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The European Commission published a white paper about "Anticipation of regulatory needs for nanotechnology-enabled health products"

 

Development of nanotechnology-based applications in health sector offer innovative therapeutic and diagnostic opportunities to address medical needs. At the moment, no specific regulatory framework exists for nano-enabled health products.

 

The white paper, published by the European Commission, summarizes the major challenges associated with the regulation of the nano-enabled health products. Depending on their mode of action nano-enabled health products are regulated either as medicinal products or medical devices. However, due to the increased complexity of such products and their size-related properties the selection of the regulatory path can become challenging since the primary mode of action might be difficult to determine.

For the nano-enabled health products classified as medical devices, the European Definition on nanomaterials will apply, determining its further classification and regulatory requirements. 

The regulatory challenges highlighted in this white paper should guide the research projects and the involved communities willing to advance the regulatory science in the area of nanomedicine.

 

More infos about the paper can be found here.