The treatment with human cells for an increasing group of pathologies represents a field of the medicine in fast evolution, characterized by important clinical potentialities and expectations. The law regulating the field is different for cellular transplant and cell and/or tissue engineering. In the first case the transplant laws are applied (91/99 Italian Law and European Directive 2004/23/EC), while, in the second one, the transplant law applies only for the donation and appraisal of suitability of cells and tissues and the remaining activities answer to the pharmaceutical law being considered drugs for the somatic cellular therapy. Recently, the European Commission has published a proposal of regulation for the medicinal products of advanced therapy that comprises drugs for gene and somatic cell therapies and the products for tissue engineering. Such a proposal will have to be approved by the Parliament and the European Council and will be operative at the end of 2007.
|Translated title of the contribution||Transplantation and tissue engineering: Italian law and research|
|Number of pages||5|
|Publication status||Published - Dec 2005|
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