WHO Regulatory Systems Strengthening Programme...WHO Regulatory Systems Strengthening Programme....
Transcript of WHO Regulatory Systems Strengthening Programme...WHO Regulatory Systems Strengthening Programme....
WHO role in building effective and efficient regulatory
systems for health products
WHO Regulatory Systems Strengthening Programme
Global context
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Overall regulatory systems’ maturity level of WHO Member States
ML 1100 countries
51%ML 2
44 countries23%
ML 3 and 450 countries
26%
(Updated 8 Feb 2019)
WHO MVP/RSS/CRS
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SDG 3 – Target 3.8
Achieve universal health coverage, including financial risk protection,
access to quality essential health-care services and access to safe,
effective, quality and affordable essential medicines and
vaccines for all.
Strategic Priorities
13th General Programme of Work 2019-2023
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WHO TransformationMajor reorganization of WHO to deliver
the mission and strategic priorities of the 13th General Programme of Work
Health Products
Policy and
Standards
Regulatory and
Prequalification
• Access to assistive technologies & medical devices
• Medicines Selection, IP & Affordability
• INN & classification of medical products
• Quality, Safety & Efficacy
• Expert Committee on Drug Dependence
• Knowledge development
• Local production assistance
• Pharmacovigilance
• Prequalification
• Regulation and safety
Mission
•Promote Health•Keep the World Safe•Serve the Vulnerable
Division: Medicines & Health Products
1• build regulatory capacity in Member States
consistent with good regulatory practices
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• promote regulatory cooperation, convergence and transparency through networking, work-sharing and reliance
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Objectives of the WHO regulatory system strengthening programme
• WHA Resolution 67.20 in 2014
✓ recognized the importance of strong regulatory
systems to a well-functioning healthcare system
and the attainment of health-related SDGs and
UHC.
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To continue to support Member States upon their request in the area of
regulatory system strengthening, including, as appropriate, by
continuing to:
Evaluate national regulatory systems
Apply WHO evaluation tools
Generate and analyze evidence of regulatory system performance
Facilitate the formulation and implementation of institutional development plans
Provide technical support to national regulatory authorities and governments
WHA Resolution 67.20 What WHO should do
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WHA Resolution 67.20 What WHO should do
Norms and
standards
Medical devices
including
Diagnostics
Health system
strengthening
Capacity building
in developing
countries
ICDRA
International and
regional
collaboration
Networks
WHO
PQ program
Regulation of
complex
biological
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WHO NRA 5 step capacity building
Development of NRA
benchmarking tool
Benchmarking of NRA
Formulation of Institutional
Development Plan (IDP)
Providing technical support,
Training/Learning, networking,
Monitoring progress and
impact
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Global context: different assessment tools collecting information from Regulatory Authorities and affiliated institutions
WHO RECOMMENDED REGULATORY FUNCTIONS FOR MEDICINES, VACCINES BASED ON PRODUCT LIFECYCLE
PRE MARKETING
Pre-clinical Clinical
Production
& Quality
Control
Marketing
and sales
Post-
Marketing
Non Common Regulatory
Function for vaccines and
blood products
Common
Regulatory Functions
for: medicines &
vaccines and blood
products
Next steps:
Medical devices and
blood products in
2019
POST MARKETING PRODUCT
LIFECYLCE
National Regulatory System (RS)
Regulatory Inspection (RI)
Laboratory access and Testing (LA)
Clinical Trial’s Oversight (CT)
Vigilance (PV)
Licensing premises
(LI)
Registration & marketing
authorization (MA)Market surveillance and
Control (MS)
NRA Lot release (LR)
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WHO Global Benchmarking ToolStructure/Hierarchy
SUB-INDICATORS
INDICATORS
SYSTEM FUNCTION
THE FACT
SHEET
QUESTIONNAIRE FOR
OTHER PRODUCTS
/ACTIVITIES
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WHO Global Benchmarking ToolStructure/Hierarchy
SUB-INDICATORS
INDICATORS
SYSTEM FUNCTION
THE FACT
SHEET
QUESTIONNAIRE FOR
OTHER PRODUCTS
/ACTIVITIES
INDICATORS
1. Legal provisions, regulations and guidelines
