药登记人登记后,可进行单独审评审批,通过审评审批的登记状态标识为"A",未通过审评审批的标识为"I".
审评审批时限和要求按照现行《药品注册管理办法》等有关规定执行.
(十)已在食品、药品中长期使用且安全性得到认可的药用辅料可不进行登记(名单详见3),由药品制剂注册申请人在制剂申报资料中列明产品清单和基本信息.
但药审中心在药品制剂注册申请的审评过程中认为有必要的,可要求药品制剂注册申请人补充提供相应技术资料.
该类药用辅料品种名单由药审中心适时更新公布.
(十一)药用辅料、药包材已取消行政许可,平台登记不收取费用.
原料药仍为行政许可,平台登记技术审评相关要求按现行规定和标准执行.
三、原辅包登记信息的使用和管理(十二)药品制剂注册申请关联审评时,原辅包登记平台研究资料不能满足审评需要的,药审中心可以要求药品制剂注册申请人或原辅包登记人进行补充.
补充资料的报送途径由药审中心在发补通知中明确.
(十三)原料药标识为"A"的,表明原料药已通过审评审批.
原料药登记人可以在登记平台自行打印批准证明文件、质量标准和标签等,用于办理GMP检查、进口通关等.
未进行平台登记而与药品制剂注册申报资料一并提交研究资料的原料药,监管部门在药品制剂批准证明文件中标注原料药相关信息,可用于办理原料药GMP检查、进口通关等.
(十四)原料药生产企业申请GMP检查程序及要求按照现行法律法规有关规定执行,通过药品GMP检查后应在登记平台更新登记信息.
completedforreviewandapproval,includingtheapplicationfortechnologytransferofAPIsreviewedbytheprovincialadministrationinaccordancewiththeCFDADepartmentofDrugRegistration[2013]No.
38Document;3.
Pharmaceuticalexcipientsandpharmaceuticalpackagingmaterialswhoseapplicationshavebeenacceptedandcompletedforreview;4.
Pharmaceuticalexcipientsthatonceobtainedapprovaldocuments;5.
Pharmaceuticalpackagingmaterialswithanexpirationdateoftheapproval/proofdocumentnoearlierthanAugust10,2016.
AEPregistranttransferredtotheregistrationplatformshallsubmittheresearchmaterialsontheplatformpertherequirementsforregistrationdossiersstatedherein,enrichtheregistrationinformation,andsubmitthedataconsistencycommitmentletter(claimingthatthetechnicaldatasubmittedbytheregistrationplatformisconsistentwiththatoftheregistrationapproval).
(9)ForAPIsofgenericsorimporteddrug/preparationdomesticallymarketed,aftertheregistrationoftheAPIregistrants,theymaybesubjecttoseparatereviewandapproval,andtheregistrationstatusofthepassedreview&approvalshallbemarkedasA,otherwise:I.
ThetimelimitandrequirementsforreviewandapprovalshallcomplywiththeProvisionsforDrugRegistrationandotherrelevantregulations.
(10)Pharmaceuticalexcipientswithlong-termusageinfoodsandmedicinesandrecognizedsafety(seeAnnex3fordetailsofthelist)candowithoutregistration,theapplicantsforregistrationofdrug/preparationshalllisttheproductlistandbasicinformationinthepreparationapplicationdossiers.
However,whereCDEconsidersitnecessaryduringthereviewprocessofdrug/preparationregistrationapplication,itmayrequesttheapplicanttoprovidethecorrespondingtechnicalinformation.
ThelistofsuchmedicinalexcipientsshallbeupdatedbyCDEinduecourse.
(11)Administrativelicenseshavebeencancelledforpharmaceuticalexcipientsandpharmaceuticalpackagingmaterials,thencenofeesarechargedforplatformregistration.
APIs,however,arestillsubjecttoadministrativelicenses,andtherelevantrequirementsforplatformregistrationandtechnicalreviewareimplementedinaccordancewithcurrentregulationsandstandards.
III.
TheuseandmanagementofAEPregistrationinformation(12)WheretheresearchmaterialsofAEPregistrationplatformcannotmeettheneedsintheassociatedreviewofapplicationforregistrationofdrug/preparation,CDEmayrequiretheapplicantortheoriginalregistranttosupplementdossiers.
ThemeansofsubmissionofsupplementaryinformationshallbespecifiedbyCDEinthenoticeforsupplementaryinformation.
