艾昆緯-2025年制藥和生物技術安全和監(jiān)管合規(guī)趨勢及預測 2025 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech

IQVIA

WhitePaper

2025Safetyand

RegulatoryComplianceTrendsandPredictionsforPharmaandBiotech

PATRICKBRADY,GlobalHead,TherapeuticInnovation&RegulatoryScienceMARCELAMI?O,GlobalHead,LifecycleManagement&RegulatoryAffairsSIMONJOHNS,Director,MedicalInformation&MarketedProductSafety

SABIKARIZVI,Director,AggregateReporting&BenefitRiskManagementServicesANAPEDROJESUíNO,AssociateDirector,MarketedProductSafety

Tableofcontents

Introduction1

Whatdevelopmentsinyourareaofexpertisesurprisedyouthemostin2024?2

Speakingofinnovation,it’sclearthatGenAIisoneofthehottesttopicsinthisspace.3

WhatroledoyouseeAIplayingin2025?

TakingintoconsiderationhownewtechnologiesandAIareimprovinglifecycle4

managementprocesses,howdoesitspecificallyaffectthepreparationandsubmission

ofchemistry,manufacturing,andcontrols(CMC)variations?

Howdoyouseeglobalregulatorybodiesmovingtowardharmonizationofsubmission5

processesin2025?Whatimpactcouldthishaveonacceleratingapprovals

inemergingmarkets?

Howcanpharmaceuticalcompaniesbetteradapttheiroperationstomeetevolving5

localregulatoryrequirements?WhatrolewillalocalQualifiedPersonfor

Pharmacovigilance(QPPV)playinensuringcomplianceacrossdifferentregions?

Whattechnologicalinnovationsareyouusingtoenhancecross-teamcollaborations?6

Howdoyouenvisionpharmaceuticalcompaniesleveragingomnichannelsystems,6

specificallyforMImanagement?Whatchallengesmayariseinmaintainingcompliance

acrossAI-drivenplatforms,callcenters,anddigitalchannels?

Onthepost-approvalsideofthings,howdoyouseeAIanddataanalyticsenhancing7

post-approvallifecyclemanagementactivitieslikeregistrationrenewalsandlabel

updatesin2025?

DoyouseeregulatorybodiesplacingstricterguidelinesontheuseofAIin2025?7

Keepingupwithregulatoryguidanceisdifficult.Overtime,we’veseenalotof8

organizationsthatchoosepartnerstorelievethatburden.Howdoyouseethat

beingdeliveredin2025?

AboutIQVIA8

Abouttheauthors9

Introduction

Asthelandscapefordrugsafetyandregulatory

compliancecontinuestoevolvetoaccommodatemorecomplextherapies,drugsponsorsareconsideringhowtohandleincreasingglobaldemand,shiftingpatient

needs,andaboonofnewtechnologies,including

artificialintelligence(AI).Whilenavigatingthese

concurrentshiftscanbeoverwhelmingintheshort

term,inthelongterm,improvedtechnologyintegrationwillhelpproducemorepatient-centricsolutionsand

accommodategrowingpatientandhealthcareproviderinquiries.Asyoureviewyourcurrentapproaches,

considerwhereinnovationmighteaseresourcestrainandenhanceexistingworkflows.

InarecentwebinarhostedbyIQVIA,apanelof

expertsspoketothelatestdevelopmentsacrosspharmacovigilance(PV),MedicalInformation(MI),andlifecyclemanagement(LCM).Readtheirsafety,regulatory,andtechnologypredictionsfor2025inthisWhitePaper.

Inthelongterm,improvedtechnologyintegrationwillhelpproducemorepatient-centricsolutions

|1

Whatdevelopmentsinyourareaofexpertisesurprisedyouthemostin2024?

SABIKARIZVI:2024hasbeenextremelyeventfulfordrugsafetyservices,especiallynichesafetyserviceslikeperiodicreportwriting,literature,andstatementmanagementservices.Weobservedasurprising

searchforlocalaffiliateservicerequestsforthis

group,especiallyinlocalliteraturesurveillance,localperiodicreportwriting,andlocalriskmanagement.

