Advanced therapy medicinal products
COMCMT1R-EP1R-C2R-EPCNCADO
Updated 227mo ago
This procedure concerns the regulation of advanced therapy medicinal products (ATMPs), which are innovative treatments like gene and cell therapies. It aims to ensure their safety, efficacy, and accessibility for patients across the EU.
The regulation impacts pharmaceutical companies developing ATMPs and healthcare providers administering them. It seeks to harmonize rules, foster innovation, and maintain high standards for patient safety in this cutting-edge field.