building capacity in countries to improve the regulation ......building capacity in countries to...
TRANSCRIPT
Building capacity in countries to improve the regulation of medical
products
Annual Technical Briefing Seminar Essential Medicines and Health Technologies
Dr Claudia P Alfonso Regulatory Systems Strengthening Team Regulation of Health Technologies Unit
Department of Essential Medicines and Health Products
20 October 2016, Geneva, Switzerland
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2 | WHO/EMP/RHT/RSS
Objective
– Build capacity for professional staff (mainly pharmacists) in the area of pharmaceuticals
Audience
– Ministry of Health, National Regulatory Authorities, WHO Regional and Country Offices, Collaborating Centres, Non-Governmental
Organizations, Academia, and others, from all continents
Expected outcome – By end of presentation, the audience became informed on the WHO
NRA capacity building model to improve in-country regulation of
medical products
Technical Briefing Seminar
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3 | WHO/EMP/RHT/RSS
Medical products shall refer to medicines, biologicals including vaccines, and medical devices including diagnostics
National regulatory authority (NRA) also called National Medicinal Regulatory Authority (NMRA) shall refer to the agency, institution or body authorized by law to exercise regulatory powers concerning the registration of, and other regulatory activities related to, medical products
Regulatory system shall refer to the combination of institutions, processes and the regulatory framework through which government controls particular aspects of an activity
Definitions
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4 | WHO/EMP/RHT/RSS
The global context
behind the WHO NRA
capacity building model to
improve in-country
regulation of medical
products
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5 | WHO/EMP/RHT/RSS
WHO Constitution*
“The States Parties to this Constitution declares …
The enjoyment of the highest attainable standard of health is one of the fundamental rights of
every human being without distinction of race, religion, political belief, economic or social
condition“
WHO Constitution, Chapter II – Functions, Article 2 (c)
* Adopted by the International Health Conference, 19 Jun-22 Jul 1946, New York. Signed by the representatives of 61 States on 22 Jul 1946. Entered into force on 7 Apr 1948
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6 | WHO/EMP/RHT/RSS
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7 | WHO/EMP/RHT/RSS
Alignment of EMP strategic direction, WHO reform, and WHA 67.20 on regulatory systems strengthening
WHO leadership priorities 2014-2019 (WHA66):
Advancing universal health coverage Health-related MDG Address challenges of non-
communicable diseases Implement international health
regulations Increased access to quality and
affordable medical products Social, economic and environmental
determinants of health
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At the request of Member States, WHO is 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; and,
Provide technical support to national regulatory authorities and governments
WHA
67.20
WHA 67.22
WHA
67.21
WHA 67.23
WHA
67.18 Others
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8 | WHO/EMP/RHT/RSS
Norms and standards
Capacity building in developing
countries Networks
Medical devices including
diagnostics ICDRA
WHO
PQ program
Health system
strengthening
International and regional
collaboration
Regulation of complex
biological
WHA Resolution 67.20 Regulatory Systems Strengthening
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9 | WHO/EMP/RHT/RSS
Achieve universal health coverage
(UHC), 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
Unifying purpose Sustainable development goal 3.8
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10 | WHO/EMP/RHT/RSS
GLOBAL OVERVIEW
Facts and figures
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11 | WHO/EMP/RHT/RSS
Current Status of National Regulatory Systems 194 WHO Member States
Fact
• ≈30% of NRA have limited capacity to perform core regulatory functions
• Applicants face a landscape of disparate regulations, frequent delays, and limited transparency
Result
• Fewer medicines are available in low-income countries than in the countries with well-regulated markets
• Cost of inefficient regulatory systems drives medicines price up
• Less prepared for public health emergencies i.e. Ebola, Zika, pandemic influenza
20% 50%
30% Developed
Variable
Limited
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12 | WHO/EMP/RHT/RSS
Vaccine producing
1990: 63 countries
2016: 43 countries
Vaccine demand increased, number of producing countries decreased 1990-2016
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13 | WHO/EMP/RHT/RSS
Number of WHO Member States according to vaccine source and regulatory functionality status as of May 2016
Vaccine source Functional Not
functional Grand Total
Domestic production 37 6 43
Direct procurement 20 28 48
UN agency 9 94 103
Grand Total 66 128 194
14 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
Regulatory capacity Countries sourcing vaccine from UN agencies (N = 14)
© World Health Organization 2014 14
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THE WHO REGULATORY CAPACITY BUILDING MODEL
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16 | WHO/EMP/RHT/RSS
The WHO five-step capacity building model for National Regulatory Authorities
Bench marking tool development
NRA assessments
Elaboration of
institutional development
plan (IDP)
Providing technical, training,
learning, and networking
support
Monitoring progress and
impact
Min
ima
l c
ap
ac
ity
me
t,
Va
cc
ine
s:
eli
gib
ilit
y f
or
PQ
1 2 3 4 5
Plan and conduct periodic assessments, re-assessments, and
self assessments
Periodic refinement and harmonization
of tools, indicators and
assessment process
Detailed plan of
action to sustain strengths and address gaps
IDP implementation
through technical expertise, global
learning opportunities, in-country training
Document NRA
information, assessment reports,
IDP, trainings, experts, impact,
others
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17 | WHO/EMP/RHT/RSS
BENCHMARKING
18 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
WHO Global Benchmarking Tool National Regulatory System and Functions
1. Regulatory System 2. Common Function 3. Non Common Functions
SYSTEM FUNCTION
INDICATORS
SUB-INDICATORS
GUIDANCE FOR ASSESSMENT Assessment Criteria + Standrad References + Evidences For Review
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
1. WHO Guidelines 2. Other Internationally recognized guidelines
(e.g. ISO standards) 3. Identified best practiced
19 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
WHO Global Benchmarking Tool Scoring System
SYSTEM
FUNCTION
INDICATORS
SUB-INDICATORS
GUIDANCE FOR ASSESSMENT Assessment Criteria + Standrad References + Evidences For Review
Yes
No
Partial
Not Applicable
No Available Info.
