Produtos de terapias avançadas: regulação e monitoramento sanitário no Brasil, Estados Unidos da América, Europa e Japão.
gene therapy, advanced cell therapy, tissue engineering, regulatory framework
Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP received marketing authorization in Europe in 2009, whereas Brazil granted the first authorization in 2020. The objective of this study was to compare the regulatory models adopted by Brazil, the USA, Japan and the European Union, which comprise the member countries of the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for ATMP