The lowdown: In December 2008, a new regulation on advanced therapy medicinal products (ATMPs) came into effect in the European Union (EU) (regulation no. 1394/2007). The regulation established the Committee for Advanced Therapies (CAT), which now assesses all marketing authorization applications for ATMPs developed in the EU and reports its findings to the Committee for Medicinal Products for Human Use (CHMP). The first ATMP, which was authorized for marketing by the EMEA's CAT and CHMP on 26 June 2009, is ChondroCelect (consisting of characterized viable autologous cartilage-forming cells, expanded ex vivo, expressing specific marker proteins) for the treatment of adults with single-symptom cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society grade III or IV). The cartilage-forming cells (chondrocytes) are taken from a small biopsy of healthy cartilage from the patient, grown outside the body and then surgically re-implanted with the aim of repairing cartilage defects by the formation of durable cartilage. The ultimate goal of the treatment is to reduce the risk of developing knee osteoarthritis in the long term.
Also, the CAT has adopted its first scientific recommendation on the classification of an ATMP for a somatic-cell therapy medicinal product intended for the treatment of chronic venous leg ulcers. It is composed of substantially modified human allogeneic fibroblasts and keratinocytes, administered in conjunction with fibrin as a structural component. All requests for classification are assessed by the CAT (see http://www.emea.europa.eu/htms/human/advanced_therapies/atmp_classification.htm).
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