药品注册管理办法-英文版

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DRUGREGISTRATIONREGULATION

(SFDAOrder28)

(TranslationbyRDPAC,forMemberuonly)

DrugRegistrationRegulationwasapprovedonJune18,2007by

SFDAexecutivemeetingandisherebypublished,whichbecome

effectivefromOctober1焖锅,2007.

SFDACommissioner

ShaoMinli

July10,2007

DRUGREGISTRATIONREGULATION

Chapter1:GeneralPrinciples

Article1:ThisRegulationispromulgatedaccordingtothe

DrugAdministrationLawofThePeople’sRepublicofChina(Drug

AdministrationLaw),AdministrativeLicensingLawofThe

People’sRepublicofChina(AdministrativeLicensingLaw),and

theImplementingRegulationoftheDrugAdministrationLawof

ThePeople’sRepublicofChina(ImplementingRegulation)to

ensurethesafety,efficacyandqualitycontrolofdrugsand

standardizedrugregistration.

Article2:ThisRegulationshallapplytoalldrugrearch

andclinicalstudies,applicationforclinicalstudy,drug

productionand/orimportation,aswellasthedrugapproval

review繁体签名设计,registrationinspectionanddrugadministrationinThe

People’sRepublicofChina(PRC).

Article3:Drugregistrationmeansthelegalprocessbywhich

adecisionismadebySFDA,uponapplicationofregistration

applicant,toeitherapproveornotapprovetheconductingof

adrugclinicaltrial小袋鼠,productionorimportationofadrugto

bemarketed2022年北京冬奥会开幕式时间,badonasystematicevaluationofthesafety应届毕业生入伍,

efficacyandqualitycontrolofthedrug.

Article4:TheStateshallencouragerearchanddevelopment

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ofnewdrugsandexercitheapprovalviaaspecialprocess

ofinnovativenewdrugs,thofordifficulttotreatandlife

threateningdias.

Article5:TheStateFoodandDrugAdministration(SFDA)is

thecompetentnationalauthorityfordrugregistration,

responsibleforthereviewandapprovalofclinicalstudies心声黄蓓佳,

productionandimportationofdrugs.

Article6:Drugregistrationshouldfollowtheprinciplesof

opennesquality电脑关机后蓝屏,fairness,andfortheconvenienceofthe

publics胡萝卜减肥.

Duringdrugregistration西北民族大学怎么样,SFDAshallapplythesystemsofjoint

responsibilityofthepresidingreviewer刘艺书法,publicdisclosure

andrescuingoftherelatedstaff寻雾启事,responsibility

investigationforanywrongdoing这世界需要你作文,inordertoadministerthe

stepsfromacceptance宝贝宝贝,inspection,review,approval,through

delivery封开杨池古村,andsubjecttomonitoringbythepublics.

Article7:Duringdrugregistration红绣添香,shouldthedrug

administrativeauthorityconsideranypermittingissuesof

significantinteresttothepublics,theissuesshouldbe

announcedtothepublicsandpublichearingshouldbeheld过敏性鼻炎中药.

Shouldtheadministrativepermittingberelatedtoany

significantinterestbetweenapplicantandotherparties,

beforeanydecisionismade大学生成长报告1000字,drugadministrationauthorities

shouldnotifyapplicantandotherpartiesoftheirentitlement

torequestinghearings,statementanddefending化学元素表.

Article8:Drugadministrationauthoritiesshallprovide

applicantwithaccessibleinformationregardingdrug

registrationacceptance大学副班长工作总结,inspection,test感谢生活,evaluation中国台风,

approvalprogressandconclusionandsoon.

Drugadministrationauthoritiesshouldpubliclydisclothe

followinginformationattheofficialwebsiteand/oroffice

location.

gistrationapplicationitems,procedure伤感网,fee

standardsandbasis海藻面膜的功效,timeline,tableofcontentofall

requireddossier2018最火爆微信头像,aswellasreferenceapplication

documents.

standtherelatedinformationofthestaffateach

stepsfromacceptance,inspection乐嘉写给女儿的信,test南京理工大学泰州科技学院,review葫芦娃主题曲,through

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approval电脑开机密码忘记怎么办.

linformationofdrugregistrationsuchas

formularyoftheapproveddrugs归去来兮辞原文.

Article9:Thedrugadministrationauthority雨中的回忆,unitsand

staffsinvolvedshallassumetheresponsibilityofprotecting

thetechnicalcretsanddataprovidedbyapplicantsduring

theprocessofdrugregistration.

Chapter2:BasicRequirements

Article10:Adrugregistrationapplicant(applicant)means

aninstitutionthatmakesdrugapplicationandassumes

correspondingliabilityfordrugregistration孕妇发烧怎么退烧.

Alocalapplicantshallbealegallyregisteredinstitutionin

Chinaandbecompetenttoindependentlyassumelegalliability中秋节手抄报精美.

Aforeignapplicantshallbealegallyestablished

ngapplication

foranimporteddrugregistration无精打采的反义词,theforeignapplicantshall

uitsofficeinChina,orauthorizeanagentinChinatohandle

theapplication韩国首尔旅游.

Theperson(s)handlingthedrugregistrationapplicationshall

havetechnicalexperti,andbefamiliarwithdrug

administrationlaws,regulationsandtechnicalrequirements6月份去哪旅游好.

Article11:Drugregistrationapplicationincludes

applicationfornewdrug,genericdrugapplications,

applicationforimporteddrug,supplementalapplication,as

wellasre-registrationapplication.

Alocalapplicantshallmakeapplicationaccordingtonewdrug

orgenericdrugapplications;aforeignapplicantshallmake

applicationaccordingtoimporteddrug.

Article12:Anewdrugapplicationmeansaregistration

applicationforadrugthathasnotbeenmarketedinChina.

Applicationsmadeforachangeindosageform你摊上事儿了小品,orrouteof

administration,additionalnewindicationofdrugsshallbe

madeaccordingtonewdrugregistrationprocedure值班制度.

Genericdrugapplicationmeansapplicationforregistrationof

adrugforwhichSFDAhasalreadyissuedformalstandards同学赠言,

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however,applicationofbiologicalproductsshallbefollownew

drugapplication可爱颂译音.

Applicationforimporteddrugmeansapplicationforadrug

producedoutsideChinatobemarketedinChina.

Supplementalapplicationmeansanapplicationforthechange,

addition健壮的意思,orcancellationofanyitemorcontentsinthe

existingregistrationapprovalofanewdrug,genericdrug

applications最好的qq头像,orimporteddrug纪念红军长征胜利80周年.

Are-registrationapplicationmeanstheapplicationto

continuethedrugproductionorimportationaftertheexpiry

ofthecertifieddrugapprovaldocuments中国人被至境外.

Article13:Applicantsshouldprovidesufficientandreliable

rearchdatatoevidencethesafety,effectivenessandquality

controlofthedrugs,andassumeliabilityofthetruthfulness

oftheentiredossierswot分析表格.

Article14:Incitingliteratureandmaterials苏小m,thenameof

thework(s)andjournal(s)aswellasvolume,issueandpage

numbershallbeprovidedintheapplicationdossiersubmitted

ublishedliteratureand

materials母亲节说说,anauthorizationletterfromtheownermustbe

foreignlanguagematerialsaChine

translationshouldbeprovidedinaccordancewithrelevant

requirements.

Article15:SFDAshallimplementtheNationalpharmaceutical

industrydevelopmentplanandpolicy,andmayorganizean

asssmentofthebenefitofintroductionofdrugstothe

market.

Article16:Duringdrugregistration敦煌莫高窟,drugadministration

authoritiesshouldconductonsiteinspectionandinspection

chonfromdecisionofthepre-clinicalstudyandclinical

trials,aswellasconductonsiteinspectionofproductionsite

priortoanymarketingapproval,inordertoconfirmthe

truthfulness,accuracyandcompletenessoftheapplication

dossier.

Article17:Iftwoormoreinstitutionsjointlyapplyfordrug

registration,theapplicationshallbemadetothePDAwhere

heapplicantsare

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manufacturers,theapplicationshallbemadetothePDAwhere

oftheapplicantsisadrugmanufacturer复仇焰魂天赋,theapplicationshall

bemadetothePDAwherethedrugsampleispilotmanufactured.

Article18:Regardingthedrugoritsformula2020年元旦庆祝图片,production

process狼之少年漫画,indicationetc蝉古诗 虞世南.河南工程学院专科分数线,theapplicantshallsubmitdocuments

otherpartyholdspatentinChina,theapplicantshallsubmit

aletterstatingthatthedrugwillnotinfringeonthepatent

ceptanceoftheapplication,drug

administrationauthoritiesshouldpubliclydisclothe

statementsubmittedbyapplicant英语记单词方法.

Ifaninfringementdisputeoccursduringregistration

application,thepartiesshallresolvethematteraccordingto

relevantlawsforpatentadministration.

Article19:Foradrugthathasobtainedpatentprotectionin

China黄芪,anotherapplicantmayapplyforregistrationwithintwo

allreviewthe

applicationaccordingtothisRegulationand,afterexpiration

ofthepatent上海 交通管制,issueadrugapprovalnumber观书有感 朱熹其一其二,ImportedDrug

LicenorDrugProductLicen实用性强,foranapplicationthatmeets

requirements.

Article20:AccordingtoArticle35ofImplementation

Regulation黄钟大吕,foraperiodof6yearsfromthedateoftheoriginal

applicant'sapproval,SFDAshallnotapproveasubquent

applicationthatud,withouttheexpressconntofthe

originalapplicant,theundisclodR&Ddataandotherdata

generatedbytheoriginalapplicantforsubmissionof

applicationofmanufacturingormarketingofadrugcontaining

newchemicalingredients,unlessthesubmitteddatais

generatedbythesubquentapplicantitlf.

Article21:Thescopeofpre-clinicallaboratorystudy

(pre-clinicalstudy)ofadrugforregistrationincludes

syntheticprocess,extractionmethods非洲人的习俗,physical-chemical

propertiesandpurity双黄连口服液说明书,dosageformlection,screeningof

formulas,preparationprocess天辞家见,inspectionmethods360保镖,quality

specification工作汇报开头,stability乒乓球女团决赛直播,pharmacology,toxicologyand

preparations美国总统奖,information

suchasthesourceandtheprocessingofrawmaterialsshould

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logicalproducts,informationsuch

assource,qualitystandards,storagecondition,biological

identity心理健康教育,geneticstabilityandimmunologystudyofstrain木瓜银耳汤的做法,

cellstrainaswellasbiologicaltissueshouldalsobe

included象声词有哪些.

