ICH - EFPIA · 2018-04-10 · E2A Clinical Safety Data Management: DefiniJon and Standard of...
Transcript of ICH - EFPIA · 2018-04-10 · E2A Clinical Safety Data Management: DefiniJon and Standard of...
Author:PärTellner,ICHCoordinatorandmemberofICHMC,EFPIA*Date:15/04/2017*
ICH Overview of ICH and industry support to implementation of ICH
guidelines by CFDA
www.efpia.eu
2018China/EuPharmaceu4calIndustryForum
2www.efpia.eu
v OverviewofICH
v ChinaintheICH
v ChallengesandOpportuni4es
OverviewofPresentaJon
3www.efpia.eu
OverviewofICH
v The ICH AssociaJon is now known as the “InternaJonalCouncil for HarmonisaJon of Technical Requirements forPharmaceuJcalsforHumanUse(ICH).”
v Unique harmonisaJon iniJaJve for regulators andpharmaceuJcalindustry
v Originallyfoundedin1990v Reformed as a non-profit legal enJty under Swiss Law onOctober23,2015
4www.efpia.eu
OverviewofICHPurpose
v Promo4on of publ ic health through internaJonalharmonisaJonthatcontributesto:
v Preven4onofunnecessaryduplica4onofclinicaltrialandpostmarketclinicalevalua4ons
v Developmentandmanufacturingofnewmedicinesv Registra4onandsupervisionofnewmedicinesv Reduc4onofunnecessaryanimaltes4ngwithoutcompromisingsafetyandeffec4veness
AccomplishedthroughTechnicalGuidelinesthatareimplementedbyregulatoryauthori4es.
5www.efpia.eu
OverviewofICHICHSuccesses
GCP(GoodClinicalPracJce)ClinicaltrialsconductedinoneICHregioncanbeuJlisedinotherICHregionsbyseLngthecommonstandardsonscienceandethics.
6www.efpia.eu
OverviewofICHICHSuccesses
CTD/eCTD(CommonTechnicalDocument)CTDbringstogetherallQuality,SafetyandEfficacyinforma4oninacommon,harmonisedformat,acceptedbyregulatorsinallICHregions.Ithasrevolu4onisedregulatoryreviewprocessesforregulatorsandindustry
CTD eCTD
Review
ICH Guidelines
Review
7www.efpia.eu
OverviewofICHICHSuccesses
MedDRA(MedicalDicJonaryforRegulatoryAcJviJes)v Highlyspecific,standardisedmedicalterminologydevelopedbyICHtofacilitatesharingofregulatoryinforma4on
v It is used for registra4on, documenta4on and safety monitoring ofmedicalproductsbothbeforeandaSermarke4ngauthorisa4on
8www.efpia.eu
KeystoICHSuccess
v Involvesexper4sefrombothregulatyauthori4esandindustry
v Science-based,consensusdriven
v Clearandeffec4velymanagedprocesswithefficientSecretariat
v Close collabora4on with par4es with comparable regulatory andtechnicalcapability
v Commitmentofregulatorstoimplementproductsofharmonisa4on
v CommonglobalplaVormandtolls
9www.efpia.eu
OverviewofICHStructureoftheICHAssociaJon
10www.efpia.eu
OverviewofICHMembershipintheAssembly–Eligibility
CriteriaforRegulators
EngagementintheICHProcess:v PastregularaWendanceinatleast3ICHmee4ngsduringtheprevious2consecu4veyears
v PastappointmentofexpertsinWGs
EngagementintheICHProcess:v HavingimplementedatleastthefollowingICHguidelines
v Q1:StabilityTes4ngguidelinesv Q7:GoodManufacturingPrac4ceGuideforAc4vePharmaceu4calIngredients
v E6:GoodClinicalPrac4ceGuidelines
11www.efpia.eu
OverviewofICHMembershipintheAssembly–Eligibility
CriteriaforIndustry
EngagementintheICHProcess:v PastregularaWendanceinatleast3ICHmee4ngsduringtheprevious2consecu4veyears
v PastappointmentofexpertsinWGs
TypeofOrganisaJon:v Beaninterna4onalpharmaceu4calindustryorganisa4onrepresen4ngaglobalcons4tuency
ImpactofICHGuidelines:v Theorganisa4onand/oritsmembersmustberegulatedoraffectedbyICHguidelines
12www.efpia.eu
OverviewofICHICHMembers16April2018
