Abstract

Get full access to this article
View all access options for this article.
References
1.Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 . Off J , 2007 ; L324 :121 –137 .
2.Commission Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use . Off J , 2001 ; L311 :67 –128 .
3.Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use . Off J , 2003 ; L159 :46 –94 .
4.Real Decreto 477/2014, de 13 de junio, por el que se regula la autorización de medicamentos de terapia avanzada de fabricación no industrial . Available from: https://www.boe.es/diario_boe/txt.php?id=BOE-A-2014-6277
5.Terapias Avanzadas . Available from: https://www.boe.es/eli/es/rd/2014/06/13/477
6.Preguntas y respuestas sobre el Real Decreto 477/2014, de 13 de junio por el que se regula la autorización de medicamentos de terapia avanzada de fabricación no industrial . Available from: www.aemps.gob.es/medicamentos-de-uso-humano/medicamentos-de-fabricacion-no-industrial/preguntas-y-respuestas-sobre-el-real-decreto-477-2014-de-13-de-junio-por-el-que-se-regula-la-autorizacion-de-medicamentos-de-terapia-avanzada-de-fabricacion-no-industrial/?lang=en#p2
7.EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products . 29 September, 2022 . Available from: www.ema.europa.eu/en/news/ema-pilot-offers-enhanced-support-academic-and-non-profit-developers-advanced-therapy-medicinal-products
8.Listado de autorización de uso . Available from: www.aemps.gob.es/medicamentos-de-uso-humano/medicamentos-de-fabricacion-no-industrial/terapias-avanzadas/listado-de-autorizacion-de-uso/
9.Advanced therapy medicines: Exploring solutions to foster development and expand patient access in Europe. Outcome of a multi-stakeholder meeting with experts and regulators held at EMA on Friday 27 May 2016 (EMA/345874/2016) . Available from: www.ema.europa.eu/en/documents/report/outcomes-workshop-multi-stakeholder-advanced-therapy-medicinal-products-atmps-expert-meeting-exploring-solutions-foster-atmps-development-and-patient-access-europe_en.pdf
10.
Valsecchi
MC
. Rescue of an orphan drug points to a new model for therapies for rare diseases . Nature News , 2023 ; doi: 10.1038/d43978-023-00145-1
