食品和药品安全外文文献翻译.docx

食品和药品安全外文文献翻译.docx

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食品和药品安全外文文献翻译

食品和药品安全的新兴技术外文翻译2018-2019

英文

Emergingtechnologiesforfoodanddrugsafety

WilliamSlikker

Abstract

Emergingtechnologiesareplayingamajorroleinthegenerationofnewapproachestoassessthesafetyofbothfoodsanddrugs.However,theintegrationofemergingtechnologiesintheregulatorydecision-makingprocessrequiresrigorousassessmentandconsensusamongstinternationalpartnersandresearchcommunities.Tothatend,theGlobalCoalitionforRegulatoryScienceResearch（GCRSR）inpartnershipwiththeBrazilianHealthSurveillanceAgency（ANVISA）hostedtheseventhGlobalSummitonRegulatoryScience（GSRS17）inBrasilia,BrazilonSeptember18–20,2017todiscusstheroleofnewapproachesinregulatorysciencewithaspecificemphasisonapplicationsinfoodandmedicalproductsafety.Theglobalregulatorylandscapeconcerningtheapplicationofnewtechnologieswasassessedinseveralcountriesworldwide.Challengesandissueswerediscussedinthecontextofdevelopinganinternationalconsensusforobjectivecriteriainthedevelopment,applicationandreviewofemergingtechnologies.Theneedforadvancedapproachestoallowforfaster,lessexpensiveandmorepredictivemethodologieswaselaborated.Inaddition,thestrengthsandweaknessesofeachnewapproachwasdiscussed.Andfinally,theneedforstandardsandreproducibleapproacheswasreviewedtoenhancetheapplicationoftheemergingtechnologiestoimprovefoodanddrugsafety.TheoverarchinggoalofGSRS17wastoprovideavenuewhereregulatorsandresearchersmeettodevelopcollaborationsaddressingthemostpressingscientificchallengesandfacilitatetheadoptionofnoveltechnicalinnovationstoadvancethefieldofregulatoryscience.

Keywords：

Globalcoalition，Emergingtechnologies，Foodsafety，Drugsafety，Regulatoryagencies，Alternativemethods，Bestpractices，Cross-training

Introduction

Emergingtechnologiesforfoodand drugsafetyassessment representagrowthareaforregulatorysciences.Withthegoaloffaster,lessexpensiveandmorepredictiveassessmentapproaches,manynewtechnologieshavebeenproposed.Althoughsomeofthesenewassessmentapproacheshavegainedconsiderableattention,fewifanyhavebeenuniversallyacceptedasavailabletoreplaceexistingtestingparadigms.Withthisinmindthefocusofthe7thannualGlobalSummitonRegulatoryScience（GSRS17）wasEmergingTechnologiesforFoodandDrugSafety.GSRS17isaninternationalconferenceheldundertheauspicesoftheGlobalCoalitionforRegulatoryScienceResearch（GCRSR）,withthegoalofdiscussinginnovativetechnologiesanddevelopingpartnershipstoenhancetranslationofbasicscienceintoregulatoryapplicationswithintheglobalcontext.Theconferenceprovidesaninteractiveplatformforscientistsfromgovernment,industry,andacademic-researchcommunitiestoobjectivelyassesstheutilityofemergingtechnologies（suchas nanotechnology,imaging, omics fortranslationalscience,precisionmedicine, bioinformatic approaches,medicalproductsafety,andfoodsafety）foraddressingregulatoryresearchquestionsandtodiscussthebestwaytotranslatethesetechnologiesintoreal-worldapplications.GSRS17alsoallowedtheopportunitytoexchangeviewsandpracticesthatcanassisttheregulatoryresearchcommunityinharmonizingeducationalandtrainingopportunitiesworld-wide.

Globalregulatorylandscape

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

1）Whatarethecommonregulatoryscienceissuesandpracticesacrossgovernmentalagencies?

2）Whichinfrastructure/mechanismshouldbedevelopedtoaddressthesecommonissuesandpractices?

3）Howdoyouenvisionthecross-trainingopportunitiestofacilitateknowledgetobeexchangedacrossagencies?

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

InANVISA,regulationiscoordinatedbytwooffices:

