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Ensuring quality, safety and efficacy of vaccines

World Health Organization (WHO) Pan American Health Organisation (PAHO). Ensuring quality, safety and efficacy of vaccines. Prequalification & assessment of National Regulatory Authority (NRA). Lahouari Belgharbi, (WHO/HQ) & Jose Pena , Eji Pons Machado (PAHO). World Health Organization.

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Ensuring quality, safety and efficacy of vaccines

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  1. World Health Organization (WHO) Pan American Health Organisation (PAHO) Ensuring quality, safety and efficacy of vaccines Prequalification & assessment of National Regulatory Authority (NRA) Lahouari Belgharbi, (WHO/HQ) & Jose Pena , Eji Pons Machado (PAHO) World Health Organization

  2. Outline • Overview of the findings • Findings for each function • Discussions on the findings and recommendations • Next steps following assessment

  3. Vaccine regulatory system, Brazil, October 2008 Organization & Institutions involved Ministry of Health State Level (VISA) ANVISA CEIVS INCQS PNI MAA & Licensing Lab.access Regulatory functions Lot release Oversight of Clinical trials Regulatory functions Regulatory inspections PMS/AEFIs Experts Group Experts Group Experts Group

  4. Vaccine regulatory system, Brazil, October 2008 Organization & Institutions involved Ministry of Health State Level (VISA) ANVISA CEIVS INCQS PNI MAA & Licensing Lab.access Lot release Oversight of Clinical trials Regulatory functions Regulatory inspections PMS/AEFIs Experts Group Experts Group Experts Group

  5. Brazil, Status of vaccine regulatory functions As of 17 October 2008 if no action taken Not applicable

  6. BRAZIL: National Regulatory system, Status of vaccine indicators, October , 2008All functions implemented if urgent action taken by 1st January 2009 Action urgently required to validate all functions as implemented Institution Score Year Regulatory system Monitor staff Qualifications& build internal expertise 86 % YES ANVISA 100% YES 1. MAA & licensing 100% YES 2. PMS & AEFI Regulatory functions 3. NRA Lot release 50% YES Enforce regulation ANVISA/INCQS 100% YES 4. Laboratory access Involved product experts & Monitor inspections/follow up YES 67% ANVISA /States 5 .Regulatory inspections 6. Auhtorisation/approval Of clinical trials 75% YES 6 Total FUNCTIONS ----->

  7. Presentation of the findings WHO assessment of the vaccine regulatory system 17 October 2008, Brasilia, Brazil , WHO Country office Vaccine regulatory system in "Country" 2.Postmarketing Surveillance including AEFI 1.Marketing authorisation & Licensing activities 3.NRA lot release 4.Laboratory access 5.Regulatory inspections 6.Authorisation /approval clinical trials

  8. Summary of recommendations • System functional: • System component is assessed as having a robust legal basis, vision and strategies integrated and coordinated to serve an unified national Health System • Synergies and institutional coordination with Ministry of Health • Quality management system: Long term and gradual approach integrated with Government plan however needs to speed up implementation of basics SOPS and guidelines in several critical areas (regulatory inspections, MAA/Licensing , Lot release and Oversight of Clinical trials) • Leadership and expertise: Management skilled and committed to develop an efficient regulatory system and open to external input/audits. However previous WHO recommendations were not implemented or lately implemented • Transparency & Communication: Important and gradual development of interaction with stakeholders and public

  9. Summary of recommendations • Coordination: Routine coordination and consultation among States and Federal Agencies before regulations are issued and enforced • Transparency & Ethics: Published information about decisions and code of Ethics enforced • Effectiveness: Central coordination of regulatory policy and decentralisation of activities however state level needs special attention in the area of regulatory inspections • Strategic planning: Vision & Strategic plan exists however needs to address long term manpower/expertise required to meet potential challenges (attrition of skilled staff, staff career development, risk approach/wrokload, decentralisation)

  10. Brazil, Status of vaccine regulatory functions As of 17 October 2008 if no action taken Not applicable

  11. Brazil, Status of vaccine regulatory functions As of 17 October 2008 if action taken by 1st January 2009 For all these functions, critical indicators Should be met by 1st January 2009 in the area of: Lot release and Regulatory inspections, these two functions Will impact positively the system component. Not applicable

