化学原料药生产起始物料的选择和论证要求思考

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1、Reflectionpaperontherequirementsforselectionandjustificationofstartingmaterialsforthemanufactureofchemicalactivesubstances化学原料药生产起始物料的选择和论证要求思考AgreedbyCHMP/CVMPQualityworkingparty11July2014AdoptionbyCHMPSeptember2014AdoptionbyCVMPSeptember2014KeywordsStartingmaterial,activesubstance

2、.关键词起始物料、活性物质Introduction: 概述ThisreflectionpaperaimstoclarifysomeoftheexpectationsofEUcompetentauthoritiesarisingfromtheguidancefoundinICHQ11(DevelopmentandManufactureofDrugSubstances(ChemicalEntitiesandBiotechnological/BiologicalEntities)1regardingtheinformationtobesubmittedinmarke

3、tingauthorisationdossierstojustifytheselectionofstartingmaterials.WhilstICHQ11isnotgenerallyapplicabletoveterinaryproducts,theprinciplesoutlinedinthisdocumentshouldapplyequallyforactivesubstancesdestinedtotreatbothhumansandanimals.Thedocumentre-producesextractsfromsection5ofICHQ11 v

4、erbatim inblacktext,andprovidessubsequentcommentaryonEUexpectationsintheformofexplanatorynoteswithingrey-shadedboxes.本思考文章目的是澄清由ICHQ11指南（原料药研发和生产（化学实体和生物技术/生物制品实体））引出的，关于上市许可文件提交的用于论述起始物料选择的资料中，欧盟药监机构的态度。尽管ICHQ11并没有普遍应用于兽药产品，在本文中列出的原则还是同样适用于人兽共用活性物质。文件中摘要的ICHQ11第5部分内容以黑体字表示，相应的欧盟态度的

5、解说以注释形式放在灰色阴影方框中。ItshouldberecognisedthatthisdocumentisnotintendedasarevisionofICHQ11,andratherasareflectionpaperwithintheEUmedicinesregulatorynetworkaspreparedbytheQualityWorkingParty(QWP).读者应知本文并无意作为ICHQ11的修订版本，而只是由质量工作组起草，反映了欧盟药监机构网络的思考的文章。Problemstatement: 问题说明Disagreementsbetwe

6、enapplicantsandqualityassessorsonthesuitabilityofproposedstartingmaterialshavebecomemorefrequentinrecenttimes.Thissuggeststhatthecurrentguidelines,1-3intentionallyhighleveltoallowapplicationtothewiderangeofchemicalsynthesessubmittedtoregulatoryauthorities,areopentointerpretation.Fur

7、thermore,itisincreasinglycommonforapplicantstoproposeveryshortsyntheticrouteswithcomplexcustom-synthesizedstartingmaterials.Anothertrendisforsome,orall,oftheactivesubstancemanufacturetobeoutsourcedtothirdparties.Theuseofexternalsourcesforanystepsinamanufacturingprocessmayleadtoahigh

8、erdegreeofrisktoqua