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 medi...
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Series: | Precision Nanomedicine |
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doaj-9788e24d75bf47bbae2232a3bcf317d32020-11-25T03:53:23ZengAndover House Inc.Precision Nanomedicine2639-9431Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health productsBlanka Halamoda-KenzaouiHelen BoxMerel van ElkSandra GaitanRobert E. GeertsmaEusebio Gainza LafuenteAndrew OwenAngel del PozoMatthias RoessleinSusanne Bremer-HoffmannThe 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.http://prnano.scholasticahq.com/article/13521-launching-stakeholder-discussions-on-identified-regulatory-needs-for-nanotechnology-enabled-health-products.pdf |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Blanka Halamoda-Kenzaoui Helen Box Merel van Elk Sandra Gaitan Robert E. Geertsma Eusebio Gainza Lafuente Andrew Owen Angel del Pozo Matthias Roesslein Susanne Bremer-Hoffmann |
spellingShingle |
Blanka Halamoda-Kenzaoui Helen Box Merel van Elk Sandra Gaitan Robert E. Geertsma Eusebio Gainza Lafuente Andrew Owen Angel del Pozo Matthias Roesslein Susanne Bremer-Hoffmann Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products Precision Nanomedicine |
author_facet |
Blanka Halamoda-Kenzaoui Helen Box Merel van Elk Sandra Gaitan Robert E. Geertsma Eusebio Gainza Lafuente Andrew Owen Angel del Pozo Matthias Roesslein Susanne Bremer-Hoffmann |
author_sort |
Blanka Halamoda-Kenzaoui |
title |
Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products |
title_short |
Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products |
title_full |
Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products |
title_fullStr |
Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products |
title_full_unstemmed |
Launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products |
title_sort |
launching stakeholder discussions on identified regulatory needs for nanotechnology-enabled health products |
publisher |
Andover House Inc. |
series |
Precision Nanomedicine |
issn |
2639-9431 |
description |
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. |
url |
http://prnano.scholasticahq.com/article/13521-launching-stakeholder-discussions-on-identified-regulatory-needs-for-nanotechnology-enabled-health-products.pdf |
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