食品和药品安全外文文献翻译2018-2019Word文件下载.docx

食品和药品安全外文文献翻译2018-2019Word文件下载.docx

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EmergingtechnologiesforfoodanddrugsafetyWilliamSlikker

Abstract

Emergingtechnologiesareplayingamajorroleinthegenerationofnewapproachestoassessthesafetyofbothfoodsanddrugs.However,the integration of emerging technologies in the regulatorydecision-makingprocessrequiresrigorousassessmentandconsensusamongstinternationalpartnersandresearchcommunities.Tothatend,theGlobal Coalition for Regulatory Science Research （GCRSR） inpartnershipwiththeBrazilianHealthSurveillanceAgency（ANVISA）hostedtheseventhGlobalSummitonRegulatoryScience（GSRS17）inBrasilia,BrazilonSeptember18–20,2017todiscusstheroleofnewapproachesinregulatorysciencewithaspecificemphasisonapplicationsinfoodandmedicalproductsafety.Theglobalregulatorylandscapeconcerningtheapplicationofnewtechnologieswasassessedinseveralcountriesworldwide.Challengesandissueswerediscussedinthecontextofdevelopinganinternationalconsensusforobjectivecriteriainthedevelopment,applicationandreviewofemergingtechnologies.Theneedforadvancedapproachestoallowforfaster,lessexpensiveandmorepredictivemethodologieswaselaborated.Inaddition,thestrengthsand

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weaknessesofeachnewapproachwasdiscussed.Andfinally,theneedforstandardsandreproducibleapproacheswasreviewedtoenhancetheapplicationoftheemergingtechnologiestoimprovefoodanddrugsafety.TheoverarchinggoalofGSRS17wastoprovideavenuewhereregulatorsandresearchersmeettodevelopcollaborationsaddressingthemostpressingscientificchallengesandfacilitatetheadoptionofnoveltechnicalinnovationstoadvancethefieldofregulatoryscience.

Keywords：

Globalcoalition，Emergingtechnologies，Foodsafety，

Drugsafety，Regulatoryagencies，Alternativemethods，Bestpractices，Cross-training

Introduction

Emerging technologies for food anddrug safetyassessmentrepresentagrowthareaforregulatorysciences.Withthegoaloffaster,lessexpensiveandmorepredictiveassessmentapproaches,manynewtechnologieshavebeenproposed.Althoughsomeofthesenewassessmentapproacheshavegainedconsiderableattention,fewifanyhavebeenuniversallyacceptedasavailabletoreplaceexistingtestingparadigms.Withthisinmindthefocusofthe7thannualGlobalSummitonRegulatoryScience（GSRS17）wasEmergingTechnologiesforFoodandDrugSafety.GSRS17isaninternationalconferenceheldundertheauspicesoftheGlobalCoalitionforRegulatoryScienceResearch（GCRSR）,withthegoalofdiscussinginnovativetechnologiesand

developingpartnershipstoenhancetranslationofbasicscienceintoregulatory applications within the global context. The conferenceprovidesaninteractiveplatformforscientistsfromgovernment,industry,andacademic-researchcommunitiestoobjectivelyassesstheutilityofemerging technologies （such asnanotechnology, imaging,omicsfortranslational science, precision medicine,bioinformaticapproaches,medicalproductsafety,andfoodsafety）foraddressingregulatoryresearch questionsandtodiscussthebestwaytotranslatethesetechnologiesintoreal-worldapplications.GSRS17alsoallowedtheopportunitytoexchangeviewsandpracticesthatcanassisttheregulatoryresearch community in harmonizing educational and trainingopportunitiesworld-wide.

Globalregulatorylandscape

Tocomparethestatusofregulatoryscienceasappliedtofoodanddrugsafetyaroundtheworld,theGlobalRegulatoryLandscapewasassessed.TofocusthepresentationsfromBrazil,theEuropeanUnion,NigeriaandJapan,severalcommonquestionswereaddressedbythepresenters.Theseincluded:

1）Whatarethecommonregulatoryscienceissues and practices across governmental agencies?

2） Whichinfrastructure/mechanismshouldbedevelopedtoaddressthesecommonissues andpractices?

3） Howdoyou envisionthe cross-trainingopportunitiestofacilitateknowledgetobeexchangedacrossagencies?

Dr.MeiruzeSousaFreitas,DeputyDirector,AuthorizationandHealthRegistry,BrazilianHealthSurveillanceAgency（ANVISA）,describedthatANVISAhasahierarchybasedonlegislationandacompetencytoeditlegislationonhealthsurveillance-relatedsubjects.ANVISAisveryconnectedtotheglobalcommunityandtheGoodRegulatoryPracticesProcess.Internationalapproachesandinformationarecollectedthroughcontactwithauthoritiesanddiscussionsbasedonthetechnicalprocedureswithinternationalcooperationgroups.

InANVISA,regulationiscoordinatedbytwooffices:

DrugGeneralManagementOffice（GGMED）andFoodGeneralManagementOffice（GGALI）, whicharesubordinate tothe AuthorizationandHealthRegistrationDirectory（DIARE）.TheGGMEDiscomposedoftheOfficeof Safety and Efficacy Evaluation （GESEF）, the DepartmentofTherapeuticEquivalence（CET