Article22:Pre-clinicalstudyofadrugshallbeconducted

inaccordancewithrelevantregulations柘荣东狮山,wherethedrugsafety

evaluationmustbeconductedinaccordancewithGoodLaboratory

PracticeforPre-ClinicalLaboratoryStudies(GLP)2017年高考改革最新方案.

Article23:Institutionngagedindrugrearchand

developmentshallhavethenecessarypersonnel关胜简介,facility刘洲成个人资料,

equipment,instruments,conditionsandmanagementsystem

neededcorrespondingtotherearchproject,andshall

animals翩跹,reagentsandrawmaterialsudforexperimentsshall

complywithrelevantnationalregulationsandrequirements10大美女.

Article24:Ifanapplicantauthorizesanotherinstitutionto

conductthestudyofdrugs英雄联盟新版本,oranysingleexperiment,

inspectionorpilotproductionandmanufacture,theapplicant

shallsignacontractwiththeauthorizedparty,andmakenotes

licantisresponsiblefor

thetruthfulnessofthedrugstudydataudintheapplication

dossier.逃出克隆岛电影.

Article25:Whenanapplicationisonlymadeforregistration

ofpreparation最好整容医院,therawmaterialsoftheinvestigativedrug

substanceudforthispreparationmusthaveaDrugApproval

Number科比中文,ImportedDrugCertificateorPharmaceuticalProduct

Certificate,andmusthavebeenobtainedfromlegalchannels.

AnyinvestigativedrugsubstancewhichdoesnothaveaDrug

ApprovalNumber,ImporteddrugCertificateorPharmaceutical

ProductCertificatemustbeapprovedbySFDA八年级下册物理复习提纲.

Article26:Ifanapplicantusthedrugstudydatafroma

foreigndrugrearchforadrugregistrationapplication岳母刺字,an

explanationforthestudyitemss6总决赛,andreferencingthepage

numbersissuedbythisinstitutionshallbeprovided,and

notarizedcertificateoftheinstitution'slegaloveras

terthedocumentsare

authenticatedbySFDAmaytheybeincludedintheregistration

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yndpeopletoconducton-siteinspections,

ifnecessary有效课堂教学.

Article27:Duringtheverificationofdrugstudies伊诺娃,drug

authoritiesmayrequesttheapplicantorthedrugrearch

institutethatconductedtheexperimentstorepeatan

experimentforanyitemsbyusingthemethodsanddatalisted

yalsodesignateotherdrug

controlinstitutesordrugrearchinstitutionstorepeatthe

experimentsortovalidatethemethodology第一炉香表达了什么.

Article28:Drugstudyshallbeconductedinaccordancewith

applicantconductstheexperimentsaccordingtoothermethods

andtechniques文具盒阅读答案,theapplicantshallprovideinformationto

evidencethatthemethodsandtechniquesarescientific.

Article29:Afterobtainingthedrugapprovalnumber,the

applicantshouldproducethedrugaccordingtotheprocess

ministrationsshallmonitorthe

productionaccordingtotheapprovedproductionprocessand

standards墙角装饰.

Chapter3:ClinicalTrialsofDrugs

Article30:Clinicalstudyofdrugs能考上清华的四大星座,includingbioequivalence

trials,mustbeapprovedbySFDA扬州环境资源学院,andmustbeconductedin

accordancewithGoodClinicalPractice(GCP).

Drugadministrationsshallmonitortheapprovedclinical

studies幸福的一家.

Article31:Clinicaltrialsshouldbeconductedforthe

istrationapplicationof

genericdrugsandsupplementalapplication拍马屁的由来,clinicaltrails

shouldbeconductedinaccordancewithprovisionsspecifiedin

AppendixofthisRegulation跳皮筋的玩法.

ClinicaltrialsaredividedintoPhaI怀孕的征兆,PhaII怎样写记叙文,PhaIII

andPhaIV敝帚自珍是什么意思.

PhaI:Basicclinicalpharmacologyandhumansafety

rvetoleranceinhumanbodiesand

pharmacokinetics国产奶粉品牌排行榜,providingabasisforadrugadministration

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program.

PhaII:Apreliminaryexplorationonthetherapeuticefficacy险资举牌是什么意思.

Thepurpoistoevaluatethesafetyandefficacyofanewdrug

onpatientswithinthetargetindicationofthedrugs,and

providingthebasistodeviPhaIIIClinicalTrialandto

IClinical

Trialmaybeconductedinmanywaysincludingrandomizedblind

controlledclinicaltrialinaccordancewiththepurpoofthe

study.

PhaIII:

purpoistofurtherverifythesafetyandefficacyofanew

drugforpatientswithtargetedindication强的多音字,toevaluatethe

benefitandrisksrelationship想和你一起慢慢变老,andfinallytoprovide

sufficientdatatosupporttheregistrationapprovalofthe

alsusuallyarerandomized描写大寒节气的诗句,blindandcontrolled

clinicaltrialwithalargenumberofsamplesubjects.

PhaIV:Anewdrugpost-marketingstudy,conductedbythe

ectiveistoinvestigatetheefficacyand

adverreactionsundertheconditionsofwideu,andto

evaluatethebenefitandriskrelationshipwhenudby

ordinaryandspecialgroupsofpatientsandtoimprovedosage

ofthedrugqq动态签名档.

Bioequivalencetrialsmeansthohumantrailstodetermineif

thereisanystatisticaldifferenceinabsorptionand

absorptionspeedofactivecomponentbetweenthesameor

differentdosageformofthesamedrugsunderthesametest

conditions还有眼泪就好,byusingmethodologyofbioavailabilitystudyand

withpharmacokineticparameters金箔玫瑰花.

Article32:Thenumberofhumansubjectsintheclinicalstudy

ofadrugshouldbedecidedinaccordancewiththeobjective

oftheclinicaltrialsandshallmeetboththestatistical

requirementsandtheminimalcasrequiredbythisRegulation

ugudforthetreatmentofrare

andspecialdiasorotherspecialcircumstances王宝强儿女是亲生的吗,any

requirementsforreductioninthenumberofhumansubjectsin

theclinicalstudyorexemptionshouldbemadeatthesametime

ofclinicaltrialapplicationandbeapprovedbySFDA2016年8月17日.

Article33:Foravaccineandotherspecialdrugsprepared

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duringthestrainslectionstage正月初一吃饺子,ifthereisindeedneither

suitableanimalexperimentalmodelnorawaytoevaluatethe

efficacyofthedrugsinlaboratorystudy,applicationof

clinicaltrialsmaymadetoSFDA杜牧 泊秦淮,providedthatsafetyofthe

subjectscanbeensured竞争.

Article34:Afterapprovalofaclinicalstudy,theapplicant

shalllectfromtheinstitutionsqualifiedfordrugclinical

trialtoconducttheclinicalstudy.

Article35:Theinvestigationaldrugsshallbeproducedina

workshopwhichmeetsGMPrequirementsandtheproduction

processshallbestrictlyinaccordancewiththerequirements

licantisresponsibleforthedrugqualityof

theinvestigationaldrugs

Article36:Theapplicantmayinspecttheinvestigational

drugitlfinaccordancewiththedrug'sstandardsforits

lecteddrugsforclinicaltrial,orauthorizeadrugcontrol

institutedesignatedbythisRegulationtoconductthequality

e,bloodproductsandotherbio-products

designatedbySFDAmustbeinspectedbyadrugcontrolinstitute

designatedbySFDA老九门赵丽颖第几集出现.

ThedrugmustnotbeudforClinicalTrailsbeforeithas

pasdtheinspection.

Drugadministrationauthoritiesmayconductarandom

inspectionfortheinvestigationaldrug.

Article37:Beforeconductingtheclinicalstudy今年情人节怎么过,the

applicantshallfilewithSFDAinformationsuchastheclinical

studyprotocol原理主义,nameoftheprincipleinvestigatorofthe

leadinginstitution双胞胎是怎么形成的,participatinginstitutionsand

investigators葫芦娃搞笑歌词,approvalletterfromethicscommittee历山学院,andthe

sampleoftheInformedConntForm登山鞋十大品牌,alsoprovidingacopyto

thePDAwheretheinstitutionsarelocatedandPDAwherethe

applicationwasfiled如何重装win7系统.

Article38:Ifanapplicantdiscoversthataninstitution

conductingclinicalstudyisinviolationofrelevant

regulations书香浙江,orisnotfollowingtheclinicalstudyprotocol市场总监职责,

riousviolation,theapplicantmayrequesttosuspendorstop

theclinicalstudyandshallsubmitawrittenreporttoSFDA

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andtherelevantPDA女性游戏名字.

Article39:Uponthecompletionoftheclinicalstudy,the

applicantshallsubmitaclinicalstudysummaryreport,

statisticalanalysisreport引人注目怎么造句子,anddatabatoSFDA.

Article40:Aclinicalstudyshallstartwithin3yearsof

itheapprovalcertificateshall

-applicationshallbe

submittedtoresumethestudy拽个性网名.

Article41:Shouldanyriousadvereventoccurduring

clinicaltrails电子市场反馈代理程序,theinstitutionsshouldreporttoPDA大连商务英语,SFDA员工餐桌,

aswellastheapplicantwithin24hoursofoccurrence西瓜酱,and

timelyreporttotheEthicsCommittee如何举报非法网站.

Article42:SFDAmayrequesttheapplicanttoamendthe

clinicalstudyprotocol,suspendorstoptheclinicalstudyin

anyofthefollowingcircumstances:

1)theEthicsCommitteehasfailedtoperformitsduty;or;

2)thesafetyofthesubjectscannotbeeffectivelyensured;

3)riousadvereventwasnottimelyreported;

4)evidencethattheinvestigativedrugisnoteffective;

5)qualityproblemsinthedrugudforclinicaltrials;

6)fraudintheclinicalstudy;

7)othercircumstancesviolatingGCP.

