Agência Nacional de Vigilância Sanitária
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Workshop Session 3 International Session: Focus on Latin America
Laura Castanheira
Brazilian Health Surveillance Agency – ANVISA
Jan, 2014 *
Agência Nacional de Vigilância Sanitária
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Regulatory Aspects for Biologicals in Brazil
Laura Gomes Castanheira
Brazilian Health Surveillance Agency
ANVISA
Agência Nacional de Vigilância Sanitária
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ANVISA
Development of Biological Products Regulation
Law 6360/1976 – general regulation about medicines, including biological products
RDC 80/2002 – first regulatory act, specific for
biological products. Same approach for new products and copies
Agência Nacional de Vigilância Sanitária
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ANVISA
Development of Biological
Products Regulation RDC 315/2005 – second regulation regarding
biological products. Same approach for new products and copies, with more detailed information
RDC 55/2010 – current regulation. Specific
approach for copies of biologicals
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ANVISA
Types of Biological Products
1.Vaccines; 2. Hiperimmune sera; 3. Blood products; 4. Biomedicines: - medicines obtained from biological fluids or
animal tissues; - medicines from biotechonological procedures.
Agência Nacional de Vigilância Sanitária
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ANVISA
Types of Biological Products
5. Monoclonal antibodies; 6. Medicines containing live, attenuated or dead
microorganisms; 7. Probiotics; 8. Allergens.
Agência Nacional de Vigilância Sanitária
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ANVISA
Regulatory acts concerning biological products
RDC 55/10
Specific Guidelines
REGISTRATION
RDC 49/11, RDC 24/13
POST-APPROVAL
RDC 46/00
Blood products
RDC 323/03
Probiotics
RDC 47/09
RDC 60/12
Package insert
RDC 71/09, RDC 168/02
RDC 61/12
Label
RDC 17/10
Good Manufacturing
Practices
RDC 233/05
Allergenics
RDC 50/11, RDC 25/13
Stability
RDC 81/08, RDC 234/05,
RDC 38/10,RDC 58/12
Import
Law 6360/76 General Regulation
RDC 234/05
Quality Control
Portaria 174/96
Antivenom serums
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ANVISA
Classification of Biological
Products
I – New Biological Product: is the biological product containing molecule with known biological activity, still not registered in Brazil and that has undergone all stages of manufacturing
RDC 55/2010
Agência Nacional de Vigilância Sanitária
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ANVISA
Classification of Biological
Products
II – Biological product: is the biological drug that is not new or is known, containing molecule with known biological activity, already registered in Brazil and that has undergone all stages of manufacturing
RDC 55/2010
Agência Nacional de Vigilância Sanitária
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ANVISA
Regulatory Pathways
Biological product
Individual route
of development
Comparability
development
Complete
dossier
Comparative
Phase III
Comparability
exercise
Quality, Safety,
Efficacy
New biological
product
Individual route
of development
Complete
dossier Non innovative
biological product Biosimilar
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Partnerships
INCA – National Cancer Institute – Brazil
Brazilian Rheumatology Society
National Network of Clinical Studies
Technical Advisory Committee for Biologicals (CATEBIO)
Agência Nacional de Vigilância Sanitária
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ANVISA
Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
• Comparability Exercise Guideline
Agência Nacional de Vigilância Sanitária
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Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
• Heparin Guideline
Agência Nacional de Vigilância Sanitária
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Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
• Interferon alpha Guideline
Agência Nacional de Vigilância Sanitária
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ANVISA
Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
• Guideline for Elaboration of Clinical Study Reports
Agência Nacional de Vigilância Sanitária
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ANVISA
Guidelines – Future perspectives
• etanercept • rituximab • Non clinical studies guideline • Establishment and evaluation of cell
substrates used in production of biological
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ANVISA
Thank you for your attention!
