Introduction to PQDx assessment update. Irena Prat, Group Lead Prequalification Team Diagnostics assessment

Transcription

1 Introduction to PQDx assessment update Irena Prat, Group Lead Prequalification Team Diagnostics assessment Copenhagen, Denmark September

2 Introduction of Diagnostics assessment Team Copenhagen, Denmark September

3 IVDs prequalified Overall 73 IVDs listed 9 new IVDs in 2017: Aptima HIV 1 Quant Dx Assay OraQuick HIV Self Test Xpert HIV 1 Viral Load Geenius HIV 1/2 Confirmatory Assay with Geenius HIV1/2 Confirmatory Controls Genie Fast HIV 1/2 Xpert HCV Viral Load OraQuick HCV Rapid Antibody Test Kit SD BIOLINE HBsAg WB Xpert HPV + 39 changes 3

4 2018: new product pipeline In 2018*, 17 PQ applications: 10 HIV: 5 RDT, 1 EIA, 2 NAT, 2 CD4 3 HCV: 1 RDT, 1 EIA, 1NAT 1 HIV/syphilis: RDT 1 malaria: RDT 1 cholera: RDT 1 G6PD: RDT and 43* Change Notifications * to September

5 PQDx financing model PQ fees structure changed in 2016 for medicines and vaccines For IVDs: consultation of proposed model, closed on 30 April Model went live on 1 August 2018 What has changed: the type of assessment: whether a full or abridged assessment of a new application, or assessment of changes; an annual maintenance fee. New application full assessment New application abridged assessment Annual fee Change assessment fee 5, ,000 8,000 4,000 3,000

6 Prequalification scope PQ eligibility consultation HIV HCV HPV PoC G6PD Cholera Syphilis malaria HBV 2019 Expansion of PQDx scope over time

7 Performance evaluations: evaluating sites and alternative evaluation pathway 11 laboratories listed as evaluating sites for PQ purposes Working with laboratories on sample sharing network Alternative evaluation pathway rolled out: 7 applications at various stages of assessment Impact on assessment timelines will be assessed in 2019 Copenhagen, Denmark September

8 Malaria RDTs WHO procurement eligibility shift from product testing to PQ listing New applications can be submitted at any time Performance evaluation now coordinated by PQ CDC Atlanta Copenhagen, Denmark September

9 Assessment timelines Timelines document publicly available Full assessment: 270 WHO calendar days, if the alternative performance evaluation pathway is selected by the manufacturer; and 350 WHO calendar days, if WHO coordinates the performance evaluation. Abridged assessment: 100 WHO calendar days, if the alternative performance evaluation pathway is selected by the manufacturer; and 180 WHO calendar days, if WHO coordinates the performance evaluation. Copenhagen, Denmark September

10 Assessment timelines cont d Timeline extensions granted within agreed ranges Changes in submission timelines can be very disruptive: Assessment resources lined up Laboratories ready to start Let us know ASAP Industry feedback on financing model: request to inform Mx when WHO is late; new measure introduced TSS enforcement timelines Copenhagen, Denmark September

11 International harmonization and convergence IMDRF-related convergence EPs ToC and dossier restructuring Report restructuring GRRP: new reliance mechanisms AHWP Labelling Changes Copenhagen, Denmark September

12 Where to find information Broadcasting Quarterly newsletter Copenhagen, Denmark September

13 Electronic Prequalification System (e-pqs) Expected to be launched on Q1-Q No more s, communication on applications through a wizard Single user sign in Copenhagen, Denmark September