Abstract
<jats:p>Extracellular vesicles (EVs) represent a promising frontier in biotherapeutics, offering novel approaches for drug delivery, regenerative medicine, and cosmetics. However, their clinical translation faces significant regulatory challenges due to the absence of harmonized frameworks across major jurisdictions. This chapter explores the regulatory landscape for EV-based products, focusing on the perspectives of Brazil’s Anvisa, the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Despite increasing interest, none of these agencies have issued specific guidelines tailored to EV therapies, leaving developers to navigate ambiguous classifications and inconsistent requirements. In contrast, South Korea’s National Institute of Food and Drug Safety Evaluation (NIFDS) has taken a pioneering step by publishing the “Guideline on Quality, Non-clinical and Clinical Assessment of Extracellular Vesicle Therapy Products.” This document provides a structured approach to product characterization, safety evaluation, and clinical development, serving as a valuable reference for global stakeholders. By comparing regulatory gaps and emerging strategies, this chapter underscores the urgency for international harmonization and highlights the importance of science-based policy development. It offers a critical resource for researchers, manufacturers, and regulators seeking to advance EV-based therapies responsibly and efficiently.</jats:p>