Article43:Duringtheclinicalstudymac内存不足怎么清理,incaalargerange

orunexpectedadverreactionorriousadvereventoccurs,

orthereividencetoprovethattheinvestigationaldrughas

significantqualityproblems孕妇可以喝酸奶吗,SFDAorPDAmayadoptemergency

mandatoryadministrativemeasurestosuspendorstopthe

clinicalstudy,andtheapplicantandinstitutionsmust

immediatelystopthestudy.

Article44:Aforeignapplicantwhowantstoconductan

internationalmulti–centerclinicalstudyshallapplyatSFDA

inaccordancewiththefollowingprovisions:

1)Theinvestigationaldrugudforaninternational

multi–centerclinicalstudyshallbeonealreadyregistered

inaforeigncountryorinphaIIorphaIIIclinical

icationforaninternationalmulti–center

clinicalstudyofnewpreventivevaccinefromaforeign

applicantstillnotregisteredoutsideChinashallnotbe

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acceptedbySFDA.

2)Inapprovinganinternationalmulti–centerclinicalstudy

inChina,SFDAmayrequesttheapplicanttofirstlyconduct

thePhaIclinicaltrialsinChina.

3)DuringastudyconductedinChina,theApplicantshall变形计之少年何愁,in

accordancewiththerelevantregulations,reporttoSFDAany

riousadvereventsorunexpectedadvereventswhich

occurinanycountries.

4)Uponthecompletionofthestudy,theApplicantshallsubmit

thecompleteclinicalstudyreporttoSFDA.

5)Datageneratedfromaninternationalmulti–centerclinical

trial,ifudfordrugregistrationinChina,shallbein

accordancewiththerelevantprovisionofthisRegulation关于五一的黑板报,

andtheapplicantshallsubmitthecompleterearch

informationofthestudy结膜炎怎么办.

Chapter4:ApplicationandApprovalofNewDrugs

Article45:SFDAmayuspecialapprovalprocessforthe

followingnewdrug缉熙楼,wheredetailregulationwillbepromulgated

parately:

1)Newdrugmaterialanditspreparation关于鲁迅的名言,activeingredients

anditspreparationextractedfromplant掉头发怎么治疗,animaland

minerals,whichhavenotbeenmarketedinChinaand;

2)chemicaldrugrawmaterialanditspreparations成外附小,and/or

biologicalproductthathavenotbeenmarketeddomestically

oroutsideChina;

3)newdrugsforAIDS,cancerandorphandiathatare

superiortothemarketeddrugs.

4)newdrugswhichtreatdiasforwhichthereisno

effectivetherapy医学检验就业前景.

ForthodrugsmeetingtheaboveprovisionsofthisRegulationremoteview,

duringthedrugregistration,theapplicantmayapplyfora

specialapproval天堂隔壁,SFDAshallorganizespecialistmeetingto

decidewhethertouspecialapprovalforthedrug

application怎么说我不爱你歌词.

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Detailedprovisionsofspecialapprovalshallbepromulgated

parately.

Article46:Whenanewdrugisjointlydeveloped最新祝福短信,the

applicationshallbemadebyoneoftheparties熊掌的作用,andother

ointapplication

needstobemadelucky什么意思,theapplicationshallbesignedbyallthe

pproval,allthenewdrugs为什么火烧圆明园,includingdifferent

strengthsofthesamedrugsshallonlybemanufacturedbyone

party解决问题ppt.

Article47:Forthoregistrationapplicationsofchangein

dosageformofdrugbutwithnochangeinrouteof

administration,newtechnologyshouldbeudtoimprovedrug

qualityandsafety随意识记,andthereshouldbeobviousclinical

advantageincomparingwithoriginaldosageform冰心的原名.

Exceptfortargeteddeliverypreparation,sustainedor

controlledreleapreparation,theregistrationapplications

ofchangeindosageformofdrugbutwithnochangeinroute

ofadministrationshouldbemadebythecompanywithproduction

condition保密.

Article48:Duringreviewprocessofnewdrug退保申请书,evenifthe

marketingapprovalofotherdrugofthesameactivesubstance

isapprovedoveras倦怎么组词,theregistrationcategoryandtechnical

requirementsofthedrugshallremainunchangedinthereview

processinChina.

Duringthereviewprocessofnewdrug,evenwhenthemarketing

approvalofotherdomesticdrugofthesameactivesubstance

isapprovedinChina讶组词,theregistrationcategoryandtechnical

requirementsofthesamekindofdrugshallremainunchanged

inthereviewprocessinChina求职信封面.

Article49:Drugapplicaniondossiershouldbesubmittedin

onetime,theapplicantshallnotlfsubmitsupplemental

technicalmaterialtoSFDAonceanyapplicationisaccepted,

exceptfornewinformationrelatedtothedrugsafetyortho

icantconsidersthenewtechnical

materialsmustbeadded欢腾的近义词,theapplicantshouldwithdrawthe

applicantre-apply隐形的翅膀电视剧,theapplication

proceduresofthisregulationshouldbemetandthereshould

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.

Section1:ClinicalTrialsforNewDrugs

Article50:Uponthecompletionofthepre-clinicalstudy,the

applicantshallcompletetheApplicationFormforRegistration

ofNewDrugs工作检查书范文,andsubmittheauthenticdossiertothelocalPDA奶瓶怎么消毒.

Article51:PDAshallexaminetheformatoftheapplication

dossier,andiftherequirementsaremet什么是数字货币,theapplicationwill

beacceptedwithissuingofacceptancenotificationofdrug

equirementsarenotmet,the

applicationwillnotbeacceptedwithissuingofnon-acceptance

notificationofdrugregistrationapplication上海免费景点,with

explanationofreasons我的中国心歌词.

Article52:PDAshall原电池原理,within5daysuponacceptanceofthe

application学雷锋做美德少年,organizeandconducton-siteinspectionofthe

drugrearchandtheoriginaldata林俊杰内地家族,conductpreliminary

rugtobe

registeredisbiologicalproduct烫发技巧,PADshalltakesampledrugs

of3batches,andnotifythedrugcontrolinstitutefor

inspection.

Article53:PDAshouldqq飞车宝石合成技巧,withintheprescribedtimelimit,

submittheexaminationrecommendation,verificationreportand

applicationdossiertotheCenterofDrugEvaluationofSFDA庆祝六一儿童节作文,

andnotifytheapplicant.

Article54:Drugcontrolinstitutereceivedtheregistration

inspectionnotificationshouldinspectthesampleaccordingto

thedrugstandardssubmittedbytheapplicantfighting意思,verifythedrug

standards,andsubmittheinspectionreporttoCenterofDrug

Evaluation(CDE)ofSFDAwithintheprescribedtimelimit,and

copyapplicantin依法行政工作总结.

Article55:Uponreceiptoftheapplicationdossier开封美食,CDEof

SFDAshallwithintheprescribedtime,organizepharmaceutical传统文化节日,

medicalandothertechnicalstafftoconducttechnical

examinationoftheapplicationdossier,andmayrequest中国世界文化遗产的作文500字,with

explanationofreason,theapplicanttoprovidesupplemental

ompletingthe

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technicalexamination,technicalexaminationrecommendation

willbeissuedandsubmittedtoSFDAalongwiththerelated

applicationinformationqq怎么抢红包.

SFDAshallmakeapprovaldecisionbadonthetechnical

DAconsiderthe

requirementsaremet心理病,ApprovalforDrugClinicalStudywillbe

DAdoesnotconsidertherequirementsaremet,

NotificationofApprovalOpinionwillbeissuedwith

explanation.

Section2:ProductionofNewDrug

Article56:Aftercompletionofaclinicalstudy,the

applicantshallfillouttheDrugRegistrationForm农业科技信息,andsubmit

productionapplicationdossiertothePDAwheretheapplicant

ametime美国大选结果什么时候出来,theapplicantshallsubmitthe

rawmaterialandrearchdatarelatedtostandardsubstance

forthepreparationofthestandardsubstancetoNICPBP表达豪情壮志的诗句.

Article57:PDAshallexamineforformtheapplicationdossier战争诗词,

andiftherequirementsaremetdnf刷图职业排行,theapplicationwillbe

acceptedwithissuingofacceptancenotificationofdrug

equirementsarenotmet,the

applicationwillnotbeacceptedwithissuingofnon-acceptance

notificationofdrugregistrationapplication,with

explanationofreasons西游记梗概.

Article58:PDAshall,within5daysuponacceptanceofthe

application中药美白祛斑面膜配方,organizeandconducton-siteinspectionforthe

clinicaltrialandrelevantoriginaldata电脑配置清单,conductpreliminary

drugs

otherthanbiologicalproduct上海普陀山船票,PDAshouldalsoneedtotake

sampleof3batchesofthedrugs医院病假条范文,andnotifythedrugcontrol

institutetoverifythestandards.

PDAshall,withintheprescribedtimelimit,submitits

recommendations,inspectionreportandapplicationdossierto

CDE,andnotifytheapplicant.

Article59:Drugcontrolinstituteshouldverifythedrug

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standards,andthensubmittheverificationrecommendationto

CDEwithintheprescribedtimelimit,atthesametime,copy

inthePDAthatissuedthenotificationtoverify三开头的成语,andcopythe

applicantin.

Article60:Uponreceiptoftheapplicationdossier天冷了关心的话暖心,CDEof

SFDAshallwithintheprescribedtime,organizepharmaceutical情感龙门阵,

medicalandothertechnicalstafftoconducttechnical

examinationoftheapplicationdossier福尔摩斯探案故事,andmayrequest,with

explanationofreason铁林是什么电视剧角色,theapplicanttoprovidesupplemental

informationanddrugsampleifnecessary凡卡全文.

Aftertheexamination自考论文,iftherelatedprovisionsaremet,CDE

shallnotifytheapplicanttofileapplicationforonsite

inspectionofproductionsite,andnotifytheCentrefor

CertificationAdministration(CCA)ofSFDA.

Aftertheexamination金钩王月饼,iftherelatedprovisionsarenotmet,

CDEshallsubmittherecommendationandapplicationdossierto

allmakedecisionnottoapprovebadonthe

technicalexaminationrecommendation,andNotificationof

ReviewOpinionwillbeissuedwithexplanation.

Article61:Uponreceiptofthenotificationofonsite

inspectionofproductionsite,applicantshouldfileatCCA

applicationforonsiteinspectionofproductionsitewithin

6months.觅食的近义词是什么.

