ANVISA vs FDA: A COMPARATIVE ANALYSIS OF REGULATORY PRACTICES IN BRAZIL AND THE UNITED STATES

This study presents a comparative analysis of the regulatory practices of ANVISA (Brazil) and the FDA (United States) in the field of drugs and vaccines, focusing on the evaluation, approval, and monitoring of these products. The research, narrative and documental in nature, utilized official sources, legislation, guidelines, and scientific literature published between 2010 and 2025, including information produced during the COVID-19 pandemic. The objective was to understand the similarities, differences, and implications of these agencies in protecting public health, highlighting technical, legal, and institutional aspects that influence the efficiency, transparency, and agility of regulatory processes. Results indicate that, although both agencies share science-based foundations, the FDA demonstrates greater agility, higher transparency, and a more robust technical infrastructure, while ANVISA faces institutional and legal challenges impacting its timelines and operations. Both regulate clinical trials according to international guidelines; however, the FDA has more detailed and integrated regulations with ethics committees, whereas ANVISA coordinates its process with local committees, leading to greater heterogeneity. Additionally, the FDA stands out for its rapid response capacity in emergencies, using mechanisms such as fast track, while ANVISA has been advancing in modernization but still faces obstacles limiting its agility. It is concluded that global harmonization and institutional strengthening are essential to expand timely access to innovations while maintaining sanitary safety.