Overview of regulatory clinical research in Brazil: current situation of an inefficient system

Background: In Brazil, the regulatory process for clinical research is notably intricate, encompassing a series of pivotal phases. These include ethical evaluation and approval by Research Ethics Committees and health evaluation conducted by the Brazilian Health Surveillance Agency (Anvisa). Moreover, the Drug Market Regulation Chamber (CMED) imposes price limitations, which can prevent the return on investment for both national and foreign companies in most cases. Objectives: to present an analysis of the current state of clinical research in Brazil, based on publicly available information, in order to identify the weaknesses and challenges that Research faces in the country. Methods: The data science team obtained statistical data and information on the pharmaceutical market, as well as epidemiological data, from public databases, which allowed the team to organize the evidence according to the objectives of this study. Results and challenges: Despite the widely spread opinions investment in innovation, as compared to those of other countries, at present, there is a shortage of new products and innovative treatments. This outlook is further complicated for the most research, which is affected by the regulatory system and currently conducted by the local pharmaceutical industry with fewer resources.