regulatory systems strenghthening feedback on the 2 nd who international consultation for...
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REGULATORY SYSTEMS STRENGHTHENING
Feedback on the 2nd WHO International Consultation for Strengthening National Regulatory Systems
HIS/EMP/RHT/RSS
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OutlineOutline
1. Between the 1st and the 2nd International Consultations
2. Discussions of the 2nd International Consultation
3. Outcomes and next steps
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OutlineOutline
1. Between the 1st and the 2nd International Consultation
2. Discussions of the 2nd International Consultation
3. Outcomes and next steps
WHO role is to focus on improved accessto health products and health technologies
IDPs
(country plan)
Assessment of
National Regulatory System
Benchmarking
(Assessment tool)
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.
WHA
67.20
WHA
67.22
WHA
67.21
WHA 67.23
WHA
67.18
Others
9 (nine) World Health Assembly (WHA) resolutions target
Regulatory Systems
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Development of the Global ToolDevelopment of the Global Tool
Vaccine 2011
Medicine 2007
Harmonized tool Prototype I
PAHO 2012
May 2014Jun 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
1st IC 2nd IC
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Regulatory Systems Functions and Maturity LevelRegulatory 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)
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II – METHODOLOGY & PROCESS
I - POLICY
III- BENCHMARKING SYSTEM
IV - TERMINOLOGY
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
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I - POLICY
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
1st 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
Model proposed
Model proposed
Model proposed
Model proposed
Pathway
Coordination
Road Map
Coordination
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II – METHODOLOGY & PROCESS
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
1st 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
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III- BENCHMARKING SYSTEM
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
1st 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
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IV - TERMINOLOGY
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
1st International Consultation Implementation: Action taken (Feb-Nov.2015)
1. Gathering terminology from relevant areas of work
2. Updating existing inventoryInventory
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WHO 2nd International Consultation:
WebEx discussions and Meetings conductedJune, Aug, and 13 Nov.- 4 December 2015
Meetings in Geneva30th Nov-4 Dec.
Jun Aug 13 17 18 19 24 25 26
WHOROs
NRAs ‘meetingDonorsTechnicalPartners
WebEx sessions13 Nov-27 Nov.
Policy
November December30 1 2 3 4
MethodologyProcess
Tools & Indicators
Methodology
Tool
Policy
1A1B
4A4B
3A3B
2A2B
5A5B
6A6B
7A7B
WrapUp
JWG
27
WrapUp
JWG
WrapUp
JWGWhite Paper
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SEAR 16%
EMR 16%
WPR 12%
WHO NRA 2nd International Consultation, 2015
Countries’ participation per WHO region 13 - 26 Nov, 2015
WHO NRA 2nd International Consultation, 2015
Countries’ participation per WHO region 13 - 26 Nov, 2015
Denominator= 24 countries
Country WHO Region
South Africa AFRZimbabweArgentina
AMRPAHO
BrazilCanadaColombiaCubaMexico USA Egypt
EMRIran Pakistan
Saudi ArabiaEMA
EUR
Albania
Italy
Lithuania
France
Indonesia
SEARSri Lanka
Thailand
India
China
WPRJapan
Korea
AMR 28%
EUR 20%
AFR 8%
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WHO NRA 2nd international consultation, 2015 Webex consultation: 7 sessions
13 - 26 November 2015
WHO NRA 2nd international consultation, 2015 Webex consultation: 7 sessions
13 - 26 November 2015
South Afri
ca
Zimbabwe
Argentina
Brazil
Canada
ColombiaCuba
Mexico USA
Egy
ptIra
n
Pakist
an
Saudi A
rabia
AlbaniaIta
ly
Lithuania
EMAFra
nce
Indonesia
Sri La
nka
Thailand
IndiaChina
Japan
Korea0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
AFR AMR EMR EUR SEAR WPR
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OutlineOutline
1. Between the 1st and the 2nd International Consultation
2. Discussions of the 2nd International Consultation
3. Outcomes and next steps
2nd International Consultation, 2015
Objectives & & DeliverablesSeek 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
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.
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.
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
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OutlineOutline
1. Between the 1st and the 2nd International Consultation
2. Discussions of the 2nd International Consultation
3. Outcomes and next steps
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Actions for WHOActions 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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