Navigating the Global Regulatory Landscape for Exosome-Based Therapeutics: Challenges, Strategies, and Future Directions

Extracellular vesicle (EV)-based therapies have attracted considerable attention as a novel class of biologics with broad clinical potential. However, their clinical translation is impeded by the fragmented and rapidly evolving regulatory landscape, with significant disparities between the United States, European Union, and key Asian jurisdictions. In this review, we systematically analyze regional guidelines and strategic frameworks governing EV therapeutics, emphasizing critical hurdles in quality control, safety evaluation, and efficacy demonstration. We further explore the implications of EVs' heterogeneity on product characterization and the emerging direct-to-consumer market for EVs and secretome…