The French National Agency for the Safety of Medicines and Health Products (ANSM) has set up a commission to examine the prospects offered by new non-animal methods, in particular organoids and organs-on-a-chip. Since 2020, the commission has carried out several bibliographical analyses and held numerous hearings to determine the advantages of these methods, their limitations (problems of sensitivity, reproducibility) and the progress expected in terms of standardization and normalization.
The commission also keeps abreast of initiatives taken in France and Europe on these subjects, within the framework of the European regulatory context (exchanges with other drug agencies, participation in congresses).
Reports from the Drug Safety and Quality Commission / Non-clinical safety restricted group: Download here
Main hearings 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”.
