dr nora dellepiane - world health organization · dr nora dellepiane unique situaon • a vaccine...
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Regulatorypathways
DrSureshJadhavDrNoraDellepiane
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Uniquesitua6on
• AvaccinebeingmadebyadevelopingcountrymanufacturerforSub-SaharanAfrica.
• Thiswasunprecedented• Posedquiteafewchallenges
VaccinemadeinIndia+TrialsinAfrica=LicenseinIndia???
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Challenges
• WhywillIndianNCLreleaselots?• TheprotocolsofAfricantrialsnotapprovedbyDCGI
• Howwilltheyreviewthisdata?• AfricanNRAsnotexperiencedinreviewoftrialprotocols.
• WillIndiantrialdataberelevanttoAfrica?
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Lotrelease
• AllvaccinelotsmadeinIndiamustbereleasedbyNCLi.e.CDL,Kasauli,India
• Thelabdidn’thavetheexper6se• CDLfolkstraveledtoPoPersBar,UKfortrainingatNIBSC.
• SeveralR&DlotswerethentestedbothatNIBSCandCDL
• ThefirstGMPlotwasproducedbySIIandthenreleasedbyCDLin2004!
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Interac6onswithDCGI
• Beginningin2004,severalmee6ngswereheldwithDCGI,toreviewtheen6reprojectandthe6melines.
• TheoverallclinicalplanthatincludedaPhaseIstudyinIndiawasapprovedbyDCGI
• withonesugges6onthataPhase2studyin2-10yearoldsalsobedoneinIndia.
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Onthewaytolicensure
• RegulatorydossiersubmiPedtoDCGIinApril2009.
• ButDCGIwasunderreviewbyWHOtocon6nueasafunc6onalNRA
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Onthewaytolicensure
• HealthCanadasteppedintoassistDCGIinreviewofthedossier.
• Inaddi6on,WHOappliedafasttrackPQprocedurebyreviewingthedossierinparalleltoDCGI&HCandbuiltonthereviewbytheauthori6estobasetheirPQdecision.
• Ajointinspec6onofproduc6onfacili6esbyDCGIandHealthCanadain2009.
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Facilita6ngregistra6oninusercountries• WHOinvitedthethreeearlyintroducingcountries(Niger,BurkinaFasoandMali)toperformtheirevalua6onoftheproductinGenevaandprovidedaccesstoallWHO/PQassessmentreports.
• ForallothercountriesWHOorganized– TrainingandJointreviewmee6ngswithanglophoneandfrancophonecountries(26par6cipa6ngcountries)andsharedwiththemtheWHO/PQassessmentreports.
– Advocatedforadop6onoftheexpeditedprocedureforreviewofimportedprequalifiedvaccines.
– EmphasizedontheneedtorelyontheworkperformedbytheIndianandCanadianNRAsandWHO/PQandtobasetheirdecisionsonthereviewofabbreviatedinforma6onplusthePQassessmentreportstoensure6melyintroduc6onofthevaccineincountries.
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Somehurdle…
• Onemajorfindingoftheinspec6on-changeinthesiteofproduc6onforpolysaccharide.
• ClinicaldataindossieronSynCoBioPartnersmaterial(Netherlands)whilelicenseaskedforSIILmaterial(India)
• notacceptedbyDCGI.
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Resolu6on…
• TheproblemdiscussedintenselybyDCGI,SIIL,PATH,andWHO.
• Thenewvaccineshouldundergoanimaltoxicitystudies.
• Animalstudiesshowednotoxicity
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Alliswellthatendswell…
• Thevaccinewaslicensedon24December2009solelyforuseinAfrica!!!
• WHOPQinJune2010!!!
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Many“new”sintheproject
• IndiancompanymakingvaccineonlyforAfrica• IndianNCLgehngtrainedonlotrelease• AfricanNRAsgehngtrainedtoreviewclinicaltrialapplica6ons
• IndianNRAundercloudatthesame6me
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Many“new”sintheproject
• Cri6calrawmaterial(polysaccharide)changedmid-way(wehadnochoiceJ)
• AhighlyregulatedcountryNRA(HealthCanada)reviewinganIndiandossier
• Exportonlylicense• WHOPQforavaccinenotsoldinthecountryoforigin
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Keylearnings…
• Pre-INDmee6ngwithNRAishighlyvaluable• Constantdialoguewithregulatorscansolvemostoftheissues
• Keepingtheminloop– AfricantrialprotocolsweresubmiPedtoDCGIeventhoughtheydidnotapprovethem
• Bereadyforsurprises…– Thepolysaccharideissuepushedlicensureby1year
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Keylearnings…
• Helpthemhelpyourself– TrainingstoIndianandAfricanNRAswaspivotal
• TimingmaPers!– NigeriaepidemicsforcedWHOforparallelreview
• Crea6vesolu6onshelp– remember“exportonlylicense”?
• Collabora6on,andnotconfronta6onisamustforsuccessofaproject!
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Thankyou!