(13)WheretheAPIismarkedasA,itindicatesthattheAPIhaspassedthereviewandapproval.
TheAPIsregistrantcanprinttheapproval/proofdocument,qualitystandardsandlabelsetc.
viatheregistrationplatformvoluntarilyforGMPinspectionandimportcustomsclearance.
ForAPIsnotregisteredontheplatformandwhoseresearchmaterialsaresubmittedtogetherwiththedrug/preparationregistrationapplicationdossiers,theregulatorydepartmentshallindicatetherelevantAPIsinformationinthedrug/preparationapprovaldocument,whichmaybeusedfortheGMPinspectionofAPIsandimportcustomsclearance.
(14)TheproceduresandrequirementsofAPIsmanufacturers'applicationforGMPinspectionshallcomplywiththerelevantprovisionsofthecurrentlawsandregulations,andtheregistrationinformationshallbeupdatedontheregistrationplatformVolumeVII20195(十五)标识为"A"的原料药发生技术变更的,按照现行药品注册管理有关规定提交变更申请,经批准后实施.
原料药的其他变更、药用辅料和药包材的变更应及时在登记平台更新信息,并在每年第一季度提交的上一年年度报告中汇总.
(十六)原辅包发生变更时原辅包登记人应主动开展研究,并及时通知相关药品制剂生产企业(药品上市许可持有人),并及时更新登记资料,并在年报中体现.
药品制剂生产企业(药品上市许可持有人)接到上述通知后应及时就相应变更对药品制剂质量的影响情况进行评估或研究,属于影响药品制剂质量的,应报补充申请.
(十七)已上市药品制剂变更原辅包及原辅包供应商的,应按照《已上市化学药品变更研究技术指导原则(一)》《已上市化学药品生产工艺变更研究技术指导原则》《已上市中药变更研究技术指导原则(一)》及生物制品上市后变更研究相关指导原则等要求开展研究,并按照现行药品注册管理有关规定执行.
(十八)境外原辅包供应商更换登记代理机构的,提交相关文件资料后予以变更.
包括:变更原因说明、境外原辅包供应商委托书、公证文书及其中文译本、新代理机构营业执照复印件、境外原辅包供应商解除原代理机构委托关系的文书、公证文书及其中文译本.
四、监督管理(十九)各省(区、市)药品监督管理局对登记状态标识为"A"的原料药,按照药品进行上市后管理,并开展药品GMP检查.
(二十)各省(区、市)药品监督管理局应加强对本行政区域内药品制剂生产企业(药品上市许可持有人)的监督检查,督促药品制剂生产企业(药品上市许可持有人)履行原料药、药用辅料和药包材的供应商审计责任.
药用辅料和药包材生产企业具有《药品生产许可证》的,继续按原管理要求管理,许可证到期后按本公告要求登记场地信息.
(二十一)各省(区、市)药品监督管理局根据登记信息对药用辅料和药包材供应商加强监督检查和延伸检查.
发现药用辅料和药包材生产存在质量问题的,应依法依规及时查处,并要求药品制剂生产企业(药品上市许可持有人)不得使用相关产品,并对已上市产品开展评估和处置.
延伸检查应由药品制剂生产企业(药品上市许可持有人)所在地省局组织开展.
药用辅料和药包材供afterpassingthedrugGMPinspection.
(15)WhereatechnicalchangeofAPIsidentifiedasAoccurs,anapplicationforchangeshallbesubmittedinaccordancewiththerelevantprovisionsonthecurrentdrugregistrationmanagement,andshallbeimplementedafterapproval.
OtherchangesinAPIs,changesinpharmaceuticalexcipientsandpharmaceuticalpackagingmaterialsshouldbeupdatedinatimelymannerontheregistrationplatformandsummarizedinthepreviousyear'sannualreportsubmittedinthefirstquarterofeachyear.
(16)WhereanychangearisesforAEP,theAEPregistrantshallinitiateresearchonitsowninitiative,andpromptlynotifytherelevantdrug/preparationproductionenterprise(DrugMarketingAuthorizationHolders),updatetheregistrationinformationinatimelymannerandspecifyitintheannualreport.
Afterreceivingtheabovenotice,thedrug/preparationmanufacturer(MarketingAuthorizationHolder)shallpromptlyevaluateorstudytheimpactofthecorrespondingchangeonthequalityofthedrug/preparation,ifqualityisaffected,itshallfileasupplementaryapplication.
