Abstract

Innovative therapies, such as Chimeric antigen receptor T-cell (CAR-T), are regulated in the European Union (EU) via the centralised procedure. However, national requirements on genetically modified organisms (GMO) apply and can vary among EU member states (MS). This article provides a short explanation on GMO and CAR-T therapy in the EU and gives a high-level overview of the requirements regarding clinical trial applications involving CAR-T products in the EU. One of the main concerns of regulators is the long-term safety of CAR-T products. With the development of label extension of CAR-T, Europe will probably adapt the regulatory framework to enhance the approval procedure of clinical trials with CAR-T.