Advanced-Therapy Medicinal Products
Advanced therapy medicinal products (ATMPs) are medicines based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). Advanced therapies are revolutionary treatments for a number of diseases or injuries, such as skin in burn victims, Alzheimer's, cancer or muscular dystrophy*.
ATMPs are covered by Regulation (1394/2007) , designed ‘to ensure their free movement within Europe, to facilitate their access to the EU market and to foster the competitiveness of European companies in the field, while guaranteeing the highest level of health protection for patients’ ** .
*, ** see this link for more info
In addition, like any other medicinal products, ATMPs must also comply with the requirements set forth by the legislation applicable to pharmaceuticals (such as clinical trials, pharmacovigilance). ATMPs are also impacted by the directives related to blood (Directive 2002/98/EC) as well as human tissues and cells (Directive 2004/23/EC).
EuropaBio member companies, and in particular a number of SMEs, are involved in the research and development of ATMPs and they are supportive of the implementation of Regulation (EC) 1394/2007.