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推进纳米技术健康产品监管科学的未来展望。

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

机构信息

European Commission Joint Research Centre (JRC), Ispra, Italy.

Centre for Health Protection, National Institute for Public Health & the Environment (RIVM), Bilthoven, The Netherlands.

出版信息

Drug Deliv Transl Res. 2022 Sep;12(9):2145-2156. doi: 10.1007/s13346-022-01165-y. Epub 2022 Jun 12.

DOI:10.1007/s13346-022-01165-y
PMID:35691982
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9360093/
Abstract

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.

摘要

确定纳米技术医疗产品的监管挑战,然后与相关利益攸关方进行讨论,是对未来如何成功应对这些挑战进行战略规划的第一步。为了更好地了解所确定的监管需求是针对特定于医疗产品的部门,还是也可能阻碍其他领域的进展,REFINE 联盟联系了代表其他也利用纳米技术潜力的部门的社区,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于部门的挑战,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界之间的合作,以有针对性地为监管决策制作和利用学术数据。此外,协调使用知识共享平台和数据库、跨部门标准化活动以及协调地理区域之间的监管活动,是符合即将出台的欧洲政治倡议(如可持续性化学战略)的可行途径。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观点。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/972bd3d29f13/13346_2022_1165_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/c0d6000b64d8/13346_2022_1165_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/7b49b4651ffb/13346_2022_1165_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/65cb9905032d/13346_2022_1165_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/972bd3d29f13/13346_2022_1165_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/c0d6000b64d8/13346_2022_1165_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/7b49b4651ffb/13346_2022_1165_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/65cb9905032d/13346_2022_1165_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39f/9360093/972bd3d29f13/13346_2022_1165_Fig4_HTML.jpg

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J Control Release. 2021 Aug 10;336:192-206. doi: 10.1016/j.jconrel.2021.06.016. Epub 2021 Jun 12.
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Breast Cancer (Dove Med Press). 2025 Jan 21;17:27-51. doi: 10.2147/BCTT.S501448. eCollection 2025.
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