Article62:Uponreceiptoftheapplicationofonsite

inspectionofproductionsite,CCAshallwithin30days

organizeonsiteinspectionoftheproductionprocessofthe

sample,confirmthefeasibilityoftheverifiedproduction

process,takesampleof1batchofproduct(3batchfor

biologicalproduct),submitthemforinspectiontothedrug

controlinstitutewherethedrugstandardswasverified,submit

theinspectionreportofproductionsitetoCDEwithin10days

uponcompletionoftheonsiteinspection.

Article63:Thesampleproductshallbemanufacturedina

wlyestablished

drugmanufacturingenterpriorworkshoporforthe

manufactureofadditionaldrugdosageforms景观铺装设计,theprocessof

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productionofthesampleproductshouldcomplywithrequirement

ofGMP.

Article64:TheDrugControlInstituteshalltestthesample

productinaccordancewiththeverifieddrugstandards,and

submitthedrugtestreporttoCDEwithintheprescribedtime,

andndcopiestotherelatedPDAandtheapplicant野生花菇.

Article65:CDEshallconcludeageneralexamination

recommendationbadonthetechnicalexamination

recommendation亚里士多德的故事,inspectionreportofproductionsiteofthe

sampleandsampletestreport三八妇女节讲话,andthensubmittoSFDAalong

allmakeapprovaldecisionbad

equirementsaremet,new

drugcertificatewillbeissued,iftheapplicantisalready

aholderofDrugManufacturingLicenandmeettheproduction

requirement,drugapprovalnumberwillbeissuedatthesame

equirementsarenotmet,NotificationofApproval

Opinionwillbeissuedwithexplanation高中军训日记.

Exceptforthospecialdosageformssuchastargeteddelivery

preparation,sustainedandcontrolledreleadpreparations,

afterapproval,nonewdrugcertificatewillbeissuedforthe

registrationofallotherapplicationsofchangeindosageform

butnochangeinrouteofadministration时间停了,aswellasapplication

foradditionalindication伽蓝寺听雨声.

Section3:MonitoringPeriodofNewDrugs

Article66:Badontherequirementtoensurepublichealth帽子英文翻译,

SFDAmayimplementamonitoringperiodfortheapprovednew

drugssoastocontinuetomonitorthesafetyofthenewdrug高中化学实验报告.

Thedrug-monitoringperiodshallstartfromthedateof

approvalforproduction,andshallnotexceed5years朱元璋墓.

Forthenewdrugsunderthemonitoringperiod,SFDAshallnot

approveproduction回头一笑百媚生,dosagechangeandimportationofthedrug

byotherenterpris扬州中考查分.

Article67:Duringthemonitoringperiodofanewdrug网络监控系统方案,drug

manufactureenterprishallregularlyinspecttheproduction

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process炖肉怎么做,quality2016年里约热内卢奥运会女排,stability,efficacyandadverreaction会飞的木屋作文400字,

uldorderacorrection

iftheenterprifailstoperformthedutyrequiredbythe

monitoringperiod英语成语故事.

Article68:Whenariousqualityproblem手抄报网,orriousor

unexpectedadverreactionsisdiscoveredbyrelevant

institutionsduringthemanufacture,distribution,uor

inspection,oradministrationofthedrug,itshallbereported

llimmediatelyorganizean

investigationofthedrugwithriousqualityproblems,

riousand/orunexpectedadverreactions,andreportto

SFDA周玉书.

Article69:Ifanewdrugunderamonitoringperiodhasnot

begunproductionwithin2yearsfromtheapprovaldate,SFDA

mayapprovetheproductionapplicationforthenewdrugby

anotherapplicantandcontinuetomonitor多彩的活动作文500字.

Article70:Asanewdrugentersmonitoringperiod,foran

applicationwhoclinicalstudyhasalreadybeenapprovedby

SFDA东张西望的张是什么意思,theapplicationshallcontinueintheregularreview

yapprovetheproductionorimportationifthe

applicationmeetstherequirements,andmonitorthisnewdrug

togetherwiththepreviouslyapprovednewdomesticdrug发呆的意思.

Article71:Asanewdrugentersthemonitoringperiod八字祝福短句老师,

applicationofthesamedrugbyotherswillnotbeaccepted,

andforanapplicationwhichhasbeenacceptedbutwho

clinicalstudyhasnotbeenapprovedbySFDA我们的价值观,theapplication

ecompletionofmonitoringperiod灰姑娘的童话故事,

anotherapplicantmayapplyforgenericdrugorimporteddrug.

Article72:Foranimporteddrugthathasalreadyreceived

marketingapproval,ifanapplicationwhoclinicalstudyhas

alreadybeenapproved,theapplicationmaycontinueinthe

FDAmayapprovetheproduction

ofthedrugiftheapplicationmeetstherequirements,the

applicantmaywithdrawtheapplicationandapplyforgeneric

pplicationwhichhasbeenaccepted

butwhoclinicalstudyhasnotbeenapproved,theapplication

shallbereturned波导手机主题下载,andapplicantmayapplyforgenericdrug

applications.

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Chapter5:ApplicationandApprovalofGenericDrugs

Article73:Applicantofgenericdrugapplicationsshoulda

gforwhichapplicationismadeshall

beconsistentwiththeproductionscopedescribedinDrugs

ManufacturingLicen可爱甜美发型.

Article74:Genericdrugsshouldhavethesameactive

component,routeofadministration,dosageform,strengthand

e

drugsitcopiesfromarefrommanycompanies孟母戒子,acomparisonstudy

ofthedrugsitwillcopyfromshouldbeconductedbadonthe

relatedtechnicalguidanceandprinciples阳光普照大地.

Article75:Applicantofgenericdrugregistrationshouldfill

outtheDrugRegistrationForm鸦片战争教案,andsubmitproduction

applicationdossierandapplicationforinspectionof

productionsitetothePDAwheretheapplicantislocated伏天多少天.

Article76:PDAshallexaminetheformatoftheapplication

dossier,andiftherequirementsaremet神兽麻将馆,theapplicationwill

beacceptedwithissuingofacceptancenotificationofdrug

equirementsarenotmet,the

applicationwillnotbeacceptedwithissuingofnon-acceptance

notificationofdrugregistrationapplication杨成武强攻东团堡,with

explanationofreasons.

ForthoTCMdrugsunderapplicationforTCMprotection,

applicationforgenericdrugofthesamedrugwillbesuspended

fromthedateprotectionapplicationwasacceptedtothedate

anadministrationdecisionismade通用 召回.

Article77:PDAshall,within5daysuponacceptanceofthe

application,organizeandconducton-siteinspectionofthe

drugrearchandtheoriginaldata,andconductonsite

inspectionoftheproductionsiteaccordingtotheproduction

processandqualitystandardsprovidedbytheapplicant乳腺癌早期症状,take

sampledrugsof3concutivebatchesonsite士兵突击经典台词,andnotifythe

drugcontrolinstituteforinspection.

Productionofthesampledrugsshouldcomplywiththe

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provisionsofArticle67ofthisRegulation.

Article78:PDAshouldwithintheprescribedtimelimit

conductexaminationoftheapplicationdossierandissue

equirementaremet,theexamination

recommendation,verificationreportandinspectionconclusion

ofproductionsiteandapplicationdossierwillbesubmitted

toCDE,ftherequirements

arenotmet草长莺飞2月天的下一句是,NotificationofApprovalOpinionwillbeissued

withexplanation但国庆,atthesametime,notifythedrugcontrol

institutetostoptheregistrationinspectionofthedrugs.

Article79:Thedrugcontrolinstituteshalltestthesample

productandsubmitthedrugtestreporttoCDEwithinthe

prescribedtime,andndcopiestothePDAthatrequestedthe

testandtheapplicant福州华伦中学网站.

Article80:CDEofSFDAshallorganizepharmaceutical百科知识网站,

medicalandothertechnicalstafftoexaminetheverification

recommendationandtheapplicationdossier,andmayrequest,

withexplanationofreason,theapplicanttoprovide

supplementalinformationifnecessary.

Article81:CDEofSFDAshallconcludeageneralexamination

recommendationbadonthetechnicalexamination

recommendation小学生最牛作文,inspectionreportofproductionsiteofthe

sample,andsampletestreport侍女们,andthensubmittoSFDAalong

allmakeapprovaldecisionbad

equirementsaremet 甜 作文六年级500字,drug

therequirementsarenotmet我们会更好的 歌词,decisionnottoapprovewillbe

madeandNotificationofApprovalOpinionwillbeissuedwith

explanation.

Article82:Uponcompletionofclinicaltrails,theapplicant

all,

badonthetechnicalexaminationrecommendation,issuewith

drugapprovalnumberorNotificationofApprovalOpinion飞的拼音.

Article83:ForthodrugsthatconfirmedbySFDAtobe

defectiveintermofsafety发型师简介,SFDAmaydecidetosuspend

acceptanceorapprovaloftheapplicationofgenericdrugs形容随声附和的成语.

-19-计算机三级网络技术成绩查询。

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Chapter6:ApplicationandApprovalforImporteddrugs

Section1:RegistrationofImporteddrugs

Article84:Thedrugsunderimportapplicationshouldhave

obtainedmarketingapprovalinitscountry/regionof

tsuchamarketingapprovalwin7网络共享,adrugtobe

importedmaystillbeapprovedifSFDAconfirmsthesafetyand

efficacyofthekindofdrug企业绩效管理,andifthereisaclinicalneed

forthedrug.

Theproductionofdrugsunderimportapplicationshouldmeet

theGMPstandardintheforeigncountry/regionaswellasthe

requirementsofGMPinChina.

Article85:Foranimporteddrugapplication大国重器第六集,theapplicant

shallcompleteApplicationFormforDrugRegistrationand

submittherelevantapplicationdossierandsampleproduct,and

lication

shallbemadewithSFDA.

Article86:SFDAshallexamineforformtheapplication

dossier,iftherequirementsaremet93年属什么,theapplicationshallbe

accepted,

shallnotifyNICPBPfordrugregistrationinspectionof3

DAdoesnotconsiderthe

requirementsaremet,NotificationofNon-Acceptancewillbe

issuedwithexplanation鼠年新年贺词.

SFDAmayorganizetheon-siteinspectionabouttherearch

statusandmanufacturingstatus,andtakesample.

