Current pipeline for WHO PQ of Diagnostics programme

1. Current pipeline for WHO PQ of Diagnostics programme How WHO is bringing innovative POC diagnostics to the field and assuring quality AIDS2012 Satellite Session 25 July 2012, Washington DCAnita SandsDiagnostics & Laboratory Technology Department of Essential Medicines & Health Products

2. Contents • Market share • WHO Prequalification of Diagnostics programme • Remaining challenges • Next steps

3. Global market for diagnostics Value of procurement (USD) Based on available data from SCMS, UNICEF, WHO, UNITAID (when available) and GFATM

4. 2008 HIV RDTs Market Share by Volume

5. 2010 HIV RDTs Market Share by Volume

6. Contents • Market share • WHO Prequalification of Diagnostics programme • Remaining challenges • Next steps

7. Aim of WHO Prequalification of Diagnostics • To promote and facilitate access to safe & appropriate diagnostic technologies of good quality in an equitable manner • To increase in-country capacity to effectively regulate & to monitor quality in-market

8. WHO Prequalification of Diagnostics Manufacturing Site Inspection Laboratory Evaluation Application by Manufacturer Dossier Assessment Product Prequalified Meets Requirements Post Market Surveillance See WHO website for more details http://www.who.int/diagnostics_laboratory/evaluations/en/

9. PQ Dx applications received Test format Analyte Status as of 20 July 2012, based on analysis of PQ tracking document

10. Recent progress Status as of 20 July 2012, based on analysis of PQ tracking document

11. WHO prequalified products (HIV RDTs) • In addition, list of products eligible for WHO procurement still stands until sufficient number of prequalified products (all have submitted for PQDx) • As of 20 July 2012 • More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory

12. WHO prequalified products (malaria RDTs) • As of 20 July 2012 • More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory

13. WHO prequalified products (CD4 technologies) • As of 20 July 2012 • More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory

14. WHO prequalified products (HIV viral load technologies) • As of 20 July 2012 • More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory

15. WHO prequalified products (HIV viral load technologies) • As of 20 July 2012 • More information and WHO Public Reports can be found on the WHO website www.who.int/diagnostics_laboratory

16. PQ Dx progress: applications • PQ applications • 152 applications received • 84 priority applications accepted • 22 applications closed • 20 applications withdrawn • Remaining applications • Not for priority disease/ format • Multiple applications from same Mx • with on-going quality concerns Status as of 17 July 2012, based on analysis of PQ tracking document

17. PQ Dx progress: dossiers • 67 dossiers screened for completeness • 27 HIV RDT/EIA/other • 6 CD4 technologies • 11 HIV quantitative NAT (viral load) • 2 HIV qualitative NAT • 6 HCV • 2 HBsAg • 11 malaria RDTs • All dossiers required amendments before full assessment • Up to 4 rounds of amendments required • 43 dossier assessments completed • 11 dossiers still under full assessment • All dossiers required action plan after full assessment

18. PQ Dx progress: laboratory evaluations 13 HIV RDTs completed 8 RDTs on-going/scheduled 4 EIAs on-going 5 CD4 technologies on-going Results Q3-Q4 2012 HIV viral load on dried blood spots Results Q4 2012 Malaria RDTs completed under WHO/TDR product testing programme

19. PQ Dx progress: site inspections Conducted for 37 products (21 manufacturers) 13 HIV RDTs 8 HIV viral load technologies 5 CD4 technologies 11 malaria RDTs 8 products (4 manufacturers) have required re-inspection 15 products (6 manufacturers) scheduled for inspection in Q3/Q4 2012

20. PQ Dx progress Status as of 17 July 2012

21. Time to PrequalificationFT vs non-FT

22. Contents • Market share • WHO Prequalification of Diagnostics programme • Remaining challenges • Next steps

23. Challenges • Multiple regulatory versions for the "same" product • Variable stringency of regulatory review by NRAs • depends on risk classification • if product is for export-only, minimal review • Variable stringency of conformity assessment bodies/inspection agencies • Some inspections may be outsourced to in-country agencies • Differences in QC lot release procedures for CE-marked products for different notified bodies

24. Challenges • Still poor understanding and implementation of quality management systems at manufacturing site • Inadequate product dossier to demonstrate performance claims including • Product stability • Both in-use and transportation stability • QC and lot release procedure • Customer service in resource-limited settings

25. Contents • Market share • WHO Prequalification of Diagnostics programme • Remaining challenges • Next steps

26. Next steps • Amplifying post-market surveillance activities • Should be the onus of the manufacturer, but poorly executed • Role for global/national entities to collect data on poorly performing products & feedback to Mx and other users • Strengthening regulatory capacity in both country of origin and country of sale and use • RDTs are often not widely, if at all, used in the country of origin

27. Next steps Measure impact of prequalification on Capacity of Mx to consistently produce good quality products Market dynamics Access to new innovative diagnostics Extend prequalification to new product categories of public health value TB, HBsAg, HCV,HIV/syphilis, other multiplexed tests, etc. male circumcision devices

28. Updated information The status of each PQDx application is posted on the WHO website & updated monthly The PQ Update newsletter is issued regularly & sent by direct mail & posted on the WHO website Thank you www.who.int/diagnostics_laboratory Email: diagnostics@who.int