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CAT scientific recommendation

A literature review was conducted with the expressions “CAT Scientific recommendation” and “CAT classification”, in English and in French between the 3 and 4 February 2025, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Brill and Cairn, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.

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.

Boráň, Tomáš, Margarida Menezes-Ferreira, Ilona Reischl, Patrick Celis, Nicolas Ferry, Bernd Gänsbacher, Hartmut Krafft, Michele Lipucci di Paola, Dariusz Sladowski, and Paula Salmikangas. ‘Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?’ Human Gene Therapy Clinical Development 28, no. 3 (September 2017): 126–135. https://doi.org/10.1089/humc.2016.193.

Farkas, Andreas M., Segundo Mariz, Violeta Stoyanova-Beninska, Patrick Celis, Spiros Vamvakas, Kristina Larsson, and Bruno Sepodes. ‘Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe’. FRONTIERS IN MEDICINE 4 (16 May 2017): 53. https://doi.org/10.3389/fmed.2017.00053.

Flory, Egbert, and Jens Reinhardt. ‘European Regulatory Tools for Advanced Therapy Medicinal Products’. Transfusion Medicine and Hemotherapy 40, no. 6 (December 2013): 409–412. https://doi.org/10.1159/000356364.

Goetz, Karen Brigitta, Yuansheng Sun, Katrin Féchir, Evelyne Kretzschmar, and Isabel Buettel. ‘Regulatory Aspects and Approval of Biopharmaceuticals for Mucosal Delivery: Quality, Toxicology, and Clinical Aspects’. In Mucosal Delivery of Biopharmaceuticals, 539–589. Springer, Boston, MA, 2014. https://doi.org/10.1007/978-1-4614-9524-6_25.

Izeta, Ander, Concha Herrera, Rosario Mata, Giuseppe Astori, Rosaria Giordano, Carmen Hernández, Laura Leyva, et al. ‘Cell-Based Product Classification Procedure: What Can Be Done Differently to Improve Decisions on Borderline Products?’ Cytotherapy 18, no. 7 (1 July 2016): 809–815. https://doi.org/10.1016/j.jcyt.2016.03.292.

Jekerle, V., C. Schröder, and E. Pedone. ‘Legal Basis of the Advanced Therapies Regulation’. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 53, no. 1 (1 January 2010): 4–8. https://doi.org/10.1007/s00103-009-0990-6.

Mittra, J., J. Taït, M. Maestroni, and M.L. Turner. ‘Identifying Viable Regulatory and Innovation Pathways for Regenerative Medicine: A Case Study of Cultured Red Blood Cells’. New Biotechnology 32, no. 1 (25 January 2015): 180–90. https://doi.org/10.1016/j.nbt.2014.07.008.

Raposio, Edoardo, and RosaGemma Ciliberti. ‘Clinical Use of Adipose-Derived Stem Cells: European Legislative Issues’. Annals of Medicine and Surgery 24 (1 December 2017): 61–64. https://doi.org/10.1016/j.amsu.2017.11.002.

Salmikangas, Paula, Martina Schuessler-Lenz, Sol Ruiz, Patrick Celis, Ilona Reischl, Margarida Menezes-Ferreira, Egbert Flory, Matthias Renner, and Nicolas Ferry. ‘Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective’. In Regulatory Aspects of Gene Therapy and Cell Therapy Products, 103–130. Springer, Cham, 2015. https://doi.org/10.1007/978-3-319-18618-4_6.

Salvatore, Vincenzo. ‘Exploring Solutions to Foster ATMP Development and Access to Patients in Europe Special Issue: Innovative Medicine and Research: Ethical, Legal and Regulatory Issues’. European Journal of Health Law 27, no. 3 (2020): 259–273. https://doi.org/10.1163/15718093-BJA10016.

Scherer, Jürgen, and Egbert Flory. ‘[Classification of cell-based medicinal products and legal implications: An overview and an update]’. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 58, no. 11–12 (November 2015): 1201–1206. https://doi.org/10.1007/s00103-015-2235-1.

Schuessler-Lenz, Martina, Carla Herberts, Ilona Reischl, Sol Ruiz, Patrick Celis, Claire Beuneu, Rune Kjeken, and Marcos Timón. ‘Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe’. In Regulatory Aspects of Gene Therapy and Cell Therapy Products, 1–21. Springer, Cham, 2023. https://doi.org/10.1007/978-3-031-34567-8_1.

Schüssler-Lenz, Martina, Claire Beuneu, Margarida Menezes-Ferreira, Veronika Jekerle, Jozef Bartunek, Steven Chamuleau, Patrick Celis, et al. ‘Cell-Based Therapies for Cardiac Repair: A Meeting Report on Scientific Observations and European Regulatory Viewpoints’. European Journal of Heart Failure 18, no. 2 (2016): 133–141. https://doi.org/10.1002/ejhf.422.

Vamvakas, Spiros, Jorge Martinalbo, Ruben Pita, and Maria Isaac. ‘On the Edge of New Technologies (Advanced Therapies, Nanomedicines)’. Drug Discovery Today: Technologies, Innovative Methods in Drug Regulatory Sciences (EMA), 8, no. 1 (1 March 2011): e21–28. https://doi.org/10.1016/j.ddtec.2011.04.001.

Voltz-Girolt, C., P. Celis, M. Boucaumont, L. D’Apote, M.-H. Pinheiro, and M. Papaluca-Amati. ‘The Advanced Therapy Classification Procedure’. Bundesgesundheitsblatt – Gesundheitsforschung – Gesundheitsschutz 54, no. 7 (1 July 2011): 811–815. https://doi.org/10.1007/s00103-011-1309-y.

Wilde, Sofieke de, Henk-Jan Guchelaar, Maarten Laurens Zandvliet, and Pauline Meij. ‘Clinical Development of Gene- and Cell-Based Therapies: Overview of the European Landscape’. Molecular Therapy – Methods & Clinical Development 3 (1 January 2016): 16073. https://doi.org/10.1038/mtm.2016.73.