The EMA as a potential driver of competitiveness of orphan medicines in Europe: a focus on regulatory incentives and funding opportunities

Abstract The revision of the European Union (EU) Pharmaceutical Legislation aims for a competitive environment for innovation in the EU, including actions to support the development and approval of orphan medicines. In this article, we look at the Food and Drug Administration (FDA) for references to...

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Detalhes bibliográficos

Principais autores:	Maria Ana Gomez-Ferreria, Virginia Garcia-Muñoz, Alex Zwiers
Formato:	Artigo
Idioma:	Inglês
Publicado em:	BMC 2025-10-01
coleção:	Orphanet Journal of Rare Diseases
Assuntos:	Orphan drugs Orphan medicines Clinical trials Priority Review Voucher (PRV) Rare Paediatric Disease Pharmaceutical legislation
Acesso em linha:	https://doi.org/10.1186/s13023-025-04095-3
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