(17)WheretheAEPandAEPsupplierofmarketedpharmaceuticalpreparationsaresubjecttochange,researchshallbeconductedfollowingtheTechnicalGuidelinesforStudiesontheAlterationsofPost-MarketedChemicals(I),TechnicalGuidelinesforStudiesontheProductionProcessAlterationsofPost-MarketedChemicals,andTechnicalGuidelinesforStudiesonAlterationsofPost-MarketedTCMs(I),aswellastherelevantprovisionsonthecurrentdrugregistrationmanagement.
(18)WheretheoverseasAEPsupplierreplacestheregistrationagency,itshallbechangedaftersubmittingrelevantdocumentsandmaterials,including:explanationofreasonsforchange,letterofentrustmentbyoverseasAEPsupplieralongwithitsnotarizeddocumentanditsChinesetranslation,copyofbusinesslicenseofnewagency,documentofforeignAEPsuppliertocanceltheentrustmentrelationshipoftheoriginalagencyalongwithitsnotarizeddocumentandChineseTranslation.
IV.
Supervisionandmanagement(19)Thedrugregulatoryauthoritiesoftheprovinces(autonomousregionsandmunicipalities)shall,afterthemarketingoftheAPIswiththeregistrationstatusmarkedA,conductpost-marketingmanagementaccordingtothedrugs,andcarryoutdrugGMPinspections.
(20)Thedrugregulatoryauthoritiesoftheprovinces(autonomousregionsandmunicipalities)shallstrengthenthesupervisionandinspectionofdrug/preparationenterprises(DrugMarketingAuthorizationHolder)withintheirrespectiveadministrativeregions,superviseandurgedrug/preparationenterprises(DrugMarketingAuthorizationHolder)toperformsupplierauditresponsibilityforAPIs,pharmaceuticalexcipientsandpharmaceuticalpackagingmaterials.
ForpharmaceuticalexcipientsandpharmaceuticalpackagingmaterialsmanufacturersholdingtheDrugManufacturingCertificate,theyshallcontinuetobemanagedaccordingtotheoriginaladministrativerequirements.
AftertheCertificateexpires,thesiteinformationshallberegisteredinaccordancewiththerequirementsofthisAnnouncement.
(21)Thedrugregulatoryauthoritiesofallprovinces(autonomousregionsandmunicipalities)shallstrengthensupervision,inspectionandextensioninspectionofsuppliersofpharmaceuticalexcipientsandpharmaceuticalpackagingmaterialsaccordingtotheregistrationinformation.
Wherequalityproblemsarespottedintheproductionofpharmaceuticalexcipientsandpharmaceuticalpackagingmaterials,theyshallbeinvestigatedanddealtwithinaccordancewiththelawsandregulationsinatimelymanner,thecorrespondingdrug/preparationmanufacturers(drugMarketingAuthorizationHolders)shallnolongerusetherelevantproducts,andthemarketedproductsshallbesubjecttoevaluationanddisposal.
Theextendedinspectionshallbeorganizedbytheprovincial6NATIONALMEDICALPRODUCTSNEWSLETTER应商的日常检查由所在地省局组织开展联合检查.
药用辅料生产现场检查参照《药用辅料生产质量管理规范》(国药监安〔2006〕120号)开展检查,药包材生产现场检查参照《直接接触药品的包装材料和容器管理办法》(原国家食品药品监督管理局局令第13号)中所附《药包材生产现场考核通则》开展检查.
各省(区、市)药品监督管理局可根据监管需要进一步完善相关技术规范和检查标准,促进辅料和药包材质量水平稳步提升.
国家药品监督管理局将根据各省监督检查开展情况和需要,适时修订相关检查标准.
五、其他(二十二)在中华人民共和国境内研制、生产、进口和使用的原料药、药用辅料、药包材适用于本公告要求.
(二十三)本公告自2019年8月15日起实施.
原发布的原辅包相关文件与本公告要求不一致的,以本公告为准.
原食品药品监管总局发布的《关于发布药包材药用辅料申报资料要求(试行)的通告》(2016年第155号)同时废止.
1.
药用辅料登记资料要求(试行)(略)2.
药包材登记资料要求(试行)(略)3.
可免登记的产品目录(2019年版)(略)4.
