ARM calls for pan-European action to fast-track use of RWE for ATMPs

The Alliance for Regenerative Medicine (ARM) has called for pan-European action to fast-track the use of real world evidence (RWE) for advanced therapy medicinal products (ATMPs) to help ensure patient access to transformative therapies.

The ARM’s newly-published position paper provides clear recommendations for the European Commission (EC) to include as part of the European Union (EU) Pharmaceutical Strategy, which is designed to improve and accelerate patients’ access to transformative therapies that are safe and affordable medicines, and to support innovation.

The group wants the EC to fast-track the use of RWE for ATMPs, including subject matter experts from the ARM, manufacturers and patient advocacy groups, to set up a European infrastructure for regular RWE use.