Regulatory Standards in Orphan Medicinal Product Designation in the EU

Twenty years of orphan regulation in Europe have now elapsed, with almost 2,400 orphan designated medicinal products and more than 190 orphan products authorised in the EU. Alongside the evolution in understanding of rare diseases, considerable regulatory knowledge has also been accumulated regardin...

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Detalles Bibliográficos
Autores principales: Tsigkos, Stelios, Mariz, Segundo, Sheean, Maria Elzbieta, Larsson, Kristina, Magrelli, Armando, Stoyanova-Beninska, Violeta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268149/
https://www.ncbi.nlm.nih.gov/pubmed/34249982
http://dx.doi.org/10.3389/fmed.2021.698534

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268149/
https://www.ncbi.nlm.nih.gov/pubmed/34249982
http://dx.doi.org/10.3389/fmed.2021.698534

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