EMEA and Gene Therapy Medicinal Products Development in the European Union
| Autor: | Isabelle Moulon, Francesco Pignatti, Nirosha Amerasinghe, Alexis Nolte, Daniel Gustafsson, Marisa Papaluca Amati, Patrick Le Courtois |
|---|---|
| Rok vydání: | 2003 |
| Předmět: |
Knowledge management
lcsh:Biotechnology Health Toxicology and Mutagenesis media_common.quotation_subject lcsh:Medicine lcsh:Chemical technology Bioinformatics Marketing authorization lcsh:Technology Promotion (rank) lcsh:TP248.13-248.65 Report Agency (sociology) Genetics media_common.cataloged_instance Medicine lcsh:TP1-1185 Quality (business) European union Molecular Biology media_common lcsh:T business.industry lcsh:R General Medicine Directive Clinical trial Good clinical practice Molecular Medicine business Biotechnology |
| Zdroj: | Journal of Biomedicine and Biotechnology Journal of Biomedicine and Biotechnology, Vol 2003, Iss 1, Pp 3-8 (2003) |
| ISSN: | 1110-7251 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|