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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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Dades bibliogràfiques
Autors principals: Papaluca Amati, Marisa, Pignatti, Francesco, Nolte, Alexis, Amerasinghe, Nirosha, Gustafsson, Daniel, Moulon, Isabelle, Le Courtois, Patrick
Format: Artigo
Idioma:Inglês
Publicat: Hindawi Publishing Corporation 2003
Matèries:
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC179762/
https://ncbi.nlm.nih.gov/pubmed/12686717
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1155/S1110724303209104
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