A few years ago, the French National Agency for Medicines and Health Products Safety (ANSM) established a commission to explore the potential of new non-animal methods, particularly organoids and organs-on-a-chip. Since 2020, the commission has conducted several literature reviews and numerous hearings to determine the benefits of these methods, their limitations (issues with sensitivity and reproducibility), and the expected progress in terms of standardization and regulation.
The European Commission also monitors initiatives taken in France and across Europe on these issues, within the framework of the European regulatory context (through exchanges with other drug regulatory agencies and participation in conferences).
The minutes of the “Committee on Drug Safety and Quality / Restricted Group on Non-Clinical Safety” are available on the ANSM website here
Key hearings already held:
- Sanofi
- Cherry Biotech
- Servier
- NETRI
- CN-BIO
- BioValley France
- CNRS/IPGG: microfluidics
- CNRS GDR Organoïdes
- Presentation of project: “Langherans islands and organs on a chip”.
