Verma Nagendra, Arora Swati
Applied Education in the MedTech Industry, St. Cloud State University, Plymouth, MN 55442, USA.
Department of Chemistry, University of Pittsburgh, 219 Parkman Ave, Pittsburgh, PA 15260, USA.
Pharmaceutics. 2025 Jul 30;17(8):990. doi: 10.3390/pharmaceutics17080990.
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 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 EV-based interventions into clinical practice.
基于细胞外囊泡（EV）的疗法作为一类具有广泛临床潜力的新型生物制品，已引起了广泛关注。然而，其临床转化受到零散且快速演变的监管环境的阻碍，美国、欧盟和亚洲主要司法管辖区之间存在显著差异。在本综述中，我们系统地分析了管理EV疗法的区域指南和战略框架，强调了质量控制、安全性评估和疗效证明方面的关键障碍。我们进一步探讨了EV异质性对产品特性的影响以及新兴的EV和分泌组制剂直接面向消费者的市场。基于这些见解，在本综述中，我们旨在提供一个路线图，以协调监管要求、推进标准化分析方法，并促进监管机构、行业利益相关者和学术研究人员之间的持续合作。这种协调一致的努力对于保障患者福利、确保产品一致性以及加速基于EV的干预措施在临床实践中的合理整合至关重要。
