Verification and issuance of registration certificates for imported chemicals.docx
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Verification and issuance of registration certificates for imported chemicals.docx
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Verificationandissuanceofregistrationcertificatesforimportedchemicals
Verificationandissuanceofregistrationcertificatesforimportedchemicals
2013-12-06
I.Projectname:
ImportedDrugRegistration
II.Contentoflicensing:
Verificationandissuanceofregistrationcertificateforimportedchemicals,theirclassificationfollowstheAnnexIIoftherovisionsforDrugRegistration,namely:
RegistrationCategory1,drugsnotmarketedathomeandabroad.
RegistrationCategory3,drugsthathavebeenmarketedoverseasbutnotyetmarketedinthedomesticmarket.
III.Legalbasis:
rugAdministrationLaw,""RegulationsforImplementationoftheDrugAdministrationLaw,androvisionsforDrugRegistration
IV.Charges:
Reviewandapprovalfeeforimporteddrugs:
RMB45,300yuan.
Forregistrationapplicationsafterthecompletionofclinicaltrials,sincetheapplicationforclinicaltrialsofimporteddrugshasbeencharged,therefore,theapplicationisfreeofcharge.
Chargingbasis:
"NoticeoftheStatePlanningCommissionandtheMinistryofFinanceontheAdjustmentofFeesforDrugReview,ApprovalandTests"[J.J.G.(1995)No.340]
V.Quantityrestrictions:
Noquantitylimitforthelicensing
VI.Listofapplicationdossiers:
"ApplicationFormfortheRegistrationofImportedDrugs
(I)Summarydata
1Drugname.
2Proofdocuments.
3Projectrationaleandbasis.
4Summaryandevaluationofmajorfindings.
5Drugpackageinserts,draftinginstructionsandrelevantreferences.
6Packagingandlabeldesignsamples.
(II)Pharmaceuticalresearchdata
7Overviewofpharmaceuticalresearchdata.
8APIproductionprocessresearchdataandliterature;drugformulationsandprocessesresearchdataandliterature.
9Testingdataandliteratureforconfirmationofchemicalstructureorcomponents.
10Testingdataandliteraturedataforqualityresearch.
11Drugstandardsandthedraftinginstructions,andstandardsubstanceorreferencesubstance.
12Sampleinspectionreport.
13SourcesofPharmaceuticalAPIsandexcipients,qualitystandards,andinspectionreports.
14Testingdataandliteraturefordrugstabilitystudies.
15Rationaleforselectionandspecificationsofimmediatepackagingmaterialandcontainer.
(III)Pharmacologyandtoxicologyresearchdata
16Reviewofpharmacologyandtoxicologyresearchdata.
17Mainpharmacodynamictestingdataandliterature.
18Generalpharmacologytestingdataandliterature.
19Acutetoxicitytestingdataandliterature.
20Long-termtoxicitytestingdataandliterature.
21Allergic(topical,systemicandlightsensitivetoxicity),hemolyticandlocal(bloodvessels,skin,mucousmembranes,muscle,etc.)irritationandotherspecialsafetyrelatedtestingdataandliterature.
22Testingdataandliteratureforinteractionsoftheefficacy,toxicityandpharmacokineticsofmultipleingredientsincompoundpreparation.
23Carcinogenicitytestingdataandliterature.
24Reproductivetoxicitytestingdataandliterature.
25Carcinogenicitytestingdataandliterature.
26Dependencetestingdataandliterature.
27Non-clinicalpharmacokineticstudiesandliterature.
(IV)Clinicaltrialsdata
28Summaryofrelatedclinicaltrialdataathomeandabroad.
29Clinicaltrialprotocolsandstudyprotocol.
30Clinicalinvestigator'sbrochures.
31AdraftofInformedConsent,EthicsCommitteeapprovalletters.
32Clinicaltrialreports.
SpecificrequirementsfortheaboveapplicationdossiersaredetailedinAnnexIIofthe鈥淧rovisionsforDrugRegistration.
VII.Requirementsforapplicationdossiers:
(I)Generalrequirementsforapplicationdossiers:
1.Thefirstpageofthedossiersshallbeadirectoryforapplicationitems,whichshallbearrangedinorderasperAnnexIoftherovisionsforDrugRegistration(SFDAOrderNo.28).Eachdossiershallindicateonitscover:
thenameofthedrugandapplicationitem,documentitemnumber,andthename,phonenumberandaddressofcontactpersonandtheapplicant.
2.AlldocumentsinthedossiershallbeprintedorcopiedinA4sizepaper.Thecontentshallbecomplete,standardized,clear,withoutalteration,andthedatamustberealandreliable.
3.Thedocumentsshallbeputinportfolioenvelope(s),onwhichtheapplicationclassification,registrationcategory,drugname,theenvelopenumberofsetX,thetotalnumberofenvelopesintheset,originalorcopy,thecontactperson,phonenumberandthenameofregistrationapplicationagentshallbeindicated.
4.Twosetsofcompleteapplicationdossiers(atleastonesetisintheoriginal)andonesetofreviewdocumentsinhardcopyshallbesubmittedforregistrationapplication,accordingtopreviouspracticesandactualsituation.Fourapplicationforms(1intheoriginaland3inhardcopy)shallbeseparatelyputintoeachsetofdossier(theoriginalapplicationformandahardcopyshallbeputinthesetofthedossierintheoriginal).
