Author:PärTellner,ICHCoordinatorandmemberofICHMC,EFPIA*Date:15/04/2017*

ICH Overview of ICH and industry support to implementation of ICH

guidelines by CFDA

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2018China/EuPharmaceu4calIndustryForum

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v OverviewofICH

v ChinaintheICH

v ChallengesandOpportuni4es

OverviewofPresentaJon

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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

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OverviewofICHPurpose

v Promo4on of publ ic health through internaJonalharmonisaJonthatcontributesto:

v Preven4onofunnecessaryduplica4onofclinicaltrialandpostmarketclinicalevalua4ons

v Developmentandmanufacturingofnewmedicinesv Registra4onandsupervisionofnewmedicinesv Reduc4onofunnecessaryanimaltes4ngwithoutcompromisingsafetyandeffec4veness

AccomplishedthroughTechnicalGuidelinesthatareimplementedbyregulatoryauthori4es.

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OverviewofICHICHSuccesses

GCP(GoodClinicalPracJce)ClinicaltrialsconductedinoneICHregioncanbeuJlisedinotherICHregionsbyseLngthecommonstandardsonscienceandethics.

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OverviewofICHICHSuccesses

CTD/eCTD(CommonTechnicalDocument)CTDbringstogetherallQuality,SafetyandEfficacyinforma4oninacommon,harmonisedformat,acceptedbyregulatorsinallICHregions.Ithasrevolu4onisedregulatoryreviewprocessesforregulatorsandindustry

CTD eCTD

Review

ICH Guidelines

Review

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OverviewofICHICHSuccesses

MedDRA(MedicalDicJonaryforRegulatoryAcJviJes)v Highlyspecific,standardisedmedicalterminologydevelopedbyICHtofacilitatesharingofregulatoryinforma4on

v It is used for registra4on, documenta4on and safety monitoring ofmedicalproductsbothbeforeandaSermarke4ngauthorisa4on

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KeystoICHSuccess

v Involvesexper4sefrombothregulatyauthori4esandindustry

v Science-based,consensusdriven

v Clearandeffec4velymanagedprocesswithefficientSecretariat

v Close collabora4on with par4es with comparable regulatory andtechnicalcapability

v Commitmentofregulatorstoimplementproductsofharmonisa4on

v CommonglobalplaVormandtolls

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OverviewofICHStructureoftheICHAssociaJon

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OverviewofICHMembershipintheAssembly–Eligibility

CriteriaforRegulators

EngagementintheICHProcess:v PastregularaWendanceinatleast3ICHmee4ngsduringtheprevious2consecu4veyears

v PastappointmentofexpertsinWGs

EngagementintheICHProcess:v HavingimplementedatleastthefollowingICHguidelines

v Q1:StabilityTes4ngguidelinesv Q7:GoodManufacturingPrac4ceGuideforAc4vePharmaceu4calIngredients

v E6:GoodClinicalPrac4ceGuidelines

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OverviewofICHMembershipintheAssembly–Eligibility

CriteriaforIndustry

EngagementintheICHProcess:v PastregularaWendanceinatleast3ICHmee4ngsduringtheprevious2consecu4veyears

v PastappointmentofexpertsinWGs

TypeofOrganisaJon:v Beaninterna4onalpharmaceu4calindustryorganisa4onrepresen4ngaglobalcons4tuency

ImpactofICHGuidelines:v Theorganisa4onand/oritsmembersmustberegulatedoraffectedbyICHguidelines

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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

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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

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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

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ChinaintheICHICHguidelineimplementaJonbyCFDA

v TierIIguidelinesarethefollowing

v  E2ACLINICALSAFETYDATAMANAGEMENT:DEFINITIONSANDSTANDARDSFOREXPEDITEDREPORTING

v  E2B(R3)CLINICALSAFETYDATAMANAGEMENT:DATAELEMENTSFORTRANSMISSIONOFINDIVIDUALCASESAFETYREPORTS;IWGIMPLEMENTATION:ELECTRONICTRANSMISSIONOFINDIVIDUALCASESAFETYREPORTS

v  E2D:Post-approvalSafetyDataManagement:Defini4onsandStandardsforExpeditedRepor4ng

v M4CommonTechnicalDocumentv M1MedDRATerminology

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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

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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

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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

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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

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Presenta4onforTITCK,Ankara

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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

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NewtopicsforICH

AttheJune2017mee4nginMontreal, ICHdecidedtoini4atetwonewtopicsforharmonisa4on:v E8 (R1): Revision of General Considera4ons for Clinical Trials (Topiclead:FDA)

v E11A:Paediatricextrapola4on(Topiclead:FDA)

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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

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StepsintheICHProcessforGuidelineDevelopment

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• 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)

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• 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:

par.tellner@efpia.eu

EFPIABrusselsOfficeLeopoldPlazaBuilding*RueduTrône108

B-1050Brussels*BelgiumTel:+32(0)26262555

www.efpia.eu*info@efpia.eu