Advanced Therapy Medicinal Products

The Advanced Therapy Medicinal Products (ATMPs) include gene therapy and somatic cell therapy medicinal products and tissue engineered products, for which the starting materials involve genes and their vectors (viruses, plasmids) and viable cells/ tissues. Regulation (1394/2007/EC ) for ATMPs came into force in EU in 2009 and with that the centralised MA process became mandatory for these products. ATMPs can also contain medical devices (e.g. structural components, matrices) and in such cases they are considered as combination products.

The EMA´s Committee for Advanced Therapies (CAT) is responsible for the assessment of MAAs of ATMPs together with CHMP. Along with the regulation the deficitions of ATMPs were revised and Directive 2001/83/EC was renewed with regards to the technical requirements of these products (implementing directive 2009/120/EC). In addition to evaluation of MA applications, the CAT gives recommendations concerning classification of ATMPs and evaluates quality and non-clinical studies of ATMP certification applications. The guidelines for classification and certification can be found on the CAT webpage, as well as agendas and minutes of the monthly CAT meetings.

Summaries of all CAT classification recommendations are available online: Scientific recommendations on classification of advanced therapy medicinal products

Outside of the ATMP regulation have been left ATMPs that are produced under a national manufacturing license (so-called hospital exemption, article 28). This manufacturing is regulated by article 15c of the Finnish Medicines Act and it requires a license from Fimea.