A bibliographic research was conducted with the expressions “Innovation Task Force” and “Briefing meeting”, in English and in French between the 18 and 31 March 2025, in the following databases: Dalloz, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Cairn revues, Bibliothèque numérique en droit de la santé, Lamyline Reflex, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.
Please find below the most relevant results of this review:
Ancans, Janis. ‘Cell Therapy Medicinal Product Regulatory Framework in Europe and Its Application for MSC-Based Therapy Development’. Frontiers in Immunology 3 (14 August 2012).
https://doi.org/10.3389/fimmu.2012.00253
Pignatti, Francesco, Falk Ehmann, Robert James Hemmings, and Bertil Jonsson. ‘Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union | Clinical Cancer Research | American Association for Cancer Research’. Clinical Cancer Research 20, no. 6 (15 March 2014): 1458–1468.
https://doi.org/10.1158/1078-0432.CCR-13-1571
Rodríguez-Gómez, Francisco D., Dominique Monferrer, Oriol Penon, and Pilar Rivera-Gil. ‘Regulatory Pathways and Guidelines for Nanotechnology-Enabled Health Products: A Comparative Review of EU and US Frameworks’. Frontiers in Medicine 12 (5 March 2025).
https://doi.org/10.3389/fmed.2025.1544393
Uster, David W., Valentina Cordo, Emmanuel Cormier, and Falk Ehmann. ‘Insights into Early Interactions on Innovative Developments with European Regulators’. Therapeutic Innovation & Regulatory Science 58, no. 6 (1 November 2024): 1108–1119.
https://doi.org/10.1007/s43441-024-00686-7
Verbeken, Gilbert, Jean-Paul Pirnay, Daniel De Vos, Serge Jennes, Martin Zizi, Rob Lavigne, Minne Casteels, and Isabelle Huys. ‘Optimizing the European Regulatory Framework for Sustainable Bacteriophage Therapy in Human Medicine’. Archivum Immunologiae et Therapiae Experimentalis 60, no. 3 (1 June 2012): 161–172.
https://doi.org/10.1007/s00005-012-0175-0
