EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation

Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission. In common with other medicinal products, various r...

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Detalles Bibliográficos
Autores principales: Detela, Giulia, Lodge, Anthony
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Gene & Cell Therapy 2019
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6378853/
https://www.ncbi.nlm.nih.gov/pubmed/30815512
http://dx.doi.org/10.1016/j.omtm.2019.01.010

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6378853/
https://www.ncbi.nlm.nih.gov/pubmed/30815512
http://dx.doi.org/10.1016/j.omtm.2019.01.010

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