Medicina personalizada - companion diagnostics: análise dos aspectos regulatórios
Data
2019-06-26
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
O crescente progresso da ciência e tecnologia tem modificado de forma significativa
as decisões e práticas médicas na atualidade, direcionando-as cada vez mais para
terapias personalizadas. Um Companion Diagnostic é considerado um dispositivo
médico, geralmente para uso diagnóstico in vitro, que fornece informações essenciais
para o uso seguro e eficaz de um medicamento ou produto biológico. Diante das novas
tecnologias que surgem dia após dia, o papel das autoridades sanitárias se faz cada
vez mais necessário para garantir que estes produtos sejam seguros e eficazes antes
de serem disponibilizados no mercado. Neste trabalho, foi verificado que o Brasil deve
acompanhar tendências regulatórias de países como Estados Unidos da América,
Japão e União Europeia para incluir o conceito de Companion Diagnostics na atual
regulamentação.
The growing progress of science and technology has significantly modified medical decisions and practices today, directing them increasingly to personalized therapies. A Companion Diagnostic is considered a medical device, generally for in vitro diagnostic use, that provides essential information for the safe and effective use of a drug or biological product. Due to the new emerging technologies, it is really necessary that health authorities ensure that these products are safe and effective before they are made available on the market. In this work, it was verified that Brazil should follow regulatory trends from countries such as the United States of America, Japan and European Union to include the concept of Companion Diagnostics in the current regulation.
The growing progress of science and technology has significantly modified medical decisions and practices today, directing them increasingly to personalized therapies. A Companion Diagnostic is considered a medical device, generally for in vitro diagnostic use, that provides essential information for the safe and effective use of a drug or biological product. Due to the new emerging technologies, it is really necessary that health authorities ensure that these products are safe and effective before they are made available on the market. In this work, it was verified that Brazil should follow regulatory trends from countries such as the United States of America, Japan and European Union to include the concept of Companion Diagnostics in the current regulation.