AUTHOR=Gravanis Iordanis , Berntgen Michael , Vamvakas Spiros , Demolis Pierre , Foggi Paolo 

TITLE=Challenges and ongoing initiatives towards better integrated EU scientific advice

JOURNAL=Frontiers in Medicine

VOLUME=Volume 12 - 2025

YEAR=2025

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1473346

DOI=10.3389/fmed.2025.1473346

ISSN=2296-858X

ABSTRACT=Scientific advice is the main avenue for clarification of EU regulators’ scientific evidence requirements during medicines development. There are multiple avenues for seeking scientific advice in the EU with partially overlapping scope which creates room for divergence and contradictions; simplification and better integration among them could help harmonize EU regulators’ requirements. Interaction with other decision makers providing advice along the lifecycle of medicines and other healthcare solutions reduces development uncertainties. The proposal for a new EU pharmaceutical legislation solidifies existing advice mechanisms and creates new avenues for enhanced integration of development support.