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oai:uvadoc.uva.es:10324/461892026-01-13T20:00:38Zcom_10324_40357com_10324_952com_10324_894com_10324_1133com_10324_931col_10324_40358col_10324_1209

López Paniagua, Marina De La Mata Sampedro, Ana Galindo de la Rosa, Sara Blázquez Araúzo, Francisco Calonge, Margarita Nieto Miguel, Teresa 2021-04-14T09:31:36Z 2021-04-14T09:31:36Z 2021 Pharmaceutics. 2021; 13(3):347. 1999-4923 http://uvadoc.uva.es/handle/10324/46189 10.3390/pharmaceutics13030347 1 13(3) 18 Pharmaceutics 13 1999-4923 Producción Científica Advanced therapy medicinal products (ATMPs) are a group of innovative and complex biological products for human use that comprises somatic cell therapy medicinal products, tissue engineered products, gene therapy medicinal products, and the so-called combined ATMPs that consist of one of the previous three categories combined with one or more medical devices. During the last few years, the development of ATMPs for the treatment of eye diseases has become a fast-growing field as it offers the potential to find novel therapeutic approaches for treating pathologies that today have no cure or are just subjected to symptomatic treatments. Therefore, it is important for all professionals working in this field to be familiar with the regulatory principles associated with these types of innovative products. In this review, we outline the legal framework that regulates the development of ATMPs in the European Union and other international jurisdictions, and the criteria that each type of ATMP must meet to be classified as such. To illustrate each legal definition, ATMPs that have already completed the research and development stages and that are currently used for the treatment of eye diseases are presented as examples. Junta de Castilla y León (Consejería de Educación) y el Fondo Social Europeo de Desarrollo Regional (subvención VA168P18) Ministerio de Ciencia e Innovación y Agencia Estatal de Investigación (subvención PID2019-105525RB-100/AEI/10.13039/501100011033) Instituto Nacional de Salud Carlos III, CIBER-BBN (CB06/01/003 MICINN/FEDER, UE) application/pdf eng MDPI info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by/4.0/ © 2021 The Author(s) Attribution 4.0 Internacional Cell therapy Terapia celular Tissue engineering Ingeniería de tejidos Gene therapy Terapia génica Ophthalmology Oftalmología Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion https://www.mdpi.com/1999-4923/13/3/347/htm SI