annex是什么意思ex在线翻译读音例句

Annex2:RegistrationCategoriesandApplicationInformationRequirementsofChemicalDrugs

IRegistrationCategories

1)Newchemicalentitynevermarketedinanycountry.

bstanceanditspreparationsmadebysynthesisorsemi-synthesis.

almonomer(includingdrugsubstanceandpreparation)extractedfromnatural

sourcesorbyfermentation.

lisomer(includingdrugsubstanceandpreparation)obtainedbychiralseparationor

synthesis.

thfewercomponentsderivedfrommarketedmulti-componentdrug.

binationproducts.

rationalreadymarketedinChinabutwithanewlyaddedindicationnotyet

approvedinanycountry.

2)Drugpreparationwithchangedadministrationrouteandnotmarketedinanycountry

3)Drugmarketedex-China,including:

bstanceanditspreparations,and/orwithchangeddoseform,butnochangeof

administrationroute.

ationpreparations,and/orwithchangeddoseform,butnochangeof

administrationroute.

ationswithchangedadministrationrouteandmarketedex-China.

rationalreadymarketedinChinabutwithanewlyaddedindicationapproved

ex-China.

4)Drugsubstanceanditspreparationwithchangedacidoralkalineradicals(ormetallic

elements),butwithoutanypharmacologicalchange,andtheoriginaldrugentityalready

approvedinChina.

5)Drugpreparationwithchangeddoseform,butnochangeofadministrationroute,andthe

originalpreparationalreadyapprovedinChina,

6)Drugsubstanceorpreparationfollowingnationalstandard.

IIApplicationDossierItems

ASummary

1)Nameofthedrugs.

2)CertifiedDocuments.

3)ObjectivesandbasisforR&D.

4)Summaryofmainstudywork.

5)Draftofpackaginginsert,notetothedraft,andlatestliterature.

6)Designofpackagingandlabeling.

BPharmaceuticaldata

7)SummaryofPharmaceuticalStudy,

8)Researchinformationandrelevantliteratureoftheproductionprocessofthedrug

substance,researchinformationandrelevantliteratureofformulaandprocessofthe

preparations.

9)Studyinformationandrelevantliteratureforthechemicalstructureandcomponents

determination.

10)Studyinformationandliteratureforqualityspecification.

11)Draftofqualityspecificationandnotes,andprovidingreferencestandard.

12)Testreportofdrugsample.

13)Thesource,testreportandqualityspecificationofdrugsubstanceandexcipient.

14)Stabilitystudyandrelevantliterature.

15)Selectionbasisandqualityspecificationofimmediatepackingmaterialandcontainer.

CPharmacologyandtoxicologystudyinformation.

16)Summaryofpharmacologyandtoxicologystudy.

17)Primarypharmacodynamicsstudyandliterature.

18)GeneralPharmacologystudyandliterature.

19)Acute/singledosetoxicitystudyandliterature.

20)Repeateddosetoxicitystudyandliterature.

21)Specialsafetystudyandliteratureofhypersensitive(topical,systemican筵怎么读 dphoto-toxicity),

hemolyticandtopicalirritative(bloodvessel,skin,mucousmembrane,andmuscle)reaction

relatedtotopicalandsystemicuseofthedrugs.

22)StudyandrelevantliteratureonPharmacodynamics,toxicityandpharmacokineticschange

causedbytheinteractionsamongstmultiplecomponentsinthecombinationproducts.

23)Studyandliteratureofmutagenicitytest.

24)Studyandliteratureofreproductivetoxicity.

25)Studyandliteratureofcarcinogenicitytest.

26)Studyandliteratureofdrugdependence.

27)Studyandliteratureofpre-clinicalpharmacokinetics.

DClinicalStudyInformation

28)Summaryofglobalclinicalstudyinformation.

29)Clinicalstudyprotocol.

30)Investigator’sBrochure.

31)DraftofInformedConsentForm,approvaloftheEthicsCommittee.

32)Clinicalstudyreport.

IIINotestoApplicationInformationItems

1)InformationItem1,Nameofthedrugs,includesInternationalNonproprietaryName(INN),

ChemicalName,EnglishName,alstructure,MolecularWeight,

enclatureofthedrugshouldbeexplainedforany

newname.

