1. REGULATORY SYSTEMS STRENGHTHENING Update on the WHO NRA Global Benchmarking Tool HIS/EMP/RHT/RSS

2. | 2 |2 | Outline 1.Between the 1 st and the 2 nd International Consultations 2.Discussions of the 2 nd International Consultation 3.Outcomes and next steps 4.Work done after the 2 nd International consultation

3. | 3 |3 | Outline 1.Between the 1 st and the 2 nd International Consultation 2.Discussions of the 2 nd International Consultation 3.Outcomes and next steps

4. WHO role is to focus on improved access to health products and health technologies Alignment of EMP strategic direction against WHO reform agenda & WHA resolutions Contribute to the achievement of the WHO leadership priorities, such as : (1) Universal Health Coverage (2) The acceleration of achievement of the MDG goals expected for end 2015 (3) The reduction of deaths from “non-Communicable diseases” 2014-2019: As approved in May 2013. By the WHA66. 9 (nine) World Health Assembly (WHA) resolutions target Regulatory Systems

5. | 5 |5 | Development of the Global Tool Vaccine 2011 Medicine 2007 Harmonized tool Prototype I PAHO 2012 May 2014 Jun 2013 Dec 2014 Harmonized tool Prototype I Discussion Global tool Prototype II Jul 2015 As part of preparatory work for IC Istanbul workshop to implement IC recommenda- tion Refining the tool and develop prototype II Rev.2 Filed test in 3 countries Informal consultation meeting, Geneva, June 2013 Nov 2015 1 st IC 2 nd IC

6. 6 |6 | Model of Regulatory Oversight throughout the product lifecycle for vaccine and medicines ClinicalPre-clinical Marketing and sales Post- Marketing PRODUCT LIFECYLCE Common Regulatory Functions for: medicines & vaccines (2015) Non Common Regulatory Functions for medicines, medical devices and diagnostics Next steps: Medical devices, Blood & Traditional medicines (2016) PRE MARKETING POST MARKETING Production & Quality Control Registration of Health personnel (RHP) Control of Promotion and advertisement(CPA) Control of Narcotics, Psychotropic & Substances and precursors (NPSP) NRA Lot release (LTR) National Regulatory System (NRS) Licensing premises (LIC) Inspection & Enforcement (INE) Laboratory access and Testing (LAT Clinical Trial’s Oversight (CTO) Vigilance (PVL) Registration & marketing authorization (RMA) Market surveillance and Control (MSC) X X √

7. 7 |7 | National Regulatory System (NRS) Licensing premises (LIC) Inspection & Enforcement (INE) Laboratory access and Testing (LAT) Clinical Trial’s Oversight (CTO) Vigilance (VIG) Registration & marketing authorization (RMA) Control of Narcotics, Psychotropic & Substances and precursors (NPSP) Market surveillance and Control (MSC) Elements to be considered under relevant functions NRA Lot release (LTR) Registration of health personnel (RHP) Recommended Regulatory Functions according products or technologies stream Common functions Not common functions Vaccines Control of Drug promotion & Advertisement CPA) Medicines Medical Devices??? Blood & blood products Traditional medicines???

8. 8 |8 | Regulatory Systems Functions and Maturity Level National Regulatory System (NRS) Licensing premises (LIC) Inspection & Enforcement (INE) Laboratory access and Testing (LAT) Clinical Trial’s Oversight (CTO) Vigilance (VIG) Registration & marketing authorization (RMA) Control of Narcotics, Psychotropic & Substances and precursors (NPSP) Market surveillance and Control (MSC) Elements to be considered under relevant functions Maturity level PHASE 1 PHASE 2 1 5 BEST IN CLASS PERFORMANCE NO FORMAL APPROACH NRA Lot release (LTR) Registration of health personnel (RHP)

9. 9 |9 | Blended tools: new benchmarking system Global Benchmarking tool: Outside WHO assessme nt tools PAHO assessme nt tools WHO assessme nt tools 1.Address all health products and technologies to help countries to achieve recommended level of maturity 2.Integrating concept of using reliance to meet expectations of well functioning system 3.Avoiding duplication of work And to burden countries. Alignments on Commonalities And addressing the specific

