Advanced therapies: marketing authorisation

The European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all advanced therapy medicinal products (ATMPs) in the European Economic Area, as they fall under the mandatory scope of the centralised procedure.

Companies can receive a confirmation from EMA that a medicine they are developing meets the scientific criteria for defining an ATMP before submitting a marketing authorisation application.

In this section

• Advanced therapy classification
• Scientific recommendations on classification of advanced therapy medicinal products
• Marketing-authorisation procedures for advanced-therapy medicinal products