2)InformationItem2,CertifiedDocuments,includes,

iedDocumentsoflawfulregistrationoftheApplicant,copiesofDrugManufacturing

License,applicationofproductionofnewdrugs,copiesofGMP

Certificatefortheworkshopwherethesampleproductofthedrugswasmanufacturedshould

beprovided.

iedDocumentsstatingpatentstatusandownershipofthisentityandformula,

productionprocessofthedrug,andletterofguaranteestatingthatnoinfringementuponthe

patentrightsofothers.

ofofficialapprovalsoftheresearchproposalofnarcotics,psychotropic,medical-use

toxicdrugsandradioactivedrugs.

applicationofproductionofnewdrugs,copyofApprovalofClinicalStudyofNew

Drugsandthequalitystandardofinvestigationaldrugsshouldbeprovidedforthemarket

authorizationapproval.

applicationofproductionofpreparation,certifieddocumentstoevidencethelegal

channelsofdrugsubstanceshouldbeprovided,includingcopiesofcertifiedapprovaldocument

ofdrugsubstance,drugstandards,testreport,businesslicensesofmanufacturersofdrug

substance,DrugManufacturingLicense,GMPCertificate,salesinvoice,andsupplycontract.

oftheDrugPackingMaterialandContainerCertificateorImportDrugPacking

MaterialandContainerCertificatefortheimmediatepackingmaterialandcontainer.

3)InformationItem3,objectivesandbasisoftheapplication,includesR&D,marketingstatus,

andtherelatedliteratureofthedrugs,aswellasthesummaryoftheuseandproductionofthe

drugs,domesticallyandoverseas,

4)InformationItem4,summaryandevaluationofmainresearchresults,includesthe

summaryofmainresearchresultsbytheApplicant,andacomprehensiveanalysisofsafety,

efficacy,andqualitycontrollabilityofthedrugsoftheapplication.

5)InformationItem5,draftofinsertsheet,notestothedraftandlatestliterature,includesthe

sampleofdraftofpackaginginsertsheetdraftedinaccordancewiththerelevantregulations,

notesonhoweachitemsoftheinsertsheetweredrafted,latestrelevantliterature.

6)InformationItem7,SummaryofPharmaceuticalStudy,referstothesummaryof

experimentandgloballiteratureofPharmaceuticalStudyofthedrugintheapplication

(synthesisprocess,selectionofdosageform,screeningofformula,determinationofstructure,

qualitystudyanddeterminationofqualitystandards,andstabilitystudy).

7)InformationItem8,researchinformationoftheproductionprocessofthedrugsubstance,

includestechnologyprocessandchemicalreactionequation,initialrawmaterialandorganic

menstruum,reactionconditions(temperature,pressure,duration,catalyst)andoperation

procedure,materialinput,and

outputyield,aswellaspossibleimpuritiesorotherby-productsproducedormixedduringthe

productionprocessshouldbeexplained.

8)InformationItem10,experimentsinformationandliteratureforqualityresearch,includes

physical-chemicalproperties,purityinspection,dissolution,assay,andmethodologyvalidation,

aswellasthedataandresultscollectedatvariousstages.

9)InformationItem11,draftofdrugqualityspecificationandnotes,andreferencestandard

shallbeprovided:Qualityspecificationshallcomplywiththeformatofthecurrentversionof

ChinesePharmacopoeia,andtheterminologyandunitsofmeasureofChinesePharmacopoeia

ts,reagentsolution,buffersolution,titrantandothersusedandtheir

cventofa

differentonewasused,ncestandardshallbe

providedwithseparateinformationattachedtoexplainthesource,physical-chemicalconstants,

purity,content,andmeasurementmethodanddataofthedrugs.

Notestothedraftofdrugstandardsshallincludetheselectionofitemstobecontrolled,

selectionofmethod,inspectionandpurityandlimitationrange,aswellasthebasistodecide

eachitem.

10)InformationItem12,thetestreportofthesampleproducts,meanstheself-testreportof

-testreportforatleastonebatchof

-testreportsoftheconsecutive

3batchesofsampleproductsshouldbeprovidedforthemarketauthorizationapprovalafter

completionoftheclinicalstudy.

11)Informationitem14,experimentsinformationandliteratureofthestabilitystudyofthe

drugs,includesstabilitytestconductedtogetherwiththeuseoftheimmediatepackingmaterial

andcontainer.

12)Informationitem16,Summaryofpharmacologyandtoxicologystu感时花溅泪恨别鸟赏析 dy,referstothe

summaryofexperimentandgloballiteratureofpharmacologyandtoxicologystudyofthedrug

intheapplication(includingpharmacodynamics,mechanismofaction,generalpharmacology

andtoxicology,andpharmacokinetics).

13)Informationitem27,summaryofpre-clinicalpharmacokinetics,refertothesummaryof

experimentandliteratureofpre-clinicalpharmacokinetics(animal)ofthedruginapplication

(absorption,metabolite,distribution,execration)

14)Informationitem28,Summaryofglobalclinicalstudyinformation,referstosummaryof

globalliterature,abstractandlatestupdatingregardingtheclinicaltrialofthedruginthe

application.

15)Informationitem29,Clinicalstudyprotocol:Clinicalstudyprotocolshouldcoverdetailsto

dealwiththecriticalitemsincludingproposedindication,usageanddosage,whichshouldbe

alstudyprotocolshouldbescientific,

completeandthereshouldbeacomprehensivesummaryofpre-clinicalandclinicalinformation

relatedtothekeyanalysisofthepotentialrisksandbenefitofproposedtrials.