10. 10 | WHO Global Assessment Tool 2015 Work Prioritization to address 1 st International consultation recommendations VaccineMedicinePAHOVac-MedPIC/SMDBloodOther Non WHO tools Priority 1 (Done, Istanbul 21-25 Jul 2015) Priority 2 Priority 3 Priority 4 Vac-Med: Harmonized Vaccine-Medicine Tool MD: Medical Devices PIC/S: Pharmaceutical Inspection Cooperation Scheme RAPS: Regulatory Affairs Professionals Society USP: United States Pharmacopeia

11. 11 | II – METHODOLOGY & PROCESS I - POLICY III- BENCHMARKING SYSTEM IV - TERMINOLOGY 1 st International Consultation Implementation: Action taken (Feb-Nov.2015)

12. 12 | I - POLICY 1 st International Consultation Implementation: Action taken (Feb-Nov.2015) 1.Prioritization 2.Minimal capacity 3.Reliance 4.Publication of results 5.Linking maturity level to PQ 6.Joint Working Group (JWG) 7.Coordination with WHO experts committees (ECBS, ECSPP, BRN). 8.Good Regulatory Practices (GRP) 9.Expectation for Phase II benchmarking system Model proposed Pathway/Reliance Model Coordination Road Map Coordination

13. 13 | II – METHODOLOGY & PROCESS 1 st International Consultation Implementation: Action taken (Feb-Nov.2015) 1.Manual for assessment 2.Manual for self assessment workshop 3.Guidance for assessment 4.Re-assessment 5.Ensuring consistency of the new benchmarking methodology against ISO 19011:2011 Model proposed Manual Inventory Manual Quality assurance

14. 14 | III- BENCHMARKING SYSTEM 1 st International Consultation Implementation: Action taken (Feb-Nov.2015) 1.Mapping of current tools 2.Computerized system for integrating new tools 3.Finalization of the phase 1 Tool & alignment against WHO, PAHO, PICs tools, ISO standard, and SSFFC indicators 4.Expert consultation to develop Medical device tool 5.Piloted tool in China, Mexico, Saudi Arabia, and Jordan. 6.Refinement of the tool to ensure consistency and coherence. 7.Model to apply the maturity level concept 8.Update WHO observed audit manual and develop a computerized tool WHO Global Benchmarking Tool, Prototype II

15. 15 | IV - TERMINOLOGY 1 st International Consultation Implementation: Action taken (Feb-Nov.2015) 1.Gathering terminology from relevant areas of work 2.Updating existing inventory Inventory

16. 16 | WHO 2 nd International Consultation: WebEx discussions and Meetings conducted June, Aug, and 13 Nov.- 4 December 2015 Meetings in Geneva 30 th Nov-4 Dec. Jun Aug 13 17 18 19 24 25 26 WHO ROs NRAs ‘meeting Donors Technical Partners WebEx sessions 13 Nov-27 Nov. Policy November December 30 1 2 3 4 Methodology Process Tools & Indicators Methodology Tool Policy 1A 1B 4A 4B 3A 3B 2A 2B 5A 5B 6A 6B 7A 7B Wrap Up JWG 27 Wrap Up JWG Wrap Up JWG White Paper

17. 17 | SEAR 16% EMR 16% WPR 12% WHO NRA 2nd International Consultation, 2015 Countries’ participation per WHO region 13 - 26 Nov, 2015 Denominator= 24 countries CountryWHO Region South Africa AFR Zimbabwe Argentina AMR PAHO Brazil Canada Colombia Cuba Mexico USA Egypt EMR Iran Pakistan Saudi Arabia EMA EUR Albania Italy Lithuania France Indonesia SEAR Sri Lanka Thailand India China WPR Japan Korea AMR 28% EUR 20% AFR 8%

18. 18 | WHO NRA 2nd international consultation, 2015 Webex consultation: 7 sessions 13 - 26 November 2015 AFR AMR EMR EUR SEAR WPR

19. | 19 | Outline 1.Between the 1st and the 2nd International Consultation 2.Discussions of the 2 nd International Consultation 3.Outcomes and next steps

20. 2nd International Consultation, 2015 Objectives & & Deliverables Seek advice to proceed with the piloting of the WHO phase 1 Global benchmarking tool and to conclude the integration of other tools and products with the objective of strengthening National Regulatory Systems for all health products and technologies Advise the World Health Organisation (WHO) about the implementation of the WHA resolution 67.20 Provide guidance for the development of phase II benchmarking/assessment tool for advanced/stringent regulatory systems Discuss and agree on way forward on the concept of the Centres of Excellence (CoE) to build upon the Reference NRA concept using similar PAHO approach WHO global benchmarking tool to be used by all NRAs or institutions conducting NRA benchmarking Recommendations to meet Member States’ expectations Road map and timeline for the development of the phase II benchmarking/assessment tool Agreement to move forward and to finalize and/or submit a final proposal to be endorsed at global level by Member States. Objective 1 Objective 2 Objective 3 Objective 4 Deliverables 1 Deliverables 2 Deliverables 3 Deliverables 4

21. 2nd International Consultation, 2015 Discussions  Support for CATEGORIZING REGULATORY SYSTEMS ACCORDING TO LEVELS OF MATURITY/PERFORMANCE that … … establishes a level that is considered to fulfill WHA 67.20, and … also recognizes more advanced regulatory levels of performance.  Support for a SINGLE WHO BENCHMARKING TOOL and policy for use by the WHO and/or other organizations that allows for use across product lines.  Support in principle for WHO efforts to promote a more STRATEGIC, EFFECTIVE AND COORDINATED APPROACH to regulatory system strengthening through a COALITION OF TRUSTED TECHNICAL PARTNERS based on similar standards/approach and a single institutional development plan.

22. 2nd International Consultation, 2015 Discussions  Support for an ABRIDGED TOOLS of regulatory systems benchmarking that takes account the work done by other organizations.  Support for increased TRANSPARENCY, including with respect to: Publishing information related to NRA assessments (based on the consent), The operations and work products of regulatory authorities, and The process for establishing and evaluating reliance.  Support for a TRANSPARENT METHOD/TOOL FOR PRIORITIZATION of the benchmarking/assessment of regulatory systems that is not overly complex and that takes into consideration qualitative measures.

23. 2nd International Consultation, 2015 Discussions  Reliance Recognition that reliance/cooperation is increasingly important in helping to fulfill regulatory mandates Acknowledgement that a regulator may be considered ‘functional’ even if relying on others for certain regulatory functions Support for developing WHO guidance and tools to assist member states in promoting a sound, pragmatic and transparent approach to establishing suitable forms of reliance Such guidance would form part of a Good Regulatory Practices framework and would define terms and principles to consider in relying on the output of an external body (“supplier control”) WHO benchmarking/assessment tool must be able to evaluate the appropriateness of one authority’s reliance in another’s work

24. | 24 | Outline 1.Between the 1st and the 2nd International Consultation 2.Discussions of the 2nd International Consultation 3.Outcomes and next steps

25. | 25 | Actions for WHO  PILOTING AND IMPLEMENTING WHO global benchmarking tool to meet WHA 67.20 for medicines and vaccines product streams  Finalize the MEDICAL DEVICES TOOL as part of the Global Benchmarking Tool  Develop and implement proposal on the publication and sharing of information on the outcomes of benchmarking/assessment, including a GLOBAL ELECTRONIC PLATFORM accessible to NRAs (and others)  Develop GUIDANCE to promote and a tool to measure RELIANCE (under umbrella of Good Regulatory Practices framework)

26. | 26 | Complete work associated with the use of the tool to meet a level consistent with WHA 67.20 across product lines, keeping in mind maturity level continuum (implementing the tool) Prioritization: further discussion required, building on existing work In a second phase, further develop guidance and tools that allows for modular progression to advanced levels of maturity/performance. Develop guidance to promote and a tool to measure reliance (under umbrella of GRP framework) Transparency: Develop and implement proposal on the publication and sharing of information on the outcomes of benchmarking/assessment, including a global electronic platform accessible to NRAs (and others) Actions for the WHO (Further details)

