COST Action CA21113 GenE-HumDi WG6 Meeting. Regulatory Frameworks and Clinical Applications in Genome editing: Formulating Guidelines and Industrial Agreements
On October 7, 2025 , The WG6 held a session focused on advancing shared understanding and alignment of regulatory, ethical, and clinical frameworks for genome editing (GE) applications within Europe. The aim was to identify key challenges and review existing ethical and regulatory responses in light of the rapid increase in new GE tools ready for application in clinical settings throughout Europe. This critical review will enable the development of updated, appropriate and robust frameworks that will meet the needs of various stakeholders, balancing harmonization with subsidiarity, and that offer recommendations for developing coherent European and potentially global guidelines in governing clinical translation of GE technologies.
The program revolved around critical topics in the field:
- Regulatory Frameworks for GE: A Key Deliverable for the GenE-HumDi COST Network.
- Overview of EU Regulatory Framework for ATMPs.
- International Harmonization and Preclinical Requirements.
- Ethical, Legal, and Social Implications (ELSI).
- Regulatory Guidelines and Clinical Roadmaps.
- Planning an EU-Level Intervention.
- WG6 Collaborative Publications and Regulatory Roadmap.
And let to an open table discussion on Regulatory Frameworks and guidelines for Genome Editing and ATMPs.
The assistants including: Maria Ortíz Bueno; Rafael Cuervas; Paula Heredia Velázquez; Oliver Feeney; Viviana Giannuzzi; María del Mar Macías-Sánchez; Jose-Carlos Segovia; Petros Patsali; Claudio Mussolino; Aurélie Mahalatchimy; Alessia Cavazza; Carsten Werner Lederer; Gloria Carmona Sanchez; Karim Benabdellah; resolved to draft a concept note for a European Genome Editing Roadmap, integrating regulatory, ethical, and clinical perspectives.
To close the session, Dr Lederer invited attendees to propose ideas for venues and synergies of a future meeting with other events or scientific society meetings. He once more called for collaboration on the nascent WG6 drafts to those present and to their contacts bringing in complementary regulatory or business experience, to leave no gap from GE conception to commercialization in the output of GenE-HumDi. Therefore, this closing reaffirmed the group’s dedication to responsible innovation, grounded in equity, safety, and interdisciplinary dialogue.
GenE-Humdi members can access the full report in the Private Area:
Alternatively, refer to the public version deposited in Zenodo, doi: 10.5281/zenodo.17608400
