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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...
Autores principales: | Papaluca Amati, Marisa, Pignatti, Francesco, Nolte, Alexis, Amerasinghe, Nirosha, Gustafsson, Daniel, Moulon, Isabelle, Le Courtois, Patrick |
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Formato: | Texto |
Lenguaje: | English |
Publicado: |
Hindawi Publishing Corporation
2003
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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 |
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