EMEA and Gene Therapy Medicinal Products Development in the European Union

[摘要] The evaluation of quality, safety, and efficacy of medicinalproducts by the European Medicines Evaluation Agency (EMEA) viathe centralized procedure is the only available regulatoryprocedure for obtaining marketing authorization for gene therapy(GT) medicinal products in the European Union. Theresponsibility for the authorization of clinical trials remainswith the national competent authorities (NCA) acting in aharmonized framework from the scientific viewpoint. With theentry into force of a new directive on good clinical practiceimplementation in clinical trials as of 1 May 2004, proceduralaspects will also be harmonized at EU level. Scientifically sounddevelopment of medicinal products is the key for the successfulregistration of dossiers and for contributing to the promotionand protection of public health. The objective of this paper isto introduce the EMEA regulatory processes and scientificactivities relevant to GT medicinal products.

[学科分类] 基础医学