Experience of regulating antisera: possibilities for ......Experience of regulating antisera:...
Transcript of Experience of regulating antisera: possibilities for ......Experience of regulating antisera:...
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Experience of regulating antisera: possibilities for international cooperation to ensure quality and availability
Laura Gomes Castanheira
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14 International Conference of Drug Regulatory Authorities
Laura Gomes Castanheira Head
Biological CoordinationSafety and Efficacy Office
ANVISA – The Brazilian Health Surveillance Agency
Experience of regulating antisera: possibilities for international cooperation to ensure quality and availability
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Antisera Control in Brazil• Snakebites as compulsory notification event
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Antisera Availability in Brazil
Antivenom Immunoglobulin Number of products Procducers Snakes Species Name
Anticrotálico 3 FUNED, Butantan, IVB CrotalusCrotalus durissuss
Antielapídico 2 FUNED, Butantan Micrucurus croralinnus, Micrucurus spp.
Antibotrópico 4 FUNED, Butantan, IVB, CPPI Bothrops alternatus, Bothrops atrox, Bothrops jararaca, Bothrops jararacussu, Bothrops moojeni, Bothrops neuwedi
Antibotrópico-crotálico 3 FUNED, Butantan, IVB Bothrops alternatus, Bothrops atrox, Bothrops jararaca, Bothrops jararacussu, Bothrops moojeni, Bothrops neuwedi, Crotalus
Crotalus durissuss
Antibotrópico -antilaquético
3 FUNED, Butantan, IVB Bothrops alternatus, Bothrops atrox, Bothrops jararaca, Bothrops jararacussu, Bothrops moojeni, Bothrops neuwedi,Cachesis mula
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Antisera Availability in Brazil
• 4 Producers: Instituto Butantan, Fundação Ezequiel Dias (FUNED); Instituto Vital Brazil (IVB); Centro de Produção e Pesquisa de ImunobiológicosCPPI
• All the producers belongs to Brazilian Ministry of Health-Official Manufacturers
• All antivenom Immunoglobulin (antisera) are distributed by the same program that distributes vaccine in Brazil.
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Antisera Availability and Control in Brazil
• Government responsible for antisera distribution:
- Quality ControlNational Instituter of Quality Control (INCQS)
National reference materials- Venom and antivenomAnalisys and release of each batch that is used in Brazil or
exported
- Storage
- Distribution
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Antisera Regulation in Brazil
• Regulatory Framework: Portaria nº 107, de 20 de setembrode 1994 and Portaria n° 174/96- INCQS responsable formarketing authorization
• Since 2002: RDC 80/02 (General regulation for biological products); replaced by RDC 315/05 (General regulation for biological products, including antivenom immunoglobulins);
• Lack of sepcific regulation for antivenom immunoglobulin
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Antisera Regulation in Brazil
• 2010-2011- New regulation for antisera underrevision
- Implementation of WHO Guidelines Production,Control and Regulation of Snake AntivenomsImmunoglobulins according Brazilian situation
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Antisera Regulation and Development in Brazil
• Multidiscilpinary working group:
- National Regulatory Authority (MarketingAuthorization; Clinical Trails; GMP Inspections;Pharmacovigilance)
- National Control Laboratory (INCQS)- Producers- National Immunization Program
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Antisera Regulation and Development in Brazil
• Multidiscilpinary working group:
- Create clinical database- Discuss clinical trial designs- Review regulations and establish specific regulation- Discuss GMP issues- Discuss Suitability of antivenom immunoglobulins products
(ex.: containers, presentations, types, etc).
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Antisera: Possibility of Cooperation
- Spread and reinforce clinical experiences andcapacities.
- Change experience and start cooperativeinitiatives in quality control of antivenomimmunoglobulin
- Discuss regulatory issues and pathways inregional and global level having the WHOGuideline as a base.