Historically,theoutsourcingofthesetypesofactivitieshasbeenlimitedconsideringthecomplexnatureofthiswork.However,withhigh-costpressuresandglobal

microeconomicconditions,sponsorsarenowlookingforamorecost-efficientsolutiontomanageregionalPVserviceswithelevatedqualityandcompliance.

Forthesenichegroups,thereisoftenahesitancytotrynewtechnologyconsideringthecomplexitiesinvolvedandthesignificantdependencyonhumanexpertiseandmedicaljudgment.Butin2024,weobservedsponsorswhowereaskingforsophisticatedtechplatforms,

whichhasledtotheuseoftechnologytodrivelow-cost,reliablesolutions.

SIMONJOHNS:We’veobservedacontinuedpost-

pandemiceffectonMIintermsofchangesinbehaviorfromhealthcareproviders,patients,andconsumers

forourpharmacustomers.There’sbeenadefinite

trendtowardaself-servicemodeofengagingwithMIacrossdigitalchannels.Inaddition,we’veseenpharmacompaniesviewingMIastheironlyremaininginboundcommunicationchannel.Asaresult,MIisreceiving

awiderrangeofinquiriesathighervolumes.

ANAPEDROJESUíNO:Acrosstheboard,wewere

surprisedbythespeedoftechnologyintegration.

BringingtechnologyintothefieldofPVhelpedintegratereal-worlddata,ensuregreateraccuracy,andseta

precedentforhowtechnologiescanbeharnessedmorebroadlyacrossthepharmaceuticalindustrytoaddress

“BringingtechnologyintothefieldofPVhelpedintegratereal-worlddata,ensuregreateraccuracy,andseta

precedentforhowtechnologiescanbeharnessedmorebroadlyacrossthepharmaceuticalindustrytoaddresscomplexchanges.”

—PedroJesuíno

complexchanges.Wenowhaveabetterunderstandingofthedatawearereceiving,andwecancollectand

analyzemoreinformationmorerapidly.

PATRICKBRADY:In2024,theFDAheldpublic

workshopswithdifferentstakeholdergroupsaround

clinicaltrialinnovation.TheystartedtheCDERCenter

forClinicalTrialInnovation(C3TI)andreleaseddraft

guidanceonmasterprotocolsforproductdevelopment.OneofthethingsthattheEMAisdoingtoencourage

clinicaltrialinnovationistheAcceleratingClinicalTrialsintheEuropeanUnion(ACTEU)initiative.Therehas

beenalotofstakeholderengagementthere,andthe

EMAhasshownleadershipindetermining,whatdoweneedtodotomakeEuropeanattractiveenvironment

forconductingclinicalresearch?Itisencouragingtoseehowregulatorsacrossdifferentjurisdictionsaretakingstepstoattractclinicalresearch.

2|2025SafetyandRegulatoryComplianceTrendsandPredictionsforPharmaandBiotech

Speakingofinnovation,it’s

clearthatGenAIisoneofthehottesttopicsinthisspace.

WhatroledoyouseeAIplayingin2025?

JOHNS:In2025,AIwillcontinuetoenhancerather

thanreplacehuman-to-humaninteractioninMI.ThetechnologybenefitsofAIwillbeusedtodriveboth

productivityenhancementsandimprovedcustomerengagement.Forexample,youmightbereceivinglargevolumesoflow-complexityMIinquiries.AIsupport

canallowhumanteammemberstofocusonhandlingmorecomplexinquiries,whichwillhelpdrive

customerengagement.

“In2025,AIwillcontinuetoenhance

ratherthanreplacehuman-to-humaninteractioninMI.”

—Johns

MARCELAMI?O:Inpost-marketing,Iseeacleartrendinthreesignificantareas.Thefirstisobtainingregulatoryintelligenceglobally,whichiscrucialformaintaining

licenses.Areal-timeunderstandingofregulatorychangesisessentialforensuringcompliance.Thesecondis

theautomationoffileauthoring.Certaintechnologies

alreadyofferthis,butthetrendwillcontinueinto2025.Thethirdaspectisstrategicplanning.AIwillfacilitate

real-timestatusupdatesoftheentireportfolio,enablingfasterdecisionsandefficientplanningforpost-marketingvariations.Theregulatoryaffairsprofessionalswill

easilyidentifytherightapproachfortheirupcomingapplicationstothehealthauthorities.

