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POLICY BRIEF article

Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1473346
This article is part of the Research Topic The Changing Focus of Regulatory Frameworks Around the Globe and the Opportunities for Harmonization View all 6 articles

Challenges and ongoing initiatives towards better integrated EU scientific advice

Provisionally accepted
Iordanis Gravanis Iordanis Gravanis 1*Michael Berntgen Michael Berntgen 1Spiros Vamvakas Spiros Vamvakas 1Pierre Demolis Pierre Demolis 2Paolo Foggi Paolo Foggi 3
  • 1 Division of Human Medicines, European Medicines Agency, Amsterdam, Netherlands
  • 2 Agence Nationale de Sécurité du Médicament et Des Produits de Santé (ANSM), Paris, France
  • 3 Italian Medicines Agency (AIFA), Rome, Lazio, Italy

The final, formatted version of the article will be published soon.

    Scientific advice is the main avenue for clarification of EU regulators’ scientific evidence requirements during medicines developmentThere 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’ requirementsInteraction with other decision makers providing advice along the lifecycle of medicines and other healthcare solutions reduces development uncertaintiesThe proposal for a new EU pharmaceutical legislation solidifies existing advice mechanisms and creates new avenues for enhanced integration of development support

    Keywords: R&D, Scientific advice, clinical trials, medical devices, innovative combination products, Health Technology Assessment, new EU pharmaceutical legislation

    Received: 30 Jul 2024; Accepted: 10 Jan 2025.

    Copyright: © 2025 Gravanis, Berntgen, Vamvakas, Demolis and Foggi. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Iordanis Gravanis, Division of Human Medicines, European Medicines Agency, Amsterdam, Netherlands

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.