1. REGULATORY SYSTEMS STRENGHTHENING Feedback on the 2 nd WHO International Consultation for Strengthening National Regulatory Systems 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

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 Field test in 4 countries Informal consultation meeting, Geneva, June 2013 Nov 2015 1 st IC 2 nd IC

6. 6 |6 | 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)

7. 7 |7 | II – METHODOLOGY & PROCESS I - POLICY III- BENCHMARKING SYSTEM IV - TERMINOLOGY 1 st International Consultation Implementation: Action taken (Feb-Nov.2015)

8. 8 |8 | 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 Coordination Road Map Coordination

9. 9 |9 | 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

10. 10 | 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: Phase I

11. 11 | 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

12. 12 | 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

13. 13 | 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%

14. 14 | WHO NRA 2nd international consultation, 2015 Webex consultation: 7 sessions 13 - 26 November 2015 AFR AMR EMR EUR SEAR WPR

15. | 15 | Outline 1.Between the 1st and the 2nd International Consultation 2.Discussions of the 2 nd International Consultation 3.Outcomes and next steps

16. 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

17. 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.

18. 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.

19. 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

20. | 20 | Outline 1.Between the 1st and the 2nd International Consultation 2.Discussions of the 2nd International Consultation 3.Outcomes and next steps

21. | 21 | 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)

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