de Freitas Daniel Roberto Coradi
National Agency for Health Surveillance-ANVISA, AOS 04 Bloco B, Apto 423, Área Octogonal, Brasília, DF, 70660-042, Brazil.
Adv Exp Med Biol. 2015;871:213-9. doi: 10.1007/978-3-319-18618-4_12.
The regulation of cell therapy and gene therapy products is a major challenge for the Brazilian state. From a legal point of view, the legislative apparatus, including constitutional, prohibits the marketing and patent of human substances. From the point of view of the organization of the state bureaucracy, the responsibilities for the regulation of research and application of these technologies in humans may involve up to four different institutions. The National Agency for Health Surveillance (ANVISA) has been the protagonist in structuring the regulation of cell therapy and gene therapy in Brazil, and steps have been taken to ensure quality of these products. However, obstacles such as the commercialization of these therapies and the need to determine whether these products will be regulated following the assumptions adopted in Brazil for drugs and biological products or for human blood and tissues still remain.
细胞疗法和基因疗法产品的监管对巴西政府来说是一项重大挑战。从法律角度看，包括宪法在内的立法机构禁止人体物质的销售和专利。从国家官僚机构的组织角度看，监管这些技术在人体中的研究和应用的职责可能涉及多达四个不同机构。巴西国家卫生监督局（ANVISA）一直是构建巴西细胞疗法和基因疗法监管体系的主角，并且已经采取措施确保这些产品的质量。然而，诸如这些疗法的商业化以及需要确定这些产品是按照巴西对药品和生物制品还是对人体血液和组织所采用的假设进行监管等障碍仍然存在。