药用原辅料、药包材年度报告基本要求(略)(2019-07-16)为深入贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号)精神,加快推进医疗器械产业创新发展,在前期上海、广东、天津自贸区开展医疗器械注册人制度试点工作的基础上,2019年8月1日,国家药品监督管理局发布《关于扩大医疗器械注册人制度试点工作的通知》(国药监械注〔2019〕33号,以下简称《通知》),进一步扩大医疗器械注册人制度试点,为全面实施医疗器械注册人制度国家药品监督管理局发布《关于扩大医疗器械注册人制度试点工作的通知》NMPAIssuedtheNoticeonExpandingthePilotoftheMedicalDeviceRegistrantSystemadministrationwherethedrug/preparationmanufacturer(drugMarketingAuthorizationHolder)islocated.
Thedailyinspectionofsuppliersofpharmaceuticalexcipientsandpharmaceuticalpackagingmaterialsshallbeorganizedbythelocalprovincialadministrationforjointinspection.
On-siteinspectionoftheproductionofpharmaceuticalexcipientsshallbecarriedoutinaccordancewiththeGMPforPharmaceuticalExcipients(SFDADepartmentofDrugSupervision[2006]No.
120).
Theon-siteproductioninspectionofthepharmaceuticalpackagingmaterialsshallfollowtheGeneralRulesforProductionSiteInspectionofPharmaceuticalPackagingMaterialsattachedtotheMeasuresfortheAdministrationofPackagingMaterialsandContainersforDirectContactwithMedicines(FormerSFDAOrderNo.
13).
Thedrugregulatoryauthoritiesofvariousprovinces(autonomousregionsandmunicipalities)mayfurtherimproverelevanttechnicalspecificationsandinspectionstandardsaccordingtoregulatoryneeds,andpromotethesteadyimprovementofthequalityofexcipientsandpharmaceuticalpackagingmaterials.
NMPAshallrevisetherelevantinspectionstandardsinduetimeaccordingtothesituationandneedsofvariousprovinces'supervisionandinspection.
AspertheOpinionsoftheGeneralOfficeoftheCPCCentralCommitteeandtheGeneralOfficeoftheStateCouncilonDeepeningtheReformofReview&ApprovalSystemtoEncourageInnovationinDrugsandMedicalDevices(GeneralOffice[2017]No.
42),toacceleratetheinnovationanddevelopmentofthemedicaldeviceindustry,onthebasisoftheearlypilotsofmedicaldeviceregistrantsysteminShanghai,GuangdongandTianjinFreeTradeZones,onAugust1,2019,NMPAissuedV.
Others(22)APIs,pharmaceuticalexcipientsandpharmaceuticalpackagingmaterialsdeveloped,produced,importedandusedwithintheterritoryofthePeople'sRepublicofChinashallbeapplicabletotherequirementsofthisAnnouncement.
(23)ThisAnnouncementshallcomeintoforceasofAugust15,2019.
WheretheoriginaldocumentsrelatedtoAEPareinconsistentwiththerequirementsofthisAnnouncement,thisAnnouncementshallprevail.
TheAnnouncementontheReleaseofRequirementsforApplicationDossiersofPharmaceuticalPackagingMaterialsandPharmaceuticalExcipients(Interim)(AnnouncementNo.
155,2016)issuedbytheformerCFDA,shallberepealedsimultaneouslyAnnexes:1.
Requirementsforregistrationofmedicalexcipients(Interim)(omitted)2.
Requirementsforregistrationofmedicalpackagingmaterials(Interim)(omitted)3.
Catalogueofproductsthatcanbeexemptedfromregistration(2019edition)(omitted)4.
Basicrequirementsfortheannualreportofmedicinalrawmaterials,excipientsandpharmaceuticalpackagingmaterials(omitted)(July16,2019)theNoticeonExpandingthePilotoftheMedicalDeviceRegistrantSystem(NMPADepartmentforMedicalDeviceRegistration[2019]No.
33,hereinafterreferredtoastheNotice,tofurtherexpandthepilotprogramofthemedicaldeviceregistrantsystem,andfurtheraccumulateexperienceforthefullimplementationofit.
TheNoticestipulatesthecorrespondingconditionsandobligationsfortheregistrantsandtheentrustedmanufacturers医疗器械MedicalDevicesVolumeVII20197为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号),配合医疗器械注册电子申报工作的开展,根据《医疗器械注册管理办法》(原国家食品药品监督管理总局令第4号)等文件要求,国家药品监督管理局组织制定了《医疗器械产品注册项目立卷审查要求(试行)》等立卷审查要求,于2019年7月10日发布,自2019年9月1日起实施.
