Proposed Pathways for WHO PQ Listing

Transcription

1 Proposed Pathways for WHO PQ Listing

2 Building Regulatory Pathways KEY PRINCIPLES Identify the customers Identify actions and their responsible parties Develop actions from a customer benefit mindset Strive for the Minimum Viable Pathway (MVP) Each action is a building block ADEQUACY EFFICIENCY FLEXIBILITY

3 Pre-submission Meeting Types New Paradigm New Product Existing Paradigm Variation

4 Pre-submission Meeting Type New Product, New Paradigm New Product, Existing Paradigm Variation WHO Groups Involved PQ NTD GMP PQ NTD* GMP* PQ NTD* GMP* Outcome Determination of Regulatory Pathway, existing or ad hoc VCAG review of proposed paradigm Address questions regarding dossier requirements specific to the proposed submission Determination of Regulatory Pathway New AI, Existing AI, Generic Address questions regarding dossier requirements specific to the proposed submission Determination of Variation track (Minor/Major) Address questions regarding dossier requirements specific to the proposed submission *Included for Normative Guidance Consultation

5 New Paradigm Existing Paradigm Variation VCAG Major Minor Notification New AI Existing AI Generic Non-chemical/Other LLIN Non-LLIN LLIN Non-LLIN LLIN Non-LLIN

6 Building a Regulatory Pathway WHO pieces WHO Action Item Duration (months) WHO Groups Notes/Outcome Pre-submission Meeting 1 PQ, NTD, GMP Applicant has clear understanding of path to submission and dossier requirements EFFICACY PROTOCOL REVIEW Phase 1 Efficacy Consultation 3 PQ, NTD, GMP Phase 2 Efficacy Consultation 3 PQ, NTD, GMP Documented review of protocol, shared with applicant Documented review of protocol, shared with applicant. Includes review of RA to ensure human safety for Phase 2 trials Phase 3 Efficacy Consultation 3 PQ, NTD, GMP Documented review of protocol, shared with applicant

7 Building a Regulatory Pathway WHO pieces Variations WHO Action Item Duration (months) WHO Groups Notes/Outcome Major 7 PQ Includes label and/or formulation changes which require the review of new data by any part of the science or inspections team Minor 2 PQ Includes label and/or formulation changes which do not require review of new studies or data. Risk Assessment Development CAGP Risk Assessment (RA) 15 CAGP, PQ Evaluation of AI and development of RA for PQ use PQ Decision PQ Interim Decision 1 PQ Only associated with non-generic LLIN products. Allows WHO to pre-qualify an LLIN for use during the Phase 3 Efficacy Trials. PQ Final Decision 4 PQ After reviewing Phase 3 Efficacy data, PQ will finalize decision to list product as pre-qualified.

8 Building a Regulatory Pathway WHO pieces WHO Action Item Duration (months) WHO Groups Notes/Outcome PRODUCT REVIEWS New Product, New Paradigm?? PQ, NTD, GMP Duration is dependent on the new paradigm. Completed review of a new VC paradigm. New Product Existing Paradigm New AI Review 12 PQ Includes screen, PQ and ASVCP evaluation of dossier to finalize PQ review of the New AI, New Product Existing AI Review 12 PQ Includes screen, PQ and ASVCP evaluation of dossier to finalize PQ review of the Existing AI, New Product Generic Review 7 PQ Includes screen, PQ and ASVCP evaluation of dossier (including product and AI equivalency determination) to finalize PQ review of the Generic, New Product, and listing decision

9 Build a Regulatory Pathway Applicant Pieces Applicant Action Item DOSSIER DEVELOPMENT Est. Duration (months) Outcome Applicant Dossier Development 24 Finalized tox, chem, and eco studies ready to submit to WHO, includes an applicant prepared RA and may include SRA RA Phase 1 Efficacy Trials 9 Finalized study report ready to submit to WHO for inclusion in RA Phase 2 Efficacy Trials 9 Finalized study report ready to submit to WHO for Phase 3 Consult Phase 3 Efficacy Trials (LLIN) 12 Finalized study report ready to submit to WHO for Final PQ decision Phase 3 Efficacy Trials (non-llin) 36 Finalized study report ready to submit to WHO for Final PQ decision

10 Build a Regulatory Pathway NRA Pieces Applicant Action Item Establish NRAs in PQ Collaborative Registration Procedure (CRP) Duration (months) Notes/Outcome 6 PQ and applicant will engage NRAs during the PQ Product review process in order to encourage participation in the CRP NRAs Approval Decision 3 After a PQ interim/final decision, NRAs involved in CRP register products within their country

11 Let s Build!!! EFFICACY Trials Phase 3 Consult New AI Review NRA APPROVAL Phase 1 Consult Dossier Development Existing AI Review

12 Possible Pathways Existing Paradigm Variation Minor Major New AI Existing AI Generic LLIN Non-LLIN LLIN Non-LLIN LLIN Non-LLIN

13 Existing Paradigm, New AI, non-llin

14 Existing Paradigm, New AI, LLIN

15 Existing Paradigm, Existing AI, non-llin

16 Existing Paradigm, Existing AI, LLIN

17 Existing Paradigm, Generic

18 Variations Major and Minor