4.6 Article

Future perspectives for advancing regulatory science of nanotechnology-enabled health products

Journal

DRUG DELIVERY AND TRANSLATIONAL RESEARCH
Volume 12, Issue 9, Pages 2145-2156

Publisher

SPRINGER HEIDELBERG
DOI: 10.1007/s13346-022-01165-y

Keywords

Nanomedicine; Nanomedical devices; Regulation; Method standardisation; Harmonisation

Funding

  1. European Union [761104]

Ask authors/readers for more resources

The identification of regulatory challenges for nanotechnology-enabled health products is crucial, and greater collaboration between regulatory and research communities is needed to support regulatory decision-making with academic data. Through cross-sector workshops, common and sector-specific challenges can be identified and solutions can be discussed.
The identification of regulatory challenges for nanotechnology-enabled health products, followed by discussions with the involved stakeholders, is the first step towards a strategic planning of how such challenges can be successfully addressed in the future. In order to better understand whether the identified regulatory needs are sector-specific for health products or might also hinder the progress in other domains, the REFINE consortium reached out to communities representing other sectors that also exploit the potential of nanotechnology, i.e. industrial chemicals, food and cosmetics. Through a series of trans-sectorial workshops, REFINE partners identified common as well as sector-specific challenges and discussed possible ways forward. Potential solutions lie in a more strengthen collaboration between regulatory and research communities resulting in a targeted production and exploitation of academic data for the regulatory decision-making. Furthermore, a coordinated use of knowledge sharing platforms and databases, trans-sectorial standardisation activities and harmonisation of regulatory activities between geographical regions are possible ways forward, in line with the upcoming European political initiatives such as the Chemical Strategy for Sustainability (CSS). Finally, we also discuss the perspectives for further development and sustainability of methods and tools developed in the REFINE project.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.6
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

No Data Available
No Data Available