vaccine production and regulation - bums.ac.ir salamat/vac.iran.pdf · vaccine production and...
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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
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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
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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
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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
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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
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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
i ll ft i i ti
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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
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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
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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
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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
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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
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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
y p
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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
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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
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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
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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
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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
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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)
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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