16)Informationitem29,Investigator’sBrochure,referstosummaryofexistingpre-clinicaland

clinicalinformationofthedrugintheapplication,forthepurposetoprovideInvestigatorand

otherparticipatorswithinformationtoaidtheminunderstandingthecharacteristicofthedrug

igator’sBrochureshouldbeconciseandobjective.

IVTableofApplicationInformationItemandNotes

ATableofApplicationInformationItem

InformationcategoryinformationitemRegistrationcategoryandinformationitem

requirement

123456

Summaryinformation1＋＋＋＋＋＋

2＋＋＋＋＋＋

3＋＋＋＋＋＋

4＋＋＋＋＋＋

5＋＋＋＋＋＋

6＋＋＋＋＋＋

PharmaceuticalInformation7＋＋＋＋＋＋

8＋*5＋＋*5*5

9＋＋＋＋＋＋

10＋＋＋＋＋＋

11＋＋＋＋＋＋

12＋＋＋＋＋＋

13＋＋＋＋＋＋

14＋＋＋＋＋＋

15＋＋＋＋＋＋

Pharmacologyandtoxicologystudyinformation16＋＋＋＋＋＋

17＋*16*18－－

18＋*16*18－－

19＋*16*18－－

20＋*16*18－－

21*19*19*19*19*19*19

22*13－－－－－

23＋－－

24＋－－

25*8－*8*8－－

26*9－－－－－

27＋*20*20＋*20－

ClinicalStudyinformation28＋＋＋＋＋＋

29＋＋＋＋＋△

30＋＋＋＋＋△

31＋＋＋＋＋△

32＋＋＋＋＋△

Notes:

1.+Denotetheinformationmustbesubmitted,

Denoteturecanbeusedinsteadoftestinformation,

Denotetheationmaybeexempted,

Denotetheinformationshallbesubmitted4.8refertonote8.accordingtothe

requirement,

5.△denotethattheprovisions4of“V,RequirementForClinicalStudy”shallapply.

turereferstoliteratureand/orsummaryofliteratureofallPharmacologyand

toxicologystudyinformationofthedrugintheapplication(includingpharmacodynamic,

mechanismofaction,generalpharmacologyandtoxicologyandpharmacokinetics)

BNotes

1)nderRegistration

icationsreferred

inRegistrationCategories1.6and3.4meanthecaseswherepreparationalreadymarkedin

Ch很皮的搞笑撩人句子 inaaddnewindicationsthataredifferentwiththeoriginalindicationintermof作用机制.

2)InformationItems1-30(exceptInformationItem6)shallbesubmittedfortheapplication

-compiled

summaryInformationItems1-6,InformationItem12and14,clinicalInformationItems28-32

andotherchangesandsupplementalinformationshallbesubmittedandnumberedwiththe

numbersofInformationItemsuponthecompletionoftheclinicalstudy.

ForthedrugsunderRegistrationCategory1,uponthecompletionoftheclinicalstudy,allthe

requiredinformationofInformationItems1-30shouldbere-editedaccordingtotheresultof

trailsconductedduringclinicalstudy,andthenbere-submitted.

Whentheregistrationofdrugsubstanceandregistrationofpreparationofthechemicaldrug

underRegistrationCategory3and4areappliedatthesametime,theregistrationofdrug

substanceshouldcomplywiththerequirementforproduction.

3)InformationItems1-16and28-30shallbesubmittedfortheapplicationforadrugalready

withNatio

clinicalstudywasrequired,uponcompletionoftheclinicalstudy,InformationItems28-32and

otherchangesandsupplementalinformationshallbesubmittedandnumberedwiththe

numbersofInformationItems.

4)DuringtheregistrationofthedrugalreadywithNationalStandards,thereshouldbea

comprehensivequalitystudyoftheprocessandformulaofthedrug,andqualitycomparison

isnotpossibleto

conductthequalitycomparisonwiththealreadymarketeddrugsaccordingtothenational

standards,aqualitystudyshouldbeconductedaccordingtotherequirementforregistrationof

newdrug,andifnecessary,qualityprovisionsinthenationalstandardcanbeappendedand/or

revised.

5)Duringtheapplicationonlyforpreparations,thelawfulCertifiedDocumentstoevidencethe

lawfulsourcingofthedrugsubstancesshallbeprovidedin2duplicates,whichshouldbe

respectivelycategorizedintoinformationitem2(certifieddocument)andinformationitem13

(Thesource,testreportandqualityspecificationofdrugsubstanceandexcipient).Forthe

applicantusingdomesticdrugsubstance,thedocumentsthatshouldbeprovidedinclude

copiesofcertifiedapprovaldocumentofdrugsubstance,drugstandards,testreport,business

licensesofmanufacturersofdrugsubstance,DrugManufacturingCertificate,andGMP

Certificate,supplycontractsignedwithmanufacturersofdrugsubstance,purchasingreceipts.

