Future perspectives for advancing regulatory science of nanotechnology-enabled health products.
Blanka Halamoda-Kenzaoui, Robert Geertsma, Joost Pouw, Adriele Prina-Mello, Moreno Carrer, Matthias Roesslein, Adrienne Sips, Klaus Michael Weltring, Kathleen Spring, Susanne Bremer-Hoffmann
Author Information
Blanka Halamoda-Kenzaoui: European Commission Joint Research Centre (JRC), Ispra, Italy.
Robert Geertsma: Centre for Health Protection, National Institute for Public Health & the Environment (RIVM), Bilthoven, The Netherlands.
Joost Pouw: Centre for Health Protection, National Institute for Public Health & the Environment (RIVM), Bilthoven, The Netherlands.
Adriele Prina-Mello: Laboratory for Biological Characterization of Advanced Materials (LBCAM), Trinity Translational Medicine Institute (TTMI), Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.
Moreno Carrer: Laboratory for Biological Characterization of Advanced Materials (LBCAM), Trinity Translational Medicine Institute (TTMI), Trinity College Dublin, St James's Hospital, Dublin 8, Ireland.
Matthias Roesslein: Swiss Federal Laboratories for Material Science and Technology, EMPA, St. Gallen, Switzerland. ORCID
Adrienne Sips: Centre for Safety of Substances and Products, National Institute for Public Health & the Environment (RIVM), Bilthoven, The Netherlands.
Klaus Michael Weltring: Gesellschaft Für Bioanalytik Muenster E.V, Muenster, Germany.
Kathleen Spring: Gesellschaft Für Bioanalytik Muenster E.V, Muenster, Germany.
Susanne Bremer-Hoffmann: European Commission Joint Research Centre (JRC), Ispra, Italy. susanne.bremer-hoffmann@ec.europa.eu. ORCID
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.
