Abstract
Introduction: The global pharmaceutical market continues to grow, driven by population aging, personalized medicine, biotechnological therapies, and the demand for treatments for rare and chronic diseases. In this context, the regulatory environment is crucial, acting both in the control and promotion of innovation and access, with increasing appreciation for harmonization in clinical research. ANVISA, FDA, and EMA stand out worldwide, and comparison with FDA and EMA allows the identification of barriers, potentialities, and strategies adaptable to Brazil, while preserving technical independence and health sovereignty. Objective: To compare the regulatory frameworks and practices adopted by ANVISA, FDA, and EMA in the conduct and approval of clinical research, focusing on understanding institutional structures, procedural workflows, accelerated approval mechanisms, and regulatory harmonization strategies. Methods: Theoretical, exploratory, and descriptive research based on bibliographic and documentary surveys from official sources and scientific literature. Legislation, regulations, submission guidelines, institutional reports, and publications regarding the three agencies studied were analyzed, addressing institutional structure, division of responsibilities, submission and approval workflows, accelerated approval programs, reliance strategies, participation in international networks, and the use of digital systems for process management. Results: The FDA has a structured and integrated regulatory system, combining ethical and technicalregulatory analyses and accelerating processes through consolidated programs such as Fast Track, Breakthrough Therapy, and Priority Review. The EMA coordinates the regulatory process in the European Union, working with national authorities and using the Clinical Trials Information System (CTIS) to centralize submissions and evaluations, in addition to mechanisms such as Accelerated Assessment and PRIME. ANVISA has advanced in predictability, transparency, priority workflows, and reliance practices, but maintains separate ethical and technicalregulatory evaluations, which may extend timelines. Conclusions: Despite the advances achieved by ANVISA over the past decade, there is still an important path to be covered for Brazil to reach the levels of speed and integration observed in agencies such as the FDA and EMA. Modernization of the regulatory framework, combined with the full adoption of accelerated approval mechanisms and the strengthening of reliance strategies while maintaining technical independence, may contribute to reducing timelines and increasing the country’s competitiveness in attracting clinical studies. International regulatory alignment, when conducted responsibly and adapted to Brazilian epidemiological and social realities, has the potential to expand population access to innovative therapies, strengthen health sovereignty, and promote national scientific and technological development.
