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

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Outline

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


Outline

Outline

  • Global 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


Global initiatives coalition to support immunization

Global initiatives: coalition to support immunization

Decade of vaccines (DoV)

2020

WHO reform

2015

2011

2010

Global Immunization Vaccine Strategy

2000

2006

2015

2006

Measles

elimination

IFFIm

International Finance Facility

For Immunization

UN Millennium Development Goals

(MDGs)

2000

Global Alliance for

Vaccine & Immunization (GAVI)

1999

Polio eradication

1988

WHO

Vaccine prequalification (PQ)

1987

Universal Child Immunization (UCI) -1990

Smallpox

eradication

1959

1980

1990

Expanded Programme on Immunization - 1974

WHO Expert Committee on Biological Standardization (ECBS)

1947


Global challenges

Global challenges

Demand for more vaccines

Raise of public awareness about vaccines

New standards promoted by WHO

Anticipate new needs for regulation vaccines

Quality control systems established in countries need increased investment to be sustained

Domestic 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.


Outline

Vaccine demand increases while number of producing countries decreases

Vaccine producing

1990: 63 countries

1997: 52 countries

2012: 44 countries


Outline

Major vaccine producing countries 1997-2012

146 vaccine manufacturers, 95% global production in 16 countries

Denmark

Russia

Belgium

Canada

Bulgaria

France

Italy

China

USA

Japan

Cuba

Korea

India

Senegal

Indonesia

Brazil

Developing countries


Outline

12 Developing countries

with emerging vaccine production or high potential

to account for 80-70% of the global production

Russia

Bulgaria

China

Iran

Egypt

Cuba

Viet Nam

India

Mexico

Senegal

Indonesia

Brazil

Largest volume production


Outline

UNICEF purchases 40% of global volume of vaccine doses mainly EPI vaccines which represents only 5% of market value

Global Volume of Doses

Global Value of Doses

40%

5%


Vaccines are different from drugs

Vaccines 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


Who prequalification principals

WHO 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


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

Ensuring vaccine quality for use in national immunization programmes: concept evolution

Training

Benchmarking

Assessment

Impact

Technical

support

Monitoring

Progress

1996 1997 1997 1998 2004 2011

Regulatory Systems Strengthening

60 functional NRAs, 80% of all producing countries, 97% vaccines of assured quality


Who nra five step capacity building model

WHO NRA Five-Step Capacity Building Model

Functional NRA

2

1

5

3

4

Revised indicators (2-3 years)

Re-assessment

Every 2-5 years


Vaccine regulatory process

Vaccine regulatory process

Applicants Dossier

(manufacturer or

distributor)

Pre-marketing phase

Post Marketing phase

Market distribution

Licensing/Registration=evaluation process

Product

Evaluation

Post marketing

AEFI

surveillance

Lot release

testing

Application

testing

Laboratory

access

Regulatory

inspections

Licensing

facility

Quality

Inspections

Safety

monitoring

Authorization clinical trials

(Ethical review process, compliance against GLP, GMP, GCP)

Efficacy

Marketing Authorization


Chronology of indicators in the who nra assessment tool for vaccines

Chronology of indicators in the WHO NRA assessment tool for vaccines


Harmonized tool regulatory functions

Harmonized tool: regulatory functions

1. NATIONAL REGULATORY SYSTEM

2. REGISTRATION AND MARKETING AUTHORIZATION

3. LICENSING ACTIVITIES

4. POST-MARKETING SURVEILLANCE (+ LOT RELEASE FUNCTION)

5. OVERSIGHT OF CLINICAL TRIALS

6. INSPECTIONS AND ENFORCEMENT ACTIVITIES

7. LABORATORY ACCESS AND TESTING

8. VIGILANCE AND RISK MANAGEMENT

9. CONTROL OF PROMOTION AND ADVERTISING

10. CONTROL OF NARCOTICS, PSYCHOTROPIC SUBSTANCES AND PRECURSORS

11. PHARMACEUTICAL PERSONNEL


Outline

Regulatory functions: former and harmonized tool


Outline

Regulatory functions: former and harmonized tool


2013 nra status per who region

2013 NRA STATUS PER WHO REGION


Outline

GRACIAS

MERCI


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