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WHO Regulatory Systems Strengthening Program Presented by: Alireza Khadem
WHO/HIS/EMP/RHT/RSS/CRS
WHO Technical Briefing Seminar, 2017
Sustainable Development Goals
WHA Resolution for regulatory System Strengthening
WHO regulatory system capacity building model
WHO Global Benchmarking Tool
Minimum Required Regulatory Functions
Innovative Approaches Toward Regulatory System Strengthening
Challenges
Global overview
12/10/2017 2
Outline
12/10/2017 3
12/10/2017 4
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.
12/10/2017 5
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
12/10/2017 6
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
12/10/2017 8
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
Min
imal cap
acit
y m
et
Vaccin
e:
eli
gib
ilit
y f
or
PQ
1 2 3 4 5
Re-benchmarking Based on a risk management
approach
Revision of indicators &
benchmarking process
With or without a road map for
prequalification of products
WHO support through: Global Learning
Opportunities (GLO)
Technical Support In-country training Networking Harmonization
WHO electronic platform to monitor
NRAs information and benchmarking, IDP, training, etc.
12/10/2017 9
From gap analysis to capacity building
9
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
12/10/2017 | WHO National Regulatory Authorities Global Benchmarking Tool (GBT) and pathway for regulatory systems strengthening 10
WHO NRA Benchmarking Policy Benchmarking Methodology
Benchmarking Pre visit Self benchmarking Follow up and Monitoring
Pre IDP
Observed Audit
Vigilance field visit
IDP implementation (Monitoring + Capacity building activities)
Validation of information
WHO Global Benchmarking Tool
Legal
framework
mandate and
enforcement
power
Norms and
standards
Leadership,
coordination
& Strategic
Planning
Quality
Management
/Risk
Management
System
Resources
HR, FR, IMS,
Infrastructure
Access to Affordable Medical Products
Assuring quality of products
Quality control/testing
Inspection/Audit and
Enforcement
Vigilance and Surveillance
Scientific evaluation and
oversight
Competency Independency Transparency
12/10/2017 13
WHO RECOMMENDED REGULATORY FUNCTIONS FOR MEDICINES AND VACCINES BASED ON PRODUCT LIFECYCLE
PRE MARKETING
Pre-clinical Clinical
Production
& Quality
Control
Marketing
and sales
Post-
Marketing
Non Common
Regulatory
Functions (vaccine)
Common
Regulatory Functions
for: medicines &
vaccines (2015)
Next steps: Medical
devices, Blood &
(2017)
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)
12/10/2017 14
WHO Global Benchmarking Tool Structure/Hierarchy
SUB-INDICATORS
INDICATORS
SYSTEM FUNCTION
THE FACT
SHEET
QUESTIONNAIRE FOR
OTHER PRODUCTS
/ACTIVITIES
12/10/2017 15
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
12/10/2017 16
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)
12/10/2017 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
12/10/2017 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
4
5RS
MA
VL
MC
LI
IN
LA
CT
Maturity Level
12/10/2017 19
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
WHO/EMP/RHT/RSS/ NRA assessment group
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
China: The Success Story
2005 Mar/2011 Oct/2013 Q2/2014
NRA
Benchmarking Functional
NRA, after
benchmarking
in Dec 2010
NRA Re-
Assessment
IDP IDP
1st PQ vaccine
More vaccine
submitted for PQ
Minimum Required Regulatory Functions
12/10/2017 23
a) Thru reliance/recognition b) apply for GDP and may be GCP c) applies in case of CT performed in-country d) applies only for vaccines and blood products
Proposed core regulatory functions and minimum maturity level required according to the source of products
MINIMOM CAPACITY
Innovative Approaches Toward Regulatory System Strengthening
12/10/2017 25
The Future: new business model and innovative approaches
Development of NRA
benchmarking tool
Benchmarking of NRA
Formulation of Institutional
Development Plan (IDP)
Providing technical support, Training/Learning,
networking,
Monitoring progress and
impact
Min
ima
l c
ap
ac
ity m
et
Va
cc
ine
: e
lig
ibil
ity f
or
PQ
1 2 3 4 5
Re-benchmarking Based on a risk management approach
Revision of indicators & benchmarking process
With or without a road map for prequalification of products
WHO support through: Global Learning Opportunities (GLO) Technical Support In-country training Networking Harmonization
WHO electronic platform to monitor NRAs information and benchmarking, IDP, training, etc.
CoRTE
CIP
Challenges
• 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
12/10/2017 27
Major challenges
Fact and figures GLOBAL OVERVIEW
12/10/2017 29
WHO NRA Assessment Visits: 1997
12/10/2017 30
WHO NRA Assessment Visits: 2014
12/10/2017 31
Countries targeted for WHO Regulatory System Strengthening Program 2016-2017:
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 25 September 2017)
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
Lao’s PDR
Lebanon
Mongolia
Kyrgyzstan
Syria
Korea
Bangladesh
Cambodia
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
WHO/EMP/RHT/RSS/ NRA assessment group
STRENGTHENING NATIONAL REGULATORY AUTHORITIES (NRA) TRAINING CONDUCTED, 1996-2017 8068 PARTICIPANTS FROM NRAs, NCLs*, EPI** AND/OR VM
8068 head counts have been trained by WHO between
1996 till Sept. 2017
GLO, 2306, 29%
InCountry, 4079, 50%
Meeting, 1232, 15%
Other, 392, 5%
Placement, 59, 1%
12/10/2017 33
WARD, Michael Coordinator, HQ/HIS/EMP/RHT/RSS
wardmi@who.int
KHADEM BROOJERDI, Alireza khadembroojerdia@who.int
BROWN, Laura Kay brownl@who.int
YAP, Maria Bernadette yapm@who.int
OSTAD ALI DEHAGHI, Razieh ostadalidehaghir@who.int
ALFONSO, Claudia alfonsoc@who.int
REFAAT, Mohamed refaatm@who.int
EL HEMSY, Samir M.A. Abdel Wahab awahabs@who.int
Ahmed Samy ahmedsamy_who@yahoo.com
Alaa Magdy alaamagdy.who@gmail.com
CRS Group
12/10/2017 34
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Thank you
Dr Alireza Khadem
Regulatory Systems Strengthening
Regulation of Medicines and Other Health Technologies
Essential Medicines and Health Products
World Health Organization (Geneva, Switzerland)
Office: +41 (0)22 791 2950
Email: rosskopfu@who.int