The Horizon 2020 project REFINE – Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices (http://refine-nanomed.com/) has newly published a white paper on Anticipation of regulatory needs for nanotechnology-enabled health products, which is of high interest for everybody involved in the development and translation of nano-enabled medical products and devices. Today, nanotechnology-enabled health products are regulated either as medicinal products or medical devices, dependent on their mode of action. No single regulatory framework exists for such products. However, the complexity of such products often makes the determination of the primary mode of action – and thereby the choice of regulatory path – difficult. Another challenge is the lack of standardised testing methods suitable and reliable for nanomaterial testing. This REFINE white paper summarizes and highlights the major regulatory needs that have been identified, as well as a review of existing documents published by regulatory scientists. It also provides the context and underlying information related to challenges in regulating nanotechnology-enabled health products. In conclusion, this white paper is both a source of comprehensive information in the field of regulations for nano-enabled medical products and devices and it is a stimulator for a public debate on how the regulatory science in the field of nanotechnology-enabled health products can be further progressed.
The research needs described in detail in the white paper are shown in the included figure (Source White Paper):
We encourage all stakeholders involved in the R&D&I, as well as regulatory science of nanotechnology-enabled health products to contribute to the debate initiated in this white paper. You can find the document here: https://ec.europa.eu/jrc/en/publication/thematic-reports/anticipation-regulatory-needs-nanotechnology-enabled-health-products