Classification system for nanotechnology-enabled health products with both scientific and regulatory application

The lack of specific regulatory guidelines for nanotechnology-enabled health products (NHPs) is hampering development and patient access to these innovative technologies. Namely, there an urgent need harmonized definitions classification systems that allow establishing a standardized framework NHPs assessment. In this work, novel system proposed. This can be applied sorting nano-based innovations according the type they address. Said methodology combines scientific principles it based on following criteria: principal mode action, chemical composition, medical purpose nanomanufacturing approach. could serve as useful tool sensor state art which particularly regulators support strategy guidelines. Additionally, would also manufacturers align their plans with applicable standards thus fulfill expectations.