With the introduction of the Advanced Therapy Medicinal Products Regulation (Regulation No. 1394/2007), the European Medicines Agency’s Committee for Advanced Therapies (CAT) introduced an optional and free of charge procedure for the classification of ATMPs as somatic cell therapy medicinal products (SCTMPs), gene therapy medicinal products (GTMPs), and tissue-engineered products (TEPs). The aim of this ATMP Classification procedure is to enable developers of such products, particularly those which may be borderline, understand the appropriate regulatory framework that applies to their product.
In 2012, the CAT published the Reflection Paper on Classification of ATMPs (document number EMA/CAT/600280/2010), which provides guidance on the ATMP Classification procedure based on experience from applications received. Following a consultation period, the CAT has now adopted the reflection paper and the final version can be accessed from the EMA website. This reflection paper provides valuable guidance for product developers considering using the ATMP Classification procedure.
Author: Patrick Ginty