Whentheimportdrugsubstanceswereused,copiesofsupplycontractsignedwith

manufacturersofdrugsubstanceoritslegaldomesticagent,ImportDrugCertificate,or

PharmaceuticalProductCertificate,testreportfromDrugControlInstituteofthelocalCustoms,

drugregistration,useininvestigativepreparation

withthedrugsubstanceswithoutImportDrugCertificate,orPharmaceuticalProduct

CertificatemustbeapprovedbySFDA.

6)Fortheregistrationofthedrugstransformedamonginjections,powderforinjectionand

intravenousinfusion,theapplicationshallbeappliedbythequalifiedenterprisewiththe

productionscopeofthecorrespondingdosageform.

7)Thereproductivetoxicityresearchinformationcorrespondingtothedrugusedforthe

peopleatchild-bearingageshouldbesubmittedbasedonthenaturesoftheindicationsand

characteristicofthenewdrug

8)Foranyofthedrugswithexpectedtreatmentperiodlongerthan6monthsinclusive,orused

fortreatmentofchronicandrecurrentdisease,orintermittentuseforaregularperiodoftime,

experimentinformationorliteratureonCarcinogenicityshouldbeprovided,andinformationof

carcinogenicitytestorliteratureshouldbesubmittedforthefollowingnewdrugs,basedonthe

indicationandcharacteristicofaction:

gswithchemicalstructurerelatingtotheknowncarcinogenorthemetaboliteofthe

newdrugsaresimilartotheknowncarcinogen.

long-termtoxicityexperiment,cytotoxiceffectswereshownorextraordinary

activationonthegrowthofcellsincertainvisceralorgansandtissueswerecaused.

thapositivetestresultduringmutagenicitytest.

9)Fornewdrugsactingoncentralnervoussystem,suchasanalgesics,depressants,

stimulants,anddrugswithchemicalstructurerelatedtothosecompoundsliabletocausedrug

dependence,experimentinformationofdrugdependenceshouldbesubmitted.

10)ForthenewdrugunderRegistrationCategory1,toxicokineticsstudyshouldusuallybe

conductedduringtherepeateddosestoxicitystudy.

11)UndertheRegistrationCategory1,theopticalisomerobtainedfromaknowndrugthrough

chiralseparationorsyntheticmethodanditspreparation,theresearchinformationandrelevant

literaturecomparedbetweenracemateandmono-isomerinareasonpharmacodynamics,

pharmacokineticsandtoxicology(normallyacutetoxicity)shouldbeprovidedtoindicatethe

justificationoftheR&esafetyrangeofracemateisnarrow,andtheavailable

informationindicatesthattheunexpectedtoxicology(irrelevanttopharmacology)is

considerablyhigh,thetoxicologytestofmonoisomerwithrepeateddoses(normallylastingfor

3months)orothertoxicologytests(suchasreproductivetoxicology)shallbeprovidedbased

onthecomprehensiveinformationsuchasclinicalcourseoftreatment,dosage,andindications

ofthedrugs,aswellasthepeopleusingthedrugs.

12)FordrugsunderRegistrationCategory1withfewercomponentsderivedfromalready

marketedmulti-componentdrugs,ifthecomponentdidnotincludethesubstanceexplainedin

note8herein,thenInformationItems23-25maybeexempted.

13)ForthenewcombinationproductsunderRegistrationCategory1,InformationItem22

shouldbesubmitted.

14)ForthenewcombinationproductsunderRegistrationCategory1,informationoftoxicity

testofrepeateddosagecomparedwithsingledosageshouldbeprovided,andifthe-toxicity

testofrepeateddosageindicatednoincreaseintoxicity,andnochangeinthetargettissue,

InformationItem27shouldbeexempted.

15)ForthenewcombinationproductsunderRegistrationCategory1,ifthereis早发白帝城全诗的意思 nosignificant

changeinanimalpharmacokineticstudyresults,thenItem23-25shouldbeexempted.

16)ForthenewdrugsunderRegistrationCategory2,therouteofadministrationduringthe

pharmacologyandtoxicologystudyshouldbethesamewiththattobeusedinclinicalstudy.

Generally,thepharmacokinetictestortherelatedtoxicologystudyinformation(suchastopical

andrepeateddosetoxicity)comparedwiththeoriginalrouteofadministrationshouldbe

provided.

17)ForthedrugsunderRegistrationCategory3,thepreparationswithchangeinrouteof

administrationandalreadymarketedoverseas,emphasisshouldbefocusedmoreonthedrug

absorptionortopicaltoxicityinfluencedbytheexcipient,andifnecessary,thepharmacokinetic

testorothertoxicologystudyshouldbeprovided.

