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EMEA and Gene Therapy Medicinal Products Development in the European Union

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The...

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Detalles Bibliográficos
Autores principales: Papaluca Amati, Marisa, Pignatti, Francesco, Nolte, Alexis, Amerasinghe, Nirosha, Gustafsson, Daniel, Moulon, Isabelle, Le Courtois, Patrick
Formato: Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2003
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC179762/
https://www.ncbi.nlm.nih.gov/pubmed/12686717
http://dx.doi.org/10.1155/S1110724303209104