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Agência Nacional de Vigilância Sanitária - Anvisa
Brazilian Health Surveillance Agency – Anvisa
CASSS LATAM 2015
Marcelo Mario Matos MoreiraGeneral-Manager of Biological Products, Blood, Tissues,
Cells and Organs – GGPBS
Updates on Regulatory issues for Biotherapeutics Products License in BrazilAugust, 24th 2015
Agência Nacional de Vigilância Sanitária - Anvisa
Anvisa´s Mission
To protect and promote public health and to intervene in the
risks caused by the production and use of products regulated
by health surveillance. This mission must be carried out in
coordination with states, municipalities and the Federal
District, according to the Brazilian Health System principles,
in order to improve the quality of life of the population.
Agência Nacional de Vigilância Sanitária - Anvisa
Areas of action
Post-marketing surveillance
Drugs
Food
Medical Devices
Toxicology (pesticides)
Cosmetics
Blood, Cells, Tissues and Organs
Tobacco
Marketing control
Ports, airports and frontiers
International Market regulation
Sanitizing Products
Health services Laboratories
Agência Nacional de Vigilância Sanitária - Anvisa
ACTIONS OPERATIONALIZATION
TACTICAL MANAGEMENT
TRANSVERSAL CONSULTING
STRATEGIC ORIENTATION
CONSULTIVE COUNCIL
Organization chart
General Office ofBiologicals
Agência Nacional de Vigilância Sanitária - Anvisa
RDC 55/10Registration
RDC 49/11 e 24/13Post-approval
RDC 46/00Blood products
RDC 323/03Probiotics
RDC 50/11 and 25/13Stability
RDC 47/09 e 60/12 Package insert
RDC 71/09, RDC 168/02RDC 61/12
Label
RDC 17/10Good Manufacturing
Practices
RDC 233/05Allergenics
Ordinance 174/96Antivenom serums
RDC 81/08Import
Law 6360/76Decree 8.077/13
RDC 234/05RDC 38/10
Quality control
Regulatory acts concerning biological products
Agência Nacional de Vigilância Sanitária - Anvisa
Regulatory Convergence
1. RDC 55/2010
2. Harmonized requirements for the licensing of vaccines in the Americas and Guidelines for the preparation of application
Agência Nacional de Vigilância Sanitária - Anvisa
Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
Comparability exercise Guideline
Agência Nacional de Vigilância Sanitária - Anvisa
Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
Heparin Guideline
Agência Nacional de Vigilância Sanitária - Anvisa
Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
Interferon Alpha Guideline
Agência Nacional de Vigilância Sanitária - Anvisa
Guidelines
http://s.anvisa.gov.br/wps/s/r/lg
Guideline for Elaboration of Clinical Study Reports
Agência Nacional de Vigilância Sanitária - Anvisa
Guidelines – Future perspectives
1. Etanercept
2. Rituximab
3. Review the current guidelines
Agência Nacional de Vigilância Sanitária - Anvisa
Transparency
Drug Approval and Refusal Letters
http://www.anvisa.gov.br/datavisa/Fila_de_analise/index.asp
Agência Nacional de Vigilância Sanitária - Anvisa
Top 3 Challenges
Interchangeability1
Extrapolation of indications2
International non-proprietary name or INN3
Agência Nacional de Vigilância Sanitária - Anvisa
Interchangeability
EMA FDA Health Canada Anvisa
Individual countries in EU have adopted
varying policies
US law permits FDA to designate a product as interchangeable. However, decisions about substitution by the pharmacy are governed by the state laws
Health Canada doesn´t declare interchangeabilityfor biosimilars
Interchangeabilityis underdiscussion. Bynow, Anvisa willdeclare interchangeabilityafter reviewclinical data withthis purpose
Agência Nacional de Vigilância Sanitária - Anvisa
Interchangeability
1. A medical practice of change one medicine for another that is expected to achieve the same clinical effect;
2. It´s not a requirement to license a biosimilar;
3. It´s necessary to conduct clinical trials;
4. Develop international Guidelines (WHO)
Agência Nacional de Vigilância Sanitária - Anvisa
Extrapolation of indications
1. Reflection paper on extrapolation of indication
- Working group to discuss the theme and propose areflection paper
- Strong scientific justification for extrapolation ofindication by companies should be emphasized inthe paper
Agência Nacional de Vigilância Sanitária - Anvisa
International non-proprietary name or INN
Agência Nacional de Vigilância Sanitária - Anvisa
International Non-proprietary Name or INN
Board Directors Resolution – RDC nº 63/2012
Provides for the rules used for the Brazilian Non-proprietary Names - DCB.
Agência Nacional de Vigilância Sanitária - Anvisa
References
- Brazil, Resolution RDC n° 55, December, 16th, 2010, Anvisa
- Brazil, Resolution RDC n° 50, September, 20th, 2011, Anvisa
- Brazil, Resolution RDC n° 49, September, 20th, 2011, Anvisa
- Brazil, Resolution RDC n° 63, December, 28th, 2012, Anvisa
- Brazil, Law n° 6360, September, 23th, 1976
- www.anvisa.gov.br
Agência Nacional de Vigilância Sanitária - Anvisa
Take Home Message
FOLLOW-ON PROTEIN PRODUCT
OR FOLLOW ON BIOLOGICS SUBSEQUENT
ENTRY BIOLOGICS
SIMILAR BIOTHERAPEUTICPRODUCTS
FOLLOW ON BIOLOGICS (FOB)
MEDICAMENTO BIOLÓGICO SIMILAR
(BIOSIMILAR)
BIOSIMILAR
PRODUTO BIOLÓGICOOR BIOSSIMILAR
• Generic Biological•Biogenerics
BIOSSIMILAR BIOSIMILAR
Agência Nacional de Vigilância Sanitária - Anvisa
Thank you
Acknowledgments
GPBIO and GSTCO StaffSUMED/ANVISA
Contacts
phone: +55(61)3462-5593E-mails: [email protected]
[email protected]@anvisa.gov.br
Agência Nacional de Vigilância Sanitária - AnvisaSIA Trecho 5 - Área especial 57 - Lote 200
CEP: 71205-050Brasília - DF
Phone: +55(61)3462 6000
www.anvisa.gov.brwww.twitter.com/anvisa_oficialAnvisa Atende: 0800-642-9782