Vaccine Production and Regulation

Dr Houda LANGARDr Houda LANGAR

Essential Vaccines and Biologicals PolicyDepartment of Health Systems & Services Development

Capacity Development Workshop on Health System DevelopmentTehran, Islamic Republic of Iran, July 11-14, 2010

Essential Vaccines and Biologicals PolicyDepartment of Health Systems & Services Development

Capacity Development Workshop on Health System DevelopmentTehran, Islamic Republic of Iran, July 11-14, 2010

Introduction• Important tool in diseaseprevention program• A main technology input inhealth system• Issues of availability ofvaccines in the Region.

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• Issues of accessibility tovaccines with assured qualityand affordable pricesespecially for low middle andmiddle income countries.• Potentials for vaccine self-sufficiency in EMR

WHO’s Goal

• Assured quality for 100% of vaccinesused in all national immunization program

• Definition of assured quality: ECBS andrecommendations on safety, efficacy and quality in WHO

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eco e da o s o sa e y, e cacy a d qua y OTRS):� National Regulatory Authority independent� National Regulatory Authority functional,� Non unresolved reported problem with vaccine

Strategy to improve vaccine quality

• Strengthening the National Regulatory Authority in eachcountry� Priority 1: vaccine producing countries� Priority 2: vaccine self-procuring countries� P i it 3 t i d th h UN i� Priority 3: countries procured through UN agencies

• Improving the vaccine production to reach theprequalification status of the vaccines

• Ensuring a vaccine self-sufficiency production

Why an efficient NationalRegulatory Authority?

• Biologicals and complex products• Vaccines used for prophylactic purposes on

healthy population• Ensure the quality, efficacy and safety of vaccines

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Ensure the quality, efficacy and safety of vaccines• Knowing all kind of vaccines circulating in the

country and all lots marketed• Knowing the specifications of vaccines• AEFI causality assessment

Role of NRA

• Ensure that vaccines released for use areevaluated properly and meet internationalstandards: safety, efficacy and quality

• Covering a cycle starting from vaccinedevelopment until the administration of the

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vaccine as well as after immunization• Define scientific documentation and criteria for

licensing• Issue, vary, suspend or withdraw licenses for

vaccines on the basis of quality, safety andefficacy of vaccines

Role of NRA (Cont’d)

• Continually oversee the quality of vaccines byreleasing each lot intended for use in the country

• Monitor the impact of vaccines in use through a wellfunctioning surveillance system for safety andquality

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• Regulatory role in the procurement andmanagement processes and practices of use

• Regular review of standardization and control ofvaccines according to the current state of scienceand technology

Key elements for an efficient NRA

• Government commitment• Legal basis• National Policy/strategy for regulation and control• Independence, competency, objectivity,

impartiality, transparency & integrity

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• Effective Quality Management System: organization,responsibilities, communication, long term visionand strategic plan, skilled & qualified humanresources and sustainable financial resources,documentary system (quality manual, procedures,records), tools, monitoring and evaluation

National Regulatory Functions& vaccine supply source

Source of vaccinesRegulatory functionsProduceProcureUN agency

���Regulatory system

���MarketingAuthorization/Licensing

���Post marketingill /AEFI

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surveillance/AEFI

��Functionsundertaken inproducingcountries

Lot release

��Laboratory access

�Regulatory inspections

In countries that conduct clinical trialsAuthorization/Approval of CT

WHO Process to evaluateperformance of regulatory system

NRA assessment using tools5 d t

NRA Network of regulatory experts

Planning to address gaps

Benchmarking

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Follow - up visit

5 day assessment

GTN placementwithin 1-3 months

15-24 months(6-8 months in needsmuch improvement)

to address gaps

Institutional Development Plan

Training & Technical assistance

What is WHO Prequalification?• A service provided to UN purchasing agencies.• Provide Independent opinion/ advice on the

quality, safety and efficacy of vaccines forpurchase

• Ensure that candidate vaccines are suitable for• Ensure that candidate vaccines are suitable forthe target population and meet the needs of theprogramme

• Ensure continuing compliance withspecifications and established standards ofquality

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Prequalification process

Review ofProduct

Summary File

Testing ofConsistency

lots

Visit tomanufacturing

facilities

Consultationwith NRA

Satisfactorily completed

Pre-requisite: Reliance on NRA

Evaluation ofClinical data

Vaccine pre-qualified: accepted for supply to UN agenciesand posted on the Web list of WHO prequalified vaccines athttp://www.who.int/vaccines-access/quality/un_prequalified/prequalvaccinesproducers.html

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Why is it recommended to useWHO prequalified vaccines ?

• ASSURED QUALITY: Effective andreliable NRA

• Evaluated by WHO

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y� Initial evaluation� Regular reassessment� Continuous monitoring by WHO

Vaccine production situation in EMR

� Few types of mainly traditional vaccines:• EGY: TT, DT, dT, DTP, Cholera, Typhoid,• IRA: PI (BCG- Hep B- Cholera & Typhoid); RAZI

Institute (TT, DT, dT, DTP, Measles, Rubella,MMR, OPV, Rab)

• PAK: NIH (TT, Cholera, Typhoid, Rab), AmsonCompany (TT, Hep B, from bulk received fromother manufactures)

• TUN: IPT (BCG)�No WHO prequalified vaccines

Status of the Vaccine NRA in Iran(2000-2010)

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• 5 formal assessments in 1997, 2002, 2004, 2006 & 2010 and 6 follow-upvisits in 1998, 1999, 2000,2005, 2007 & 2009• May 2010: NRA functional

50RS: regulatory systemMA: marketingauthorizationPMS: post-marketingsurveillanceLR: lot releaseLA: laboratory accessRI: regulatory inspectionCT: clinical trials

Issues in the regulatory systems

• Governance issue: lack of policies, unclear orweak legal basis for authority, issue ofindependence

• Weak or limited quality management system:roles and responsibilities not well defined lackroles and responsibilities not well defined, lackof organization and communication, lack oflong term vision and strategic plan, limitedhuman and financial resources

• Misunderstanding of the regulatory system

Issues in vaccine production• No GMP compliance• Weak quality management system• Weak or no process control in some

critical steps of the production and thet lcontrol

• No vaccine security and no vaccine self-sufficiency: vaccine supply, affordability ofprice, assured quality, response toemerging pandemic situation

Way Forward

• Mapping vaccine regulatory system in EMRcountries

• WHO technical support for strengthening theNRAs

• Regional technical committee for evaluation ofi

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vaccines• Regional network for lot release of vaccines• Global network for Post-marketing surveillance:

Iran, Tun• Vaccine self-sufficiency (strengthening vaccine

production, pooled vaccine procurement)

Thank you

Essential Vaccines and Biologicals Policy Unit,World Health Organization, Eastern Mediterranean Regional Office,

Abdul Razzak Al Sanhouri Street, P.O.Box 7608, Nasr City (11371), Cairo, Egypt