National reflection on organs-on-chip for drug development: New regulatory challenges - Normandie Université Accéder directement au contenu
Article Dans Une Revue Toxicology Letters Année : 2023

National reflection on organs-on-chip for drug development: New regulatory challenges

Résumé

Organs-on-chip (OoC) are innovative and promising in vitro models, particularly in the process of developing new drugs, to improve predictivity of preclinical studies in humans. However, a lack of regulatory consensus on acceptance criteria and standards around these technologies currently hinders their adoption and implementation by end-users. A reflection has been conducted at the National Agency for Medicines and Health products safety (ANSM) in order to address this issue, which has gained momentum at the international level in recent years. If the subject of OoC is of international interest, France is also in the process of structuring an OoC network, in order to best support the emergence of this new technological innovation. Focusing on liver-on-a-chip, the authors drafted a first list of regulatory requirements to help standardize these devices and their use. Technological and biological relevance of liver-on-a-chip was also evaluated, in comparison with current in vitro and in vivo models, based on the available literature. The authors offer an analysis of the current scientific and regulatory situation, highlighting the key regulatory issues for the future.
Fichier non déposé

Dates et versions

hal-04420629 , version 1 (26-01-2024)

Identifiants

Citer

Sonia Gomes Teixeira, Paul Houeto, Florence Gattacceca, Nicole Petitcollot, Danièle Debruyne, et al.. National reflection on organs-on-chip for drug development: New regulatory challenges. Toxicology Letters, 2023, 388, pp.1-12. ⟨10.1016/j.toxlet.2023.09.011⟩. ⟨hal-04420629⟩
21 Consultations
0 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More