2. Organization and governance
3. Policy and strategic planning
4. Leadership and crisis management
5. Transparency, accountability and communication
6. Quality and risk management system
7. Regulatory process
8. Resources (HR, FR, Experts, Infrastructure, Equipment
and IMS)
9. Monitoring progress and assessing impact
Indicators Categorization (cross cutting subjects)
Categories enable assessment of cross sectional subjects (across
some and/or all functions)
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Current Status of Regulatory Systems WHO Global Benchmarking (for medicines and vaccines: as of September 2019)
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Advanced/referenceRegulatory Authorities
Can ensure the quality of products if rely on ML3 / ML4 regulatory systems
Target of WHA Resolution 67.2
100COUNTRIES
44COUNTRIES
50COUNTRIES 16
No formal approach
Reactive approach Stable formal system approach
Continual improvement emphasized
1 2 3 4
ISO
90
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Regulatory system operating at advanced level of
performance and continuous improvement
Evolving national regulatory system
that partially performs essential regulatory functions
Stable, well-functioning and integrated regulatory system
Some elements of regulatory system exist
WH
O G
BT
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Updated Figures of the WHO GBT revision VI
Item Function RS MA VL MC LI RI LA CT LRGrand
Total
Number of Sub-
Indicators60 35 26 27 19 26 28 30 17 268
Sub-Indicators
measuring maturity level
1
4 6 5 3 2 3 2 2 1 28
Sub-Indicators
measuring maturity level
2
7 2 3 4 1 2 2 8 3 32
Sub-Indicators
measuring maturity level
3
27 23 14 15 13 13 18 17 11 152
Sub-Indicators
measuring maturity level
4
22 4 4 5 3 8 6 3 2 56
Minimal
capacity
Advanced/r
eference
NRAs
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Recommended activities to be included in Institutional Development (IDP)
Regulatory functions Total number of
Recommendations
No. of
recommendations
required to reach
ML3
01-NATIONAL REGULATORY SYSTEM (RS) 29 10
02-REGISTRATION AND MARKETING AUTHORIZATION (MA) 28 12
03-VIGILANCE (VG) 16 9
04-MARKET SURVEILLANCE AND CONTROL (MC) 10 1
05-LICENSING PREMISES (LI) 5 1
06-REGULATORY INSPECTION (RI) 13 4
07-LABORATORY ACCESS AND TESTING (LA) 3 1
08-CLINICAL TRIAL’S OVERSIGHT (CT) 15 10
09-NRA LOT RELEASE (LR) 5 2
Total 123 50
WHO/EMP/RHT/RSS/ NRA assessment group
Business model and new innovative approaches
Bench Marking
Development of NRA assessment
tool
Benchmarking of NRA
Development of Institutional
Development Plan (IDP)
Providing technical support, Training/Learning, networking, etc.
Monitoring progress and
impact
CIP
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This will be achieved by • Identifying existing and potential partners with an interest in regulatory
strengthening;
• Establishment of a coordination mechanism among partners to develop
one agreed roadmap and/or institutional development plan (IDP).
China: The Success Story
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2005 Mar/2011 Oct/2013 Q2/2014
NRA
Benchmarking
Functional NRA,
after benchmarking
in Dec 2010
NRA
Re-Assessment
IDPIDP
More
vaccine
submitted
for PQ
1st PQ vaccine
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Tanzania: The Success Story
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Overall regulatory systems’ maturity level of WHO Member States
ML 1100 countries
51%ML 2
44 countries23%
ML 3 and 450 countries
26%
(Updated 8 Feb 2019)
WHO MVP/RSS/CRS
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System &
Functions
Regulator
• Benchmarking (GBT)
• Performance evaluation of
regulators
• Global competency
framework (draft)
Training
Specialized
technical
support
• WHO guidelines related to
regulatory functions (MA,
RI, VL, QMS, LR, etc.)
• Global and regional
networks
• GRP & GRelP guidelines
• WHO Listed Authority
(WLA)
• Variety of trainings for
regulators in various areas
including theoretical and
hands on
• Provide technical support
to advise on regulatory
matters
Benchmarking
(Gap analysis)
Capacity
building
Smart
regulation
Guidelines
Promoting
harmonization
and GRP
Promoting
reliance
Countries benchmarked against GBTJan 2016 - Sep 2019
* in accordance with United Nations Security Council resolution 1244 (1999)
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization (WHO) concerning the
legal status of any country, territory, city or area of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on map represent approximate border lines for which there
may be not yet be full agreement.
