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WHO Prequalification of Diagnostics

WHO Prequalification of Diagnostics WHO Technical Briefing Seminar on Essential Medicines and Health Products WHO HQ, Geneva , 28 October - 1 November 2013 Mercedes Pérez González Department of Essential Medicines & Health Products . Regulation of diagnostics (IVDs).

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WHO Prequalification of Diagnostics

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  1. WHO Prequalification of Diagnostics WHO Technical Briefing Seminar on Essential Medicines and Health Products WHO HQ, Geneva, 28 October - 1 November 2013 Mercedes Pérez González Department of Essential Medicines & Health Products

  2. Regulation of diagnostics (IVDs) • Regulation specifically for diagnostics is often poorly understood and/or poorly enforced • Production of many diagnostic products has been moved to countries with less strict regulatory framework. • 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 • Different regulatory versions of the same product

  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 • Based on best international practice (ISO, EN, GHTF, CLSI); follow the content of the GHTF STED • Looks into critical aspects for WHO Member States often not dealt with/dealt with from a local prospective by SRAs (stability, IFU, RA, etc.). • Dossier must demonstrate that the IVD conforms to the Essential Principles of Safety and Performance of Medical Devices (GHTF/SG1/N41R9:2005)

  11. Dossier: requirements

  12. 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

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

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

  15. Inspection: requirements • Dossier submission data – to confirm is true • Production • 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

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

  17. Evaluations performed • WHO evaluation protocols followed, based on existing international standards and best practice and adapted to assay type • Performance and operational characteristics • WHO Collaborating Centres performs evaluation under supervision of WHO • WHO Composite Reports of all products produced • Report 17 to be released

  18. 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

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

  20. 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

  21. PQDx fast track procedure • The process relies on provision of relevant “evidence” of certification issued by a stringent regulatory authority (SRA) or their authorised representative(s) • Submitted evidence will be considered for its suitability in satisfying WHO requirements. • This applies to • the dossier assessment (product design and development), • and/or inspections of the site of manufacture and the quality system • And/or the laboratory evaluation

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

  25. Post-market surveillance • Should be the onus of the manufacturer, but poorly executed • 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 • Pilot project on PMS • Regulatory capacity building • Capacity building at the NRL level

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

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