fch/ivb/qss, lahouari belgharbi global & regional overview on the who programme on strengthening...

FCH/IVB/QSS, Lahouari Belgharbi

Global & Regional overview on the

WHO Programme on Strengthening

National Regulatory Authority (NRAs)

Global & Regional overview on the

WHO Programme on Strengthening

National Regulatory Authority (NRAs)

19th ACCSQ-PPWG meeting2-6 July 2012, Bangkok, Thailand

19th ACCSQ-PPWG meeting2-6 July 2012, Bangkok, Thailand

Lahouari Belgharbi, Scientist, WHO HQ, Geneva

Vaccines

FCH/IVB/QSS, Lahouari Belgharbi Vaccine Development Pipeline

1960 1980 2000// //Diphtheria

Pertussis

Tetanus

YF Influenza

Polio

Measles

JE RubellaHepB

Hib (conj)

Typhoid

CholeraPneumo (conj)

RotavirusHPVMening (conj)

Dengue

MalariaTB

HIV/AIDS

Traditional Expanded Program on Immunization

Underutilized Vaccines

Future

The Vaccine PipelineThe Vaccine Pipeline


เงิ�นลงิทุ�น WHO USD 1.9 billion immunization (2006-2011)

เงิ�นลงิทุ�น WHO USD 1.9 billion immunization (2006-2011)

Vaccine producing1990 :63 countries2010 :44 countries

Vaccine demand increases While producing countries decreased


Pays producteurs de vaccins

1990 :63 countries2010 :44 countries

Majors vaccines producing countriesChina……………..23%India......………….30%Indonesia………..10%S.Korea……..…....5%Brazil……………....3%Bulgaria……………5%France……………..8%Russia……………..2%Italy………………..3%Belgium…………...5%

Other countries….5% Thai ….X.....%

4 ASIAN countries account for 68% of global vaccine production


The UNICEF : buying 40% of the global volume of vaccine doses, mainly EPI vaccines, but representing only 5% of market value

The UNICEF : buying 40% of the global volume of vaccine doses, mainly EPI vaccines, but representing only 5% of market value

40%5%

Volume Value

Global EPI Vaccines:(1 )Diphtheria )2( Tetanus )3( Pertussis )Whooping cough(

)4( Poliomyelitis )5( TB )6( Measles and )7( Hepatitis B


Vaccine producers in the market (source: Mercer study to GAVI, 2002)

Vaccine producers in the market (source: Mercer study to GAVI, 2002)

US multinationals

Europeanmultinationals

OECDlocals

Emerging suppliers

Developing country

local

Product range

Narrow Broad Narrow Narrow-Moderate

Narrow

Scale Low High Low Moderate-High Low-High

Customer focus

Mostly high income

All buyer segments

Mostly in country

In country and other low moderate income buyers

All in country

R&D activity High High Low Low-Moderate Low

Producers Merck, Wyeth Sanofi-Pasteur (France), GSK (Belgium), Chiron (Italy)

SSI (Denmark), CSL (Australia), Powderject

SII (India), Biofarma (Indonesia), Green Cross (Rep.Korea)

State owned producers: China, Egypt, Mexico, Vietnam, Thailand


การวางิแผนงิานเพื่��อ Global challenges


1.Specificity of Biologicals to be addressed in most pharmaceutical regulation to anticipate regulatory requirements to ease vaccine introduction

2.Use of existing technical/scientific guidelines rather than producing new one that increase duplication and insistencies among member states

3.Demand for vaccines increased due to new initiatives and global coalition efforts

4.Public awareness about vaccines safety, quality and efficacy is increasing through media and internet and social networks.




5. Implementation and enforcement of standards promoted by developed countries may reduce capacity of developed countries

6. Quality control systems established in countries need increased investment and sustainable support to be able to meet new demand on vaccine testing.

7. Domestic production in developing countries not consistent in volume and quality.

8. Shift in vaccine market and increase segmentation.


How quality of vaccines is met? WHO Standards: GMP ASEAN PIC/S

Vaccine regulation…


Quality Efficacy Safety

1 .License facility to manufacture vaccines

2 .Enforce Good Manufacturing Practices (GMP)

3 .Enforce and monitor recall procedure

4 .Investigate complaints

1 .Authorize clinical trials (CT)-Review of CT against national regulations

-Ethical review, GLP, GCP, GMP.2 .Providing input (epidemiology and bio-

statistic) to ensure highest standards of CT method.

3 .Involve product expert in reviewing CTStop or suspend CT if not meeting national regulations

4 .Ensure that any AEFI occurring during CT is fully documented and reported

What NRA does to safeguard National Immunization

Laboratory access

Laboratory access

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 Authorization (M.A.)

Marketing Authorization (M.A.)

Vaccine regulatory processVaccine regulatory process

InspectionsInspections

testing

testing

monitoring


Source of vaccines

UN agencyUN agency ProcureProcure ProduceProduce

PRIORITIES FOR IMPLEMENTATIONto ensure that all EPI vaccines are

of assured quality

Reg

ula

tory

fu

ncti

on

s

Regulatory functions

CTs : Clinical trials, UN: United Nations, AEFI: Adverse Events Following Immunization

Marketing Autorization & Licensing activities

Laboratory access


Lot release

Authorization & monitoring of CTs

Postmarketing: AEFI

Regulatory system

for countries that conduct clinical trials

Functionsundertakenin producing Countries with functional NRA

Sources of Vaccines ?Sources of Vaccines ?