BRADY:Severalregulatoryagencieshavepublished

discussionpapersontheuseofAIindrugdevelopment.

“AIwillfacilitatereal-timestatusupdatesoftheentireportfolio,enablingfasterdecisionsandefficientplanningforpost-

marketingvariations.”

—Mi?o

ItisencouragingtoseeregulatoryacknowledgmentandreceptivitytowardtheuseofAIacrossallphasesofdrugdevelopment.Itisimportantforsponsorsanddrugdeveloperstopayattentionastheregulatory

frameworkevolves.

WhatIhearregulatorssayingisthatthey’rewilling

totakearisk-basedapproach.IfyouthinkaboutAI

usageacrossthedrugdevelopmentlifecycle,some

implementationsaremuchmoreupstream,likeusingAItoscreendruglibrariesortargets.ThereislessinterestfromregulatorsintryingtoregulatethatcomponentofAIusage.Therisk-basedapproachcomesinasyougetclosertothepatient,if,forexample,we’reusingAIforpatientidentification,diagnosis,safetyscreening,

ortodeveloptreatmentrecommendations.

Takearisk-basedapproach,thinkaboutregulatorytransparencyorexplainability,andfindthose

opportunitiestomeetwiththeregulatoryagenciesasitrelatestoyouruseofAIindrugdevelopment.

“Takearisk-basedapproach,thinkaboutregulatorytransparency

orexplainability,andfindthose

opportunitiestomeetwiththe

regulatoryagenciesasitrelatestoyouruseofAIindrugdevelopment.”

—Brady

|3

PEDROJESUíNO:If2024markedthegrowthofAI,

we’llobserveamaturingofAIin2025.Whenit

comestoAIapplicationsinPV,Iwouldexpectto

seecontinuedevolutionandexpansion,including

increasedautomationandintegration.PVsystemsareexpectedtoincreasedigitalizationofAIandexplorethepotentialofmachinelearning.ThiscanbeappliedtoPVcaseprocessingbyautomatingdatacollection

processingandinitialadverseeventreporting,whichwillminimizehumanerrorandleadtomoreaccurate,timelyreporting.

Anotherthingwecanexpectistobeclosertopatients

byengagingpatientsonsafetyandengaginghealthcareprofessionalsonreporting.Weexpecttoseestreamlineduseofthesetools,whichwillbringpatientsclosertous.

MItoolswillallowPVtogetreal-timeinformation.Oncewemakethesetoolsavailabletopatients,reporterswillgetthisinformationinrealtime.

RIZVI:WithrespecttoPVandmodeofsafetystudies,

AIhasalreadystartedtoplayaninstrumentalrole.

Ithelpsusstreamlineoperations,drivedowncosts,

andincreaseoperationalefficiency.Itisbeingused

foropticalcharacterrecognition(OCR),whichallows

forintakeautomationandeliminatesmanualeffort.

Neuralmachinetranslationisbringingdownthecost

ofglobalcaseprocessingandallowingrapidtranslationofliteraturecases.Naturallanguageprocessingwillallowyoutoreviewabstractsandtextarticlesfaster.

“Neuralmachinetranslationis

bringingdownthecostofglobalcaseprocessingandallowingrapidtranslationofliteraturecases.”

—Rizvi

TakingintoconsiderationhownewtechnologiesandAIareimprovinglifecycle

managementprocesses,howdoesitspecificallyaffectthepreparationandsubmissionofchemistry,manufacturing,andcontrols(CMC)variations?

MI?O:AIwillinfluencetheprocessofCMCvariations

fromtheverybeginning.Allmanufacturingcompaniesadheringtogoodmanufacturingpracticesandgood

documentationpracticesinitiatetheirCMCvariation

processbyissuingadocumentcalledChangeControl,whichaims,amongotherthings,toevaluatetheimpactoftheproposedchange.Thechangecontrolassessmentistime-consumingforregulatoryprofessionalswhomayneedtoassesstheimpactofsuchchangesonmultiplelicensesglobally.WithAI,thistimelineissignificantly

shortened,leadingtoaneffectivesubmissionstrategy.Wecandeterminewhethertheproposedchange

shouldbesubmittedtothehealthauthorities(HAs),

identifyifthereareanyothervariationsunderHA

evaluationforthesameproduct,theagencyfees,andtheoverallcostofthesubmissionprocess.Additionally,automatedgatheringofspecificcountryrequirementsandsubmissionfileauthoringarereducingoperationaltimelines,acceleratingthetimeframetoeffectively

implementtheCMCvariation.

