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Título
Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework
Autor
Año del Documento
2021
Editorial
MDPI
Descripción
Producción Científica
Documento Fuente
Pharmaceutics. 2021; 13(3):347.
Abstract
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.
Palabras Clave
Cell therapy
Terapia celular
Tissue engineering
Ingeniería de tejidos
Gene therapy
Terapia génica
Ophthalmology
Oftalmología
ISSN
1999-4923
Revisión por pares
SI
Patrocinador
Department of Education, Castilla y León Regional Government (Grant VA168P18 FEDER, EU) Spain; Ministry of Science and Innovation (Grant PID2019-105525RB-100, MICINN/FEDER, EU), Spain; Institute of Health Carlos III, CIBER-BBN (CB06/01/003 MICINN/FEDER, EU), Spain; Regional Center for Regenerative Medicine and Cell Therapy of Castilla y León, Spain.
Version del Editor
Idioma
eng
Tipo de versión
info:eu-repo/semantics/publishedVersion
Derechos
openAccess
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