THE SUMMARY OF THE WHITE PAPER FROM THE EUROPEAN PROJECT REFINE TO INITIATE A DISCUSSION ON HOW TO ADVANCE THE REGULATORY SCIENCE IN THE AREA OF NANOTECHNOLOGY-ENABLED HEALTH PRODUCTS.

REFINE Project published in Precision Nanomedicine Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products. The development of nanotechnology-enabled health products offers innovative therapeutic and diagnostic opportunities to address medical needs. At the moment, no specific regulatory framework exists for such products since they can be covered by the existing frameworks for medicinal products and medical devices. However, these frameworks do require additional guidance to fully cover the particularities of nanotechnology-enabled products. After a detailed analysis of regulatory guidance documents, standards, and scientific publications originating mainly from Europe and the US, the European project “REFINE” has released a White Paper summarising the main needs in the field. The selection of the regulatory pathway, the identification of regulatory information needs, as well as the availability of standardised testing methods are among the identified regulatory challenges. Furthermore, additional guidance is needed on how the similarity of follow-on medicinal products can be demonstrated. Also, challenges related to the classification and assessment of nanotechnology-enabled medical devices are presented. The project consortium is now collecting feedback on the identified challenges through a dedicated survey and published comments on this manuscript. The resulting discussions within the scientific community should help to understand how essential knowledge, methods, tools, and approaches can be obtained with to advance the regulatory science in the area of nanotechnology-enabled health products.