• Regulatory House

EMA has published for public consultation a Guideline on core SmPC, Labelling and PIL for ATMPs

All SMEs and Stakeholders are invited to provide their comments to this guideline on texts for advanced therapy medicinals products (ATMPs) containing genetically modified cell. This document complements the information on ATMPs already provided in the QRD template and SmPC guideline with a specific focus on medicinal products containing genetically modified cells, allogeneic or autologous, including viral vector modified and genome edited cells.

Comments should be provided using this template and sent to QRD@ema.europa.eu by 31 October 2021.