TY - CONF
T1 - The regulatory framework for microbiome-based therapies
T2 - insights into European regulatory developments
AU - Rodriguez, J
AU - Cordaillat-Simmons, M
AU - Pot, B
AU - Druart, C
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/3/28
Y1 - 2025/3/28
N2 - The emergence of a broad spectrum of microbiome-based therapies has triggered changes in European regulatory frameworks. The first part of the review describes these innovative therapies. The second part provides an overview of the current framework and key changes introduced by the Regulation on substances of human origin (SoHO) for the development of microbiome-based therapies, highlighting the need of microbiome regulatory science to unlock the full potential of microbiome-based therapies.
AB - The emergence of a broad spectrum of microbiome-based therapies has triggered changes in European regulatory frameworks. The first part of the review describes these innovative therapies. The second part provides an overview of the current framework and key changes introduced by the Regulation on substances of human origin (SoHO) for the development of microbiome-based therapies, highlighting the need of microbiome regulatory science to unlock the full potential of microbiome-based therapies.
UR - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=myvubstarterapi&SrcAuth=WosAPI&KeyUT=WOS:001455836400001&DestLinkType=FullRecord&DestApp=WOS_CPL
UR - http://www.scopus.com/inward/record.url?scp=105001370547&partnerID=8YFLogxK
U2 - 10.1038/s41522-025-00683-0
DO - 10.1038/s41522-025-00683-0
M3 - Unpublished paper
C2 - 40155609
SP - 53
ER -