Article87:NICPBPshouldwith5daysuponreceiptofthedata

andsample,organizetheregistrationinspection克隆的利与弊.

Article88:Within60daysuponreceiptofdata,sampleand

relatedstandardsubstance,thedrugcontrolinstitute

undertakingimportdrugregistrationinspectionshould

completetheregistrationinspectionandsubmittheinspection

reporttoNICPBP1400x900高清壁纸.

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Sampletestanddrugstandardverificationforspecialdrugs

andvaccineproductsisallowedtobecompletedwithin90days.

Article89:NICPBPshould笔胜影视,within20daysuponreceiptof

verifieddrugstandardsandthedrugregistrationinspection

reportfromdrugcontrolinstitute,organizespecialistto

conducttechnicalexamination,andifnecessary关于生命的格言,conduct

re-verificationbadontheexaminationrecommendation岂有此理的意思.

Article90:NICPBPshould歌曲今天是你的生日,uponcompletionofimportdrug

registrationinspection,submittheverifieddrugstandards,

drugregistrationinspectionreportandverification

recommendationtoCDEofSFDA,andcopytoapplicant.

Article91:CDEofSFDAshouldwithinlimitedtimeorganize

pharmaceutical肖像权合同,medicalandothertechnicalstafftoconduct

technicalexamination幼儿园个人工作总结,andmayrequest,withexplanationof

reason,theapplicanttoprovidesupplementalinformationif

necessary学教网.

Article92:CDEshallconcludeageneralexamination

recommendationbadonthetechnicalexamination

recommendationwindows7天气小工具,inspectionreportofproductionsiteofthe

sampleandsampletestreport贾斯汀汀布莱克,andthensubmittoSFDAalong

allmakeapprovaldecisionbad

equirementsaremet重阳节吃重阳糕饮什么酒,Drug

equirementsare

notmet,NotificationofApprovalOpinionwillbeissuedwith

explanation.

Article93:Uponapprovaloftheclinicalstudy拍马屁的技巧,theapplicant

shallconducttheclinicalstudyinaccordancewiththe

provisionunderChapter3ofthisRegulation.

Uponthecompletionofclinicalstudy,theapplicantshallfound,in

accordancewithrelevantrequirements郑爽图片,submittoSFDAthe

clinicalstudyreport,relevantchangesandsupplemental

information,withdetailedexplanationandjustifications工地宿舍管理制度,and

therelevantcertifieddocuments.

Article94:CDEshouldorganizepharmaceutical,medicaland

othertechnicalstafftoconductoverallexaminationofthe

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submittedclinicaltraildata可爱弟弟,andmayrequest面包店利润,with

explanationofreason,theapplicanttoprovidesupplemental

informationifnecessary.

SFDAshallmakeapprovaldecisionbadtherecommendationfrom

equirementsaremet黑发晶的作用,anImported

ation

bycompaniesfromHongKong房地产销售技巧和话术,MacaoandTaiwanshallproceedby

referencetothisRegulation规则作文,iftherequirementsaremet日常生活的小窍门,a

PharmaceuticalProductCertificateshallbeissuedtothe

equirementsarenotmet,Notificationof

ApprovalOpinionwillbeissuedwithexplanation.

Article95:Foranimporteddrugpreparationsapplication放心吧,

documentstoevidencethelegalchannelsofimmediatepackaging

materialsorcontainersofthedrug,documentstoevidencethe

legalchannelsofdrugrawmaterialandexcipientsmustbe

materialandexcipientsofdrugthathasnot

beenapprovedbySFDA亚亚图雷,standardizedinformationofrelevant

productionprocessrundll32已停止工作,qualityspecification心灵鸡汤经典语录励志,andinspection

methodsshouldbesubmitted周纯全.

Section2:ApprovalofRepackagingofImporteddrugs

Article96:Repackagingofimporteddrugsmeanstakingfrom

offshorefinisheddrugpreparationinlargepackagingand

puttingthemintosmallerpackaging,ortakingdrugsinsmaller

packagingandplacingthemintofinal(outside)packagingwith

aninrtsheet,labeling,a.

Article97:Theapplicationforrepackagingofimporteddrug

shallcomplywithfollowingrequirements:

1)anImportedDrugCertificateorPharmaceuticalProduct

Certificatehasalreadybeenobtainedfortheimported

drugs;

2)thedrugsareyettobemanufacturedinChinaor,if

manufactured,notabletomeettheclinicaldemand;

3)thedrugsofonepharmaceuticalcompanyshallonlybe

repackagedbyonepharmaceuticalproductionenterpri蒋干盗书,

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generallyforaperiodnotexceedingthevalidperiodof

ImportedDrugCertificateorPharmaceuticalProduct

Certificate画眉鸟叫.

4)Withexceptionoftabletorcapsule,internalpackingof

repackeddrugsinallotherdosageformshouldbefinished

offshore;

5)thepharmaceuticalproductionenterpritoaccept

importeduncoatedtabletorcapsulearetoberepacked,

enterpritoacceptrepackingshouldalsoholdaGMP

Certificateconsistenttothedosageformofthedrugtobe

repacked医学界.

6)Anyapplicationforrepackingofimporteddrugshouldbemade

oneyearpriortoexpirationofImportedDrugCertificate

orPharmaceuticalProductCertificate空间道具狗仔队.

Article98:Theoffshorepharmaceuticalcompanyshallsigna

repackagingcontractforimporteddrugswithanonshore

pharmaceuticalproductionenterpri计算机多媒体技术,andcompletetheDrug

SupplementalApplicationForm.

Article99:Anapplicationforrepackagingadrugshallbe

submittedbytheonshorepharmaceuticalproductionenterpri

tothePDAwherethepartyislocated哈姆雷特简介,andtheDrugSupplemental

ApplicationFormsignedbytheoffshorepharmaceuticalcompany

shouldbesubmittedwiththerelevantinformationandsample

llexamineforformtheapplicationdossier项链读后感,

andiftherequirementsaremet活着是一种修行,theapplicationwillbe

acceptedwithissuingofacceptancenotificationofdrug

equirementsarenotmet,the

applicationwillnotbeacceptedwithissuingofnon-acceptance

notificationofdrugregistrationapplication双十一活动策划,with

explanationofreasons蛋黄酥怎么做.

PDAshouldmakerecommendationaftercompletionofthereview

processandsubmittheapplicationdossierandrecommendation

toSFDAforapproval,andnotifytheapplicant.

Article100:SFDAshallreviewthesubmittedapplication

DAconsidertherequirementsaremet,Approval

forDrugSupplementalApplicationandDrugApprovalNumberwill

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DAdoesnotconsidertherequirementsaremet,

NotificationofApprovalOpinionwillbeissuedwith

explanation.

Article101:Theregistrationstandardsfortheimporteddrug

shallbeappliedtotherepackageddrug我的学姐会魔法.

Article102:Thepackage最快的瘦腿方法,labelandinrtsheetofa

repackageddrugshallbeconsistentwiththatoftheimported

drugtoberepacked,andshallincludetheapprovalnumberfor

drugtoberepackedandnameofthedrugrepackaging

manufacturer花水月.

Article103:Theimportinspectionoffinisheddrug

preparationsinlargepackagingshouldbeconductedin

edrugstandardsshall

applytoboththeinspectionoftherepackageddrugandimport

inspection.

Article104:Theoffshorepharmaceuticalcompanyshallbe

qualityproblemari非主流的qq网名,SFDAmaycanceltheapprovalnumberof

thedrugrepackaging,andifnecessary,canceltheImported

DrugCertificateorPharmaceuticalProductCertificateofthe

druginaccordancewithArticle42ofDrugAdministrationLaw乡愁.

Chapter7:ApplicationofOTCDrugs

Article105:ForagenericdrugfallsintoOTCdrug,

applicantshouldchecktheOTCitemsinthe“supplemental

applicationitem”oftheDrugRegistrationForm小学英语试卷.

Article106:Foragenericdrugfallsintobothprescription

andOTCdrug不锈钢杯,applicantmayfiletheapplicationbychoosing

tofollowtherequirementofeitherprescriptionorOTCdrug婴儿健脾散.

Article107:Inthefollowingcircumstances,anapplicantmay

checktheOTCitemsinthe“supplementalapplicationitem”of

equirementsofOTCdrugs

aremet,

therequirementsofOTCdrugarenotmet锦绣山河是什么生肖,theprescriptiondrug

regulationandapprovalshallapply:

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1)changeindosageform搞笑名言名句大全,butwithoutchangeinindications小学音乐课件,

dosage维护保养,routeofadministrationofanOTCdrugasdesignated

bySFDA;

2)newcombinationpreparationsdevelopedfromactiveOTC

ingredientsdesignatedbySFDA.

Article108:ForanOTCdrugregistrationapplication,the

inrtsheetandlabelshouldcomplywithrelevantrequirement

ofOTCdrugs乐观的个性签名.

Article109:IfanimporteddrugfallsintoOTCdrug,

regulationandapprovalprocedureofimporteddrugshallapply

wheretechnicalrequirementsforthodrugsshallbe

consistentwithrequirementsfordomesticOTCdrug认证空间怎么弄.

Chapter8:SupplementalApplicationandApproval

Article110:Asupplementalapplicationshouldbefiledfor

changesofitemsintheapprovalcertificateorthecontentof

itsattachmentofnewdrugrearch太空生活资料,drugproductionanddrug

importation宗法制的特点.

Theapplicantshallassstheimpactofthechangetothedrug

safetyswitch什么意思,efficacy石榴很新鲜,andqualitycontrol万马奔腾的意思,withreferencetothe

applicabletechnicalguidance2016年6月英语六级答案,andconductthenecessary

technicalrearch.

Article111:TheapplicantshouldcompletetheSupplemental

ApplicationForm,submittoPDAwheretheapplicantislocated

llexaminefor

formtheapplicationdossier如何挑选轮滑鞋,andiftherequirementsaremet陈曼媛,

theapplicationwillbeacceptedwithissuingofacceptance

requirementsarenotmet,theapplicationwillnotbeaccepted

withissuingofnon-acceptancenotificationofdrug

registrationapplication短发 帽子,withexplanationofreasonsqq字体怎么改.

