ICH M7(step4)基因毒性杂质评估和控制◆中英.doc

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1、ASSESSMENTAND CONTROLOF DNAREACTIVE(MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTOLIMIT POTENTIAL CARCINOGENIC RISK为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制M7Current Step4 versiondated23June2014ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbyth

2、eregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA. M7DocumentHistory 文件历史Code 文件代码History 历史Date 日期M7ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.第2

3、阶段由筹委会批准，公开征求意见6February2013M7ApprovalbytheSteeringCommitteeunderStep4andrecommendationforadoptiontothethreeICHregulatorybodies.第4阶段由筹委会批准，推荐ICH三方药监局采用5June2014CurrentStep4version 现行版本第4阶段M7Corrigendumtofixtypographicalerrorsandreplaceword“degradants”with“degradationproducts”throug

4、houtthedocument.修正输入错误，将全文中“degradants”替换成“degradationproducts”.23June2014 LegalNotice: Thisdocumentisprotectedbycopyrightandmaybeused,reproduced,incorporatedintootherworks,adapted,modified,translatedordistributedunderapubliclicenseprovidedthatICH'scopyrightinthedocumentisacknowled

5、gedatalltimes.Incaseofanyadaption,modificationortranslationofthedocument,reasonablestepsmustbetakentoclearlylabel,demarcateorotherwiseidentifythatchangesweremadetoorbasedontheoriginaldocument.Anyimpressionthattheadaption,modificationortranslationoftheoriginaldocumentisendorsedorspo

6、nsoredbytheICHmustbeavoided.Thedocumentisprovided"asis"withoutwarrantyofanykind.InnoeventshalltheICHortheauthorsoftheoriginaldocumentbeliableforanyclaim,damagesorotherliabilityarisingfromtheuseofthedocument.Theabove-mentionedpermissionsdonotapplytocontentsuppliedbythirdparties.Ther

7、efore,fordocumentswherethecopyrightvestsinathirdparty,permissionforreproductionmustbeobtainedfromthiscopyrightholder.ASSESSMENTAND CONTROLOF DNAREACTIVE (MUTAGENIC)IMPURITIESIN PHARMACEUTICALSTO LIMIT POTENTIALCARCINOGENIC RISK为限制潜在致癌风险而对药物中DNA活性（诱变性）杂质进行的评估和控制ICHHarmonisedTriparti

8、teGuidelineICH三方协调指南Having