EuroGCT participated in the 2025 ESGCT Congress in Sevilla, Spain on 10 October 2025, hosting a lunchtime symposium to discuss the policies, strategies, and their impact on gene and cell therapy regulations in Europe. The symposium abstract and the presentations are available below:
Policy and regulatory strategies: current and prospective impact on gene and cell therapy development
EuroGCT Lunchtime Symposium, ESGCT 2025, 10 October 2025, Sevilla, Spain.
Chair: Aurélie Mahalatchimy
Administrative Coordinator: Auxane Delage
The field of gene and cell therapy is the subject of particular political and legal attention in view of the objectives of protecting public health and economic competitiveness associated with it. Despite a strong legal support in the EU with the adoption of the regulation 1394/2007 on ATMP ahead of all other regions of the world, challenges remain in their development, and final accessibility to patients in the EU. To address these challenges, the EU and several of its Member States are developing policy strategies with the aim of improving their leadership positions. These strategies contribute to the framing of the field of gene and cell therapy in Europe, especially via evolution in regulation.
Considering both the European Union level and the national level, this workshop will provide an overview and discuss with policy- and law-makers, and regulators, the policy strategies at stake and their current and prospective impact on the regulation of gene and cell therapy in Europe.
Presentations:
European Union policies and their impact on ATMP Research and Innovation
By Anna-Pia Papageorgiou, European Commission DG Research and Innovation
By Emmanuel Dequier, representative of the French Ministry of Research
Support for ATMPs development in Spain: the (central) role of the Spanish Medicines Agency (AEMPS)
By Marcos Timon, The Spanish Agency of Medicines and Medical Devices (AEMPS)
Please follow each of the hyperlinks above to the presentation slides.