Copenhagen, Denmark September A streamlined approach to the WHO Prequalification of In Vitro Diagnostics Programme: Overview

Transcription

1 A streamlined approach to the WHO Prequalification of In Vitro Diagnostics Programme: Overview 1

2 Dept of Essential Medicines & Health Products: structure Essential Medicines and Health Product [EMP] Policy, Access and Use [PAU] Regulation of Medicines and other Health Technologies [RHT] Public Health, Innovation and Intellectual Property [PHI] Technologies Standards and Norms [TSN] Regulatory Systems Strengthening [RSS] Prequalification Team [PQT] Safety and Vigilance [SAV] 2

3 WHO Prequalification Team: structure Essential Medicines and Health Product [EMP] Regulation of Public Health, Policy, Access and Medicines and other Innovation and Use Health Technologies Intellectual Property [PAU] [RHT] [PHI] Technologies Regulatory Systems Prequalification Standards and Safety and Vigilance Strengthening Team Norms [SAV] [RSS] [PQT] [TSN] Prequalification Team Coordinator s office Vaccines Assessment Medicines Assessment Diagnostics Assessment Inspections Technical Assistance Administrative team 3

4 EMP reorganization: single PQ programme for further impact & restructured regulatory units > Consolidated prequalification team aiming at > Enhanced management & operations > e.g. quality management system > e.g. administrative efficiencies, incl. financial management > Better relationship with stakeholders > e.g. single voice when dealing with national regulatory authorities > e.g. increased transparency around processes and outcomes > Cross-product stream learning > e.g. extension of ERP process to new product categories > e.g. bigger pool of external experts and testing laboratories > e.g. PQDx benefit from medicines and vaccines experience to improve efficiency 4

5 PQDx streamlining: Review of PQDx experience and analysis of gaps and challenges > PQDx weaknesses > Timelines > Transparency (pass/fail criteria, fast tracking, post-pq) > Guidance and specific information to Mx > Communications with stakeholders > Overloaded pipeline 5

6 Prequalification of IVDs streamlining > Jan-Jun 2014: PQDx Programme underwent streamlining to: > Increase efficiency (timelines, focus on active applications) > Improve transparency (requirements, process) > Strengthen work with key partners (NRAs, manufacturers, procurement and other agencies) 6

7 Prequalification of IVDs streamlining steps rounds decision Cap. building Process fees efficiency IMDRF Site inspections NC grading Working with partners Product dossier Lab. evaluation transparency planning Critical sections 7

8 What are the changes to the process? > PQDx assessment: > Full assessment (see flowchart) > Abbreviated assessment (see flowchart) 8

9 Full prequalification assessment: process Updated PSF asks for more detailed information on regulatory versionsof the product submitted to determine if eligible for abbreviated PQ assessment Pre-submission form Priority product Yes No Dossier screening Dossier incomplete Dossier complete Dossier review Site inspection Laboratory evaluation Prequalification decision 9

10 Abbreviated prequalification assessment Pre-submission form Priority product No Yes Full PQ assessment No Decision on abbreviated PQ assessment Yes Abbreviated site inspection Laboratory evaluation Prequalification decision 10

11 Prequalification decision > Final prequalification outcome depends on: > Results of dossier assessment and acceptance of action plan > Results of inspection(s) and acceptance of action plan > No level 5 nonconformities outstanding for either dossier or for inspection > Meeting the acceptance criteria for the laboratory evaluation > WHO PQDx Public Report is posted on WHO website and product is added to the list of WHO prequalified products > Product is then eligible for WHO and UN procurement 11

12 Results of streamlined WHO PQDx assessment > Efficient and timely prequalification of quality-assured diagnostics > Fewer steps > Defined timelines > Defined number of rounds > Improved scheduling > More interactions with Mx including more teleconferences at critical steps > Division between PQDx assessment and assistance to Mx > More transparent PQDx assessment process in place Cleared pipeline > Additional guidance to assist Mx, WebEx briefings, sample dossiers, training plan for priority topics > Robust capacity building programme in place through TA group: > advisory visits to tackle specific gaps > training programme to address most common PQ issues 12

13 PQ overarching documents published > Updated Overview of the Prequalification of IVDs assessment > Abbreviated prequalification assessment for IVDs (previously FT) > A risk based approach for the assessment of IVDs (based on GHTF/SG1/N046:2008 Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices) > Risk based classification of diagnostics for WHO Prequalification" (based on GHTF/SG1/Principles of In Vitro Diagnostic (IVD) Medical Devices Classification) > WHO procedure for changes to a WHO prequalified in vitro diagnostic" and Changes notification form > Updated Pre-submission form and Instructions 13

14 Prequalification of IVDs streamlining: working towards > Communications - Information for manufacturers and other stakeholders > Improved guidance > WebEx > Website PQDx streamlining completed but additional guidance to be published Working with Mx and NRAs 14

15 PQDx assessment status for all products > WHO website updates the status of each product undergoing PQDx assessment monthly 15

16 Post-market surveillance of WHO PQed IVDs > Onus on manufacturer and NRA, but often poorly executed > WHO coordinates complaints through the "WHO PQDx IVD complaint form" for end users to report issues > n/index.html > GHTF/SG2-N54R8:2006 > Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices > GHTF/SG2-N57R8:2006 > Medical Devices Post Market Surveillance: Content of Field Safety Notices > WHO guidance on post-market surveillance is forthcoming 16

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