国家药品监督管理局医疗器械技术审评中心在受理环节按照立卷审查要求对相应申请的申报资料进行审查,对申报资料进入技术审评环节的完整性、合规性、一致性进行判断.
立卷审查不对产品安全性、有效性评价的合理性、充分性进行分析,不对产品风险受益比进行判定.
立卷审查适用于医疗器械注册、许可事项变更、临床试验审批等申请事项.
(2019-07-10)国家药品监督管理局发布《关于医疗器械产品注册项目立卷审查要求(试行)》等文件的通告》NMPAIssuedtheAnnouncementontheRequirementsforFilingReviewofRegistrationItemsofMedicalDeviceProducts(Interim)AspertheOpinionsoftheGeneralOfficeoftheCPCCentralCommitteeandtheGeneralOfficeoftheStateCouncilonDeepeningtheReformofReview&ApprovalSystemtoEncourageInnovationinDrugsandMedicalDevices(GeneralOffice[2017]No.
42),inconjunctionwiththerolloutofelectronicapplicationofmedicaldeviceregistration,accordingtotheProvisionsforMedicalDeviceRegistration(formerCFDADecreeNo.
4)andtherequirementsofotherdocuments,NMPAorganizedtheformulationoftheRequirementsforFilingReviewofRegistrationItemsofMedicalDeviceProducts(Interim),whichhasbeenreleasedonJuly10,2019,andshallenterintoforceasfromSeptember1,2019.
TheNMPACenterforMedicalDeviceEvaluationshallexaminethedossiersofthecorrespondingapplicationsinaccordancewiththerequirementsforfilingreviewinthecase-acceptanceprocess,tojudgetheintegrity,complianceandconsistencyoftheapplicationdossiersenteringthetechnicalreviewprocess.
Thefilingreviewdoesnotanalyzetherationalityandadequacyofproductsafetyandeffectivenessevaluation,anddoesnotjudgetheproductriskbenefitratio.
Itisapplicabletoapplicationssuchasmedicaldeviceregistration,licensingalterations,andclinicaltrialapproval.
(July10,2019)进一步积累经验.
《通知》对参与试点工作的注册人和受托生产企业分别规定了相应的条件和义务责任,明确双方应当签订委托合同和质量协议,并对产品注册、变更和生产企业许可证办理程序进行了规定,同时强调各级药品监管部门应当加强对注册人履行保证医疗器械质量、上市销售与服务、医疗器械不良事件监测与评价、医疗器械召回等义务情况的监督管理.
(2019-08-01)participatinginthepilot,clarifyingthatbothpartiesshouldsigntheentrustmentcontractandqualityassuranceagreement;italsostipulatestheproceduresforproductregistration,alterationsandmanufacturerlicense.
Atthesametime,itisemphasizedthatdrugregulatoryauthoritiesatalllevelsshouldstrengthensupervisionandmanagementofregistrants'performanceofobligationssuchasguaranteeingqualityofmedicaldevices,marketsalesandservices,monitoringandevaluationofadverseeventsofmedicaldevices,andrecallofmedicaldevices,etc.
(August1,2019)为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(厅字〔2017〕42号)的要求,有序推进医疗器械注册电子申报工作,2019年7月10日,国家药品监督管理局发布《关于医疗器械电子申报有关资料要求的通告》,就有关资料的提交提出了要求.
(2019-07-10)国家药品监督管理局发布《关于医疗器械电子申报有关资料要求的通告》NMPAIssuedtheAnnouncementontheRequirementsforRelevantElectronicApplicationDossiersofMedicalDevicesPursuanttotheOpinionsoftheGeneralOfficeoftheCPCCentralCommitteeandtheGeneralOfficeoftheStateCouncilonDeepeningtheReformofReview&ApprovalSystemtoEncourageInnovationinDrugsandMedicalDevices(GeneralOffice[2017]No.
42),toorderlypromotetheelectronicapplicationofmedicaldeviceregistration,onJuly10,2019,NMPAissuedtheAnnouncementontheRequirementsforRelevantElectronicApplicationDossiersofMedicalDevices,toregulatethesubmissionofrelevantdossiers.
