| Summary: | 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 in order 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, more guidance is needed on how the similarity of follow-on medicinal products can be demonstrated. In addition, 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 to this manuscript. The resulting discussions within the scientific community should help to understand how essential knowledge, methods, tools and approaches can be obtained with the aim to advance the regulatory science in the area of nanotechnology-enabled health products.
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