食品和药品安全外文文献翻译2018-2019文档格式.docx

食品和药品安全外文文献翻译2018-2019文档格式.docx

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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（CETER）,theDrugRegistrationEvaluationOffice（GRMED）,theOfficeofSpecificandHerbalDrugsRegistrationEvaluation （GMESP）, and the Office of Post-Approval ChangesEvaluation（GEPRE）.Thestaffconsistsofhealthregulationexperts,regulationtechniciansandadministrativepersonnelincludingawiderangeofprofessionals,namely,biologists,bio-medics,chemists,doctors,engineers,lawyers,pharmacists,physiciansandstatisticians.GGMEDperformsdrugregistrationthroughevaluationofdrugsapplications,post-approvalchangeapplicationsanddrugregistrationrenewal.Other

actionsconnectedare“insitu”inspectionsoftheapplicationsmentioned,implementationofauditsontheapplicationreviewprocess,inspectionsonpharmaceuticalequivalenceandbioequivalence/bioavailabilitycenters,evaluationofsafetyandefficacy（clinicaltrials）,anddrafting/reviewinglegislation.RecentimprovementstoANVISA'

sreviewprocessincludesystematicstandardizedapproachestothebenefit/riskassessmentofmedicinesandmovingtowardsstepwiseimplementationofGoodReviewPractices（GRevP）.

ANVISA'

sothermajorcomponentistheFoodGeneralManagement

Office（GGALI）.ItencompassestheRiskAssessmentandEffectivenessOffice（GEARE）,theFoodRegistrationOffice（GEREG） andthePost-Registration Food Office （GEPRA）. The professional teamreviewing at GGALI consists of health regulation experts andadministrativepersonnel,includingseveralprofessionals,suchasfoodengineers,biologists,pharmacists,nutritionistsandveterinarians.Asanoverviewofthenationalfoodsafetycontrolsystem,the primaryproduction istheresponsibilityoftheagriculturalagencies,whileresponsibilityforthesubsequentstagesofproductionissharedbetweenthehealthandagricultureagencies.Actionsoftheseagenciesarelargelyco-dependent.InBrazil,foodhealthcontrolisamixedmodel.Inpre-marketing,assessmentinvolveshealthpromotion,registerandsafetyassessment,andfoodstandards.

In summary, ANVISA uses best practices and internationalguidelinestocreateBrazil'

sstandards.Informationisfrequentlyobtainedby contact with other regulatory and international agencies andcommunicationusingexistingtechnicalknowledgebasesavailableonvariouswebsitesandconfidentialinformationexchangewithotherregulatoryauthorities.

Hans-GeorgEichler,MD,MSc,SeniorMedicalOfficer,EuropeanMedicinesAgency（EMA）,UnitedKingdom（UK）,EU,focusedonregulatory science and the evolving role ofpharmacovigilance.Pharmacovigilancestemsfromthe1970sandmeans“closewatch”.Itisthepracticeofmonitoringtheeffectsofmedicaldrugsfollowinglicensureandmarketentry,especiallytoidentifyandevaluatepreviouslyunreportedadversereactions.Itisthescienceandactivitiesrelatedtodetection,assessment,understandingandpreventionofadverseeffectsoranyotherdrug-relatedproblem.

Dr.Eichlerdescribedsomeofthedifficultiesencounteredwhenpracticingprecisionmedicine.Oftenthestratificationcriterionisnotcompletelyunderstood,thenumbersofpatientsaresmallerbutthereareadvancedtherapies（gene,cell,tissue-based）,andsomeofthemaretrulypersonalized. Personalized treatment combinations are even morecomplexinthatthescientistsmustdealwithsmallpatientnumbersanditissometimesdifficulttodefineclinicalindications.Dr.Eichleralso

highlighted thedifference（s）betweenefficacyandeffectivenessinclinicalpractice.Efficacyistheextenttowhichaninterventiondoesmoregoodthanharmunderidealcircumstances（monitoringthepatienttakingthedrug）.Effectivenessistheextenttowhichaninterventiondoesmoregoodthanharmwhenprovidedundertheusualcircumstancesofhealthcarepractice.Accountingforheterogeneitywillleadtomorepreciseprecisionmedicineandadifferentapproachtodrugdevelopment.Dr.Eichleralsomentionedthatitisverylikelythatregulatorsandthehealthdeliverysystemwillneedtoshiftsomehealthcarepracticesinthefutureincaseweaccountforheterogeneity.

Dr.Eichlerbelievesthatthefutureevolutionofpharmacovigilancewillbefacilitatedbypay-for-performanceandpre-licensingofrealworlddata.Thiswillbethepinnacleofindividualizedpharmacovigilance.Therewillbeashiftfrompopulationtopatientlevel,frompredictiontoobservation-based decision-making. Treatment responsive andnon-responsivewillbeidentified,andtheuseofpatient-leveloutcomeswouldenableoutcome-basedcontractingand,perhapsfurtherimprovepatientsafetyandpublichealthbyfocusingonpatientexperiences.Dr.Eichler concluded by emphasizing that the development ofpharmacovigilancewilllikelybringshiftsoffocusfromsafety-onlytobenefitsandharms,frompharmacovigilancetoknowledgegeneration,andfrompopulationfocustopatient-levelfoc