India30%

Belgium16%

France12%

Brazil7%

Indonesia7%

Italy4%

USA4%

Mexico2%

Other18%

Belgium16%

France14%

Mexico8%

India7%

Brazil4%

Italy2%

Korea Rep.2%

Other11%

USA36%

Vaccine Sources (Relative % of Doses)

Vaccine Sources (Relative % in US$)

5.5 Bn doses of vaccines(2003-2004)

13.6 Bn US$ of vaccines(2003-2004)

For 158 WHO Member States (excl. China)

Context: Emerging economies are becoming a major actor of the vaccine market

Context: Emerging economies are becoming a major actor of the vaccine market

% Share by volume % Share by value

*2011 – 2012 Data based on awards already made

Developing countries

Industrialized countries

50


Developing countries with emerging vaccine production or high potential

to account for 80-70% of the global production

Brazil

South Africa

China

Mexico Senegal

Indonesia

IndiaViet Nam

Russia

SerbiaIran

EgyptCuba

Countries with WHO prequalified vaccines


Potential Collaboration

between ASEAN/PPWG

and WHO in the area of Vaccine

Regulation2012

Potential Collaboration

between ASEAN/PPWG

and WHO in the area of Vaccine

Regulation2012

PIC/S vs NRA Registration


Activities planned and supported by WHO and partners institutions

Areas of cooperation

between NRAs

Themes

Good Regulatory Practices (GRP), guidance on legislation and regulations, international assessment of NRAs, Quality management system,

Regulatory framework 1

E-learning, twining with foreign institutions, exchange programme, in country training, technical support, Observed and coach GMP audits

Capacity building to strengthen regulatory systems

2

Use of CTD, promote e-governance, exchange and sharing assessment reports, parallel review, observed and coached audits, memorandum of cooperation, address duplication of scientific assessments to reduce burden and costs, and speed up regulatory decision.

Harmonization of regulatory initiatives, standards, and sharing of information

3

Strategic NRA forum, NRA regional alliance, nter-country meeting, NRA assessment indicators meeting, network of regional references laboratories, DCVNM, GAVCS, ECBS, ICDRA.

International and regional coordination and networking

4

1st WHO NRA strategic forum, 3-5 May 2011, Bangkok.



Areas of cooperation

between NRAs

Themes

Increase exchange with industry to address duplication, redundancy of process, bureaucracy, cost increase and ensure fair treatment and competition among applicants.

Consultation with industry

5

Coordination of international and bilateral cooperation support strategic areas and enhance government commitment to support regulatory agencies

Consultation with donors and technical agencies or stakeholders

6

Publication of success stories, best practices to promote Good Regulatory Practices (GRP), exchange programme and building in country learning capacity

Advocacy and Communication

7

Coordination and mapping of international and bilateral aid to enhance support to strategic areas and priorities activities

Resource mobilization and coordination

8

1st WHO NRA strategic forum, 3-5 May 2011, Bangkok.


WHO support to vaccine evaluation for marketing authorisation of dengue vaccine

WHO support to vaccine evaluation for marketing authorisation of dengue vaccine

Planning

Agreement with NRAs & Manufacturers

Selection of NRAsMentors/mentorees

Development of training material

Product evaluation

Marketing Authorisation

2012 2013 2013 2014-15



Areas of cooperation between NRAs

Themes

Dengue, bottlenecks in vaccine regulation, CTD Consultation with industry

5

Support to vaccine producing countries (developing and middle income): China, India, Thailand, Viet Nam, Indonesia through Functional NRAs (Australia, China, Japan and S.Korea)

Consultation with donors and technical agencies or stakeholders

6

WHO book to be published in early 2014 to document Global coalition efforts to ensure vaccine quality through NRAs, Global NRA strategic plan, Posters on NRAs, Publication of success stories articles from India, Thailand, Indonesia, China and Viet Nam, WHO NRA country profile

Advocacy and Communication

7

Coordination with BMGF; GAVI and bilateral aid (Korea, Japan and Australia) to support ASEAN developing countries to strengthen their NRAs. Plan to involve ADB, UNICEF, and other partners.

Resource mobilization and coordination

8

World Health Organisation : Areas of cooperation2012-2013.


How to move forward to develop capacity building activities in ASEAN member states


Organise a cooperation meeting with WHO to :1. Discuss the integration plan of NRA institutional

Development Plan (IDP) into the ASEAN agenda ‘s capacity building programme,

2. Map all capacity building activities such as :

1. Governance including Legal framework, institutional regulation and technical guidelines development,

2. Learning and training activities3. E-governance4. Internal expertise in product evaluation, clinical trial, inspections,

regulatory oversight, pharmacovigilance, testing, advocacy, communication, economic of regulation, performance indicators development,




Organise a cooperation meeting with WHO to :3. Develop a joint workplan to address implementation

including planning, technical support and financial support through:

1. Recruitment of expert to map the current activities in both organization (WHO and ASEAN) and to provide a report for discussion of the coordination workplan,

2. Publish a report and an biennium workplan that detailed activities: planned, responsibilities, performance indicators, milestones, reporting and update mechanisms including accountability framework , estimated budget, technical support and fundraising needs.

3. Develop and publish joint report (WHO and ASEAN) to document the progress and impact to WHO and ASEAN relevant meetings


19th ACCSQ-PPWG Meeting2-6 July 2012, Bangkok,

Thailand

ได้�ร�บทุ��จะน�าเร��องิ Vaccine มา

เตร�ยมการ (ACTD) ใน

ASEAN ยาแผนปั!จจ�บ�น

Thank you

19th ACCSQ-PPWG Meeting2-6 July 2012, Bangkok,

Thailand

ได้�ร�บทุ��จะน�าเร��องิ Vaccine มา

เตร�ยมการ (ACTD) ใน

ASEAN ยาแผนปั!จจ�บ�น

Thank you

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