RT info:eu-repo/semantics/article
T1 Advanced Therapy Medicinal Products for the Eye: Definitions and Regulatory Framework
A1 López Paniagua, Marina
A1 De La Mata Sampedro, Ana
A1 Galindo de la Rosa, Sara
A1 Blázquez Araúzo, Francisco
A1 Calonge, Margarita
A1 Nieto Miguel, Teresa
K1 Cell therapy
K1 Terapia celular
K1 Tissue engineering
K1 Ingeniería de tejidos
K1 Gene therapy
K1 Terapia génica
K1 Ophthalmology
K1 Oftalmología
AB 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.
PB MDPI
SN 1999-4923
YR 2021
FD 2021
LK http://uvadoc.uva.es/handle/10324/46189
UL http://uvadoc.uva.es/handle/10324/46189
LA eng
NO Pharmaceutics. 2021; 13(3):347.
NO Producción Científica
DS UVaDOC
RD 22-dic-2024