Academic challenges on advanced therapy medicinal products’ development: a regulatory perspective

Author:

Olesti EulaliaORCID,Nuevo Yoana,Bachiller Mireia,Guillen Elena,Bascuas Juan,Varea Sara,Saez-Peñataro JoaquínORCID,Calvo Gonzalo

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics (clinical),Oncology,Immunology,Immunology and Allergy

Reference56 articles.

1. EMA. Advanced therapies medicinal products: overview. https://www.ema.europa.eu/en/human-regulatory/overview/advanced-therapy-medicinal-products-overview (2022). [accessed 01.04.2023].

2. European Comission. Advanced therapies. https://ec.europa.eu/health/medicinal-products/advanced-therapies_es (2022). [accessed 01.04.2023]

3. Official Journal of the European Union. Comission Directive 2009/120/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 as regards advanced therapy medicinal products. (2009). https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF

4. An assessment of the hospital exemption landscape across European Member States: regulatory frameworks, use and impact;Hills;Cytotherapy,2020

5. Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products;Cuende;Cytotherapy,2022

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