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Drug Regulatory Systems Strengthening (RSS)
WHO Technical Briefing Seminar on Essential Medicines and Health Products
31 October 2013WHO Headquarters, Geneva, Salle M 505
Dr Claudia P Alfonso
Drug Regulatory Systems Strengthening (RSS)
WHO Technical Briefing Seminar on Essential Medicines and Health Products
31 October 2013WHO Headquarters, Geneva, Salle M 505
Dr Claudia P Alfonso
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OutlineOutlineGlobal overview of vaccine production and immunization
The WHO Regulatory Systems Strengthening (RSS) Programme and the five-step capacity building model
Assessments of national regulatory authorities (NRA) and harmonized tool development
NRA Institutional Development Plans (IDP)
Link between WHO Prequalification and NRA assessment
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Global initiatives: coalition to support immunizationGlobal initiatives: coalition to support immunization
WHO Expert Committee on Biological Standardization (ECBS)
Smallpox eradication
Polio eradication
Measles elimination
Global Immunization Vaccine Strategy
Decade of vaccines (DoV)
Global Alliance for Vaccine & Immunization (GAVI)
UN Millennium Development Goals (MDGs)
WHO reform
WHOVaccine prequalification (PQ)
Universal Child Immunization (UCI) -1990
1947
1959 1980
19881987
1990
1999
2000
2006
2000
20102011
20202015
2015IFFImInternational Finance Facility
For Immunization
2006
Expanded Programme on Immunization - 1974
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Global challengesGlobal challenges1. Demand for more vaccines
2. Raise of public awareness about vaccines
3. New standards promoted by WHO
4. Anticipate new needs for regulation vaccines
5. Quality control systems established in countries need increased investment to be sustained
6. Domestic production not consistent in volume and quality has difficulty to meet cGMP standards
7. Shift in vaccine market and increase segmentation
1. New initiatives and global coalition efforts: GAVI, DoV, influenza, polio eradication, measles immunization, introduction of new vaccines, others
2. Public and media expectations increased through media, internet and social networks
3. Vaccine science requires new standards
4. Vaccines needs thorough regulations to address specificity
5. QC is more complex and expensive
6. Volume increasing and cGMP standards raising too
7. EPI vaccines are traditionally produced by developing countries while new vaccines are produced by developed countries.
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Vaccine producing1990 :63 countries1997 :52 countries
2012 :44 countries
Vaccine demand increases while number of producing countries decreases
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Major vaccine producing countries 1997-2012146 vaccine manufacturers, 95% global production in 16 countries
Brazil
ChinaUSA
Senegal
Indonesia
India
Russia
France
Belgium
Italy
Canada
Japan
Korea
Denmark
Cuba
Developing countries
Bulgaria
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12 Developing countries with emerging vaccine production or high potential
to account for 80-70% of the global production
Brazil
China
Mexico Senegal
Indonesia
IndiaViet Nam
Russia
IranEgypt
Cuba
Largest volume production
Bulgaria
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UNICEF purchases 40% of global volume of vaccine doses mainly EPI vaccines which represents only 5% of market value
40%
5%
Global Volume of Doses Global Value of Doses
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Vaccines are different from drugsVaccines are different from drugs
Biological products (Variation)
Heat sensitive (Cold chain)
Sensitive to light and freezing
Limited shelf life
Mandated by public health programme (EPI or NIP)
Targeted to healthy children and mothers
Given for prevention - recipient cannot judge treatment
Pennies per dose, new vaccines are more expensive
Limited number of products and manufacturers
Given once or only a few times
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WHO Prequalification PrincipalsWHO Prequalification Principals
Reliance on NRAs
General understanding of the product – presentations offered – production process – quality control methods – quality system in place – clinical data relevant to the target population
Assurance of production consistency through compliance with GMP
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WHO DEFINITION OF VACCINES OF ASSURED QUALITY
WHO DEFINITION OF VACCINES OF ASSURED QUALITY
The National Regulatory Authority (NRA) is able to regulate independently vaccines against standards of quality, safety and efficacy (QSE) in accordance with the WHO recommended functions defined by WHO, and
There are no unresolved confirmed reports of quality-related problems.
