EMA releases guidance on advanced therapy product classification
Publishes six detailed guidelines
The European Medicines Agency (EMA) has released six detailed guidelines on classifying cutting-edge advanced therapy medicinal products. These include, for example, those based on ex vivo autologous corneal epithelium containing stem cells.
Another definition focuses on medicines based on viable autologous keratinocytes and melanocytes grown on an AS210 matrix.
The other four are pharmaceuticals using allogeneic activated leukocytes; ex vivo expanded autologous skeletal myoblasts; retinal pigment epithelium cells derived from human induced pluripotent stem cells; and genetically modified adenovirus coding for human granulocyte-macrophage colonies.
The classification states what the target treatment of these medicines should be. For instance, the allogeneic activated leukocytes are designed to treat chronic lower extremity ulcers in adult diabetic patients. And it states the intended production method. In this case, for instance, the medicine 'contains somatic cells that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered'.