A Not-Yet-Defined Field

The development of nanotechnology-based applications in the health sector offers innovative therapeutic and diagnostic opportunities to address medical needs. At the moment, no specific regulatory framework exists for nanotechnology-enabled health products, but the current regulatory practice requires additional guidance documents in order to fully cover the particularities of such products (see Refine).

A regulatory framework is needed in order to give companies and academia a safe guidance on how to develop novel therapies. Here are some current challenges: