Advanced Therapy Medicinal Products (ATMPs) – encompassing gene therapies, somatic-cell therapies, and tissue-engineered products – have been regulated in the European Union under a dedicated framework since 2009. As of 2025, the European Medicines Agency (EMA) has authorised close to 20 ATMPs (below), most of them gene therapies for rare or serious conditions. In comparison, the US Food and Drug Administration (FDA) has cleared over 40 cell and gene therapies, reflecting differences in regulatory scope and pace of approvals between the two regions.  

Made with Visme Infographic Maker