Members:v FoundingRegulatoryAuthoriJes:EC/EMA,MHLW/PMDA,FDAv FoundingIndustryAssociaJons:EFPIA,JPMA,PhRMAv StandingRegulatoryAuthoriJes:Swissmedic,HealthCanadav IndustryAssociaJons:IGBA(Generics),WSMI(OTC)andBIO(Biotech)
v Regulatory AuthoriJes:MFDS (South Korea), ANVISA (Brazil), CFDA(China)andHSA,Singapore
13www.efpia.eu
OverviewofICHICHObservers16April2018
v StandingObservers:WHO,IFPMAv Observers:
v Regionalharmonisa.onini.a.ves(RHIs):APEC,ASEAN,EAC,GCC,PANDRAandSADC
v Regulatoryauthori.esfromRussia,Australia,ChineseTaipei,India,Mexico,Singapore,SouthAfrica,Cuba,KazakhstanandColumbia
v Interna.onalpharmaceu.calindustryorganisa.ons:APICv Interna.onalorganisa.ons:IPEC,CIOMS,EDQM,USP,PIC/SandBill&MelindaGatesFounda.on
v Ad-hocobservers:Uponinvita4on
14www.efpia.eu
ChinaintheICHICHguidelineimplementaJonbyCFDA
v CFDA translated all ICH guidelines to Chinese several years ago. The na4onal industryassocia4onsformul4na4onals,RDPAChelpedwiththetransla4ons
v CFDAstartedwork to implement themedicaldic4onaryMedDRAseveralyearsago. Inaddi4ontotransla4ons,ITinfrastructureneedstobeimplemented
v SeveraloftheTierIIguidelines,whichshouldbeimplementedinordertobeeligibletobe elected as member of the ICH MC requires considerable investment in ITinfrastructure,whichis4meconsuming
v The ICHMC has therefore decided only to require full implementa4on of one Tier IIguidelineandpar4alimplementa4onoftherestoftheTierIIguidelines
15www.efpia.eu
ChinaintheICHICHguidelineimplementaJonbyCFDA
v TierIIguidelinesarethefollowing
v E2ACLINICALSAFETYDATAMANAGEMENT:DEFINITIONSANDSTANDARDSFOREXPEDITEDREPORTING
v E2B(R3)CLINICALSAFETYDATAMANAGEMENT:DATAELEMENTSFORTRANSMISSIONOFINDIVIDUALCASESAFETYREPORTS;IWGIMPLEMENTATION:ELECTRONICTRANSMISSIONOFINDIVIDUALCASESAFETYREPORTS
v E2D:Post-approvalSafetyDataManagement:Defini4onsandStandardsforExpeditedRepor4ng
v M4CommonTechnicalDocumentv M1MedDRATerminology
16www.efpia.eu
OverviewofICHICHguidelineimplementaJonbyCFDA
v CFDA has built up an ICH office, which leads the work withimplementa4onoftheICHguidelines.
v Duringthelastyearstheyhavemodernizedlegisla4onandguidelinesinordertoimplementthebasicICHguidelinesandworkisongoingforimplementa4onofotherICHguidelines
v An extensive program with training courses on ICH guidelines havestarted in2018,with ICHE17 Interna4onalMul4-centerclinical trials,as the first course in January 2018. EFPIA and PhRMA experts havebeengiveninputtoprogramandpresentedatthesetrainingcourses
17www.efpia.eu
ChinaintheICHICHguidelineimplementaJonbyCFDA
v Duringthefirsthalfof2018trainingcoursesinthefollowingICHguidelinesareplannedinChina April2018 M4CommonTechnicalDocumentsCTD
E2AClinicalSafetyDataManagement:DefiniJonandStandardofReport
E2DPost-ApprovalSafetyDataManagement
E2BClinical SafetyDataMgm:Data Factors for Transmission of Individual
CaseSafetyReports
M1MedicalTerminologyMedDRA
May2018 E6GuidelineforGoodClinicalPracJce
E8GeneralConsideraJonsofClinicalTrial
E11ClinicalTrialofPediatricPopulaJon
E17InternaJonalMulJ-centerClinicalTrial
18www.efpia.eu
ICHguidelineimplementaJonbyCFDA-ChallengesandOpportuniJes*
Challenges/possibleroomforimprovement:v Short no4ce re individual training courses, makes it some4mesdifficulttofindEFPIAand/orEMAexpertstomakepresenta4ons
v Wewouldhavesavedsomedays,ifitwouldhavebeenclarifiedfromthebeginningthatEFPIAshouldreachoutbothtoEuropean industryandregulatorexperts.
