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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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Foilsithe in:Front Med (Lausanne)
Main Authors: Tsigkos, Stelios, Mariz, Segundo, Sheean, Maria Elzbieta, Larsson, Kristina, Magrelli, Armando, Stoyanova-Beninska, Violeta
Formáid: Artigo
Teanga:Inglês
Foilsithe: Frontiers Media S.A. 2021
Ábhair:
Rochtain Ar Líne:https://ncbi.nlm.nih.gov/pmc/articles/PMC8268149/
https://ncbi.nlm.nih.gov/pubmed/34249982
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fmed.2021.698534
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