Ensuring vaccine quality for use in national immunization programmes: concept evolution
AssessmentTraining Technical support
MonitoringProgress
ImpactBenchmarking
Regulatory Systems Strengthening 60 functional NRAs, 80% of all producing countries, 97% vaccines of assured quality
1996 1997 1997 1998 2004 2011
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WHO NRA Five-Step Capacity Building Model
WHO NRA Five-Step Capacity Building Model
Bench Marking
Development of NRA assessment
tool
Assessment of NRA
Development of Institutional
Development Plan (IDP)
Providing technical support, Training/Learning
, networking,
Monitoring progress and
impact
Fu
nc
tio
na
l NR
A
1 2 3 4 5
Revised indicators (2-3 years)
Re-assessmentEvery 2-5 years
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Laboratory access
Laboratory access
Regulatory inspections
Regulatory inspections
Authorization clinical trials (Ethical review process, compliance against GLP, GMP, GCP)
Authorization clinical trials (Ethical review process, compliance against GLP, GMP, GCP)
Pre-marketing phasePre-marketing phase Post Marketing phasePost Marketing phase
Post marketingAEFIsurveillance
Post marketingAEFIsurveillance
Lot releaseLot release
Market distribution
QualityQuality
SafetySafety
EfficacyEfficacy
ProductEvaluation
ProductEvaluation
Licensingfacility
Licensingfacility
ApplicationApplication
Licensing/Registration=evaluation process
Applicants Dossier(manufacturer ordistributor)
Applicants Dossier(manufacturer ordistributor)
Marketing AuthorizationMarketing Authorization
Vaccine regulatory processVaccine regulatory process
InspectionsInspections
testing
testing
monitoring
Regulatory function to implement
Vaccine source
UN agency Procure Produce
Regulatory system (RS) √ √ √
Marketing authorization and licensing (MA) √ √ √
Pharmaco-vigilance (PV) including AEFI monitoring
√ √ √
Lot release (LR) Undertaken by WHO on behalf of UN agencies or producing countries
√ √
Laboratory access (LA) √ √
Regulatory inspections (RI)
Undertaken by the
producing country
√
Oversight or clinical trials (CT) √
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Chronology of indicators in the WHO NRA assessment tool for vaccines
NRA ASSESSMENT TOOLS: 1999, 2001, 2002, 2004 & 2007Progress of the number of total & critical indicators and sub-indicators
54 53 51
32 38
45
173164
173
183 181
128
616354
4* 4*
88**
70**
0
20
40
60
80
100
120
140
160
180
200
1999 2001 2002 2004 2007 2011
NRA assessment tools
Total indicators Total critical indicators Total sub-indicators Total critical sub-indicators
*Critical but not for Pre-qualification (PQ)**Critical as required for vaccine PQ
18 |National Regulatory System, Status of vaccine indicators
Harmonized tool: regulatory functionsHarmonized tool: regulatory functions
1. NATIONAL REGULATORY SYSTEM2. REGISTRATION AND MARKETING AUTHORIZATION3. LICENSING ACTIVITIES4. POST-MARKETING SURVEILLANCE (+ LOT RELEASE FUNCTION)5. OVERSIGHT OF CLINICAL TRIALS6. INSPECTIONS AND ENFORCEMENT ACTIVITIES7. LABORATORY ACCESS AND TESTING8. VIGILANCE AND RISK MANAGEMENT9. CONTROL OF PROMOTION AND ADVERTISING10. CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS11. PHARMACEUTICAL PERSONNEL