18)ForthenewdrugsunderRegistrationCategory4,pharmacokinetic,main

pharmacodynamic,normalpharmacologyandacutetoxicitytestinformationcomparedwiththe

alreadymarketeddrugsshouldbeprovidedtoreflectthedifferencebeforeandafterthe

changes,andifnecessary,theresearchinformationonrepeateddosestoxicityandother

reparationismadeby

changingtheacidicoralkalineradicals(ormetallicelements)ofthesaltofamarketeddrug,it

hasbeenalreadymarketedoverseas,thentheapplicationinformationrequirementunder

RegistrationCategory3shallbeprovided.

19)Forthedrugsfortopicaluse,inadditiontotheinformationrequiredundertherelevant

RegistrationCategoryandInformationItems,theinformationunderInformationItem21

shouldalsobesubmitted;topicalabsorptiontestshouldbeconducted,ifnecessary.

20)Whenthereisanobvioussafetyconcernsintheimmediate,sustainedandcontrolled

releasedpreparations(narrowsafetyrange,significantincreaseindosage),animal

pharmacokineticstudyinformationcomparedwiththemarketedimmediate,sustainedand

controlledreleasedpreparationsregularpreparationsshouldalsobeprovidedatsingledose.

VRequirementforClinicalStudy

1)ForthenewdrugsunderRegistrationCategory1and2,clinicaltrialsshouldbeconducted.

fpatientsforclinicaltrialsshouldmeetthestatisticalrequirementandtheminimal

casesrequired.

imalcasesrequired(trialgroup)ofclinicaltrialsareasfollowing,20-30forPhaseI,

100forPhaseII,300forPhaseIII,2000forPhaseIV,

clinicalt

PhaseIIclinicaltrial,arandomizedcontrolledclinicalstudyshouldbeconductedonatleast100

eIIItrial,anopentrialonatleast

eIVtrial,variable

factorsofsuchkindofdrugsshouldbecarefullyconsideredtofinishthetrialwithadequate

numbersofcases.

2)ForthenewdrugsundertheRegistrationCategories3and4,humanpharmacokineticstudy

andrandomizedcontrolledclinicaltrialsonatleast100pairsofsubjectsshouldbeconducted.

Intheeventofmorethanoneindication,casesforeachmainindicationshallnotbelessthan

harmacokineticsstudyandanopentrialonatleast500casesfor12

menstruationcyclesshouldbeaccomplishedforcontraceptives.

Humanpharmacokineticsstudymaybeexemptedforthefollowing2cases:

preparationoftopcialusewithonlytopicaltreatmenteffect.

oralpreparationthatnotbeabsorbed.

3)TheclinicalstudyforthenewdrugunderRegistrationCategory5shouldbeconductedin

accordancewiththefollowingprinciples,

ivalencetrialsshouldbeconductedfororalsolidpreparationsonnormally18-24cases.

ioequivalencetrialisdifficulttobeconductedfororalsolidpreparationsorother

non-oralsolidpreparations,爱在云尽雨歇时免费阅读 clinicaltrailsshouldbeconducted,andcasesfortheclinicaltrials

shouldbeatleast100pairs.

preparationsofsustainedandcontrolledreleasedpreparations,controlledhuman

pharmacokineticstudyandclinicaltrialsrelatedtotherapeuticsshouldbeconductedonsingle

doseandrepeateddosesofthedrugs,andthecasesforclinicaltrialsshouldbeatleast100

pairs.

istrationofdrugtransformedamonginjections,powderforinjectionandintravenous

infusion,iftherouteofadministration,dosage,andusageareidenticalwiththeoriginaldosage

form,theclinicalstudycanbeexempted.

4)FortheoralsolidpreparationsundertheRegistrationCategory6,bioequivalencetests

shouldbeconductedonnormally18-24cases.

Ifthequalityofdrugneedstobecontrolledbyprocessandstandards,clinicaltestsshouldbe

conductedonnormally100cases.

5)Duringthenewdrugregistrationofchemicaldrug,whenatthesametimetheregistration

ofinjection,powderinjectionandintravenousinfusionthatmadeofthischemicaldrugisalso

applied,ifthepreparationsarefromthesameapplicant,clinicaltrialisonlyneededforoneof

erpreparation,aslongasrequirementofexemptionofclinicaltrailare

met,reparationsarefromdifferentapplicants,clinical

trailshouldbeconductionrespectively.

