Advanced therapy medicinal products comprise gene therapy products (e.g. a DNA plasmid or human gene to proliferate arterial cells), somatic cell therapy products (e.g. cell lysates to counter renal cancer) and tissue engineered products (e.g. skin substitutes that merge with natural skin to treat venous ulcers and foot skin ulcers). Both gene therapy and sometic cell therapy products (classified as “medicinal products”) are currently regulated under the Medicinal Products Directive (2003/63/EC). A current commission proposal aims at establishing a harmonised EU regulatory framework for human tissue engineered products.
