Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells - Scientific guideline

This guideline describes the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells. This applies to allogeneic or autologous, including viral vector modified and genome edited cells.

Keywords: Advanced therapy medicinal products, genetically modified cells, CAR-T cells,CD34+ cells, core SmPC, core labelling, core package leaflet

Current version

Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells

Adopted Reference Number: EMA/CAT/CHMP/158266/2021

Overview of comments received on draft 'Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells' (EMA/CAT/CHMP/158266/2021)

Reference Number: EMA/CAT/CHMP/679290/2021

Draft guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells

Draft: consultation closed Consultation dates: 30/07/2021 to 31/10/2021 Reference Number: EMA/CAT/CHMP/158266/2021 Summary:

This guideline describes the information to be included in the summary of products characteristics (SmPC), labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells. This applies to allogeneic or autologous, including viral vector modified and genome edited cells.