Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer’s, cancer or muscular dystrophy. They have huge potential for patients and industry.
The lack of an EU-wide regulatory framework in the past led to divergent national approaches which hindered patients’ access to products, hampered the growth of this emerging industry and ultimately affected EU competitiveness in a key biotechnology area.
The EU institutions agreed on a Regulation on advanced therapies (Regulation (EC) 1394/2007) designed to ensure the free movement of advanced therapy products within Europe, to facilitate 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.
To read more about advanced therapy medicinal products on the European Commission website go to: Advanced therapies – European Commission