Regulation and Standardi Sation of Gene Transfer Products in the European Union

In Germany gene therapy is used as a general term for human somatic gene and (genetically modified) cell therapy. It encompasses the use of recombinant drugs in humans. These drugs are on the one hand naked DNA, viral or non-viral vectors in vivo, or, on the other hand, genetically modified cells in vivo. The active ingredient is the gene product made in vivo, and thus, indirectly, also the gene to be delivered. The vector, if used, may be considered as a component of the drug. The formulation may contain additional ingredients.