19 |National Regulatory System, Status of vaccine indicators
PAHO TOOL MEDICINES TOOL MEDICAL DEVICES & DIAGNOSTICS
VACCINES TOOL WHO-PAHO HARMONIZED TOOL
1. SISTEMA NACIONAL DE REGULACIÓN
Module 2 - NATIONAL REGULATORY SYSTEM
NRS: NATIONAL REGULATORY SYSTEM
RS: NATIONAL REGULATORY SYSTEM
1.NATIONAL REGULATORY SYSTEM
2. AUTORIDAD REGULADORA NACIONAL
Module 3 - NATIONAL REGULATORY AUTHORITY
3. REGISTRO SANITARIO Module 4 - MARKETING AUTHORIZATION
MA: MARKETING AUTHORIZATION (MA) FOR MEDICAL DEVICES AND DIAGNOSTICS
FUNCTION 1: MARKETING AUTHORIZATION AND LICENSING ACTIVITIES
2.REGISTRATION AND MARKETING AUTHORIZATION
4. LICENCIAMIENTO DE PRODUCTORES
Module 5 - LICENSING OF MANUFACTURERS
LI: LICENSING OF MANUFACTURERS, IMPORTERS, DISTRIBUTERS AND RETAILERS OF MEDICAL DEVICES AND DIAGNOSTICS
3.LICENSING ACTIVITIES
Module 6 - LICENSING OF IMPORTERS, EXPORTERS, WHOLESALERS AND DISTRIBUTORS
Module 7 - LICENSING OF PHARMACIES AND RETAIL OUTLETS
Module 8 - REGISTRATION OF PHARMACY PERSONNEL
11.PHARMACEUTICAL PERSONNEL (HEALTH/REGULATORY??)
Regulatory functions: former and harmonized tool
20 |National Regulatory System, Status of vaccine indicators
PAHO TOOL MEDICINES TOOL MEDICAL DEVICES & DIAGNOSTICS
VACCINES TOOL WHO-PAHO HARMONIZED TOOL
5. VIGILANCIA DEL MERCADO Module 9 - POST-MARKETING SURVEILLANCE AND CONTROLS
PMS: POST- MARKETING SURVEILLANCE
FUNCTION 2: POST-MARKETING ACTIVITIES INCLUDING SURVEILLANCE OF ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI)
4.POST-MARKETING SURVEILLANCE (includes vaccine lot release function)
6. FARMACOVIGILANCIA Module 11 - PHARMACOVIGILANCE
VR: VIGILANCE AD RISK MANAGEMENT ACTIVITIES ON MEDICAL DEVICES AND DIAGNOSTICS
8.VIGILANCE AND RISK MANAGEMENT
Module 10 - CONTROL OF MEDICINES PROMOTION AND ADVERTISING
PR: CONTROL OF PROMOTION AND ADVERTISSEMENT FOR HEALTH PRODUCTS
9.CONTROL OF PROMOTION AND ADVERTISING
7. CONTROL DE ENSAYOS CLÍNICOS
Module 12 - CLINICAL TRIALS CT: OVERSIGHT OF CLINICAL TRIALS on IVDs and MD
FUNCTION 6: REGULATORY OVERSIGHT OF CLINICAL TRIALS
5.OVERSIGHT OF CLINICAL TRIALS
8. INSPECCIONES REGULADORAS Y ACTIVIDADES DE FISCALIZACION
Module 13 - REGULATORY INSPECTIONS AND ENFORCEMENT ACTIVITIES
IE: INSPECTIONS AND ENFORCEMENT ACTIVITIES
FUNCTION 5: REGULATORY INSPECTIONS
6.INSPECTIONS AND ENFORCEMENT ACTIVITIES
9. LABORATORIO NACIONAL DE CONTROL DE CALIDAD
Module 14 - QUALITY CONTROL LABORATORY
LABORATORY ACCESS AND TESTING
FUNCTION 4: LABORATORY ACCESS
7.LABORATORY ACCESS AND TESTING
FUNCTION 3: NRA LOT RELEASE
Module 15 - CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS
10.CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS
Module 16 - INTERNATIONAL COOPERATION AND HARMONIZATION
Regulatory functions: former and harmonized tool
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2013 NRA STATUS PER WHO REGIONGrand Total Not functional Functional
46 41 5 AFR
35 31 4 AMR
22 15 7 EMR
53 20 33 EUR
11 7 4 SEAR
27 20 7 WPR
194 134 60 Grand Total
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GRACIASMERCI