4|2025SafetyandRegulatoryComplianceTrendsandPredictionsforPharmaandBiotech

Howdoyouseeglobal

regulatorybodiesmovingtowardharmonizationof

submissionprocessesin2025?Whatimpactcouldthishave

onacceleratingapprovalsinemergingmarkets?

BRADY:Thereareseveralinitiativesthatwillinfluence

howsubmissionsarehandledinthefuture.Asreflected

bytheAccumulusprojectandtheFDA’sPRISM(Post-

licensureRapidImmunizationSafetyMonitoringSystem),thereisamovementtowardamoredynamicexchangeofinformationusingcloud-basedtechnology.Though

therearesomeconditionsneededtoensuredataandIPprotection,wearetrendingtowardmorecloud-basedregulatorysubmissionsandinteractions,whichallow

forareal-timeexchangeofinformationacrossproductdevelopmentandthroughoutlifecyclemanagement.

Intermsofharmonization,moreregulatorsarecomingintotheICHenvironmentandadoptingtheelectroniccommontechnicaldocument(eCTD).Thisisakeen

enablerofamoreharmonizedapproachtowardsubmissionsandinteractionswithregulators.

“Wearetrendingtowardmorecloud-basedregulatorysubmissionsandinteractions,whichallowfora

real-timeexchangeofinformationacrossproductdevelopmentandthroughoutlifecyclemanagement.”

—Brady

Howcanpharmaceuticalcompaniesbetteradapttheiroperationstomeet

evolvinglocalregulatory

requirements?WhatrolewillalocalQualifiedPersonforPharmacovigilance(QPPV)playinensuringcomplianceacrossdifferentregions?

PEDROJESUíNO:LocalQPPVswillplayakeyrolein

ensuringthatcompaniesaremeetinglocalrequirementswhileabidingbyglobalprocesses.LocalQPPVsmust

understandhowtointegratetheseexpectationsinto

localreportingrequirements.Whendetermininghowtobringtechnologiesandefficienciestodatacollectionmethodsandsafetymonitoringprotocols,companiesshouldrelyonthelocalQPPVs’expertisetomeetall

regulatorystandards,whetherglobal,local,orregional.GlobalcompaniesshouldenlistlocalQPPVstoliaiseandestablishconnectionswithregulatorybodies.

|5

Whattechnological

innovationsareyouusingtoenhancecross-team

collaborations?

RIZVI:AtIQVIA,weimprovecollaborationbyadoptingandimplementingbest-in-classtechnologies.We

leverageanintelligentbalanceofhumanexpertise

andtechnology,especiallyinfunctionsthatdepend

onhumaninterventionandmedicaljudgment.Cross-functionalcollaborationisessentialforproducinghigh-qualitydeliverablesconsideringthevariationsinsourcedataacrossdifferentfunctions.

Weleverageanelectronicplatformthatallowsseamlesscontributorinputandtouchpointsacrossdifferent

stakeholders.Professionalservicesautomationprovidesmanagementofcorebusinessprocessesbyvarious

functionalareas,whichfacilitatesintegratedproject

management,oversight,andoperations.Thereare

severalveryrobustdocumentcollaborationplatformsthatprovidetheopportunityforcollaborativeinput,review,andapprovalofdocuments.Whenwetalkaboutcross-functionalcollaborationacrosssafetyandregulatory,

regulatoryintelligencedatabasesmustprovidearobust,comprehensiveone-stopshopforregulationsand

regionalrequirementsthathelpsreducemanualeffort.

Howdoyouenvision

pharmaceuticalcompaniesleveragingomnichannel

systems,specificallyfor

MImanagement?What

challengesmayarisein

maintainingcomplianceacrossAI-drivenplatforms,call

centers,anddigitalchannels?

