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Building Regulatory Capacity in Countries to Improve the Regulation of Health Products
2
Overall regulatory systems’ maturity level of WHO Member States
ML 1 99 Countries
51%
ML 2 45 Countries
23%
ML 3 and 4 50 Countries
26%
(Updated 15 May 2018)
WHO MVP/RSS/CRS
Global context
08/10/2018 4
08/10/2018 5
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.
08/10/2018 6
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
08/10/2018 7
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
WHO capacity building model
08/10/2018 9
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
•M
inim
al cap
acit
y m
et
•E
lig
ibil
ity f
or
va
ccin
e P
Q
•W
HO
lis
ted
NR
As
1 2 3 4 5
08/10/2018 10
From gap analysis to capacity building
10
Gap
analysis
• Assessment report
IDP
• Recommendations & activities to address it
Addressing gaps
• Providing technical support
• Learning/Training/international cooperation
Monitoring progress and
impact
• IDP follow-up : progress and impact
• Re-assessment to sustain PQ or NRA functionality until expected maturity is achieved
Global Learning
Opportunities (GLO)
In-county workshop
Technical Support and on
site consultan
ts
Placement, joint review
, twining, others
Regulatory functions targeted: 1.NATIONAL REGULATORY SYSTEM
2.REGISTRATION AND MARKETING
AUTHORIZATION
3.LICENSING OF PREMICES
4.MARKET SURVEILLANCE AND CONTROL
5.VIGILANCE
6.REGULATORYINSPECTIONS
7.CLINICAL TRIALS OVERSIGHT
8.LABORATORY ACCESS AND TESTING
9.NRA LOT RELEASE
WHO Global Benchmarking Tool
08/10/2018 | Title of the presentation 12
08/10/2018 13
WHO Global Benchmarking Tool Structure/Hierarchy
SUB-INDICATORS
INDICATORS
SYSTEM FUNCTION
THE FACT
SHEET
QUESTIONNAIRE FOR
OTHER PRODUCTS
/ACTIVITIES
08/10/2018 14
WHO Global Benchmarking Tool Structure/Hierarchy
SUB-INDICATORS
INDICATORS
SYSTEM FUNCTION
THE FACT
SHEET
QUESTIONNAIRE FOR
OTHER PRODUCTS
/ACTIVITIES
National Regulatory System (NRS) and Functions (NRF)
SYSTEM FUNCTION
1. Regulatory System + Common Function 2. Non Common Functions
Common Function Non Common Functions
01-NATIONAL REGULATORY SYSTEM 02-REGISTRATION AND MARKETING AUTHORIZATION 03-VIGILANCE 04-MARKET SURVEILLANCE AND CONTROL 05-LICENSING PREMISES 06-REGULATORY INSPECTION 07-LABORATORY ACCESS AND TESTING 08-CLINICAL TRIAL’S OVERSIGHT
09-NRA LOT RELEASE
08/10/2018 15
WHO Global Benchmarking Tool Structure/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)
08/10/2018 16
Updated Figures of the WHO GBT revision VI
Item Function RS MA VL MC LI RI LA CT LR Grand
Total
Number of Sub-
Indicators 60 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
WHO-PAHO working group discussions for revision and finalization of the Global Benchmarking Tool (GBT)
* As per the last WHO – PAHO agreement, maturity level 5 will be parked for the time being so it will not be considered during our current exercise. Maturity level concept is detailed further in slide 11.
08/10/2018 17
WHO GBT Performance Maturity Levels
No formal
approach
Reactive
approach
Stable formal
system approach
Continual
improvement
emphasized
1 2 3 4
ISO
90
04
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
Can be consider as functional if
rely on other regulators for some
specific functions
Target of WHA
Resolution 67.20
Advanced/reference
Regulatory Authorities
WH
O G
BT
08/10/2018 18
Model for adoption of Maturity Level Concept Maturity Level Spider Web
• By adoption of the maturity level
concept, gaps are easily figured out
(inter-and-intra regulatory functions)
and hence capacity building
priorities are defined as shown in
this example!
• In addition, maturity level adoption
enable customization of the tool for
benchmarking of NRAs of varying
capacities.
