The rapid advancement of cell therapies has opened new frontiers in regenerative medicine, but it has also highlighted significant regulatory hurdles across global jurisdictions. One of the most pressing challenges is the varying classification of these therapies, with products often classified differently in the United States and Europe. These discrepancies lead to regulatory uncertainty, increased development costs, and delays in patient access to potentially life-saving treatments. This session aims to explore the current regulatory frameworks governing cell therapies in the US and Europe, focusing on how differences in classification can impact product development and commercialization. Experts from both regions will discuss the rationale behind these classifications, the regulatory challenges that arise, and the strategies to navigate these complex landscapes. Attendees will hear an engaging discussion that bridges the regulatory divide and explores how harmonizing classifications could accelerate innovation and improve patient outcomes worldwide.