Europe – CAT monthly report of application procedures, guidelines and related documents on advanced therapies

The Committee for Advanced Therapies (CAT) held its 119th meeting on 9 – 11 October 2019.

The CAT Monthly Report includes statistical data on CAT scientific recommendations on Advanced Therapy Medicinal Product (ATMP) classification, certifications, initial evaluations, CAT contributions to Scientific Advice and Paediatric Investigation Plans, as well as variations, line extensions, renewals.

Scientific recommendation on advanced therapy product classification

Further to consultation with the European Commission, the CAT finalised 7 scientific recommendations on the classification of advanced therapy medicinal products.

The following products were classified as a tissue engineered products

• Adipose tissue derived mesenchymal stem cells, intended for the treatment of diabetic foot ulcers;
• Adipose tissue derived mesenchymal stem / stromal cells, intended for the treatment of bone and cartilage defects including osteoarthritis;
• Combination of platelet-rich plasma and stromal vascular fraction, intended for wound healing as additional therapy to fistula surgery in patients with complex and therapy refractory perianal fistula…