Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines - PubMed (original) (raw)
Review
doi: 10.2217/nnm.13.68.
Kumiko Sakai-Kato, Ruth Duncan, Dolores Hernán Pérez de la Ossa, Ruben Pita, Jean-Marc Vidal, Ashish Kohli, Laszlo Tothfalusi, Alan Sanh, Sandrine Tinton, Jean-Louis Robert, Beatriz Silva Lima, Marisa Papaluca Amati
Affiliations
- PMID: 23656268
- DOI: 10.2217/nnm.13.68
Review
Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines
Falk Ehmann et al. Nanomedicine (Lond). 2013 May.
Abstract
Over the last three decades many first-generation nanomedicines have successfully entered routine clinical use and it is now important for medicines regulatory agencies to consider the mechanisms needed to ensure safe introduction of 'follow-on' nanomedicine products, 'nanosimilars'. Moreover, drug regulators need to ensure that 'next'-generation nanomedicines enter clinical development and consequently the market in a safe and timely way for the benefit of public health. Here we review recent European Medicines Agency activities that relate to the effective development and evaluation of nanomedicine products while keeping patient and consumer safety at the forefront.
Similar articles
- Regulation of nanomedicines in the EU: distilling lessons from the pediatric and the advanced therapy medicinal products approaches.
Chowdhury N. Chowdhury N. Nanomedicine (Lond). 2010 Jan;5(1):135-42. doi: 10.2217/nnm.09.91. Nanomedicine (Lond). 2010. PMID: 20025470 - Nanomedicines and Nanosimilars: Looking for a New and Dynamic Regulatory "Astrolabe" Inspired System.
Demetzos C, Kavatzikidou P, Pippa N, Stratakis E. Demetzos C, et al. AAPS PharmSciTech. 2020 Jan 13;21(2):65. doi: 10.1208/s12249-019-1573-y. AAPS PharmSciTech. 2020. PMID: 31933006 Review. - Nanomedicines: The magic bullets reaching their target?
Flühmann B, Ntai I, Borchard G, Simoens S, Mühlebach S. Flühmann B, et al. Eur J Pharm Sci. 2019 Feb 1;128:73-80. doi: 10.1016/j.ejps.2018.11.019. Epub 2018 Nov 20. Eur J Pharm Sci. 2019. PMID: 30465818 Review. - Nanomedicines: addressing the scientific and regulatory gap.
Tinkle S, McNeil SE, Mühlebach S, Bawa R, Borchard G, Barenholz YC, Tamarkin L, Desai N. Tinkle S, et al. Ann N Y Acad Sci. 2014 Apr;1313:35-56. doi: 10.1111/nyas.12403. Epub 2014 Mar 27. Ann N Y Acad Sci. 2014. PMID: 24673240 - Regulatory aspects on nanomedicines.
Sainz V, Conniot J, Matos AI, Peres C, Zupancic E, Moura L, Silva LC, Florindo HF, Gaspar RS. Sainz V, et al. Biochem Biophys Res Commun. 2015 Dec 18;468(3):504-10. doi: 10.1016/j.bbrc.2015.08.023. Epub 2015 Aug 8. Biochem Biophys Res Commun. 2015. PMID: 26260323 Review.
Cited by
- Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.
Guo JW, Lee YH, Huang HW, Tzou MC, Wang YJ, Tsai JC. Guo JW, et al. Int J Nanomedicine. 2014 Oct 15;9:4773-83. doi: 10.2147/IJN.S68134. eCollection 2014. Int J Nanomedicine. 2014. PMID: 25342901 Free PMC article. Review. - Intranasal Drug Delivery by Nanotechnology: Advances in and Challenges for Alzheimer's Disease Management.
Dighe S, Jog S, Momin M, Sawarkar S, Omri A. Dighe S, et al. Pharmaceutics. 2023 Dec 29;16(1):58. doi: 10.3390/pharmaceutics16010058. Pharmaceutics. 2023. PMID: 38258068 Free PMC article. Review. - A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements.
Giannakou C, Park MV, de Jong WH, van Loveren H, Vandebriel RJ, Geertsma RE. Giannakou C, et al. Int J Nanomedicine. 2016 Jun 22;11:2935-52. doi: 10.2147/IJN.S102385. eCollection 2016. Int J Nanomedicine. 2016. PMID: 27382281 Free PMC article. Review. - Nanoparticle-allergen complexes for allergen immunotherapy.
Di Felice G, Colombo P. Di Felice G, et al. Int J Nanomedicine. 2017 Jun 19;12:4493-4504. doi: 10.2147/IJN.S134630. eCollection 2017. Int J Nanomedicine. 2017. PMID: 28684909 Free PMC article. Review. - Successful in vivo hyperthermal therapy toward breast cancer by Chinese medicine shikonin-loaded thermosensitive micelle.
Su Y, Huang N, Chen D, Zhang L, Dong X, Sun Y, Zhu X, Zhang F, Gao J, Wang Y, Fan K, Lo P, Li W, Ling C. Su Y, et al. Int J Nanomedicine. 2017 May 29;12:4019-4035. doi: 10.2147/IJN.S132639. eCollection 2017. Int J Nanomedicine. 2017. PMID: 28603416 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical