Cellular Products for therapeutic benefit have been used clinically for over 30 years. Recently, many regulatory bodies from multiple countries have published minimum requirements that cell therapy facilities must follow. These standards apply to both the facilities and the products that they issue. As an increasing number of cellular products are being distributed across borders, it is important for everyone to know which regulations (both voluntary and mandatory) are in place where the cellular product was recovered, processed and released for clinical utility. This session will provide an overview of worldwide governmental regulations that apply to cellular products. In addition, there will be an update on the activities of the Alliance for Harmonization of Cellular Therapy (ACHTA) whose mission is to identify potential areas of standards that can be harmonized between organizations and between countries.