Extracellular vesicles (EV) are emergent therapeutic effectors that have reached clinical trial investigation. To translate EV-based therapeutic to clinic, the challenge is to demonstrate quality, safety, and efficacy, as required for any medicinal product. EV research translation into medicinal products is an exciting and challenging perspective. Recent papers, provide important guidance on regulatory aspects of pharmaceutical development, defining EVs for therapeutic applications and critical considerations for the development of potency tests. In addition, the ISEV Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics as well as the Exosomes Committee from the ISCT are expected to contribute in an active way to the development of EV-based medicinal products by providing update on the scientific progress in EVs field, information to patients and expert resource network for regulatory bodies. The contribution of our work group “Extracellular Vesicle translatiOn to clinicaL perspectiVEs – EVOLVE France”, created in 2020, can be positioned in complement to all these important initiatives. Based on complementary scientific, technical, and medical expertise, we provide EV-specific recommendations for manufacturing, quality control, analytics, non-clinical development, and clinical trials, according to current European legislation. We especially focus on early phase clinical trials concerning immediate needs in the field. The main contents of the investigational medicinal product dossier, marketing authorization applications, and critical guideline information are outlined for the transition from research to clinical development and ultimate market authorization.

细胞外囊泡 (EV) 是已进入临床试验研究的新兴治疗效应物。要将基于 EV 的治疗转化为临床，挑战在于证明任何医药产品所需的质量、安全性和有效性。将电动汽车研究转化为医药产品是一个令人兴奋且具有挑战性的观点。最近的论文为药物开发的监管方面提供了重要指导，为治疗应用定义 EV 以及开发效力测试的关键考虑因素。此外，基于 EV 的疗法的法规事务和临床应用 ISEV 工作组以及 ISCT 的外泌体委员会预计将通过提供最新的科学电动汽车领域的进展，向患者提供信息，并为监管机构提供专家资源网络。我们成立于 2020 年的工作组“细胞外囊泡转化为临床视角 - EVOLVE France”的贡献可以定位为对所有这些重要举措的补充。基于互补的科学、技术和医学专业知识，我们根据当前的欧洲立法为制造、质量控制、分析、非临床开发和临床试验提供针对电动汽车的建议。我们特别关注有关该领域迫切需求的早期临床试验。概述了研究药物产品档案、上市许可申请和关键指南信息的主要内容，用于从研究到临床开发和最终上市许可的过渡。