6)Applicationforreductionorexemptionofclinicaltrialshouldbemadeduringtheapplication

ofdrugregistrationwithdetailofreasonsandinformationforreductionorexemptionofclinical

nicaltrialisalreadyapproved,withexceptionofthecasewherereductionor

exemptionofclinicaltrialisallowedbythisRegulation,reductionorexemptionofclinicaltrial

eisindeeddifficultytocompletetheclinicaltrial,

applicationshouldbemadewithdetailofthebasisandplanforreductionorexemptionof

clinicaltrial,wheretherationalshouldbejustifiedintermofclinicalstatistic,statusofgroupof

patientsintheclinicaltrials.

7)Thecomparativedrugusedforthecontrolledclinicaltrailsshallbealreadymarketedin

omparativedrugmustbeimported,ty

inchoosingthecomparativedrugofpositiveclinicaltestshouldaccordingtothefollowing:

omtheoriginalmanufacturer

edrugofdefiniteclinicaltestdata

thesameactivesubstanceandrouteofadministrationbutdifferentdosageform

rugofsimilarmechanismofactioneffectandthesameindication.

VIRequirementonImportChemicalDrug.

ARequirementofApplicationInformationItems

1)ApplicationInformationshouldbesubmittedinaccordancewiththerequirementunder

applicationofthenew

chemicalentitynotyetmarketedinanycountry,ApplicationInformationshouldbesubmittedin

erdrugs,ApplicationInformationshould

derRegistrationCategory

1referstothosethatareatleastinthestageofPhaseIIClinicalTrialsex-China.

2)InformationItem5,includedraftofpackaginginsertsheet,notestothedraftandthe

updatedliterature,theoriginalPIfromthemanufacturingcountry,theactualcommercial

ginal

commercialpackagingandlabelingshouldalsobeprovidedforRegistrationCategory6.

3)Alltheclinicalstudyinformationusedforthemarketauthorizationapprovalintheoriginal

manufacturingcountriesshallbesubmittedforInformationItem28.

4)AlltheapplicationinformationshallbeinChinesewiththeoriginaltextattached,

informationinotherlanguage(ex-English)nese

translationshallbeconsistentwiththeoriginallanguage.

5)TheChinesetranslationofqualityspecificationmustcomplywiththeformatoftheNational

DrugStandardsofChina.

BRequirementandnotestotheInformationItem2,CertifiedDocuments

1)InformationItem2,CertifiedDocuments,includes,

i)CertifiedDocuments,notarizeddocumentforthefreesalecertificate(FSC)issuedfromthe

competentauthoritiesofthelocalcountryorregionwherethemanufacturerislocated,andthe

GMPCertificateofthemanufacturer,andtheChinesetranslation.

ApplicationforthedrugsunderRegistrationCategory1,t千里伴君行 heaboveCertifiedDocumentscanbe

submittedtogetherwiththeclinicalstudyreportuponthecompletionoftheclinicalstudyin

r,duringtheapplicationofClinicalTrails,certifieddocumentsofGMPCertificate

ofthemanufacturerissuedbylocalcompetentdrugadministrationwherethedrugis

manufacturedmustbeprovided.

ii)Whentheregistrationofaforeigndrugmanufacturerisconductedbymanufacturer’soffice

inChina,copiesofRegistrationCertificateOfResidentOfficeOfForeignEnterpriseshouldbe

provided.

Whenaforeigndrugmanufacturerauthorizesdomesticagenttoconducttheregistration,

copiesoftheauthorizationdocument,notarizeddocumentandtheChinesetranslation,aswell

astheBusinessLicenseofthedomesticagentshallbeprovided.

iii)Documentsandexplanationstoevidencethepatentstatusandownershipofthedrugsof

theapplication,theformulaofthedrugs,theproductiontechnologyandprocessofthedrugs,

aswellaslett曾经沧海难为水翻译 ersofguaranteestatingthatthenewdrugwillnotinfringeuponthepatentrights

ofothers.

2)Notes,

i)CertifiedDocuments,notarizeddocumentfortheFSCandGMPCertificateofthe

manufacturershouldcomplywiththerecommendedformatbyWorldHealthOrganization

(WHO).ThedocumentinotherformatmustbelegalizedbytheChineseembassyintheoriginal

country.

ii)Whenthemanufacturingsiteandpackagingsiteseparated,theCertifiedGMPCertificatesof

manufacturingandpackagingsiteissuedbythecorrespondingcountriesshouldbeprovided.

iii)Intheeventthattheproductsnotyetapprovedinthemanufactu姜夔暗香 ringcountryorregion,the

CertifiedDocumentsfromthecountrywheretheproductsbeingmarketedandGMPCertificates

tifiedDocumentsfromthecountrywherethe

productsbeingmarketedandGMPCertificatesfromthiscountryshouldberecognizedbySFDA.

iv)Forthedrugsubstance,theCertifiedDocumentsfortheapprovalofthemarketingforthe

drugsubstanceoritspreparationissuedbythecompetentauthoritiesoftheoriginal

manufacturingcountry,

MasterFile(DMF)orCertificateofSuitabilitytotheMonographsoftheEuropean

Pharmacopoeiaofthedrugsubs恼怒的反义词 tancemayalsobeaccepted.