DrugGeneralManagementOffice（GGMED）andFoodGeneralManagementOffice（GGALI）,whicharesubordinatetotheAuthorizationandHealthRegistrationDirectory（DIARE）.TheGGMEDiscomposedoftheOfficeofSafetyandEfficacyEvaluation（GESEF）,theDepartmentof TherapeuticEquivalence （CETER）,theDrugRegistrationEvaluationOffice（GRMED）,theOfficeofSpecificand HerbalDrugs RegistrationEvaluation（GMESP）,andtheOfficeofPost-ApprovalChangesEvaluation（GEPRE）.Thestaffconsistsofhealthregulationexperts,regulationtechniciansandadministrativepersonnelincludingawiderangeofprofessionals,namely,biologists,bio-medics,chemists,doctors,engineers,lawyers,pharmacists,physiciansandstatisticians.GGMEDperformsdrugregistrationthroughevaluationofdrugsapplications,post-approvalchangeapplicationsanddrugregistrationrenewal.Otheractionsconnectedare“insitu”inspectionsoftheapplicationsmentioned,implementationofauditsontheapplicationreviewprocess,inspectionsonpharmaceuticalequivalenceandbioequivalence/bioavailabilitycenters,evaluationofsafetyandefficacy（clinicaltrials）,anddrafting/reviewinglegislation.RecentimprovementstoANVISA'sreviewprocessincludesystematicstandardizedapproachestothebenefit/riskassessmentofmedicinesandmovingtowardsstepwiseimplementationofGoodReviewPractices（GRevP）.

ANVISA'sothermajorcomponentistheFoodGeneralManagementOffice（GGALI）.ItencompassestheRiskAssessmentandEffectivenessOffice（GEARE）,theFoodRegistrationOffice（GEREG）andthePost-RegistrationFoodOffice（GEPRA）.TheprofessionalteamreviewingatGGALIconsistsofhealthregulationexpertsandadministrativepersonnel,includingseveralprofessionals,suchasfoodengineers,biologists,pharmacists,nutritionistsandveterinarians.Asanoverviewofthenationalfoodsafetycontrolsystem,theprimaryproductionistheresponsibilityoftheagriculturalagencies,whileresponsibilityforthesubsequentstagesofproductionissharedbetweenthehealthandagricultureagencies.Actionsoftheseagenciesarelargelyco-dependent.InBrazil,foodhealthcontrolisamixedmodel.Inpre-marketing,assessmentinvolveshealthpromotion,registerandsafetyassessment,andfoodstandards.

Insummary,ANVISAusesbestpracticesandinternationalguidelinestocreateBrazil'sstandards.Informationisfrequentlyobtainedbycontactwithotherregulatoryandinternationalagenciesandcommunicationusingexistingtechnicalknowledgebasesavailableonvariouswebsitesandconfidentialinformationexchangewithotherregulatoryauthorities.

Hans-GeorgEichler,MD,MSc,SeniorMedicalOfficer,EuropeanMedicinesAgency（EMA）,UnitedKingdom（UK）,EU,focusedonregulatoryscienceandtheevolvingroleof pharmacovigilance.Pharmacovigilancestemsfromthe1970sandmeans“closewatch”.Itisthepracticeofmonitoringtheeffectsofmedicaldrugsfollowinglicensureandmarketentry,especiallytoidentifyandevaluatepreviouslyunreportedadversereactions.Itisthescienceandactivitiesrelatedtodetection,assessment,understandingandpreventionofadverseeffectsoranyotherdrug-relatedproblem.

Dr.Eichlerdescribedsomeofthedifficultiesencounteredwhenpracticingprecisionmedicine.Oftenthe stratification criterionisnotcompletelyunderstood,thenumbersofpatientsaresmallerbutthereareadvancedtherapies（gene,cell,tissue-based）,andsomeofthemaretrulypersonalized.Personalizedtreatmentcombinationsareevenmorecomplexinthatthescientistsmustdealwithsmallpatientnumbersanditissometimesdifficulttodefineclinicalindications.Dr.Eichleralsohighlightedthedifference（s）betweenefficacyandeffectivenessinclinicalpractice.Efficacyistheextenttowhichaninterventiondoesmoregoodthanharmunderidealcircumstances（monitoringthepatienttakingthedrug）.Effectivenessistheextenttowhichaninterventiondoesmoregoodthanharmwhenprovidedundertheusualcircumstancesofhealthcarepractice.Accountingfor heterogeneity willleadtomorepreciseprecisionmedicineandadifferentapproachtodrugdevelopment.Dr.Eichleralsomentionedthatitisverylikelythatregulatorsandthehealthdeliverysystemwillneedtoshiftsomehealthcarepracticesinthefutureincaseweaccountforheterogeneity.

Dr.Eichlerbelievesthatthefutureevolutionofpharmacovigilancewillbefacilitatedbypay-for-performanceandpre-licensingofrealworlddata.Thiswillbethe pinnacle ofindividualizedpharmacovigilance.Therewillbeashiftfrompopulationtopatientlevel,frompredictiontoobservation-baseddecision-making.Treatmentresponsiveandnon-responsivewillbeidentified,andtheuseofpatient-leveloutcomeswouldenableoutcome-basedcontractingand,perhapsfurtherimprovepatientsafetyandpublichealthbyfocusingonpatientexperiences.Dr.Eichlerconcludedbyemphasizingthatthedevelopmentofpharmacovigilancewilllikelybringshiftsoffocusfromsafety-onlytobenefitsandharms,frompharmacovigilancetoknowledgegeneration,andfrompopulationfocustopatient-levelfocus.Healsoindicateda continuum knowledgegenerationspanningthepre-andpost-licensi