Article112:Forasupplementalapplicationrelatedto

importeddrugs,theapplicantshallapplytoSFDAwithrelevant

informationanddocument,aswellastheapprovaldocumentof

thepropodchangefromthecompetentauthoritiesofthe

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shallexamineforformtheapplicationdossier,andifthe

requirementsaremet,theapplicationwillbeacceptedwith

issuingofacceptancenotificationofdrugregistration

equirementsarenotmet滑稽的意思,theapplication

willnotbeacceptedwithissuingofnon-acceptance

notificationofdrugregistrationapplication,with

explanationofreasons广东省工资支付条例.

Article113:Forasupplementalapplicationofchangeofthe

productionprocessaffectingdrugquality,amendmentofdrug

registrationstandard华歆与王朗,aswellaschangeofexcipientsof

medicalpurpointheformula,afterPDAissuewith

examinationrecommendation来不及说我爱你 小说,theapplicationshallbesubmitted

toSFDAforapproval女孩子英文名,andapplicantshouldbenotifiedatthe

sametime开盘活动.

Forasupplementalapplicationforamendmentofdrug

registrationstandards雨的诗,ifnecessary,thedrugstandards

shouldbeverifiedbydrugcontrolinstitute股东知情权.

Article114Forasupplementalapplicationofinternal

changeofthemanufacturinglocationwithinthedrug

manufacturer亲子diy,namechangeofdomesticdrugmanufacturer开机显示器无信号,as

wellasamendmentofvalidperiodofdomesticdrugs,the

A

considersalltherequirementsaremet世俱杯直播,ApprovalofDrug

SupplementalApplicationwillbeissuedandtheapprovalshall

equirementsarenotmetqq游戏名字,

NotificationofApprovalOpinionwillbeissuedwith

explanation化妆视频教程大全.

Article115Forasupplementalapplicationofchangeofdrug

labelrequiredbyregulation支离破碎是什么意思,inrtsheetamendmentrequired

bySFDA2016电影排行榜,thechangesshallbefiledatPDAforrecord.

Article116Anysupplementalapplicationrelatedtoan

eof

supplementalapplicationofimporteddrug,suchaschangeof

manufacturinglocationofrawmaterialudforimportdrug

preparation1997年多大,changeindrugappearancewithchangeindrug

standards,amendmentofinrtsheetaccordingtotheNational

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StandardorrequirementofSFDA,supplementingandperfecting

ofsafetyrelatedcontentofinrtsheet,changeofdesignof

packingorlabelofimporteddrugasrequestedbyregulation,

changeofregistrationagent,theapplicationneedstobefiled

forrecordatSFDA可行性.

Article117Forasupplementalapplicationforachangedue

todrugtechnologytransfer,changeinformulaorprocessthat

isassdtobelikelytoaffectthequalityoftheproduct企业形象广告,

PDAshall,inaccordancewithattachmenttotheDrug

RegistrationApprovalLetterortheverifiedproduction

process,organizeon-siteinspectionoftheproductionsite狗吃人,

drugcontrolinstituteshouldtestthe3batchesofsample

producttakenforinspection.

Article118SFDAshallexaminethesupplementaldrug

application,whereSFDAmayrequest旅游 英语,withexplanationof

reasons唐朝徐敬业,theapplicanttoprovidesupplementalinformation张爱玲胡兰成,if

DAconsidertherequirementsaremet,Drug

DA

doesnotconsidertherequirementsaremet千里莺啼绿映红,Notificationof

ApprovalOpinionwillbeissuedwithexplanations肚子减肥方法.

Article119Aftertheapprovalofanysupplemental

application歌曲春天里,whenthedrugapprovalcertificateneedstobe

renewed,theolddrugapprovalcertificateshallbecanceled

ditionaldrugapprovalcertificateneedsto

beissued,theoldcertificateshallcontinuetobeeffective.

Chapter9:Re-registrationofDrugs

Article120:ThevalidityperiodoftheDrugApprovalNumber男足世界杯2019预选赛,

theImportedDrugCertificateandPharmaceuticalProduct

CertificateissuedbySFDAis5yearscpu散热器.6monthspriortothe

expiration10 1大阅兵,applicationforre-registrationshallbemade,

shouldtherebeaneedforcontinuingtheproductionand/or

importation过期啤酒的用途.

Article121:WhiletheDrugApprovalNumber,theImportedDrug

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CertificateorPharmaceuticalProductCertificateisvalid,

theapplicantshouldconductsymmetricalasssmentasforthe

drugsafety2015年工作总结,efficacy,andqualitycontroldnf怎么隐藏其他玩家,suchasrelevant

studyresultduringthemonitoringperiod,monitoringofthe

adverreaction,productioncontrolandhomogeneityof

productquality,inordertoprentavidenceduringthe

re-registration联想mirage.

Article122:Theholderofadrugapprovalnumbershallapply

forre-registrationofthedrugwithlocalPDA,bycompleting

theApplicationFormforDrugRe-registrationaccordingto

relevantrequirementsandsubmittingrelevantapplication

material国际劳务输出.

Theapplicationforre-registrationofanimporteddrugshall

besubmittedtoSFDA.

Article123:PDAshallexaminetheapplicationdossier,and

iftherequirementsaremet泪水,theapplicationwillbeaccepted

withissuingofacceptancenotificationofdrugregistration

equirementsarenotmet,theapplication

willnotbeacceptedwithissuingofnon-acceptance

notificationofdrugregistrationapplication,with

explanationofreasons.

Article124:PDAshall,within6months有关天气的谚语,examinethe

re-registrationapplication大胆人体摄影,iftherequirementaremet,the

re-registrationwillbeapproved么多多,ifnotthere-registration

shallbefiledatSFDAforrecordyou light up my life.

Article125:Theapplicationforre-registrationofthe

importeddrugshallbeacceptedbySFDA环境烘托,whoshallcompletethe

reviewoftheapplicationwithin6monthsofreceipt,and

,

notificationnottoapprovewillbeissuedwithexplanationof

reasons.

Article126:Are-registrationshallnotbeacceptedinany

ofthefollowingsituations:

1)failureinapplyingforre-registrationofthedrugwithin

theprescribedtime;

2)failureinmeetingtherelevantapprovalrequirementsof

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SFDAformarketing;

3)failureincompletingPhaIVclinicaltrialsaccordingto

relevantrequirements;

4)failureinmonitoringdrugadverreactionsaccordingto

relevantrequirements;

5)thekindofdrugconsideredtobeadisputedefficacy,high

adverreaction,orotherfactorsharmfultohumanhealth财务内部控制制度,

badonthere-evaluationofSFDA,

6)thekindofdrugwhoapprovalshouldbewithdrawnaccording

totherequirementsofDrugAdministrationLaw;

7)productionconditionfailstomeettherequirementsofDrug

AdministrationLaw;

8)failuretofulfilltheresponsibilityduringthemonitoring

period;or,

9)othersituationsinwhichrelevantrequirementshavenot

beenmet.

Article127:AfterreceiptoftherecommendationsfromPDA个人师德小结,

ifthedrugstobere-registeredfailtomeettherequirement

byexamination邯郸京娘湖,SFDAshallissuethenotificationofrejection

ofthedrugforre-registrationwithexplanations眼睛黄斑.

Forthorejectedre-registration,exceptforthocertified

drugapprovaldocumentthathavebeencanceledbylawful

enforcement,thedrugapprovalnumber检讨书 范文,ImportedDrug

CertificateorPharmaceuticalProductCertificateofthedrug

shallbecanceledupontheexpiryofthevalidperiod.

Chapter10:InspectionDuringDrugRegistration

Article128:Drugregistrationinspectionincludes

inspectionofsampleproductsandverificationofdrugquality

standards去世.

Inspectionofsampleproductsmeansthatdruginspection

conductedbyadrugcontrolinstituteaccordingtothequality

standardssubmittedbytheapplicantorapprovedbySFDA.

Verificationofdrugqualitystandardsmeanslaboratory

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inspectionbyadrugcontrolinstitutetoverifythe

feasibilityandscientificnessofinspectionmethodsdescribed

inthequalitystandardsofthedrugandwhetherornotthe

assumedparameterscancontrolthedrugquality.

Article129:Drugregistrationinspectionsshallbeconducted

byNICPBPortheprovincialdrugcontrolinstitute高考总分,where

inspectionsforimporteddrugregistrationshallbeconducted

byNICPBP.

Article130:Drugregistrationinspectionshallbeconducted

byNICPBPorthedrugcontrolinstitutedesignatedbySFDAfor

thefollowingevents:

1)adrugbelongingtocategoriesofArticle45.1and45打屁股作文3000字.2of

thisRegulation;

2)biologicalproduct,orradioactivedrugs;

3)otherdrugsdesignatedbySFDA.

Article131:Whenarranginginspectionofsampleproductsand

verificationofdrugqualitystandards食醋洗脸,thedrugcontrol

instituteshallgiveprioritytoadrugacceptedforspecial

approval.

Article132:Adrugcontrolinstituteengagedindrug

inspectionforregistrationshallbestaffedandequipped

accordingtorequirementsoftheGoodLaboratoryPracticeof

DrugControlInstitutesandNationalMeasurementCertification2016猴票,

andcomplieswiththerequirementsofthequalityassurance

systemandtechnicalrequirementsofthedrugregistration

inspection.

Article133:Theapplicantshallprovidethedrugcontrol

institutewithinformationneededfordrugregistration

inspection,submitsampleproductorco-operateintaking

sampleproductsudforinspection,andprovidethestandard

untofsample

productssuppliedshallbethreetimestheamountofthedrug

ologicalproduct,therecord

ofpreparationandinspectionforthecorrespondingbatches

shallalsobeprovided.

Article134:Duringtheverificationofdrugstandards,in

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additiontoinspectionofthesampleproducts阳光下成长,thedrugcontrol

instituteshallalsoissueanverificationrecommendation

regardingthedrugstandardsofthedrug,itemstobeinspected

andverificationmethods晏殊和晏几道是什么关系,badontherearchdataofthedrug,

thedrugstandardsofsimilarproductsdomesticandinthe

foreigncountries科比个人资料简介,aswellasnationalrequirements失恋了.

Article135:Inre-makingadrug'sstandards实习生辞职信范文,theapplicant

shallnotauthorizethedrugcontrolinstitutethatissuedthe

rly六级准考证号忘了怎么办,such

instituteshallnotacceptsuchauthorization.

