Abstract：
Great advances have been made in the knowledge of development and regulatory approval of medicinal product containing genetically modified cells. Although a guideline has been available in the EU since 2012, the current updated version provides a useful guide to developers and professionals involved in the regulatory process of these medicines. This article presents the main issues communicated in that guidance, the regulators\' insights and a commentary from the academic developers\' point of view.
摘要：
在包含遗传修饰细胞的医药产品的开发和监管批准的知识方面已经取得了重大进展。尽管自2012年以来，欧盟已提供了指南，但当前的更新版本为参与这些药物监管过程的开发人员和专业人员提供了有用的指南。本文介绍了该指南中传达的主要问题，监管机构的见解和学术开发者的评论。
