experience of regulating antisera: possibilities for international

Experience of regulating antisera: possibilities for international cooperation to ensure quality and availability

Laura Gomes Castanheira

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

Antisera Control in Brazil• Snakebites as compulsory notification event

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

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.

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

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

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

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

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).

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.

Email: laura.castanheira@anvisa.gov.brprodutos.biológicos@anvisa.gov.br

Thank you for your attention!