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Drug Regulatory Systems Strengthening (RSS)
Drug Regulatory Systems Strengthening (RSS)

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WHO Technical Briefing Seminar on Essential Medicines and Health Products 31 October 2013 WHO Headquarters Geneva Salle M 505 Dr Claudia P Alfonso Outline Global overview of vaccine production and immunization ID: 734934 Download Presentation

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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 Slide3
Slide4

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 toolSlide21
Slide22

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 TotalSlide23
Slide24
Slide25

GRACIASMERCI

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