当前位置: X-MOL 学术Drug Deliv. Transl. Res. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Future perspectives for advancing regulatory science of nanotechnology-enabled health products
Drug Delivery and Translational Research ( IF 5.4 ) Pub Date : 2022-06-12 , DOI: 10.1007/s13346-022-01165-y
Blanka Halamoda-Kenzaoui 1 , Robert Geertsma 2 , Joost Pouw 2 , Adriele Prina-Mello 3, 4, 5 , Moreno Carrer 3 , Matthias Roesslein 6 , Adrienne Sips 7 , Klaus Michael Weltring 8 , Kathleen Spring 8 , Susanne Bremer-Hoffmann 1
Affiliation  

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.

Graphical abstract



中文翻译:

推进纳米技术保健产品监管科学的未来前景

确定纳米技术支持的健康产品的监管挑战,然后与相关利益相关者进行讨论,是制定未来如何成功应对这些挑战的战略规划的第一步。为了更好地了解已确定的监管需求是针对保健产品的特定部门还是可能阻碍其他领域的进展,REFINE 联盟联系了代表其他部门的社区,这些部门也利用纳米技术的潜力,即工业化学品、食品和化妆品。通过一系列跨部门研讨会,REFINE 合作伙伴确定了共同的和特定部门的挑战,并讨论了可能的前进方向。潜在的解决方案在于加强监管和研究团体之间的合作,从而有针对性地生产和利用学术数据用于监管决策。此外,协调使用知识共享平台和数据库、跨部门标准化活动和协调地理区域之间的监管活动是可能的前进方式,符合即将到来的欧洲政治倡议,如可持续发展化学战略 (CSS)。最后,我们还讨论了 REFINE 项目中开发的方法和工具的进一步发展和可持续性的前景。跨部门标准化活动和地理区域之间监管活动的协调是可能的前进方式,符合即将到来的欧洲政治倡议,如可持续发展化学战略 (CSS)。最后,我们还讨论了 REFINE 项目中开发的方法和工具的进一步发展和可持续性的前景。跨部门标准化活动和地理区域之间监管活动的协调是可能的前进方式,符合即将到来的欧洲政治倡议,如可持续发展化学战略 (CSS)。最后,我们还讨论了 REFINE 项目中开发的方法和工具的进一步发展和可持续性的前景。

图形概要

更新日期:2022-06-14
down
wechat
bug