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 responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products.
Papaluca Amati
Marisa
M
Pignatti
Francesco
F
Nolte
Alexis
A
Amerasinghe
Nirosha
N
Gustafsson
Daniel
D
Moulon
Isabelle
I
Le Courtois
Patrick
P