On the edge of new technologies (advanced therapies, nanomedicines)

Nanotechnology-based and advanced therapy medicinal products are at the cutting edge of innovation in translational drug development, potentially offering new treatment approaches for diseases with limited or no therapeutic alternatives. Their development from the laboratory to the clinic poses specific scientific and regulatory challenges, and some debate has recently arisen about the adequacy of the current EU regulatory framework for the assessment of quality, safety and efficacy of these medicinal products.