预览加载中，请您耐心等待几秒...

ACTDrequireddoxvietnam.pdf

预览
1/10
2/10
3/10
4/10
5/10
6/10
7/10
8/10
9/10
10/10

亲，该文档总共20页，到这已经超出免费预览范围，如果喜欢就直接下载吧～

下载提示 文本预览

如果您无法下载资料，请参考说明：

1、部分资料下载需要金币，请确保您的账户上有足够的金币

2、已购买过的文档，再次下载不重复扣费

3、资料包下载后请先用软件解压，在使用对应软件打开

THEASEANCOMMONTECHNICALDOSSIER(ACTD)FORTHE REGISTRATIONOFPHARMACEUTICALSFORHUMANUSE PARTII:QUALITY TABLEOFCONTENTS ScopeoftheGuideline…………………………………………………..2 SectionA:TableofContents…………………………………………..2 SectionB:QualityOverallSummary…………………………………2 SectionC:BodyofData9 1.DrugSubstance…………………………………………………9 2.DrugProduct……………………………………………………14 SectionD:KeyLiteratureReferences……….………………………..20 1 ScopeofTheGuideline Thisdocumentisintendedtoprovideguidanceontheformatofaregistrationapplication fordrugproductsregardingASEANCTR.ThisformatisappropriateforNCE(New ChemicalEntity),Biotech(BiotechnologicalProducts),MaV(MajorVariations),MiV (MinorVariations)andG(Generics).Todeterminetheapplicabilityofthisformatfora particulartypeofproduct,applicantshouldconsultwiththeappropriateNational RegulatoryAuthorities.The"BodyofData"inthisguidelinemerelyindicateswherethe informationshouldbelocated.Neitherthetypenorextentofspecificsupportingdatahas beenaddressedinthisguidelineandbothmaydependuponnationalguidanceandor acceptedleadinginternationalreferences(pharmacopoeias). ForNCEandBiotechrequirementspleaserefertotherelevantICHGuidelines. SectionA:TableofContents Atableofcontentsforthefiledapplicationshouldbeprovided. SectionB:QualityOverallSummary(QOS) No.PARAMETERSCOMPONENTSREQUIREMENTS NCEBIOTECHMaVMiVG SDRUGSUBSTANCE S1GeneralInformation 1.1.Nomenclature−InformationfromtheS1VVV*V 1.2.Structure−Structuralformula,includingrelativeandVV absolutestereochemistry,themolecular formula,andtherelativemolecularmass. −SchematicaminoacidsequenceindicatingV glycosylationsitesorotherpost- translationalmodificationsandrelative molecularmassasappropriate. 1.3.GeneralProperties−PhysicochemicalcharacteristicsandotherVVV*V relevantpropertiesincludingbiological activityforbiotech. S2Manufacture 2.1.Manufacturer(s)Nameandaddressofthemanufacturer(s).VVV 2.2.Descriptionof−ThedescriptionofthedrugsubstanceVV ManufacturingProcessmanufacturingprocessandprocesscontrol andProcessControlsth