18
Proposed Pathways for WHO PQ Listing
ProposedPathwaysforWHOPQListing
BuildingRegulatoryPathways
• KEYPRINCIPLES• Identifythecustomers• Identifyactionsandtheirresponsible parties• Developactionsfroma“customer benefit”mindset• StrivefortheMinimumViable Pathway(MVP)• Eachaction isabuildingblock
•ADEQUACY• EFFICIENCY• FLEXIBILITY
Pre-submissionMeetingTypes
NewProduct
Variation
NewParadigm
ExistingParadigm
Pre-submissionMeetingType
WHOGroupsInvolved
Outcome
New Product,NewParadigm
PQNTDGMP
• Determination ofRegulatoryPathway,existing oradhoc
• VCAGreview ofproposedparadigm• Addressquestions regardingdossier requirementsspecific totheproposedsubmission
NewProduct,Existing Paradigm
PQNTD*GMP*
• Determination ofRegulatoryPathway• New AI,Existing AI,Generic
• Addressquestions regardingdossier requirementsspecific totheproposedsubmission
Variation PQNTD*GMP*
• Determination of Variationtrack(Minor/Major)• Addressquestions regardingdossier requirementsspecific totheproposedsubmission
*Included forNormativeGuidance Consultation
Existing Paradigm
NewAI
LLIN Non-LLIN
ExistingAI
LLIN Non-LLIN
Generic
LLIN Non-LLIN
Non-chemical/Other
NewParadigm
VCAG
Variation
Major Minor Notification
BuildingaRegulatoryPathway– WHOpieces
WHOAction Item Duration(months)
WHOGroups Notes/Outcome
Pre-submissionMeeting 1 PQ,NTD,GMP
Applicanthasclearunderstanding ofpathtosubmission anddossierrequirements
EFFICACY PROTOCOL REVIEW
Phase1EfficacyConsultation 3 PQ,NTD,GMP
Documentedreview ofprotocol,sharedwithapplicant
Phase2EfficacyConsultation 3 PQ,NTD,GMP
Documentedreview ofprotocol,sharedwithapplicant.IncludesreviewofRAtoensurehumansafetyforPhase2trials
Phase3EfficacyConsultation 3 PQ,NTD,GMP
Documentedreview ofprotocol,sharedwithapplicant
BuildingaRegulatoryPathway– WHOpiecesWHOAction Item Duration
(months)WHOGroups Notes/Outcome
Variations
Major 7 PQ Includes labeland/orformulationchangeswhichrequirethereviewofnewdatabyanypartofthescienceorinspections team
Minor 2 PQ Includes labeland/orformulationchangeswhichdonotrequirereviewofnewstudies ordata.
Risk AssessmentDevelopment
CAGP RiskAssessment (RA) 15 CAGP,PQ EvaluationofAIanddevelopment ofRAforPQusePQDecision
PQInterimDecision 1 PQ Onlyassociatedwithnon-generic LLINproducts. Allows WHOtopre-qualifyanLLINforuseduringthePhase3EfficacyTrials.
PQ FinalDecision 4 PQ After reviewingPhase3Efficacydata,PQwillfinalizedecisiontolistproductaspre-qualified.
BuildingaRegulatoryPathway– WHOpiecesWHOAction Item Duration
(months)WHOGroups Notes/Outcome
PRODUCT REVIEWS
New Product,NewParadigm
?? PQ,NTD,GMP
Durationisdependent onthenewparadigm.Completed reviewofanewVCparadigm.
New ProductExistingParadigmNew AIReview 12 PQ Includesscreen, PQandASVCPevaluationofdossiertofinalize
PQreviewoftheNewAI,New Product
ExistingAIReview 12 PQ Includesscreen, PQandASVCPevaluationofdossiertofinalizePQreviewoftheExistingAI,New Product
GenericReview 7 PQ Includesscreen, PQandASVCPevaluationofdossier(includingproductandAIequivalencydetermination)tofinalizePQreviewoftheGeneric,New Product,andlistingdecision
BuildaRegulatoryPathway– ApplicantPieces
ApplicantAction Item Est.Duration(months)
Outcome
DOSSIERDEVELOPMENT
ApplicantDossierDevelopment 24 Finalizedtox,chem,andeco studiesreadytosubmittoWHO,includesanapplicant preparedRAandmayincludeSRARA
Phase1EfficacyTrials 9 FinalizedstudyreportreadytosubmittoWHOforinclusion inRA
Phase2 EfficacyTrials 9 FinalizedstudyreportreadytosubmittoWHOforPhase3Consult
Phase3Efficacy Trials(LLIN) 12 FinalizedstudyreportreadytosubmittoWHOforFinalPQdecision
Phase3Efficacy Trials(non-LLIN) 36 FinalizedstudyreportreadytosubmittoWHOforFinalPQdecision
BuildaRegulatoryPathway– NRAPieces
ApplicantAction Item Duration(months)
Notes/Outcome
Establish NRAs inPQCollaborativeRegistration Procedure (CRP)
6 PQandapplicant willengage NRAsduring thePQProduct reviewprocess inorder toencourageparticipation intheCRP
NRAs’ Approval Decision 3 AfteraPQ interim/final decision, NRAsinvolved inCRP registerproducts within theircountry
EFFICA
CY
Trials
Phase3
Consult NRAAP
PROV
AL
DossierDevelopment
NewAIReview
ExistingAIReview
Phase1Consult
“Let’s Build!!!”
PossiblePathways
Existing Paradigm
NewAI
LLIN Non-LLIN
ExistingAI
LLIN Non-LLIN
Generic
LLIN Non-LLIN
Variation
Minor Major
ExistingParadigm,NewAI,non-LLIN
ExistingParadigm,NewAI,LLIN
ExistingParadigm,ExistingAI,non-LLIN
ExistingParadigm,ExistingAI,LLIN
ExistingParadigm,Generic
Variations– MajorandMinor
![000’(-...P7 Ł7 O PQ P ƒ7 Q P7 R S7 M12 ƒ[/ 012! P7 Ł7 O PQ? @7 O PQ V ₁12 X,2 / 012 &&" P7 Ł7 O PQ PH uH • MN2 uQ ó PQ è Q í @12 O PQ º ˇ7 u] &(& P7 Ł7 O PQ Y ⁄2](https://static.documents.pub/doc/80x56/5f061dee7e708231d4165fd6/000a-p7-7-o-pq-p-7-q-p7-r-s7-m12-012-p7-7-o-pq-7-o-pq-v-a12.jpg)
