Published on November 24, 2025 by Alexis Behra
ANSM request: equipment for manufacturing autologous cell therapies
On May 22, 2025, France BioLead requested that the ANSM issue an opinion on the non-classification of equipment used in the manufacture of autologous cell therapies as medical devices.
The ANSM issued a favorable opinion and accepted France BioLead's arguments on June 16, 2025.
This document includes:
- The briefing package sent to the ANSM on May 22, 2025
- The ANSM's response sent on June 16, 2025
