Transition to WHO-PQ. Vector control product evaluation. TITLE from VIEW and SLIDE MASTER 16 June 2016

Transcription

1 Transition to WHO-PQ Vector control product evaluation 1

2 Key PQ activities to achieve transformation have been defined in the recently awarded grant Improve quality and efficiency of vector control assessment Assist NRAs to optimize national registration times Develop a sustainable model for short- to mid-term future of PQT Prequalify and maintain prequalification status of products Communicate with stakeholders to build strong trust in WHO prequalification systems 2

3 Overview of the PQT grant 1 Objectives Improve quality and efficiency of vector control assessment Key activities Create and staff vector control assessment group within PQT based on model of other PQT groups and WHOPES Develop quality assessment systems for vector control products Assist NRAs to optimize national registration times Develop a sustainable PQT model Prequalify and maintain prequalification status of vector control products Communicate with stakeholders to build strong trust in WHO prequalification systems Identify and engage NRA contacts and pilot collaborative registration 1 procedure Determine fee structure / funding model for vector control evaluation in PQT Conduct assessments of vector control products in PQT system as of 1/1/17, including quality, safety, and efficacy assessments Conduct post marketing quality inspections of manufacturing sites and finished products based on risk assessment protocols Engage with relevant stakeholders to communicate changes in WHO vector control evaluation system, and build strong trust is WHO prequalification systems 1. Collaborative procedure with NRAs to facilitate the assessment and accelerated national registration of WHO-prequalified products 3

4 Transition from NTD (WHOPES) to PQ 4

5 What is WHO-PQ? Vision Good quality medicines for everyone. Mission In close cooperation with national regulatory agencies and partner organizations, the Prequalification Team aims to make quality priority medicines available for the benefit of those in need. This is achieved through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines. 5

6 Who is WHO-PQ? 6

7 Identifying Necessary Regulatory Pathways Application New Paradigm Existing Paradigm Variation VCAG New Product Generic Nonchemical/ Other Major Minor Notification 7

8 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 8

9 General PQ review process Presubmission Screening Assessment Listing Decision Post-PQ Applicant is encouraged to communicate any planned submissions and request pre-sub meeting(s) to ensure clarity of dossier requirements and timelines PQ conducts a screen of the application to ensure that all dossier requirements are satisfied Experts are convened to conduct an assessment of the submitted application (ASVCP) Manufacturing facilities are inspected PQ Group determines the suitability for prequalification listing based on the Assessment session evaluation Collaborative Registration with National Regulatory Authorities Ongoing inspection of products and manufacturing facilities to provide quality control 9

10 WHO-PQ Vector Control Functions WHO Action Item Duration (mos) WHO Groups Notes/Outcome Pre-submission Meeting 1 PQ, NTD, GMP Protocol Review 4 PQ, NTD, GMP, ASVCP New Product Review Generic Product Review Applicant requests meeting which will be scheduled within ~4 weeks. The desired outcome is that the applicant has a clear understanding of path to submission and dossier requirements. Applicant may request that PQ conduct a review of proposed protocol for any of the required scientific disciplines. PQ will provide documentation of the review to the applicant. 12 PQ, ASVCP Includes screen, PQ/ASVCP assessment of the dossier and decision for listing. 7 PQ, ASVCP Includes screen, PQ/ASVCP assessment of the dossier (including product and AI equivalency determination) and decision for listing. Variation Review Major Variation Review Minor 7 PQ Includes label and/or formulation changes which require the review of new data by any part of the science or inspections team 2 PQ Includes label and/or formulation changes which do not require review of new studies or data. 10

11 Pre-submission Meeting Types New Paradigm New Product Variation Existing Paradigm 11

12 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 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 Utilization Guidance Consultation 12

13 Pre-submission Product Development PQ Assessment/Listing Post-PQ Listing Applicant NEW PRODUCT Joint Pre-submission Meeting for Product Development Guidance Plan PQ Expectations Toxicology Data Entomology Data Prod. Chem Data Risk Assessment Small Scale Field Study Draft Label NTD/GMP Data Expectations TBD Application Assessment of Efficacy, Safety, and Quality Sharing of information for Utilization Guidance Listing Decision NRA Potential de-listing Development of Recommendation comparative effect/cost/suitability based on alternatives Procurer Consumer Post-Market Quality Inspections Large Scale Field Study Submitted Utilization Guidance updated iteratively based on new data, expanded use and changes in disease pressure

14 New Product 14

15 Pre-submission Product Development PQ Assessment/Listing Post-PQ Listing Applicant - GENERIC Pre-submission Meeting for Product Development Guidance Plan PQ Discussion? s Predicate Product? Equivalency? Efficacy? Data usage concerns for NRA registration? Application Assessment of Quality and Equivalency to determine Efficacy and Safety Listing Decision NRA Potential de-listing Procurer Consumer Post-Market Quality Inspections Utilization Guidance already exists for predicate product

16 Generic Product 16

17 Post-PQ Listing Pre-submission PQ Variation Assessment Communication of Variation Applicant - VARIATION Joint Pre-submission Meeting for Product Development Guidance Plan PQ Discussion? s Planned Variation? Variation Major? Variation Minor? Data Req s? Draft Label? NTD/GMP Data Expectations TBD Application Assessment of Efficacy, Safety, and Quality as required by proposed variation Decision NRA Potential de-listing Utilization Guidance updated iteratively based on new data, expanded use and changes in disease pressure Procurer Consumer Quality Inspections

18 Variations 18

19 Pre-submission Product Development New Product Assessment Post-PQ Listing Data Expectations TBD NEW PRODUCT Pathway Applicant NEW PARADIGM Joint Pre-submission Meeting for Product Development Guidance Plan VCAG: NTD-STAG/GMP- MPAC/PQ Data Expectations TBD

20 Next Steps for PQ Vector Control Staffing Group Lead, Case Manager, Entomologist and Inspector Position postings closed June 2 Formulation Chemist and Risk Assessor positions to be posted in the fall. Assemble experts to serve on Assessment Session for Vector Control Products (ASVCP) Refine pathways Develop external guidance and internal SOPs Review data requirements for product and site PQ listing Develop transition plan with NTD for the transfer of product tracking responsibilities Inform NRAs on the Collaborative Registration Procedure and find volunteer countries for future pilot Utilize website to post communication plan regarding upcoming events, guidance, and point of contact references - Vector Control mailbox - pqvectorcontrol@who.int 20