OpportuniJes:v The implemen4on of ICH guidelines will speed up Chinese pa4ents´access to new medicinal products. It will also facilitate both fordomes4candmul4na4onalcompaniestoexporttheirproducts.
v The ac4on we see from CFDA with the ambi4ous program for fastimplementa4on of ICH guidelines and revision of legisla4on andguidelines has convinced me that we are now experiencing a realimprovementbothre4metoapprovalandrequality
*Myviews
19www.efpia.eu
ICH-challengesandOpportuniJes*
Challenges:v Keep up the efficiency in thework to develop ICH guidelines, whenyougetmoremembersandobservers
v Keep ICH as a scien4fic associa4on with regulatory authori4es andindustryassocia4onsasmembers
OpportuniJes:v Byopeningup ICHfornewmembers,DRAs inemergingmarketswillinfluenceand implementthe ICHguidelines.Guidelineswill thereforebeharmonisedworldwide,whichwillspeeduppa4ents´accesstonewmedicinal products. It will also facilitate both for domes4c andmul4na4onalcompaniestoexporttheirproducts.
v ICH will therefore also be relevant for the future, when produc4onandR&DaremovingoutfromEuropeandtheUS
*Myviews
Author:PärTellner,ICHCoordinatorandmemberofICHMC,EFPIA*Date:05/02/2017*
BACKUP
www.efpia.eu
Presenta4onforTITCK,Ankara
21www.efpia.eu
ProcessforselecJonofnewtopics
1. ICH members submit proposals for new/revised topics usingtemplateby15December.AtEFPIA,relevantexpertworkinggroupsegTechnicalDevelopmentexpertgropupforqualitytopicsendorsenewtopicproposalsbeforesubmission.
2. Topic proposals are presented by experts to ICH New topicssubcommiWeeinJanuary/February.
3. Ashortlistoftopicsandanassessmentsummaryreportareselectedby thenewtopicssubcommiWeeat the ICH interimmee4ng,whichtakesplaceintheperiod15March–15April
4. The ICH Management CommiWee (MC) approves the assessmentsummaryreportfromthenewtopicssubcommiWee15April–1May.
5. AssessmentsummaryreportandproposalsfortopicsaresubmiWedtoICHAssemblyonemonthbeforeAssemblymee4ng
6. FinaldecisionatICHAssemblyonnewtopicsattheICHJunemee4ng
22www.efpia.eu
NewtopicsforICH
AttheJune2017mee4nginMontreal, ICHdecidedtoini4atetwonewtopicsforharmonisa4on:v E8 (R1): Revision of General Considera4ons for Clinical Trials (Topiclead:FDA)
v E11A:Paediatricextrapola4on(Topiclead:FDA)
23www.efpia.eu
NewtopicsforICHStrategicdiscussiononharmonisaJonneeds
At the June 2017 mee4ng in Montreal, we had a strategic topicdiscussion. We then agreed to develop proposals for strategicdiscussionson:v Qualityv Genericsv Gene/Celltherapyv Vaccines
At the ICH mee4ng in Geneva in November strategic proposals onqualityandvaccineswerediscussed.Areflec4onpaperonGoodClinicalPrac4cehasalreadybeendeveloped.Pleaseseelinkbelow.hWp://www.ich.org/products/gcp-renova4on.html
24
StepsintheICHProcessforGuidelineDevelopment
25
• Step 1: • WG works to prepare a consensus draft of the technical
document. • Step2:
ü Step 2a: • The Assembly is invited to endorse the technical
document. ü Step 2b: • The ICH Regulatory Members of the Assembly are invited
to endorse the draft Guideline. Cont.
The ICH Step Process (1)
26
• Step 3: • Public consultation by the ICH Regulatory Members and
ICH Secretariat. All comments are considered by the WG. • Step 3 is finalised once concensus is reached in the WG.
• Step 4: • The Regulatory Members of the Assembly adopt the
final document. • Step 5:
• Implementation by the ICH Regulatory Members.
The ICH Step Process (2)
Thankyou!E-mail:
EFPIABrusselsOfficeLeopoldPlazaBuilding*RueduTrône108
B-1050Brussels*BelgiumTel:+32(0)26262555
www.efpia.eu*[email protected]