5."ImportDrugRegistrationApplicationForm":
thedrugregistrationapplicationformsubmissionprogramcouldbedownloadedfromCFDAwebsite();theapplicationformshallbefilledinasrequired,printedandsaved,andshallbesignedbytheoverseasapplicant,andsigned&sealedbyitsdomesticagent.
6.Whenmailingorsubmittingtheapplicationdossiers,theelectronicversionoftheapplicationformshallbesenttothefollowinge-mailaddressdedicatedfordrugregistration:
slzx@.
7.Thedatacheckingcodeontheelectronicandpaperapplicationformshouldbeidentical.
8.ForeignlanguagematerialsshallbetranslatedintoChinese.
(II)Specificrequirementsforapplicationdossiers:
1.The"ApplicationFormfortheRegistrationofImportedDrug"shouldbefilledinanaccurateandstandardizedmannerinlinewiththerequirementsofexplanatorynotes:
(1)DrugRegistrationCategory:
FillinasperthecorrespondingarticleofAnnexIIoftherovisionsforDrugRegistration(SFDAOrderNo.28).Theapplicationdossiersshallbesubmittedinaccordancewiththerequirementsfor"Itemsofapplicationdossiers"forchemicals.Asfortheapplicationfordrugsnotapprovedformarketingathomeandabroad,dossiersinaccordancewiththerequirementsofRegistrationCategory1shallbesubmittedwhilefortheapplicationforotherproducts,provisionsonRegistrationCategory3shallbefollowed.ICH-requiredCTDinformationcanalsobesubmitted,butthe"Summarydata"sectionshouldbesubmittedinaccordancewiththerequirementsfor"Itemsofapplicationdossiers"forchemicals.DrugsinRegistrationCategoryIshouldatleasthaveenteredPhaseIIclinicaltrialsinaforeigncountry.
(2)Additionalapplication:
otherapplicationscanberaisedatthesametime,suchasexemptionfromclinicaltrials,non-prescriptiondrugs,etc.
(3)Specifications:
wherethedrugforregistrationhasmultiplespecifications,anacceptancenumbershallbedesignatedforeachspecificationinaseparateapplicationform.
(4)Packagingspecifications:
multiplepackagingspecificationsshallbefilledinoneapplicationform.Multiplepackagevolumesandsizesofnon-injectableformulationslikeagents,oralsolutions,granules,ointments,eyedrops,andpasteswiththesamedrugformulationsshallbesubjecttouniformmanagementaccordingtodifferentpackagingsizes,andfilledinoneapplicationform.
(5)Theapplicant:
ontheapplicationform,organization1andorganization2refertoinformationofoverseaslicensedprovidersandproductionplant,thesetwoitemscannotbeleftblank.ExceptfortheapplicantsinHongKong,MacaoandTaiwanregions,thebusinessname,address,etc.shouldbefilledinEnglish;Organization3referstotheinformationforoverseaspackagingplantswhichshouldbecompletedinaccordancewiththeactualsituation.ExceptfortheapplicantsinHongKong,MacaoandTaiwanregions,thebusinessname,address,etc.shouldbefilledinEnglish;therelevantinformationofdomesticagenciesshouldbefilledinChinese.
(6)Theinformationontheapplicationformshouldbeconsistentwiththeproofdocumentsasprovided.
2.Whilethereisasameproductinobservationperiod,theproductasfiledshallnotapplyforimportregistration.
3.Requirementsforproofdocuments:
(1)ProofdocumentsissuedbyrelevantdrugregulatoryauthorityofthemanufacturingcountryorregionformarketingauthorizationandGMP-compliance,aswellastheirnotarizationdocumentsandChinesetranslationsthereof.
TheaboveproofdocumentsshallcomplywiththeWHOrecommendeduniformformat.FilesinotherformatsmustbenotarizedbypublicnotaryorganizationsofthecountryoforiginandcertifiedbyChineseembassiesandconsulatesinthecountry.
Forpreparationsproducedinoneplaceandpackagedinanother,theapplicantmustprovideproofdocumentsissuedbydrugregulatoryauthoritiesofthemanufacturingcountryorregiontopermitdrugmarketingandproveGMPcomplianceofthemanufacturers.
Fordrugsnotyetapprovedformarketinginthemanufacturingcountryorregion,theapplicantcanprovideproofdocumentsissuedbydrugregulatoryauthoritiesofthecountryorregionofthecertificateholders'headquarterstopermitdrugmarketingandproveGMPcomplianceofthemanufacturers.ProofdocumentsissuedbydrugregulatoryauthoritiesofcountriesorregionsotherthanthoseofthecertificateholdersheadquarterstopermitdrugmarketingandprovetheGMPcomplianceofmanufacturersmustbecertifiedbyCFDA.
ForAPIs,theapplicantcanprovideproofdocumentsissuedbydrugregulatoryauthoritiesofthemanufacturingcountryorregiontopermitthemarketingofdrugsandtoprovetheGMPcomplianceofthemanufacturers.TheapplicantcanalsoprovidecertificateofEuropeanPharmacopoeia(
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