v)Toapplyforaninternationalmulti–centerclinicalstudy,certifieddocumentofGMP

Certificateofthedrugmanufacturerissuedbylocaldrugadministrationwherethe

manufacturerislocatedmustbeprovided.

vi)Fordrugsubstanceorpreparation,wheneverapplicable,certifieddocumentofGMP

Certificateofthedrugmanufacturerissuedbylocalfoodanddrugadministrationwherethe

manufacturerislocated,ISO9000qualityassurancecertificateissuedbythecompetent

organization,and/orfreesalecertificate(FSC)issuedfromthecompetentauthoritiesofthe

localcountryorregionwherethemanufacturerislocatedshouldbeprovided

CRequirementfortheclinicalstudyconductedinChina

1)Duringapplicationofdrugnevermarketedinanycountry,clinicaltrialsshouldbeconducted

accordingtoCTstudyrequirementofRegistrationCategory1.

2)Duringapplicationofdrugthatmarketedex-ChinabutnotinChina,clinicaltrialsshouldbe

conductedaccordingtoCTstudyrequirementofRegistrationCategory3.

3)Duringapplicationofdrugwithsamerouteofadministrationbutdifferentdosageformof

thatofthedrugmarketedinChina,ifinformationitem28oftheapplicationmeetthe

requirement,clinicaltrialsshouldbeconductedaccordingtoCTstudyrequirementof

rmationitem28oftheapplicationdidnotmeettherequirement,

clinicaltrialsshouldbeconductedaccordingtoCTstudyrequirementofRegistrationCategory3.

4)DuringapplicationofdrugalreadywithNationalStandards,ifinformationitem28ofthe

applicationmeettherequirement,clinicaltrialsshouldbeconductedaccordingtoCTstudy

rmationitem28oftheapplicationdidnotmeet

therequirement,clinicaltrialsshouldbeconductedaccordingtoCTstudyrequirementof

icaltrialisneededforapplicationofdrugsubstancealreadywith

NationalStandards.

5)FortheapplicationonlyfortheimportationofthedrugsubstancewithoutavailableNational

DrugStandardsinChina,theclinicalstudyshallbeconductedwiththeuseofthepreparations

ofthedrugsubstance.

VIIApplicationInformationandRequirementforRadioactiveDrugs

ARequirementofInformationItems

1)Fortheapplicationofradioactivedrugs,theapplicationinformationshallbepreparedfor

nuclide,drugsubstance,packingcaseandpreparationsrespectively,andbeinaccordancewith

thecorrespondingCategoryofchemicaldrugs,andtheRequirementofApplicationInformation

ationItems22and26maybeexempted.

2)Fortheapplicationofdiagnosisradioactivedrugs,InformationItems23,24and25maybe

exempted.

3)Fortheapplicationofradioactivechemicalsandpackingcase,InformationItem17and18

ationrequiredunderpreparationshouldalsobeprovidedforthe

applicationofpackingcase.

BNotestotheInformationItems

1)InformationItem8shallbesubmittedinaccordancewiththefollowing,

i)Radioactivechemicals:theselectionoftheproductionmethodofthenuclide,irradiation

condition,nuclearreactionequation,chemicalprocessingtechnologyaftertargetmaterial

eradiated(withthechemicalreactionequationandproductionprocessattached),detailed

operationprocedure,possiblenuclearimpurityintroduced,refining(purifying)method,andthe

specification,standardsandanalysisoftheotherchemicalreagent(inparticulartarget

material),relevantliteratureandinformationatdomesticandoverseasshouldbeprovided.

ii)Packingcase:theexperimentbasisforthedeterminingofpackingcase,thepreparation

process,route,reactioncondition,operationstepsandqualitystandardsofallcomponentsof

omponentswasmadebythemanufacturer,thenthe

basisofdeterminingofthedetailedsynthesisroute,synthesisprocessflow,reactionequation,

chemicalequation,reactioncondition,operationprocedure,materialinput,outputratio,and

possibleimpurityintroducedandmixed,qualitycontroloftheintermediateproductsateach

steps,refining(purifying)methodoffinishedproduct,qualitystandardoftherawmaterial,

literatureandinformationatdomesticandoverseasshallbeprovided.

iii)Preparation:basistochoosetheformulaofthepreparation,preparationprocess,reaction

condition,operationprocedure,refiningorpurifyingmethod,qualitystandardsandanalysis

andtestdataofrawmaterial,andliteratureandinformationatdomesticandoverseasshallbe

provided.