Chapter11:DrugRegistrationStandardsandInrtSheets

Section1:DrugRegistrationStandards

Article136:“NationalDrugStandards”refertodrug

registrationstandards,otherdrugstandardsandPRC

PharmacopoeiaissuedbySFDA马秋波病毒,coveringtechnicalrequirements

includingqualityparameters,inspectionmethodsand

productionprocessqq空间设置密码.

“Drugregistrationstandards”meansthedrugstandardsapproved

bySFDAforaspecificapplicant,whichisthebasisfordrug

productionandthemonitoringandadministrationofthedrugs.

Drugregistrationstandardsmustnotdecreafromstandards

ofcurrentPharmacopoeia秋天作文600字.

Article137:Thedeterminationofitemsandinspection

methodsfordrugregistrationstandardsshallmeetbasic

requirementofthecurrentPharmacopoeia,therequirementsof

thetechnicalguidanceprinciplesissuedbySFDAerp系统是什么意思啊,andNational

rulesforcompilingnationaldrugstandards.

Article138:Anapplicantshouldlectreprentativesample

productsforthestudyofstandards.

Section2:DrugStandardSubstance

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Article139:Drugstandardsubstance,includingstandards双扇舞,

controlproducts,rawmaterialcontrolproducts,andreference

products记得要忘记歌词,meansasubstancewithspecificvaluesck be香水,whichisto

beudinphysical汉代风云人物之项羽,chemicalinspectionandbiologicalmethod

inspectionneededforthedrugqualitystandards,andudto

calibrateequipments苏东坡与佛印,toevaluatethemeasuringmethodsorto

assaytheinspectiondrugs.

Article140:NICPBPshallberesponsibleforstandardization

andadministrationofnationaldrugstandardsubstances.

NICPBPmayorganizetherelevantprovincialdrugcontrol

institute车险注意事项,rearchinstitutionsorpharmaceuticalproduction

enterpriforcooperationinstandardizationand

administration先有红绿灯.

Article141:NICPBPshallberesponsibleforthe

comprehensivetechnicalreviewofthestandardsubstance

regardingthelectionofrawmaterials,productionmethods,

standardizationmethods,standardizationresults,accuracyof

assayvalues上海大班,tracingoforiginofvariousvalues2014福建高考数学,stability节能宣传周活动方案,

andconditionsforrepackagingandpackaging高中音乐鉴赏说课稿,inordertoreach

aconclusionastowhethertheycanbeudasnationalstandard

substances公文包怎么用.

Section3:DrugName高尔基童年摘抄,InrtSheetsandLabels

Article142:Applicationfordrugname,inrtsheetand

labelsshouldcomplywithSFDAregulation教师中国梦演讲稿.

Article143:Druginrtsheetshallbepropodbythe

applicant,andCDEofSFDAshallexaminethecontentofinrt

sheetotherthanthoinformationrelatedtothecompany

itlfagainsttheapplicationdossier客厅风水学,andtheinrtsheets

shouldbeapprovedbySFDAuponapprovalofproductiontop崔胜贤.

Applicantsshallberesponsibleforthescientificness2019春节高速免费时间,

correctnessandaccuracyofinrtsheetsandlabels.

Article144:Theapplicantshallmonitorthesafetyand

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efficacyduringthepostmarketingperiod八宝惊风散,andmaketimely

applicationforamendmentofinrtsheetswhennecessary.

Article145:Applicantshallprinttheinrtsheetandlabels

accordingtothecontentofapprovedinrtsheet新时代好少年观后感300字,andin

accordancewiththeformatandrequirementsbySFDA宠物摄影大赛.

Chapter12:PrescribedTimeline

Article146:Drugadministrationauthoritiesshouldadhereto

therequirementofPrescribedTimelineasspecifiedinDrug

AdministrationLaw,AdministrativeLicensingLaw,andthe

scribedtimelinefordrug

registrationreferredinthisregulationmeansthemaximum

allowedtimefortherelevantacceptance,examinationand

approvaletc地平线的梦想,excludingthetimelegallyrequiredinsuspending

theapprovalandthetimeforapplicanttosubmitsupplemental

dossier.

Timelineforexaminationanddrugregulationinspectionshould

arytimeextensionfor

specialcasshouldbemadewithexplanationofreasons江苏时间,and

obtainapprovalfromSFDA,andtheapplicantshouldbenotified

inwriting战争诗句.

Article147:Uponreceiptofanyapplication,drug

administrationauthoritiesshallexamineforform,andact

accordingtothefollowing.

1)Informimmediatelytheapplicantofnon-acceptanceif

thereisnoneedforadministrativepermitsforthe

applicationitems;

2)concludeimmediatelyadecisionofnon-acceptanceifthe

applicationitemsfalloutsideoflawfuljurisdictionof

division学雷锋 树新风,andthenrefertheapplicanttotherelated

authorities;

3)allowtheapplicanttomakecorrectiononsite,ifthe

defectsintheapplicationdossiercanbemadegoodon

site;

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4)whentheapplicationdossierisincompleteorfailtomeet

thelawfulrequirementforform,theapplicantshouldbe

notifiedinonenotificationonsiteorwithin5daysof

themissingdatatobesupplemented,failuretonotify

withinthetimelineshouldbedeemedtohaveacceptedthe

applicationdossieronthedateofreceivingthedossier;

5)whentheapplicationitemsfallintolawfuljurisdiction

ofthedivision现世安稳岁月静好,applicationdossieriscompletedandin

lawfulform,orappliancehavesupplementedallthe

missinginformation胖,thedrugregistrationapplication

shouldbeaccepted.

Whenanydrugadministrationauthoritiesacceptornotaccept

adrugregistrationapplication淄博玉黛湖,apaperinwritingshouldbe

issuedwithspecialchopofdrugregistrationanddated.

Article148:Uponacceptanceoftheapplication,PDAshall

completewithin30daystheinspectionforrearchstatusand

originaldata,examinationofapplicationdossier小学心理辅导课教案,takingof

sampleproducts,notificationofthedrugcontrolinstitutefor

inspectionofsampleproduct正宗腊八蒜的腌制方法窍门,andsubmissionofthe

recommendationandinspectionreporttogetherwithinformation

submittedbytheapplicanttoSFDA,andatthesametime风中奇缘主题曲,notify

theapplicantoftheinspectionrecommendations亚冠联赛直播.

Article149:Timelinefordrugregistrationtestsshouldbe

inaccordancewiththefollowingprescribedtimeline根治.

1)Sampletests:30days童心向党内容文字,60daysifthesampletestsand

verificationofdrugstandardsareconductedatthesame

time;

2)Sampletestsforspecialdrugandvaccine:60days支票期票,90days

ifthesampletestsandverificationofdrugstandardsare

conductedatthesametime;

Article150:Technicalreviewtimelineshouldbein

accordancewiththefollowingprescribedtimeline.

1)90daysforanewclinicalstudy,80daysifadrugmeets

therequirementsofspecialapproval;

2)150daysforproductionofnewdrug湖南师范大学2020录取分数线,120daysifadrugmeets

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therequirementsofspecialapproval;and,

3)160daysforapplicationregistrationofgenericdrugsor

applicationofchangeindosageformofamarketeddrug缓交学费.

4)40daysforsupplementalapplicationifatechnicalreview

isneeded.

Theabovetimelineshallbeudasreferencetothetechnical

examinationofimportdrugregulationapplication.

Article151:Duringthetechnicalreview,SFDAshouldissue

inonenotificationregardingsubmissionofallneeded

licantmayraiquestiontothe

requiredsupplementalmaterials你是我最深爱的人歌词,andexplanationofthe

forapplicationmeetingtherequirementofspecialapproval,

wherespecialrequirementapply金丹变,theapplicantshallinone

timesubmitallthesupplementalmaterialsrequiredbythe

notificationwithin4months山水田园诗大全.

Uponreceiptofthesupplementalinformation立秋诗句,thetechnical

reviewshouldnotexceedonethirdoforiginalprescribedtimedeath on two legs,

foradrugmeetstherequirementsofspecialapproval,thetime

shouldnotexceedonequarteroforiginalprescribedtime.

Duringthedrugregistration,iftheapplicantlfwithdraws

theapplicant,theapprovalprocessautomaticallyterminates徐汇中学.

Article152:SFDAshouldconcludetheadministrativeapproval

notpossibletoconcludea

decisionwithin20days,a10dayextensionmaybegrantedwith

approvalbytheleadingdepartmenthead,wheretheapplicant

shouldbenotifiedwithexplanationofthereasonforthe

extension英语投诉信.

Article153:SFDAshouldpublish/delivertherelevant

administrativelicensingcertificatewithin10days,oncethe

administrativeapprovaldecisionisconcluded.

Chapter13:Reconsideration

Article154:SFDAshallnotapprovetheapplicationunderany

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thefollowingcircumstances:

1)thesameorsimilardataorrearchinformationareud

intheapplicationsbydifferentapplicantswithouta

justifiedreason;

2)duringtheregistration,theapplicationdossierisfound

tobeuntrue,whereapplicantcannotprovethetruthfulness;

3)designandimplementingofrearchitemsisunableto

supporttheasssmentofthequalitycontrol黄小琥没那么简单歌词,safety,

efficacyoftheproductstoberegistered;

4)significantdeficiencyinsafety元旦新年祝福语,effectiveness家用省油轿车,orquality

controlofthedrugisrevealedfromtheapplicationdossier;

5)Failuretosubmittherequiredsupplementalinformation

withintheprescribedtime;

6)Sourcingofrawmaterialfailstocomply;

7)Onsiteinspectionofproductionsiteorsampleproducttest

failstocomply;

8)Anyothersituationanapprovalshouldnotbegrantedas

specifiedbylawsandregulations

Article155:Uponlawfulconclusionofnon-acceptanceor

non-approvaldecisioninwriting,thereasonshouldbestated,

anddrugadministrationauthoritiesshallnotifyapplicantof

theentitlementtoapplyingforadministrative

re-considerationorappeal趁早原唱是谁.

Article156:Whenanapplicantobjecttothedecisionofnon

approval,theapplicantmayapplyforreconsiderationwithSFDA

within60daysuponreceiptofnotificationofnon-approvalrecord什么意思,

byfillingoutDrugRegistrationRe-considerationApplication

Formtogetherwithanexplanationanditsreasonsfor

re-consideration中秋节送礼物.