(July10,2019)8NATIONALMEDICALPRODUCTSNEWSLETTERNotes:AllChineseinformationintheNewsletterisextractedfromnewspapersandtheInternet.
AllEnglisharticlesaretranslationsfromtheChineseversion.
ForelectronicversionoftheNewsletterpleasevisithttp://www.
ccfdie.
org备注:Newsletter中所有中文信息摘自报刊及网络.
英文均系中文翻译.
电子版Newsletter阅览请登录网站http://www.
ccfdie.
orgChinaCenterforFoodandDrugInternationalExchange(CCFDIE)中国食品药品国际交流中心Address:Room1106,11thFloor,OfficeBuildingB,MaplesInternationalCenter,No.
32,XizhimenNorthStreet,HaidianDistrict,Beijing,100082,P.
R.
C.
中国北京市海淀区西直门北大街32号枫蓝国际中心B座写字楼11层1106室邮编:100082Tel:010-82212866Fax:010-82212857Email:ccfdie@ccfdie.
orgWebsite:www.
ccfdie.
orgServier(Tianjin)PharmaceuticalCo.
,Ltd.
施维雅(天津)制药有限公司Address:6Floor,WestBuilding,WorldFinancialCenter,No.
1,East3rdRingMiddleRoad,ChaoyangDistrict,100020Beijing,China北京市朝阳区东三环中路1号环球金融中心西楼6层邮编:100020Tel:010-65610341Fax:010-65610348Website:www.
servier.
com.
cn为加强独立软件类医疗器械生产监管,规范独立软件生产质量管理,根据《医疗器械监督管理条例》(国务院令680号)、《医疗器械生产监督管理办法》(国家食品药品监督管理总局令第7号),国家药品监督管理局组织起草了《医疗器械生产质量管理规范附录独立软件》,于2019年7月12日发布.
本附录是独立软件医疗器械生产质量管理规范的特殊要求.
独立软件类医疗器械生产质量管理体系应当符合《医疗器械生产质量管理规范》及本附录的要求.
(2019-07-12)国家药品监督管理局发布《关于医疗器械生产质量管理规范附录独立软件的通告》NMPAIssuedtheAnnouncementonMedicalDeviceGMPAppendix:IndependentSoftwareTostrengthenproductionsupervisionofindependentsoftwareasmedicaldevicesandregulateitsqualitymanagement,accordingtotheRegulationsfortheSupervisionandAdministrationofMedicalDevices(StateCouncilOrderNo.
680),andtheAdministrativeMeasuresfortheSupervisionofMedicalDeviceManufacturing(CFDAOrderNo.
7),NMPAorganizedthedraftingofandreleasedonJuly12,2019theMedicalDeviceGMPAppendix:IndependentSoftware.
ThisAppendixfeaturesspecialrequirementsforindependentsoftwaremedicaldeviceGMP.
TheindependentsoftwaremedicaldeviceproductionqualitymanagementsystemshallcomplywiththerequirementsoftheMedicalDeviceGMPandthisAppendix.
(July12,2019)综合信息GeneralInformation2019年7月18日,国家药品监督管理局英文网站正式上线,这是国家药品监督管理局组建后,全面推进药品监管信息公开、加强公众交流的又一重要举措.
目前,英文版网站设置了机构简介、新闻动态、法规文件、监管信息、政策解读、科普信息、药品、医疗器械、化妆品等栏目,基本与中文网站栏目保持一致,今后将努力实现中英文信息同步更新,及时将中国药品、医疗器械、化妆品监管声音传递到世界.
(2019-07-19)国家药品监督管理局英文网站上线DebutofNMPAEnglishWebsiteOnJuly18,2019,theEnglishwebsiteofNMPAwasofficiallylaunched,markinganotherimportantmeasureforcomprehensivepromotionofdrugregulatoryinformationdisclosureandpubliccommunicationinthewakeoftheestablishmentofNMPA.
Atpresent,theEnglish-versionwebsitehassetupAboutNMPA,News,Laws&Regulations,RegulatoryInformation,PoliciesInterpretation,PopularScience,Drugs,MedicalDevices,CosmeticsandotherColumnsthatarebasicallyinlinewiththoseoftheChinesewebsite.
NMPAwillstrivetoachievesynchronousupdateofChineseandEnglishinformationhenceforth,totimelytransmittheinformationofChina'ssupervisionoverdrugs,medicaldevicesandcosmeticstotheworld.
(July19,2019)