(Updated Sep 2019)
• India
• Papua new guinea
• Timor-Leste
• Tanzania
• Burundi
• Mozambique
• Ethiopia
• Kenya
• Djibouti
• Eritrea
• Sudan
• Somalia
• Uganda
• South Sudan
• Afghanistan
• Pakistan
• Malaysia
• Japan
• Iraq
• Jordan
• Lebanon
• Mongolia
• Kyrgyzstan
• Syria
• Korea
• Bangladesh
• Iran
• Egypt
• Saudi Arabia
Self BenchmarkingFormal Benchmarking
• Maldives
• Nepal
• Sri Lanka
• Bhutan
• Guinea Bissau
• Liberia
• Niger
• Cape Verde
• Gambia• Serbia
• Burkina Faso
• Benin
• Guinea
• Togo
• Mali
• Cote d’ivoire
• Senegal
• Sierra Leone
• Cambodia
• Lao PDR
• Thailand
• Indonesia• Montenegro
• Macedonia
• Bosnia and Herzegovina
• Albania
• Kosovo area*
• Kazakhstan
• Vietnam
• Rwanda
• Turkey
• China
• Eswatini
• Comoros
• Madagascar
• Malawi
• South Africa
• Zambia
• Botswana• Lesotho
• Namibia
• Seychelles
• Zimbabwe
• Congo DR • Angola
• Mauritius
• Ghana
• El Salvador
• Nigeria
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Go to our Regulatory system strengthening website
Go to SharePoint site
Go to the Global Benchmarking Tool
Go to GBT online training
Important Links
Thank you
Dr Alireza Khadem
Email: [email protected]
Regulatory Systems Strengthening (RSS)
Regulation of Medicines and Other Health Technologies (RHT)
World Health Organization (Geneva, Switzerland)
WHO/EMP/RHT/RSS/ NRA assessment group
• Responds to requests from Member States for guidance on how to develop
legal frameworks
• Foundational document that applies internationally accepted principles of GRP
to the regulation of medical products
• Relevant to all regulators, irrespective of resources and system
(centralized/decentralized/network)
• Concept development workshop, India in June 2014
• Presentation to ECSPP on way forward requesting input
(October 2017)
WHO draft Guideline on GRP
▪ Attended by Regulators from 13 Member States, WHO (HQ & Ros), others
▪ Objectives – to discuss and agree on the structure and elements of the future
WHO GReP guideline
▪ Discussions informed by survey report by the International Pharmaceutical
Regulators Programme (IPRP) on reliance and the PAHO/AMRO concept note
on reliance
▪ Outcome
✓ PAHO/PANDRH concept note should be used for the development of a WHO GRelP
document
✓ The meeting underscored the importance of reliance
➢ in addressing the challenges of regulation in a complex, global regulatory environment
and in adopting ‘smart’ regulatory approaches
➢ GRelP is one of a suite of best practices guidances for regulatory authorities.
International meeting on GRelPGuidelines, 19 Sept 2019
▪ Results from surveys and assessments of NRAs by WHO in several countries, called for:
✓ Guidance on establishment, implementation and maintenance of QMS in national regulatory
systems;
✓ WHO QMS guidance document with particular attention to NRAs in low- and middle-income
countries (LMICs)
▪ Development of a WHO guideline on implementation of QMS initiated in 2018
✓ Addressing inefficiences in regulatory processes and services
▪ Drafting Group formed and produced the first draft
▪ Two public consultations in 2019, face to face meeting in June 2019
▪ Draft guideline endorsed during the 54 ECSPP meeting held from 14 – 18 Oct 2019
WHO guideline for implementation of QMS by NRAs
▪ Network serves to promote best practices
✓ build capacity and facilitate a reduction in lot release testing on the part of
vaccine importing countries
➢ Through a reliance on test information from the NCLs of vaccine
producing countries through a secure platform and system of
confidentiality agreements
➢ Thereby promoting recognition of and access to WHO prequalified
vaccines globally
▪ Third General Meeting in Johannesburg, South Africa 5-7 November 2019
✓ Continues to expand membership
▪ More Network information is available at the WHO internet at:
http://www.who.int/immunization_standards/vaccine_quality/who_nnb/en/
WHO NCL Network for Biologicals
WHO/EMP/RHT/RSS/ NRA assessment group
▪ Term ‘Stringent Regulatory Authority’, defined as original ICH member/observer,
developed to guide procurement decisions
▪ Widely used and recognized
▪ However growing concerns with term SRA; with the fact that ICH doesn’t have
remit or competence to assess regulatory capacity; coupled with expanding
membership
▪ WHO expert committee considered new WHO proposal in October 2017
A new proposal aimed at promoting reliance - WHO Listed Authority
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