Análise comparativa de políticas de regulamentação de ensaios clínicos

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.