Presentation on theme: "Drug Regulatory Systems Strengthening (RSS)"— Presentation transcript
Slide1
Drug Regulatory Systems Strengthening (RSS)WHO Technical Briefing Seminar on Essential Medicines and Health Products31 October 2013WHO Headquarters, Geneva, Salle M 505Dr Claudia P Alfonso Slide2
OutlineGlobal 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 Slide3Slide4
Global initiatives: coalition to support immunizationWHO Expert Committee on Biological Standardization (ECBS)Smallpox eradicationPolio eradication Measles eliminationGlobal Immunization Vaccine Strategy Decade of vaccines (DoV)Global Alliance for Vaccine & Immunization (GAVI)
UN Millennium Development Goals
(MDGs)
WHO reform
WHO
Vaccine prequalification (PQ)
Universal Child Immunization (UCI) -1990
1947
1959
1980
1988
1987
1990
1999
2000
2006
2000
2010
2011
2020
2015
2015
IFFIm
International Finance Facility
For Immunization
2006
Expanded Programme on Immunization - 1974Slide5
Global challengesDemand for more vaccinesRaise of public awareness about vaccines New standards promoted by WHOAnticipate new needs for regulation vaccinesQuality control systems established in countries need increased investment to be sustainedDomestic production not consistent in volume and quality has difficulty to meet cGMP standards Shift in vaccine market and increase segmentation
New initiatives and global coalition efforts: GAVI,
DoV
, influenza, polio eradication, measles immunization, introduction of new vaccines, others
Public and media expectations increased through media, internet and social networks
Vaccine science requires new standards
Vaccines needs thorough regulations to address specificity
QC is more complex and expensive
Volume increasing and cGMP standards raising too
EPI vaccines are traditionally produced by developing countries while new vaccines are produced by developed countries.Slide6
Vaccine producing1990: 63 countries1997: 52 countries 2012: 44 countries
Vaccine demand increases while number of producing countries decreasesSlide7
Major vaccine producing countries 1997-2012146 vaccine manufacturers, 95% global production in 16 countries
Brazil
China
USA
Senegal
Indonesia
India
Russia
France
Belgium
Italy
Canada
Japan
Korea
Denmark
Cuba
Developing countries
BulgariaSlide8
12 Developing countries with emerging vaccine production or high potentialto account for 80-70% of the global production
Brazil
China
Mexico
Senegal
Indonesia
India
Viet Nam
Russia
Iran
Egypt
Cuba
Largest volume production
BulgariaSlide9
UNICEF purchases 40% of global volume of vaccine doses mainly EPI vaccines which represents only 5% of market value40%5%
Global Volume of Doses
Global Value of DosesSlide10
Vaccines are different from drugsBiological products (Variation)Heat sensitive (Cold chain)Sensitive to light and freezingLimited shelf lifeMandated by public health programme (EPI or NIP)Targeted to healthy children and mothersGiven for prevention - recipient cannot judge treatmentPennies per dose, new vaccines are more expensiveLimited number of products and manufacturersGiven once or only a few timesSlide11
WHO Prequalification PrincipalsReliance 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 GMPSlide12
WHO DEFINITION OF VACCINES OF ASSURED QUALITYThe 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.Slide13
Ensuring vaccine quality for use in national immunization programmes: concept evolutionAssessmentTrainingTechnical supportMonitoringProgressImpactBenchmarking
Regulatory Systems Strengthening
60
functional NRAs,
80%
of all producing countries
,
97%
vaccines of assured quality
1996 1997 1997 1998 2004 2011Slide14
WHO NRA Five-Step Capacity Building Model Functional NRA12
3
4
5
Revised indicators (2-3 years)
Re-assessment
Every 2-5 yearsSlide15
Laboratory access
Regulatory
inspections
Authorization clinical trials
(Ethical review process, compliance against GLP, GMP, GCP)
Pre-marketing phase
Post Marketing phase
Post marketing
AEFI
surveillance
Lot release
Market distribution
Quality
Safety
Efficacy
Product
Evaluation
Licensing
facility
Application
Licensing/Registration=evaluation process
Applicants Dossier
(manufacturer or
distributor)
Marketing Authorization
Vaccine regulatory process
Inspections
testing
testing
monitoringSlide16
Regulatory function to implement Vaccine source UN agencyProcureProduceRegulatory 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)
√Slide17
Chronology of indicators in the WHO NRA assessment tool for vaccines Slide18
Harmonized tool: regulatory functions1. 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 Slide19
PAHO TOOLMEDICINES TOOLMEDICAL DEVICES & DIAGNOSTICSVACCINES TOOLWHO-PAHO HARMONIZED TOOL1. SISTEMA NACIONAL DE REGULACIÓN Module 2 - NATIONAL REGULATORY SYSTEMNRS: 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 toolSlide20
PAHO TOOLMEDICINES TOOLMEDICAL DEVICES & DIAGNOSTICSVACCINES TOOLWHO-PAHO HARMONIZED TOOL5. VIGILANCIA DEL MERCADOModule 9 - POST-MARKETING SURVEILLANCE AND CONTROLSPMS: POST- MARKETING SURVEILLANCEFUNCTION 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 MDFUNCTION 6: REGULATORY OVERSIGHT OF CLINICAL TRIALS 5.OVERSIGHT OF CLINICAL TRIALS
8. INSPECCIONES REGULADORAS Y ACTIVIDADES DE FISCALIZACIONModule 13 - REGULATORY INSPECTIONS AND ENFORCEMENT ACTIVITIESIE: INSPECTIONS AND ENFORCEMENT ACTIVITIESFUNCTION 5: REGULATORY INSPECTIONS 6.INSPECTIONS AND ENFORCEMENT ACTIVITIES9. LABORATORIO NACIONAL DE CONTROL DE CALIDADModule 14 - QUALITY CONTROL LABORATORY LABORATORY ACCESS AND TESTINGFUNCTION 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 toolSlide21Slide22
2013 NRA STATUS PER WHO REGIONGrand TotalNot functionalFunctional
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 TotalSlide23Slide24Slide25
GRACIASMERCI
