Comparative analysis of policies regulating clinical trials Análise comparativa de políticas de regulamentação de ensaios clínicos Análisis comparativo de las políticas de reglamentación de los ensayos clínicos
Tipo
Artigo
Data de publicação
2020
Periódico
Revista Panamericana de Salud Publica/Pan American Journal of Public Health
Citações (Scopus)
0
Autores
Bataglia W.
Alves F.S.
De-Carli E.
Alves F.S.
De-Carli E.
Orientador
Título da Revista
ISSN da Revista
Título de Volume
Membros da banca
Programa
Resumo
© 2020 Pan American Health Organization. All rights reserved.The present article compares clinical trial regulations in Brazil, India, Canada, and the European Union with the aim of providing evidence for an evaluation of the Brazilian regulatory policy. For that, a document analysis approach was used, in four steps: preliminary exploratory analysis; descriptive study; categorization of information; contrasting contents. Noteworthy differences between the Brazilian regulatory framework as compared to the other regions studied include the existence of several laws and regulations in Brazil vs. a single rule in the other countries; the absence of requirements regarding drug traceability and collection and disposal of unused drugs if a study is interrupted or cancelled; and a higher time of 180 days for approval of clinical trials (vs. 30 days in the European Union or Canada, for example). This suggests opportunities for improvement and update of the Brazilian regulations vis-à-vis the international scenario.