Introduction Brazil's emergence as a key player in first-in-human trials presents both opportunities and challenges. Driven by a treatment-naive patient population and significant regulatory refor...
<h2 id="introduction">Introduction</h2> <p>Brazil's emergence as a key player in first-in-human trials presents both opportunities and challenges. Driven by a treatment-naive patient population and significant regulatory reforms, Brazil has rapidly positioned itself as a vital hub for clinical research.</p> <p>With the recent changes in Law No. 14,874/2024, the approval process has been streamlined, offering sponsors a remarkable opportunity to expedite their clinical research endeavors. However, navigating Brazil's evolving regulatory landscape can be daunting for stakeholders.</p> <p>How can they effectively leverage Brazil's unique advantages while overcoming the inherent challenges of patient recruitment and regulatory compliance? To succeed in early-stage clinical trials, stakeholders need to grasp these dynamics.</p> <h2 id="understand-the-landscape-of-first-in-human-trials-in-brazil">Understan…