JOHNS:Iviewomnichannelsystemsasanopportunityforpharmacompaniestoofferoptionstotheir

customers,whichincludeshealthcareproviders,

patients,andconsumers.Itisimportanttoprovidecustomer-centricsolutionsthatsuittheirneeds,

includingthetimetheyhaveavailabletocontactMI.

Omnichannelscandriveengagementwhileensuringthatthesolution—

theinquiryfulfillment—meetsrequirementsforindividualcustomers.

IntermsofthechallengesofmaintainingcompliancethroughtheimplementationofAIsolutions,we

musthavesuitableguardrailsinplacetoensure

thatAIisaccessingonlyapprovedcontentfromthe

6|2025SafetyandRegulatoryComplianceTrendsandPredictionsforPharmaandBiotech

pharmacompanyandthatanysuggestiveresponsesbeinggeneratedbyAIarecontrolled.Thisisdone

bymaintaininghumanoversightandensuringthatapprovedresponsesmeetpharmacompanyand

regulatoryrequirements,whichcanmitigatetheriskofAIsearchingunapprovedcontentandprovidinginformationfromunapprovedinternetsources.Inaddition,anyconfidentialinformationlinkedtotheinquirymustbehandledinacompliantfashionwithregardtodataprivacy.

Onthepost-approvalside

ofthings,howdoyouseeAIanddataanalyticsenhancing

post-approvallifecycle

managementactivitieslikeregistrationrenewalsandlabelupdatesin2025?

MI?O:UtilizingnewtechnologyandAItocompare,

draft,andimplementchangesinlabelingiscrucialfor

reducingtime,cost,andtheriskofhumanerror.Inpost-marketing,AIcanalsoassistinreviewingpromotionalmaterialbasedonthelatestregulatoryguidance.

DoyouseeregulatorybodiesplacingstricterguidelinesontheuseofAIin2025?

BRADY:TheFDAhasspokenpubliclyabouttheuse

ofAIindrugdevelopmentandabouttheirownuseofAIinthedrugsafetyspace.We’restartingtoseeearlyexpectationsbeinglaidoutbyregulators,whichare

oftenprecursorstoguidelines.IftherewereguidelinesissuedontheuseofAIindrugdevelopmentoracrossthelifecycle,Iwouldexpectthemtoberelatedto

leveragingarisk-basedapproachandsettingguidelinesaroundtransparencyandexplainability.

|7

Keepingupwithregulatory

guidanceisdifficult.Overtime,we’veseenalotof

organizationsthatchoose

partnerstorelievethat

burden.Howdoyouseethat

beingdeliveredin2025?

PEDROJESUíNO:Acompetentvendorwilldeliver

PVservicesthatcombinehumanexpertisewithan

integratedtechnologyplatformthatallowsforbetter

informationcollectionforcaseprocessing.ThisincludesAI,machinelearning,andnaturallanguageprocessing,whichwillenhancedataprocessing,signaldetection,

andriskmanagement,andprovidevaluableinputsforriskmanagementtoolstomanagethePVsystemmoreeffectively.Apartnershouldbeabletotailorasolutionspecifictoeachpharmacompanyandanticipatechangesprovokedbyregulatoryupdates.

“AcompetentvendorwilldeliverPVservicesthatcombinehumanexpertisewithanintegrated

technologyplatformthatallowsforbetterinformationcollectionforcaseprocessing.”

—PedroJesuíno

AboutIQVIA

IQVIA(NYSE:IQV)isaleadingglobalproviderofclinicalresearchservices,commercialinsightsandhealthcare

intelligencetothelifesciencesandhealthcareindustries.IQVIA’sportfolioofsolutionsarepoweredbyIQVIA

ConnectedIntelligence?todeliveractionableinsightsandaccelerateinnovations.Withapproximately88,000employeesinover100countries,IQVIAisdedicatedtoacceleratingthedevelopmentandcommercializationofinnovativemedicaltreatmentstohelpimprovepatient

outcomesandpopulationhealthworldwide.Learnmoreat.

8|2025SafetyandRegulatoryComplianceTrendsandPredictionsforPharmaandBiotech

Abouttheauthors

PATRICKBRADY,PharmD

GlobalHead,TherapeuticInnovation&RegulatoryScience,

IQVIA

Withmorethantwodecadesofexperienceinregulatoryaffairsinthebiopharmaceuticalindustry,PatrickBrady