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.

Armed with the knowledge of key differences between the US and EU regulations, developers can proceed with confidence in their vendor selection and process decision-making. Awareness of the distinct classifications and manufacturing guidance by each region can also significantly aid in appropriate documentation of details required for successful market application in each jurisdiction.

In this eBook, we share the five key differences in the drug development and review processes 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.