1. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting, 11 February 2010 Prequalification progress - Vaccines Dr David Wood, Coordinator, Quality Safety and Standards (QSS), Department of Immunization, Vaccines and Biologicals (IVB)

2. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Outline  Review of progress  Current and future synergies

3. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Review of progress

4. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Vaccines prequalified by WHO: Status 2010 (assured quality) used in 124 countries 64% total population 106 pre-qualified vaccines 106 pre-qualified vaccines 24 manufacturers 24 manufacturers 7 emerging economy country mfrs 15 industrialized country mfrs Brazil Bulgaria Cuba India Indonesia Russia Senegal Australia Belgium Canada Denmark France The Netherlands Germany Hungary Italy Japan Rep. of Korea Switzerland Sweden United Kingdom USA 36 Sites 36 Sites

5. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 100 meetings in 2009 with manufacturers and other stakeholders 31 new vaccine tests available through WHO contracted labs

6. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Revision of vaccines PQ procedure  The vaccines prequalification procedure (WHO/IVB/05.19) was last revised in 2005  WHO plans to update the vaccines prequalification procedure in 2010 to take into account technical, communication and policy revisions  The revision process is described in a concept paper available to meeting participants

7. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Prequalification of immunization related equipment – the Performance, Quality & Safety (PQS) scheme 1.Identify requirements & develop and maintain performance specifications and verification protocols. 2.Pre-qualify products and accredit test laboratories 3.Monitor products post-market & Prospect innovations 1.Secretariat hosted at WHO 2.Inter-agencies and intersectoral Steering Committee 3.Ad hoc working groups according to categories 4.Involvement of experts from: industry, laboratories, standard bodies, institutions, freelance experts. A defined scope - 3 functions A structured organization A PQS Web based database 1.At its final phase of development

8. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 1.Published SOPs for all functions 2.Guidelines for manufacturers (published 6) 3.Performance specifications & Verification protocols for all product sub-categories 4.Information sheets on laboratories 5.Product information sheets for all prequalified products 6.Soon online catalogue 1.Online search 2.Downloadable 3.Printing option Performance, Quality & Safety Online published documentation

9. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 1.Increase the number of products by category to ensure fair competition 2.Institute a functional user-feedback system 3.Build up on existing active partnerships 4.Develop a tool to assist NRAs in strengthening their role of overseeing the equipment for immunization. 5.Establish a reality check hub for needs assessments and field test of newly developed/introduced devices and equipment. The way forward …. Performance, Quality & Safety Financing of the project Annual cost: US$ 500.000 Cost recovery US$ 150.000 Gap US$ 350.000

10. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Current and future synergies

11. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Synergies with/between countries (1) Partners (UNICEF, GAVI, BMGF, PATH, manufacturers)  More and faster prequalification of vaccines Countries crisis management for vaccine safety events 100% of vaccines used in national immunization programmes are of assured quality by 2013 (SO11 MTSP indicator)

12. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Synergies with/between countries (2)  Observed audits  Regulatory Mentoring to Strengthen Capacity – Health Canada/CDSCO India case study  Networking – Developing Country Vaccine Regulator's Network - Developing Country Vaccine Manufacturer's Network Functionality of NRA's in key developing countries that supply affordable priority vaccines is sustained and increased

13. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Synergies with countries (3) Policy coherence Vaccine prequalified Prequalification process Expert Committee on Biological Standardization Global Advisory Committee on Vaccine Safety WHO policy recommendations (SAGE, vaccine position papers,..) on control of disease through vaccination; schedules for developing countries Product licensed by functional NRA Procurement by UN Agencies Industry application Critical step Interaction/influence Functional NRA Functional NRA Global Advisory Committee on Vaccine Safety Expert Committee on Biological Standardization

14. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 National AEFI surveillance, investigation and response Immunization programme AEFI review committee Other support groups* Regulatory authority Global analysis and response GACVS Other global or regional advisory bodies Global capacity building and harmonized tools WHO and partners** Brighton Collaboration CIOMS/WHO working group Global signal detection and evaluation Uppsala Monitoring Centre Global vaccine safety data link Other partners** Product monitoring Vaccine manufacturers Licensing authorities in countries of manufacture Procurement agencies Synergies with countries (4) Blueprint for a 21 st century system for global vaccine safety

15. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Synergies between PQ programmes  Joint audits of NRA's (2009) - Egypt: review and strengthening of components of the regulatory system - Bangladesh: Joint review of Medicines and Vaccines - Led to joint development plan for support to core activities  Common functions of NRA's (examples) - Marketing authorisation and licensing - Oversight of clinical trials  Internal Working Group - Comparison between the WHO PQ procedures

16. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Challenges

17. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Vaccine prequalification resource gaps  Relative modest budget (capped at 19.3 million$) given scope of work to service all WHO Member States  Funding gap from 2010 onwards (due to sun-setting of some existing grants, plus high dependency on 1 major donor)  Flexible funds are being lost - disproportionately affects core activities, eg normative work  Ways forward: (a) increase awareness of need for flexible funding of critical core functions (b) business plan to be developed

18. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting, 11 February 2010

19. Further information  www.who.int/immunizations www.who.int/immunizations  www.who.int/biologicals www.who.int/biologicals  www.who.int/vaccine_safety www.who.int/vaccine_safety

20. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Spare slides

21. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 PQS Guidelines for Manufacturers 1.A guideline for manufacturers of waste management equipment, WHO/PQS/E10/GUIDE.1.3 2.A guideline for manufacturers of cold rooms and freezer rooms, WHO/PQS/E01/GUIDE.1.2 3.A guideline for manufacturers of vaccine refrigerators, vaccine freezers and icepack freezers, WHO/PQS/E03/GUIDE.1.2 4.A guideline for manufacturers of solar power systems, WHO/PQS/E03/GUIDE.2.2 5.Guidelines for manufacturers of temperature monitoring devices PQS/E06, WHO/PQS/E06/GUIDE.1.2 6.Prequalification of single-use injection devices under the PQS system: A guideline for manufacturers, WHO/PQS/E08- E13/GUIDE.1.3

22. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 PQS categories: progress overview PQS categories DescriptionDraftedFinalizedPublished Pre- qualified products Products Under review Manufacture PQS - E01 Cold rooms and related equipment  14-Sep 07 003 PQS - E02Transport. Guidelines to be published PQS - E03 Refrigerators and freezers.  14-Sep 07 7168 PQS - E04 Cold boxes and vaccine carriers.  8-Dec 08 1249 PQS - E05Icepacks.  8-Dec 08 0147 PQS - E06 Temperature monitoring devices.  7-Jan 08 927 PQS - E07Cold chain accessoriesTo be established PQS - E08 Single use injection devices. ISO 7886 - part 3: 2005 30017 PQS - E09Steam sterilizers Abolished PQS - E10 Waste management equipment. SBs  1 May 08 905 PQS - E10 Waste management equipment. Needle cutters  4-March 09 000 PQS - E11 Specimen collection equipment. Abolished PQS - E12 PQS - E13 Therapeutic injection devices. ISO 7886 - part 4: 2006 3758

23. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Landscape analysis of regulatory oversight on PQS items Guidelines United Kingdom, Australia Tunisia, Senegal?, Thailand/Indonesia, Bolivia? Regulatory oversight on the management of time and temperature sensitive pharmaceutical products Harmonized guidelines New initiatives 2008 ECBS 2009 ECBS ECSPP

24. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 WHO-PDA Pharmaceutical Cold Chain Management on Wheels Experiential learning New initiatives 2010 course 7-12 June 2010, TURKEY Berlinger, LogTag, Blowkings, ColdPack

25. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 Prequalification – vaccines model Functional National Regulatory Authority Prequalification by WHO for UN List of products of assured quality Procure by UN agencies (UNICEF SD; PAHO RF) Self-procurement by countries Global supply base for a product

26. UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010 WHO activities that support vaccine, and related equipment, prequalification Norms and Standards for Biologicals (Knezevic) REGULATORY BENCHMARKS New or replacement standards established through ECBS Promotion and implementation of WHO standards Vaccine Quality and Regulation (Dellepiane) REGULATORY SUPPORT Strengthen regulatory systems for vaccines Develop and promote new regulatory pathways for priority vaccines Efficient prequalification of vaccines and immunization equipment Global Vaccine Safety (Zuber) REGULATORY RESPONSE Global Advisory Committee on Vaccine Safety (GACVS) Strengthened global capacity to monitor and manage AEFIs Assessment of and response to global vaccine safety issues Regional/Country Offices From Headquarters