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20 | WHO/EMP/RHT/RSS
NRA ASSESSMENT
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21 | WHO/EMP/RHT/RSS
WHO NRA Benchmarking Policy Periodic assessments
22 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
WHO Global Benchmarking Tool
23 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
NRA assessment report
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INSTITUTIONAL DEVELOPMENT PLAN
25 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
Institutional Development Plan
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TECHNICAL SUPPORT
27 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
Gap analysis
• Assessment report
Institutional Development
Plan
• Recommendations and activities to sustain strengths and address gaps within cost estimate and time frame
Address gaps
• Targeted regulatory functions • Technical support • Learning/ training/ international
cooperation opportunities
Monitoring progress and
impact
• Follow-up visit to measure progress and impact
• Re-assessment to sustain PQ or NRA functionality until expected maturity is achieved
From gap analysis to building capacity
Global Learning
Opportunities
In-county workshops
One-site technical support
Placement, joint
reviews, twining
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
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28 | WHO/EMP/RHT/RSS
Regulatory capacity building Non-vaccine producing countries (N = 14)
© World Health Organization 2014 28
Regional and in-country QMS workshops; GRP guidelines
Product evaluation training, collaborative procedure workshops, regional harmonization, WHO guidelines
Overseas and in-country training on medical product safety and vigilance, ADR and AEFI monitoring and reporting guidelines
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29 | WHO/EMP/RHT/RSS
MONITORING PROGRESS AND IMPACT
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30 | WHO/EMP/RHT/RSS
WHO NRA Benchmarking Policy Periodic assessments
31 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
WHO technology transfer to establish influenza vaccine manufacturing capacity NRA assessment for vaccine pre- qualification
Measuring and showing impact
WHO
Region
Global Action Plan for
Influenza Vaccines
country*
NRA functional**
2006 2016
AFR South Africa 0 0
AMR Brazil, Mexico Brazil Brazil, Mexico
EMR Egypt, Islamic Rep. Iran 0 Egypt, Iran
EUR Serbia, Romania,
Kazakhstan 0 0
SEAR India, Indonesia, Thailand Indonesia, India India, Indonesia,
Thailand
WPR China, Rep. Korea, Viet
Nam Rep. Korea
China, Rep.
Korea, Vietnam
Total 4/14 (29%) 10/14 (71%)
*http://www.who.int/influenza_vaccines_plan/objectives/projects/en/index.html **Vaccine producing countries, http://workspace.who.int/sites/ATT/default.aspx
32 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
The WHO five-step capacity building model for National Regulatory Authorities
Bench marking tool
development
NRA assessments
Elaboration of institutional development
plan (IDP)
Providing technical, training,
learning, and networking
support
Monitoring progress and
impact
Acc
ep
tab
le c
apa
city
me
t, V
acci
ne
s:
elig
ibili
ty f
or
PQ
1 2 3 4 5
Plan and conduct periodic assessments, re-assessments, and
self assessments
Periodic refinement and harmonization
of tools, indicators and
assessment process
Detailed plan of
action to sustain strengths and address gaps
IDP implementation
through technical expertise, global
learning opportunities, in-country training
Document NRA
information, assessment reports,
IDP, trainings, experts, impact,
others
33 | WHO/EMP/RHT/RSS/Capacity Building and Country Cooperation Group
• How many and which steps does the WHO regulatory capacity building model have?
• What medical products as well as common and uncommon functions can be assessed using the WHO Global benchmarking tool?
• How often should an NRA be benchmarked?
• For what does IDP stand?
• What support does WHO provide for IDP implementation?
• How long should investment by all partners be sustained to see impact?
Quick quiz on the WHO NRA capacity building model to improve in-country regulation of medical products
Gracias