WHO Prequalification of Diagnostics WHO/UNICEF Technical Briefing Seminar

1. WHO Prequalification of Diagnostics WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies29 Oct – 2 November, Geneva Anita Sands Diagnostics & Laboratory Technology Team Department of Essential Medicines & Health Products

2. Regulation of diagnostics (IVDs) • Regulation specifically for diagnostics is often poorly understood and/or poorly enforced • Different categories of IVDs regulated differently • HIV IVDs, particularly for blood screening, attract greateststringency • Degree of stringency is usually risk-based • Risk perception is different in different settings • Procurementpolicies drive supply of quality assured products • often acting as de facto regulatory control

3. Who sets international standards?

4. Role of WHO • To providenormative guidance to MemberStates on whenand how to use IVDs to guide clinicaldecision-making • WHO ART guidelines • To provide recommendations on quality and performance of IVDs through the WHO Prequalification of Diagnostics programme according to international standards • To increase in-country capacity to effectively regulate & to monitor quality of diagnostics in their market

5. Aim of WHO Prequalification of Diagnostics • To promote and facilitate access to safe & appropriate diagnostic technologies of good quality in an equitable manner • Through adoption of GHTF guidance and ISO requirements • Customers • WHO Member States • UN agencies • Funding and procurement agencies

6. Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance

7. Application: requirements • Manufacturer may submit application at any time to diagnostics@who.int • Must use the Prequalification of Diagnostics application form • Instructions for the completion of the application form contains information to help fill the form

8. Prioritization of PQDx applications

9. Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance

10. Dossier: requirements • Dossier must demonstrate that the IVD conforms to the Essential Principles of Safety and Performance of Medical Devices (GHTF/SG1/N41R9:2005)

11. Dossier: submission Clinical evidence to validate performance claims One clinical evaluation* performed by Manufacturer One clinical evaluation* performed independently Must clearly relate to the product undergoing prequalification (same name, same product code, same regulatory version) *The EC Common Technical Specifications (CTS) for IVDs 2009 are a useful guide http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:039:0034:0049:EN:PDF

12. Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance

13. Inspection: requirements • The manufacturer must demonstrate that the IVD is produced under a functional quality management system e.g. conforms to ISO 13485:2003

14. Inspection: requirements • Dossier submission data – to confirm is true • QC and lot release • QC panels should be challenging enough to detect failure or drift • Independence and adequately staffed QA/QC department • Deviation reporting procedures observed • WHO related/end user issues • IFU • stability (transport, in-use, expiry dates) • training • complaints reporting mechanisms

15. Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance

16. Laboratory evaluation: protocol • Specimens are characterised by • 3rd generation EIA (Ab) • 4th generation EIA (Ab/Ag) • HIV-1 24 antigen EIA (Ag) • HIV-1/2 line immunoassay (Ab only)

17. Laboratory evaluation: outcome • If RDT, results are read by 3 independent readers • Two production lots are submitted to assess lot-to-lot variation • Results of the WHO laboratory evaluation must meet the acceptance criteria

18. Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance

19. Prequalification: decision • Final prequalification outcome depends on: • Results of dossier assessment and acceptance of action plan • Results of inspection and acceptance of action plan • no critical nonconformities outstanding • 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

20. Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance

21. Post-market surveillance • WHO PQDx complaint form for end users to report issues • http://www.who.int/diagnostics_laboratory/procurement/complaints/en/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

22. PQDx assessment status for all products • WHO website updates the status of each product undergoing PQDx assessment monthly http://www.who.int/diagnostics_laboratory/pq_status/en/index.html

23. Products eligible for procurement • http://www.who.int/diagnostics_laboratory/procurement/purchase/en/index.html

24. Contact us • Contact us by email diagnostics@who.int WHO Prequalification of Diagnostics programme website http://www.who.int/diagnostics_laboratory/evaluations/en/