27. | 27 | Harmonization of tools with a single set of functions, indicators, sub- indicators and assessment guidance (including, for example, fact sheets or equivalents) Develop strategy to ensure smooth transition from existing to a future, global, unified NRA benchmarking/assessment tool –Transition phase is required to address the PAHO reference model and the shift to the Global Assessment Tool so there is a smooth transition. Re-assessment model should be further developed and take into considerations the need for organisation re-assessment using a) ongoing monitoring, b) abbreviated or abridged assessment and/or c) full assessment. –Important to reduce burden on countries assessed, for example, by populating the re- assessment database with existing information –Need to identify types of changes that are critical in triggering a re-assessment –Longer timeframe is welcome for advanced systems (based on risk and resources considerations) Actions for the WHO (Further details)

28. 28 | Expected or proposed time frame: PRIORITIES PILOTING AND IMPLEMENTING THE TOOL IMPLEMENTING GLOBAL BENCHMARKING TOOL : 2016-2017 1.For all new assessment and re- assesment planned for WHO prequalification. 2.For all demand of assessment 3.For countries that have sub-level system (States (India), and China (Provinces) and that are main exporter of health products and technologies. 4.Working group on reliance 5.Finalize the Medical devices tool as part of the Global Benchmarking Tool. 6.Transparency/platform 1.Identify countries to pilot the tool 2.Use opportunity of planned PAHO Reference NRA to pilot the tool so smooth transition is achieved for the PAHO region 3.Integrate and adapt current best practices of indicators documentation (PAHO) into the global tool (indicators fact sheet) 4.Review alignment of maturity level and Reference NRAs to ensure coherence including algorithm for its use 5.Working group on reliance 6.Document and share key terms used 7.Developing leaflets or brochures for regulatory agencies head to understand what is the context behind the concept

29. 29 | ACTIVITIES PERFORMED FOLLOWING THE 2 ND INTERNATIONAL CONSULTATION WHO RSS International consultation Update on the process and strategic Direction

30. 30 | Innovative approaches in implementing WHA resolution 67.20 Global Coalition framework: –Rational and objective –1 st ever piloting in Bangladesh in March 2016 –Donors community and technical partners meeting in Washington D.C. on 6 September –Next piloting in Afghanistan Center of Excellence –Rational and objective –Development of concept paper –Piloting in Mexico and Indonesia

31. 31 | Work done after the 2 nd International consultation PILOTING of the WHO Global Benchmarking Tool (GBT) prototype II, ver. 3 in Lebanon, Syria, Iraq, and Mozambique. ADJUSTMENT of the tool based on the experience gained during the said piloting including … –Development of guidance for the tool (fact sheets) –Adjustment of assigned maturity levels to each sub/indicator –Development of a matrix for linking minimal capacity to maturity level as well as medical products sourcing (producing, procuring and UN supplied) –Enhancing the computerized system for managing the tool FURTHER PILOTING of the tool is planned during 2016 in India, China, Iran, Egypt, Serbia, Kazakhstan, Saudi Arabia, Guinea, etc…

32. 32 | Work done after the 2 nd International consultation Integration of the MEDICAL DEVICES in the tool is ongoing considering PAHO relevant tool as well as WHO drafted model regulatory framework for medical devices (Working document QAS/16.664, May 2016). Integration of the WHO BLOOD tool in the GBT is ongoing considering WHO assessment criteria for National Blood Regulatory Systems, 2012 Draft WHO Good Regulatory Practices: Guideline for National Medical Products Regulatory Authorities (Working document QAS/16.648, March 2016). –GRP Comments review meeting, 2 to 5 May 2016 Discussion with PAHO for finalization of the Global Benchmarking Tool (GBT) including creation of a global electronic platform for information sharing with potential adoption of the relevant best practices (PAHO Regional Platform on Access and Innovation for Health Technologies “PRAIS”)

33. PAHO-WHO Roadmap for Finalization of the NRA Global Benchmarking Tool Development of the tool Consultation Finalization of the tool Presentation to the international and regional forum Publication of the tool or relevant material

34. Thank You