Workload of PQT-VC and ASVCP

Transcription

1 Workload of PQT-VC and ASVCP Dominic Schuler, Case Manager WHO Prequalification Vector Control 1

2 Types of Products Long-lasting insecticidal nets (LLIN) Insecticides for Indoor Residual Spraying (IRS) Mosquito larvicides Space spray (indoor and outdoor) Repellents applied on human skin Aircraft Disinsectants Molluscicides Rodenticides Spatial Repellents Vector Traps 2

3 Categorization of Products based on Tense - WHOPES Recommended - Submitted to WHOPES, data development ongoing - Products in Development 3

4 Types of Applications Conversions To address the past For the present and future - New Product New Equivalent Product Variation/Change Request 4

5 Conversions Products with WHOPES recommendations (interim and full) are eligible for inclusion on the List of Prequalified Vector Control Products PQT-VC is relying on existing product records, WHOPES Working Group Reports, JMPS Specifications and manufacturer input to identify products which have WHOPES recommendations. 5

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8 Conversions Conversion Package: Application Form for Conversion Current Product Labelling Product formulation(s) Description of the manufacturing process, highlighting any changes which may have been implemented since the original submission Site Master Files (SMFs) for all end use product manufacturing sites 8

9 Conversions Key considerations in conversion decision: Are there supporting WHOPES efficacy/safety assessments? Are there supporting WHO specifications established through the Joint Meeting on Pesticide Specifications (JMPS)? Have there been major regulatory actions with regard to the AI at the country level? When will additional information be submitted to PQT-VC? Convert? 9

10 Conversions Within 5 years, PQT-VC will complete for each product: Manufacturing site inspections Finished product sampling in association with post marketing surveillance activities Review of available information: Label; formulation details; study reports; incident reporting; failure reports; other adverse effect information; safety profile Results of review may determine further investigation and the request for additional information Listing Decision If any deficiencies are identified as part of the inspections, finished product sampling, or review, the manufacturer will be informed and a timeline will be established for the rectification of issues. Based on the results of the inspections, finished product sampling, review, and rectification of issues, a decision will be made to maintain the listing, suspend the listing, or delist the product. 10

11 Conversions Challenges Other than LLINs, products were not individually identified by WHOPES Product ownership, formulations, manufacturing processes, and manufacturing sites have changed over time Existing specifications can cover multiple products of a single formulation type Additional supporting information is needed to establish the full PQT-VC Product Dossier 11

12 Volume of Conversions ~100 applications for conversion are expected 13 received to date Deadline is 31 December

13 The Present and the Future Responsibility of Manufacturer to generate data and compile product dossier for submission 13

14 Pre-submission Activities Meeting Requests May require technical input from members of ASVCP Protocol Review PQT-VC does not approve protocol but can provide advice Human Risk Assessment Review Validation of risk assessment prior to full dossier submission if needed for study ethical clearance Waiver Request Review May be reviewed prior to full dossier submission 14

15 The Present and the Future Dossier Requirements and Development Considerations 15

16 The Present and the Future New Product Supported by existing policy recommendations May include new methods of application, formulation type, or combinations of AIs 16

17 The Present and the Future New Equivalent Product Reference product must be identified Determination of equivalency based on the product composition, toxicity, and physical/chemical attributes identified as part of the JMPS specification Reduced efficacy dossier dependent on product type See Determination of equivalence for public health pesticides and pesticide products The recommendations in the report will be included as part of the updated WHOPES Guidelines Labelling will be reviewed against the reference product Products which claim equivalency cannot make label claims beyond those of the reference product 17

18 The Present and the Future Variation/Change Request Formulation (including suppliers of ingredients) Manufacturing process Manufacturing sites Labelling claims, use patterns, target vectors etc. Could such changes impact the status of product with regards to the supporting policy recommendation? 18

19 The Present and the Future New Active Ingredient Repurposed vs New Publically available Risk Assessments from regulatory authority or JMPR Determination of pathway depends on: Chemical characteristics of the AI Product type through which it is delivered 19

20 Quality Requirements Description of dossier requirements can be found in the JMPS Manual WHO-HTM-NTD-WHOPES eng.pdf?ua=1 Additional information will be required by PQT-VC beyond the JMPS dossier (e.g. specific formulation(s) of the product including sources of ingredients) 20

21 Utilization of JMPS The new framework for evaluating VCPs under PQT necessitates a review of the utilization of JMPS. WHO is currently considering new approaches to ensure efficient processes and useful outcomes Interim Approach - Submit to WHO (PQT single point of entry) NTD and PQT will coordinate the inclusion of the submission on the 2018 JMPS agenda Deadline for inclusion on agenda was 31 May 2017 Deadline for submission of JMPS package was 31 October 2017

22 Utilization of JMPS Future Vision JMPS Dossiers to be submitted to PQT-VC ASVCP to assess data as part of the quality component of the application and make its determinations in order to meet its timelines PQT will then present decisions annually to JMPS for validation Existing CIPAC methods and JMPS specifications represent the minimum standards against which new products and variations will be reviewed. For end use products, if CIPAC methods and JMPS specifications do not exist, full validation of methods and product chemistry data must be submitted for PQT to assess the methods and product

23 Inspection Requirements Site Master File for each facility Facilities must be certified and in good standing according to ISO 9001 All sites must meet ISO standards by

24 Safety Requirements AI Hazard and Risk Assessment from a regulatory authority or JMPR Product specific risk assessment based on WHO Generic Risk Assessment Models (GRAMs) 24

25 Product Types for which GRAMs Exist LLIN IRS Space sprays (indoor and outdoor) Larvicides

26 Efficacy Requirements Rely on the data requirements specified in the WHOPES Testing Guidelines Protocol should be submitted to PQT-VC for review prior to study initiation In general: Laboratory Experimental Hut Field/Operational Use

27 Product Types for which Efficacy Guidelines Exist LLIN (under revision) IRS (under revision) Larvicide Space spray (indoor and outdoor) Repellents for human skin Aircraft disinsection No products evaluated due to historical lack of testing sites Spatial repellent No supporting policy recommendations Molluscicide Undergoing finalization for publication

28 Generating Data Goal All supporting data submitted to support a product is developed at GLP accredited labs/field centers Result remove redundant generation of data and allow for parallel data development While collaborating centers are undergoing GLP certification, PQT can inspect data generating facilities to ensure quality data Plans to conduct studies at non-glp facilities should be shared with PQT in order to determine if oversight is necessary 28

29 Thank You Questions? 29