2)InformationItem9shallbesubmittedinaccordancewiththefollowing,

i)Radioactivechemicals:globalliteratureandexperimentdata(illustratingspectrumanda

comprehensiveinterpretation)

radioactivenuclideoftheradioactivedrugisnotyetlistedintheChinesePharmacopoeia,then

thedecayillustratingchartofthenuclide,experimentdata(orspectrum)todeterminethe

nuclearcharacteristic,aswellasexperimentinformationandliteraturecomparedwiththe

nuclearcharacteristicofthenuclidewidelyrecognizedatdomesticandoverseasshouldbe

provided.

ii)Packingcase:Thedetailedcomponentandusageofthepackingcaseshouldbeprovided,

withe

componentswasmadebythemanufacturer,thengloballiteratureandthedetailedexperiment

data(illustratingspectrumandacomprehensiveinterpretation)usedtodeterminethe

structureshouldbeprovided.

iii)Preparation:

thereisadifficultytoprovide,thereasonshouldbeexplainedandreasonablelogiccanbeused

toconcludethepossiblechemicalstructureorquotetherelevantliteraturethatcanbeusedas

basis.

3)InformationItem10shallbesubmittedinaccordancewiththefollowing,

i)Radioactivechemicals:researchitemsforthephysical-chemicalconstants,itemsofthe

puritytesting,thescreeningofthemethodtomeasurethecontent,andthebasistodetermine

themethodshouldbeprovidedwithdetailsofthemeasuringmethod,andmeasuringdata.

ii)Packingcase:theanalyzingandmeasuringmethod,principleanddataofthecharacteristic,

determination,clarity,iningofthe

contentmeasuringmethod,theexperimentdata,testingmethodforbacteria,intracellular

toxicity,andtheresearchinformationtodecidethelimitationshouldbeprovided.

iii)Preparation:determiningmethodandexperimentdataofthephysical-chemicalproperties,

characteristic,determiningandprinciple,PHvalue,radioactivenuclearpurity(includingmain

nuclearimpurity),radioactivechemicalpurity,radioactivity,chemicalpurityofthedrugshould

injection,methodsusedfortestingforbacteria,intracellulartoxicity,data,

basistodeterminethelimitationofintracellulartoxicityshouldbeprovided.

4)InformationItem17shallbesubmittedinaccordancewiththefollowing,

i)Forthediagnosisradioactivedrug,informationaboutthetestingandmeasuringmethod,

testingconditionsandresultexplanationofimageofthetargetorganandwholebodyplanar

gepictureoritscopiesofthedevelopmentatallphaseof

test,aswellasthefunctionmeasuringresultshouldbeprovided.

ii)Forthetherapeuticallyradioactivedrug,experimentinformationofanimalexperimental

modelwithinthemainindicationsshouldbeprovided,,detailedgloballiteratureof

pharmacodynamicstudyofthedrugorothersimilardrugshouldalsobeprovided.

5)InformationItem19shallbesubmittedinaccordancewiththefollowing,

Acutetoxicitytestshouldbeconductedonmouseforthedrugsubstanceofradioactivedrug

underRegistrationCategories1and3packingcaseandpreparationsshouldbetestedwith

eisonlyalimitedquantityproducedfromrefiningandsynthesisof

thedrugsubstanceandthereisonlyatrivialclinicalusage,thentheabnormaltoxicitytestmay

alsobeadopted.

6)InformationItem20shallbesubmittedinaccordancewiththefollowing,

i)FortheradioactivedrugunderRegistrationCategory1,experimentinformationand

literatureoflong-termtoxicitytestandmedicalinternalirradiationabsorptiondose(MIRD)on

ratanddogshouldbeprovided.

ii)FortheradioactivediagnosisandtherapeuticradioactivedrugunderRegistrationCategory1,

internalirradiationabsorptiondoseafterthefulldecayoftheradioactivenuclideofthedrug,

estimationofabsorptiondoseofthehumantargetorganandnon-targetorgan,ortheliterature

ofthedrugorsimilardrugatdomesticandoverseasshouldbeprovided.

CRequirementofClinicalStudy

Theclinicalstudyoftheradioactivedrugshouldbeconductedinaccordancewiththe

specialcase,casesofclinical临江仙杨慎全文 trialsmay

beadjustedtoanappropriatelevelsubjecttothestatisticalrequirement.

DDefinition

Radioactivechemicals,packingcaseandpreparationreferredinthisprovisionhavethe

followingdefinition:

Radioactivechemicals:meansthematerialofRadioactiveNuclide,whichwillbedirectlyused

forthepreparationofradioactivedrugpreparation.

Packingcase:acollectivenameforunidentifiedligand,reducingagent,oxidant,separator,,

whichwillbeusedasauxiliaryoftheradioactivechemicalsforthepurposeofquickpreparation

beforeanyapplication.

Preparation:referstotheradioactivedrugmadeofRadioactiveNuclideandothersubstance.