اكتب مراجعة على PREreview

Exosome‐based therapies have attracted considerable attention as a novel class of biologics with broad clinical potential. However, their clinical translation is impeded by a 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 exosome therapeutics, emphasizing critical hurdles in quality control, safety evaluation, and efficacy demonstration. We further explore the implications of exosomal heterogeneity on product characterization and the emerging direct‐to‐consumer market for exosome and secretome preparations. Drawing on these insights, in this review, we aim to provide a roadmap for harmonizing regulatory requirements, advancing standardized analytical approaches, and fostering ongoing collaboration among regulatory authorities, industry stakeholders, and academic investigators. Such coordinated efforts are essential to safeguard patient welfare, ensure product consistency, and accelerate the responsible integration of exosome‐based interventions into clinical practice.