Cell and gene therapies in the US vs. the EU: Top five areas of differentiation


For cell and gene therapies (CGTs) and other complex biologics, US and EU regulatory processes vary by more than just jurisdictional oversight.

In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.