» Articles » PMID: 35691982

Future Perspectives for Advancing Regulatory Science of Nanotechnology-enabled Health Products

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.

Citing Articles

From Pioneering Discoveries to Innovative Therapies: A Journey Through the History and Advancements of Nanoparticles in Breast Cancer Treatment.

Basingab F, Alshahrani O, Alansari I, Almarghalani N, Alshelali N, Alsaiary A Breast Cancer (Dove Med Press). 2025; 17:27-51.

PMID: 39867813 PMC: 11761866. DOI: 10.2147/BCTT.S501448.


Nanosuspension Innovations: Expanding Horizons in Drug Delivery Techniques.

Jacob S, Kather F, Boddu S, Attimarad M, Nair A Pharmaceutics. 2025; 17(1).

PMID: 39861782 PMC: 11768797. DOI: 10.3390/pharmaceutics17010136.


Differences in Physico-Chemical Properties and Immunological Response in Nanosimilar Complex Drugs: The Case of Liposomal Doxorubicin.

Lipsa D, Magri D, Della Camera G, La Spina R, Cella C, Garmendia-Aguirre I Int J Mol Sci. 2023; 24(17).

PMID: 37686418 PMC: 10487543. DOI: 10.3390/ijms241713612.


Classification system for nanotechnology-enabled health products with both scientific and regulatory application.

Rodriguez-Gomez F, Penon O, Monferrer D, Rivera-Gil P Front Med (Lausanne). 2023; 10:1212949.

PMID: 37601794 PMC: 10433195. DOI: 10.3389/fmed.2023.1212949.


Regulatory aspects of a nanomaterial for imaging therapeutic cells.

van der Zee M, de Vries C, Masa M, Morales M, Rayo M, Hegger I Drug Deliv Transl Res. 2023; 13(11):2693-2703.

PMID: 37210426 PMC: 10545613. DOI: 10.1007/s13346-023-01359-y.


References
1.
Halamoda-Kenzaoui B, Holzwarth U, Roebben G, Bogni A, Bremer-Hoffmann S . Mapping of the available standards against the regulatory needs for nanomedicines. Wiley Interdiscip Rev Nanomed Nanobiotechnol. 2018; 11(1):e1531. PMC: 6585614. DOI: 10.1002/wnan.1531. View

2.
Ehmann F, Sakai-Kato K, Duncan R, Hernan Perez de la Ossa D, Pita R, Vidal J . Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines. Nanomedicine (Lond). 2013; 8(5):849-56. DOI: 10.2217/nnm.13.68. View

3.
Halamoda-Kenzaoui B, Vandebriel R, Howarth A, Siccardi M, David C, Liptrott N . Methodological needs in the quality and safety characterisation of nanotechnology-based health products: Priorities for method development and standardisation. J Control Release. 2021; 336:192-206. PMC: 8390938. DOI: 10.1016/j.jconrel.2021.06.016. View

4.
Gaspar R, Silva-Lima B, Magro F, Alcobia A, Leal da Costa F, Feio J . Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision. Front Med (Lausanne). 2020; 7:590527. PMC: 7719831. DOI: 10.3389/fmed.2020.590527. View

5.
Muhlebach S, Borchard G, Yildiz S . Regulatory challenges and approaches to characterize nanomedicines and their follow-on similars. Nanomedicine (Lond). 2015; 10(4):659-74. DOI: 10.2217/nnm.14.189. View