Regulatory requirements for clinical trial and marketing authorisation application for gene therapy medicinal products
| Autor: | G. Narayanan, S. Longhurst, Matthias Renner, Silke Schüle |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Marketing of Health Services
Clinical Trials as Topic Quality Assurance Health Care business.industry Genetic enhancement Public Health Environmental and Occupational Health MEDLINE Authorization Gene Transfer Techniques Legislation Gene transfer Guidelines as Topic Genetic Therapy Clinical trial Consumer Product Safety Medicine media_common.cataloged_instance Humans European Union European union Marketing business Genetic Engineering media_common |
| Zdroj: | Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 53(1) |
| ISSN: | 1437-1588 |
| Popis: | Over the last two decades, clinical trials using gene therapy medicinal products (GTMPs) have been carried out for a large number of rare, inherited monogeneic disorders as well as common multigeneic diseases such as cancer, cardiovascular and infectious diseases including AIDS. Despite some early difficulties and setbacks, the gene therapy field has slowly progressed and, nowadays, offers the promise of novel treatments for a growing number of diseases. On the other hand, gene therapy approaches are often associated with additional risks due to limited clinical experience with a given gene transfer system, long-lasting effects of the therapeutic gene, and/or a complex mode of action. As a result, specific regulations and guidelines have been introduced within the EU to help address these uncertainties. This article summarises the legislative framework and will provide an overview on the regulatory requirements for clinical trials and marketing authorisation applications. |
| Databáze: | OpenAIRE |
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