0
1
2
3
4RS
MA
VL
MC
LI
IN
LA
CT
Maturity Level
Bangladesh road map (2016-2020)
2016 2020 2018 2019 2017
Roadmap
Self-assessment 5 years Institutional Development Plan
Interim Assessment
Formal Assessment
Mid year review
Annual review
19
Q1 Q2 Q3 Q4
Bangladesh Roadmap 2016
2016
Roadmap
Drug policy
Drug act
Assessment
Task force
Oversight committee
Strategic plan
IDP development
Workforce analysis
Annual Progress
report
Oversight committee
meeting
20
21
Recommended activities to be included in Institutional Development (IDP)
Regulatory functions Total number of
Recommendatio
ns
No. of
recommendation
s 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
Country IDP implementation estimated cost
Function/ area for Regulatory Strengthening Current
Maturity Level Estimated cost to
reach to Maturity
level 3
1. National Regulatory System (RS) 1 330,000 USD
2. Registration and Marketing Authorization (MA) 2 180,000 USD
3. Vigilance (VL) 1 240,000 USD
4. Market Surveillance and Control (MC) 1 450,000 USD
5. Licensing Premises (LI) 2 150,000 USD
6. Regulatory Inspection (RI) 2 450,000 USD
7. Laboratory Access and Testing (LA) 2 750,000 USD
8. Clinical Trials Oversight (CT) 1 450,000 USD
9. NRA lot Release NA 0 USD
Total estimated cost 3,000,000 USD
Innovative Approaches Toward Regulatory System Strengthening
The Future: new business model and innovative approaches
CIP
Update on
WHO Listed Authorities
25
WHO Listed Authority
Term ‘Stringent Regulatory Authority’, defined as original ICH
member/observer, was developed to promote reliance and guide
procurement decisions - widely used and recognized
However, growing recognition that change required, with interim
definition endorsed by WHO Expert Committee at 51st meeting (Oct 2016)
based on membership of ‘original ICH’
Concerns with term SRA; with the fact that ICH is a harmonization
initiative for pharmaceuticals, not a body with a remit or competence to
assess regulatory capacity; coupled with expanding membership
Experts at 52nd meeting (Oct 2017) considered new WHO proposal and
comments received, made a number of recommendations
26
Expert Committee Recommendations
• Term SRA be replaced by “WHO-Listed Authority” (WLA)
• Currently identified “SRAs” will be regarded as WHO-
Listed
• Designation of additional NRAs be based on WHO Global
Benchmarking Tool (GBT) + completion of ‘confidence-
building process’
• Procedure for listing be developed through usual public
consultation process
27
Concept note under development that will
• present proposed definition for WLA
• define proposed criteria and process for designating an NRA as WLA
• describe the proposed process and timelines for finalizing the definition and
process for designating a WLA
Given implications, WHO intends to undertake a broader consultation process
Targeting early 2019 for adoption, together with introduction of WHO Global
Benchmarking Tool (version VI)
Transition phase foreseen
Definition must be assessed in context of existing WHO guidelines
Establishing a system for recognizing and listing WLA
28
Fact and figures GLOBAL OVERVIEW
08/10/2018 30
WHO NRA Assessment Visits: 1997
08/10/2018 31
WHO NRA Assessment Visits: 2015
Countries targeted for WHO Regulatory System Strengthening Program and benchmarked against GBT indicators between
January 2016 to March 2018
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 13 March 2018)
WHO MVP/RSS/CRS
• India
• Papua new guinea
• Timor-Leste
• Tanzania
• Burundi
• Mozambique
• Ethiopia
• Kenya
• Djibouti
• Eritrea
• Sudan
• Somalia
• Uganda
• South Sudan
• Afghanistan
• Pakistan
• Vietnam
• Malaysia
• Japan
• Iraq
• Jordan
• Lebanon
• Mongolia
• Kyrgyzstan
• Syria
• S. Korea
• Bangladesh
• Iran
• Kazakhstan
• Egypt
• Saudi Arabia
Self Benchmarking Formal Benchmarking
• Maldives
• Nepal
• Sri Lanka
• Thailand
• Bhutan
• Indonesia
• Ghana
• Guinea Bissau
• Liberia
• Niger
• Cape Verde
• Gambia
• Serbia • Burkina Faso
• Benin
• Guinea
• Togo
• Mali
• Nigeria
• Cote d’ivoire
• Senegal
• Sierra Leone
• Rwanda
• Cambodia
• Lao PDR
08/10/2018 | Title of the presentation 33
STRENGTHENING NATIONAL REGULATORY AUTHORITY (NRA) TRAINING CONDUCTED 1996-2018
8434 PARTICIPANTS FROM NRAs, NCLs*, EPIs** AND/OR VM***
* National Control Laboratory
** Expanded Programme on Immunization
*** Vaccine Manufacture
Source: WHO/ EMP
8434 head counts have been trained by WHO between 1996 till July 2018
AFR
1368 16%
AMR
1024 12%
EMR
1140 14%
EUR
1255 15%
SEAR
1810 21%
WPR
1837 22%
• Absence of national policy and strategic objectives for establishing
and/or developing further a National Regulatory Authority (NRA)
• Lack of minimum resources to establish and sustain regulatory
oversight
• Unclear vision and mission (what should be done and what should not)
• Avoiding duplication, reliance and recognition
• Regulatory activities that could be done collectively by countries
• Access vs. quality
• Long term process, required continues commitment and engagement
34
Major challenges
35
Go to our Regulatory system strengthening website
Go to SharePoint site
Go to the Global Benchmarking Tool
Go to GBT online training
Important Links
36
Sillo, Hiiti Baran
KHADEM BROOJERDI, Alireza [email protected]
BROWN, Laura Kay [email protected]
YAP, Maria Bernadette [email protected]
OSTAD ALI DEHAGHI, Razieh [email protected]
ALFONSO, Claudia [email protected]
REFAAT, Mohamed [email protected]
EL HEMSY, Samir M.A. Abdel Wahab [email protected]
MELOUNOU, Yvonne
CRS Group
37
Overall regulatory systems’ maturity level of WHO Member States
ML 1 99 Countries
51%
ML 2 45 Countries
23%
ML 3 and 4 50 Countries
26%
(Updated 15 May 2018)
WHO MVP/RSS/CRS
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)
