Abstract

Advanced therapies, including gene therapy, cell therapy, and tissue engineering, are at the forefront of medical innovation, offering transformative potential for treating a wide range of diseases. However, their complex nature and novel mechanisms pose significant regulatory challenges in evaluating their safety. Key issues include the limitations of preclinical models, ensuring manufacturing consistency, and addressing long-term safety concerns. The personalization of these therapies further complicates safety assessments, as do ethical and social considerations. Regulatory frameworks must evolve to address these challenges, requiring robust guidelines, long-term monitoring, and global harmonization. This paper explores these regulatory challenges and discusses the need for adaptive practices to balance innovation with patient safety.