CTD格式申报资料中原料药特性鉴定部分的解读-康建磊

ChineseJournalofNewDrugs2016,25(18)210920162518。[e-mail]。··CTD100038CTD。《》CTD。CTDＲ95C1003－3734201618－2109－04InterpretationofcharacterisationintheformCTDKANGJian-leiCenterforDrugEvaluationChinaFoodandDrugAdministrationBeijing100038ChinaAbstractThecommontechnicaldocumentCTDisastandardizedformatofregistrationdossierwhichcouldimprovethequalityandefficiencyofdrugregistrationandevaluation．Inthisarticlebasedonreviewexperiencetheinterpretationofdossierwritingrequirementsandtechnicalrequirementsonthemodule“3．2．S．3Characterisation”waspresentedinordertoprovidesomereferencesforresearchersonelucidationofstructureandimpurityprofile．KeywordscommontechnicaldocumentCTDcharacterisationinterpretationInternationalConferenceonHarmonisationofTechnicalＲequirementsforＲegis-trationofPharmaceuticalsforHumanUseICHcommontechnicaldocumentsCTD120037CTDnewdrugapplicationsNDAsFDANDAsCTD。ICHCTD20109《CTD》23、4、56CTD。CTDCTD。201654《》CTD3。《CTD》CTD。1CTD3．2．S．3“3．2．S．3．1”、“3．2．S．3．2”2“3．2．S．3．1ChineseJournalofNewDrugs2016,25(18)211020162518”“1”、“2”。“1”2007《》29“2”、“3．2．S．3．2”28、10CTD。。2“3．2．S．3．1”2．1。、、、。、UV、IＲ、NMＲ、MS、、X-、X-、、、。、、、。IＲUVNMＲ、Edman、。、、、C2/C6、。。。。、。、。X-、、、HPLC。。ICHQ6A4polymorphism、。BA/BE、、、、、。。X-XＲPD、、、、、、。ICHQ6A。。ICHQ6A、、、、ChineseJournalofNewDrugs2016,25(18)211120162518。。2．2、、/pH、、。pH。。、、、、。。3“3．2．S．3．2”。。、。3、、。1、、、。、、、。。13．1、。。、/、。、、/。、。。USP、EP。。5、FDA6、ICH7。3．2、、、。、、、。ICHQ3D81。3．3CFDA《》9、ICHQ3C10。、ChineseJournalofNewDrugs2016,25(18)211220162518、、、。4CTD、11。。1ICH．Thecommontechnicaldocumentfortheregistrationofphar-maceuticalsforhumanusequality-M4QＲ1qualityoverallsummaryofmodule2module3qualityEB/OL．2002－09－122016－05－20．http//．ich．org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_Ｒ1_Quality/M4Q_Ｒ1_．pdf．2CFDA．CTDEB/OL．2010－09－252016－05－20．http//．sfda．gov．cn/WS01/CL0844/54391．html．3CFDA．EB/OL．2016－05－042016－05－20．http//．sfda．gov．cn/WS01/CL0087/151985．html．4ICH．ICHHarmonisedTripartiteGuideline-Q6A．SpecificationsTestProceduresandAcceptanceCriteriaforNewDrugSubstancesandNewDrugProductsChemicalSubstancesEB/OL．1999－10－062016－05－20．http//．ich．org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4．pdf．5EMA．GuidelineontheLimitsofGenotoxicImpuritiesEB/OL．2007－01－012016－05－20．http//．ema．europa．eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002903．pdf．6FDAGuidanceforIndustry．GenotoxicandCarcinogenicImpu-ritiesinDrugSubstancesandProductsＲecommendedApproa-chesdraftEB/OL．2008－112016－05－20．http//．fda．gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079235．pdf．7ICH．ICHHarmonisedTripartiteGuideline-M7．AssessmentandControlofDNAＲeactiveMutagenicImpuritiesinPharmaceuti-calstoLimitPotentialCarcinogenicＲiskEB/OL．2014－06－232016－05－20．http//．ich．org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_4．pdf．8ICH．ICHHarmonisedTripartiteGuideline-Q3D．GuidelineforElementalImpuritiesEB/OL．2014－12－162016－05－20．http//．ich．org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4．pdf．9CFDA．《》EB/OL．2005－03－182016－05－20．http//．sfda．gov．cn/WS01/CL1616/83419．html．10ICH．ICHHarmonisedTripartiteGuideline-Q3C．ImpuritiesGuidelineforＲesidualSolventsEB/OL．2011－02－042016－05－20．http//．ich．org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Step4/Q3C_Ｒ5_Step4．pdf．11．CTDJ．2014238936－939．/2016－06－15