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...

Full description

Bibliographic Details
Main Authors: Marisa Papaluca Amati, Francesco Pignatti, Alexis Nolte, Nirosha Amerasinghe, Daniel Gustafsson, Isabelle Moulon, Patrick Le Courtois
Format: Article
Language:English
Published: Hindawi Limited 2003-01-01
Series:Journal of Biomedicine and Biotechnology
Online Access:http://dx.doi.org/10.1155/S1110724303209104