title: The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built.
abstract: 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.
authors.affiliation: National Agency for Health Surveillance-ANVISA, AOS 04 Bloco B, Apto 423, Área Octogonal, Brasília, DF, 70660-042, Brazil. danielcoradi@gmail.com.
authors.forename: Daniel Roberto Coradi
authors.initials: DR
authors.lastname: de Freitas
mesh_terms: D000818:Animals; D001938:Brazil; D064987:Cell- and Tissue-Based Therapy / Q000941:ethics* / Q000379:methods; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D015316:Genetic Therapy / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence; D017410:Practice Guidelines as Topic; D011786:Quality Control
keywords: ANVISA; Brazil; Cell therapy; Center for Cell Technology; Clinical trial; Gene therapy; Good manufacturing practice; National Agency for Health Surveillance; Quality control; Regulation