Regulatory News

EMA Unveils 19 Advanced Therapy Product Classifications

The European Medicines Agency (EMA) on Tuesday released a host of classification decisions for advanced therapies being developed to treat various types of tissue damage, including burns, scars and non-healing wounds.

The agency, through its Committee for Advanced Therapies (CAT), offers sponsors an optional consultation to determine whether a product meets the criteria for an advanced-therapy medicinal product (ATMP). The classification procedure is laid out in Article 17 of Regulation (EC) No 1394/2007, which states:

"Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product," the regulation says.

The procedure is intended to help sponsors when their product borders between different classifications, such as a product that combines a tissue-based product and a medical device.

Once EMA has consulted with the European Commission for a decision under this procedure, the agency publishes its decision after removing or redacting any proprietary or confidential information.

Due to the complex and novel nature of ATMPs, they are required to be submitted via the centralised procedure and cannot be approved directly by a national regulatory authority.

In total, the agency issued 19 classification decisions, 17 of which were classified as tissue engineered products, and one that was classified as a somatic cell therapy. The one product that did not meet the criteria for an ATMP was a decellularized matrix made from pig skin, which EMA said did not contain viable tissue or cells and is not a gene therapy.

EMA