  12. National Regulatory system in Brazil, as of 2008Status of vaccine indicators Score Sub-Indicator not met or partially met or that need improvement Function Regulatory system 86 % NO 2 2.2, 5.2 1.MAA & licensing 100% YES 3 8.2, 8.3,9.3 100% YES 1 2.PMS & AEFI 4.5 Regulatory functions 3.NRA Lot release 5 50% NO 1.1, 1.2, 1.3, 1.5, 2,1 100% YES 4.Laboratory access 4 2.3, 4.2,5.1,5.2 4 NO 67% 2.3, 4.2,5.1,5.2 5.Regulatory inspections 6.Auhtorisation/approval Of clinical trials 75% YES 4 1.1, 1.5, 1.6,2.1, 4 If recommendation not implemented Total FUNCTIONS ----->

  13. Next steps….urgent & important • Draft report to be submitted from WHO to ANVISA between 2-6 weeks, by 30 Nov.2008 • ANVISA comments and endorsement (including all institutions involved) to be communicated by 30 December 2008 • Final report to be submitted by 15 January 2009 • All recommendations addressing all critical indicators that are not met must be implemented by 1st January 2009 to renew prequalification status of Biomanguinos and Buthanta. • WHO follow up visit between February and June 2009.

  14. Capacity building opportunities for ANVISA,PNI and INCQS • Participation of ANVISA and PNI experts in WHO NRA assessment in Cuba (last week of Nov.2008) • Participation of 1 ANVISA experts in the Regulatory inspection training programme on rmanagement of risk planned in Pune (India) from 8-12 Dec.2008 • Provide access to WHO GTN training for ANVISA, NPI and INCQS staff • Provide list of countries where ANVISA, PNI and INCQS experts can be involved in NRA assessment, follow up or in country training

  15. 5. LABORATORY ACCESS 12 out of 12 indicators met (100%) , all critical indicators met

  16. 5. LABORATORY ACCESS

  17. 5. LABORATORY ACCESS

  18. 5. LABORATORY ACCESS

  19. 5. LABORATORY ACCESS

  20. 5. LABORATORY ACCESS Strengths (1) • Budget allocated to support and expand NCL activities • Strong quality management system (QMS) implemented, with organizational and financial support from management • Well equipped laboratory, fully validated equipment, assured regular maintenance • Highly motivated staff, with expertise and experience in quality control (QC) of vaccines • Staff training plan developed and implemented, including monitoring of impact of the training conducted.

  21. 5. LABORATORY ACCESS Strengths (2) • Commitment to ISO 17025 certification of all methods in use • Frequent internal audits based on pre approved plan, followed by monitoring of corrective action • Long history of the testing results recording in the data base, that assures consistency monitoring and analysis of data trends • Knowledge of production process end quality control through involvement in MA approval

  22. 5. LABORATORY ACCESSArea to improve& recommendations • Feedback amongst institutions: Organise feedback between institutions (ANVISA and INCQS) to improve communication & information sharing to all relevant institutions (RI, AEFI, NIP etc.) • QMS : develop more specific SOPs to clarify existing operations (eg.general SOP for retesting policy , testing policy, management of out of specification results, etc.)

  23. 4. NRA LOT RELEASE2 indicators partially met,2 indicators met, 2 critical indicators not met (50%)

  24. 4. NRA LOT RELEASE

  25. 4. NRA LOT RELEASE

  26. Strengths Institution and staff are highly committed to sustain and develop quality control activities INCQS constitutes an extensive expertise in viral and bacterial vaccines INCQS part of the regulatory system and has responsibility of INCQS for Quality control including lot release INCQS has a good knowledge on a wide range of products Expertise to conduct full Lot release activities available Strong quality management system implemented Contacts with the domestic manufacturers in place INCQS is involved in product evaluation as part of the ANVISA licensing process

  27. Area to improve Urgent enforcement of resolution CP46 : lot release Development of additional & more specific SOPs for the implementation of lot release process, including critical review of Summary Protocol

  28. Recommendations for lot release • Establish a formal lot release process: by END OF 2008 • Develop a SOP describing the Lot release process including responsibilities and issuing of the certificate. • Develop / revise more detailed SOP for critical review of Summary protocol clearly stating: who can review, what are to be reviewed, how to do it , what and how to record (ie check-list) • Develop / revise SOP with clearly defined acceptance criteria • Training • Organize training for all staff involved in the critical review of the Summary Protocol

  29. On behalf of the World Health Organization and the WHO team we would like to thanks all ANVISA; PNI, INSCQS, Biomanguinos and CEIVS for their assistance and their support to in this important exercise as well as our WHO/PAHO office colleagues. All staff from the above institutions had been very helpful, transparent, and have dedicated much of their time to assist the team Thank you

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