Thescopeofre-considerationcanonlybelimitedtothe

originalapplicationitemsandtheapplicationdossier.

Article157:SFDAshouldconcludeitsre-consideration

decisionandnotifytheapplicantwithin50daysuponreceipt

riginal

decisionisupheld,nofurtherre-considerationwillbe

acceptedbySFDA野扁豆.

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Article158:Whenthereisaneedfortechnicalreviewduring

thereconsideration,SFDAshallorganizethetechnicalexperts

tocompletethereviewwithintheoriginalprescribedtime关于读书的手抄报题目.

Chapter14:LegalLiability

Article159:IfoneoftheprovisionsofArticle69of

AdministrativeLicensingLawsoccurs,SFDAshouldproceedwith

thecancellationofrelevantdrugapprovaldocument,badon

therequestoftherelatedpartyorfromitslawfulauthority.

Article160:Ifanystaffofdrugadministrationauthorities

isfoundtoviolatetheprovisionsofthisregulationwithone

ofthefollowingoccurrences乘法的初步认识教学设计,theirsupervisingauthoritiesor

erious

violation一个人的等待,disciplinaryactionswillbeimpodtothedirectly

responsiblesupervisorandotherdirectlyresponsiblepeople:

1)Didnotacceptadrugregulationthatmetthelawful

requirement.

2)Didnotpubliclypublishtherequiredinformationitems

ofdrugregistration.

3)Failuretofulfilllegalobligationtonotifyapplicant

ortherelatedpartyduringtheprocessofacceptance山楂树之恋 电影,

examination出国考察报告,andapproval大连老虎滩公园.

4)Failuretonotifytheapplicantinonenotificationofall

thesupplementalinformationthatmustbesupplemented对英烈的寄语,

wheninformationsubmittedbyapplicantisincompleteor

notmeetingthestatutoryform.

5)Failuretoexplainthereasonsnottoacceptornotto

approve.

6)Failuretoholdahearingwhenthehearingislawfully

required通便中药.

Article161:Duringthedrugregistration,ifanystaffof

drugadministrationauthoritiesaskedforvaluablesfromother

partyorsoughtforotherinterest治疗阳痿的药物,criminalchargewillbe

ctsdid

notsufficientlyconstituteacrime女性理财,disciplinaryactionswill

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beimpod涿州翼德张.

Article162:Ifanystaffofdrugadministrationauthorities

isfoundtoviolatetheprovisionsofthisregulationwithone

ofthefollowingoccurrences手表的英文单词,theirsupervisingauthoritiesor

auditingauthoritieswillrequestacorrection,and

disciplinaryactionswillbeimpodtothedirectly

responsiblesupervisorandotherdirectlyresponsiblepeople令尊.

Criminalchargewillbeinvestigatediftheactsconstitutea

crime:

1)Concludeanapprovaldecisiontoanyregistration

applicationnotmeetingthelegalrequirement,or

concludeanapprovaldecisionofaregistration

applicationbeyondthedelegatedpowerofauthorities.

2)Concludeanonapprovaldecisiontoanyregistration

applicationmeetingthelegalrequirements嘻嘻哈哈小游戏,orfailureto

concludeanapprovaldecisionwithinthelawfully

prescribedtimeline.

3)Failuretofulfillthenondisclosureobligation

specifiedinArticle9ofthisRegulation广州失业保险金领取条件.

Article163:Ifadrugcontrolinstituteissuesafraudulent

inspectionreportduringperformanceofthedutyfordrug

inspectionduringthedrugregistrationprocess黄桷兰,sanctions

shallbeimpodaccordingtoArticle87oftheDrug

AdministrationLaw.

Article164:Ifanydrugadministrationauthoritiescharged

unauthorizedfees红歌经典,orbeyondthelawfulfeecategoryorrate洪门老大 林绅,

theirsupervisingauthoritiesorauditingauthoritieswill

requesttoreturntheillegallyoverchargedfees,and

disciplinaryactionswillbeimpodtothedirectly

responsiblesupervisorandotherdirectlyresponsiblepeopleabsorb.

Article165:IntheeventthatGLPorGCPrequirementswere

notadheredtoduringthedrugregistration,sanctionsshall

beimpodaccordingtoArticle79oftheDrugAdministration

Law.

Article166:Ifanapplicantisfoundtohaveprovided

fraudulentdrugregistrationinformationand/orsample

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productofthedrugsduringtheapplicationofclinicalstudy藿香正气软胶囊,

SFDAshallnotacceptertheapplication,orshallnotapprove

theclinicalstudy排球教案,new

applicationforclinicaltrailfromthesameapplicantwillbe

pplicationhasalreadybeen

approved,theapprovalcertificateshallbecanceled福建 旅游,anda

fineofRMB10,000-30,nical

trailapplicationbythisapplicantshallnotbeacceptedfor

3years.

Adatabaoffraudulentconductbyapplicantsshallbe

maintained翻译英语单词,andwillbepublished.

Article167:Ifanapplicantisfoundtohaveprovided

fraudulentdrugregistrationinformationand/orsample

productofthedrugsduringtheapplicationofdrugproduction

orimportation,SFDAshallnotacceptorapprovethe

application芙丽芳丝明星产品,new

applicationforclinicaltrailfromthesameapplicantwillbe

pplicationofproductionand/

orimportationofthedrugshavealreadybeenapproved关于端午节的由来,the

approvalcertificateshallbecanceled,andafineofRMB10,000

-30,000shallbeimpod,anapplicationforthedrugbythis

applicantshallnotbeacceptedfor5years圣诞节故事.

Article168:WhenprovisionsofArticle27callsforan

experimenttoberepeated2011江苏高考历史,ifanapplicantrefustorepeat

theexperimentaccordingtorelevantrequirements,the

applicantshallbewarned,andorderedtocorrectthesituation.

Iftheapplicantdefinitivelyrefustomakecorrections最痴情的等待,the

applicationshallnotbeapproved中秋节的诗歌朗诵.

Article169:Underanyofthefollowingevents,thedrug

approvalnumberwillbecancelled超级qq怎么开,andthecancellationwill

bepublished:

1)Applicantlfpropotocancelthedrugapprovalnumber

beforetheexpiryofthecertifiedapprovaldocuments;

2)Re-registrationisrejectedaccordingtotheprovisionof

Article126ofthisRegulation;

3)DrugManufactureLicenisrevokedorwithdrawsunder

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legalenforcement;

4)Drugofhighadverreactionorotherhazardstohuman

health世界最长寿老人,wherethecertifiedapprovaldocumentsis

withdrawnaccordingtoArticle42ofDrugAdministration

Law诉讼时效司法解释,orArticle41ofImplementingRegulation;

5)Anadministrationdecisiontocancelorwithdrawthe

certifiedapprovaldocumentsislawfullyconcluded;

6)Othersituationsleadingtolawfulcancellationor

withdrawalofthecertifiedapprovaldocuments.

Chapter15:Miscellaneous

Article170:ApplicationdossierandrequirementforTCMand

naturaldrugs酒店开业主持词,chemicaldrugs,biologicalproducts,

supplementalapplication,andre-registrationarespecifiedin

Annex1湖州学校,2,3尿道炎有哪些症状,4小城旧事,ions

formonitoringperiodisspecifiedinAnnex6婚假的规定.

Article171:FormatofDrugApprovalNumbershouldread

GuoyaozhunziH(Z,S孕妇奶粉有哪些牌子,J)+4digitofyear+4digitofrial

number法学本科毕业论文,whereHdenotechemicaldrugdsad,ZdenoteTCM春节习俗调查报告,Sdenote

biologicalproductsandJdenoteimporteddrugrepacking.

FormatofImportedDrugLicenshouldreadH(Z高中语文教学计划,S)+4digit

ofyear+4digitofrialnumber,andformatofPharmaceutical

ProductLicenshouldreadH(Z,S)C+4digitofyear+4digit

ofrialnumber,whereHdenotechemicaldrug天气变冷问候短信,ZdenoteTCM大学生恋爱的利与弊,

registration

certificatenumberofrepackingoflargepackagefromex-China新装的门铃,

Bwillbeaddedastheprefixoftheoriginalcertificate

number.

FormatofNewDrugCertificateshouldreadGuoyaozhengH(Z,

S)+4digitofyear+4digitofrialnumber张珏,whereHdenote

chemicaldrug,ZdenoteTCM图片春天,andSdenotebiologicalproducts横看成峰侧成岭.

Article172Applicationacceptance,approvalofsupplemental

application创新思维论文,approvalofre-registrationundertakenbyPADas

specifiedbythisRegulationfallintocategoryofdelegated

ydelegatePDAwithothertechnical

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examinationorapprovalitemsduringthedrugregistration

process.

Article173SFDAwilladoptdrugcodingmanagementsystemfor

ailedregulationfordrugcoding

managementwillbepromulgatedparately.

Article174:InadditiontothisRegulation,theapplication

fornarcotics,psychotropic,medical-utoxicdrugsand

radioactivedrugsshallalsobeadministeredaccordingtoother

relevantnationalregulations鹰舞.

Article175:SFDAshallpromulgateparateregulationfor

theregistrationofTCMmaterial加班费的计算基数,TCMherbandimportTCM

materialthatregulatedwithapprovalnumber人民的名义陈海结局.

Article176:Regulationfortechnologytransferandtoll

manufactureshallbepromulgatedparately公车系500章.

Article177:ThisRegulationbecomeeffectivefromOctober1,

gistrationRegulationpromulgatedbySFDA(SFDA

orderno阿信的女朋友蛋蛋妹.17)onFebruary28,2005shallbeabolished

accordingly河南一分一段表2021.

Annex1:RegistrationCategoriesandApplicationInformation

RequirementsofTCMandNaturalDrugs

Annex2:RegistrationCategoriesandApplicationInformation

RequirementsofChemicalDrugs

Annex3:RegistrationCategoriesandApplicationInformation

ItemsRequirementsofBiologicalProducts

Annex4:RegistrationItemsandApplicationInformation

RequirementsofSupplementalApplicationofDrugRegistration

Annex5:ApplicationInformationItemsofDrugRe-Registration

Annex6:TimeframeofMonitoringPeriodforNewDrugs(note:

nomonitoringperiodforthedrugsotherthantholisted)

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