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ID:30382786
大小:1.22 MB
页数:17页
时间:2018-12-29
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1、R&DBRIEFING59Theimpactoftheevolvingregulatoryenvironmentontheapprovalofnewmedicinesacrosssixmajorauthorities2006-2015Thelastdecade,2006-2015,hasseenaContentscontinuationoftheconvergenceandgeneraldecreaseintheapprovaltimesamongstsixmajorregulatoryauthorities,namelytheEuropeanApprovaltim
2、es………………………….......................2MedicinesAgency(EMA),theUSFoodandDrugCharacteristics………………………..........................Authority(FDA),theJapanesePharmaceuticalsReviewtype………………………….......................3andMedicalDevicesAgency(PMDA),HealthFacilitatedregulatorypathways…………………….4Can
3、ada,SwissmedicandtheAustralianTherapeuticarea...........................................5TherapeuticGoodsAdministration(TGA).Commonapprovals…………….................................7Furtherfactorsaffectingtimetoapproval.....8ConvergenceinapprovaltimeshasresultedinImprovingthequalityofsubm
4、issions...............9compoundsbeinginternationalisedinashorterFocus:EMA2015………………………........................10timeframeintherecentyears.ThesecondhalfofFocus:FDA2015………………………..........................11thedecade,2011-2015,alsosawamajorincreaseFocus:PMDA2015………………….....................
5、.......12inthenumberofapprovalsofanti-cancerandFocus:HealthCanada2015………..........................13immunomodulatornewactivesubstances(NASs),Focus:Swissmedic2015…………...........................14comparedwith2006-2010,andthesenowFocus:TGA2015…………………..............................15constit
6、uteapproximatelyathirdofallNASDefinitions…………………………………........................16approvalsacrossthesixagencies.Thesixagencieshavecontinuedtoputinitiativesinplacetoimprovethequalityandtimelinessofreview,whichmayexplaintheirgeneraldecreaseandtighteninginapprovaltimes.Oneareaagencieshavebe
7、enconcentratingonisimprovementofthecompanysubmissionsaheadoftheagencyassessmentinordertoensurethattargettimelinesaremet.Suchactivitiesfurtherimproveconsistencyandpredictabilityofthereview,buthavealsoimpactedtheoverallapprovaltimeeitherinapositiveornegativematterasseeninthelastdecade.
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