A bibliographic research was conducted with the expression “ATMP certification procedure”, in English and in French from 22 to 29 April 2025, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Brill revues – Archives ISTEX, Cairn revues, 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.
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.
Berger, A., S. Schuele, and E. Flory. ‘The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises’. BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ 54, no. 7 (July 2011): 816–821. https://doi.org/10.1007/s00103-011-1301-6.
Carvalho, Marta, Ana Paula Martins, and Bruno Sepodes. ‘Hurdles in Gene Therapy Regulatory Approval: A Retrospective Analysis of European Marketing Authorization Applications’. Drug Discovery Today 24, no. 3 (1 March 2019): 823–828.
https://doi.org/10.1016/j.drudis.2018.12.007.
Salvatore, Vincenzo. ‘Exploring Solutions to Foster ATMP Development and Access to Patients in Europe’, 28 May 2020. https://doi.org/10.1163/15718093-BJA10016.
Schneider, Christian K., Paula Salmikangas, Bernd Jilma, Bruno Flamion, Lyubina Racheva Todorova, Anna Paphitou, Ivana Haunerova, et al. ‘Challenges with Advanced Therapy Medicinal Products and How to Meet Them’. Nature Reviews Drug Discovery 9, no. 3 (March 2010): 195–201. https://doi.org/10.1038/nrd3052.
