Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines

Falk Ehmann, Kumiko Sakai-Kato, Ruth Duncan, Dolores Hernán Pérez De La Ossa, Ruben Pita, Jean Marc Vidal, Ashish Kohli, L. Tóthfalusi, Alan Sanh, Sandrine Tinton, Jean Louis Robert, Beatriz Silva Lima, Marisa Papaluca Amati

Research output: Contribution to journalArticle

89 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)849-856
Number of pages8
JournalNanomedicine
Volume8
Issue number5
DOIs
Publication statusPublished - May 2013

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Nanomedicine
Medical nanotechnology
medicine
EU
first generation
evaluation
Medicine
public health
drug
safety
market
Public health
Patient Safety
Public Health
product
Pharmaceutical Preparations

Keywords

  • block copolymer micelle
  • coating
  • colloidal iron-based nanomedicine
  • drug development
  • liposomal formulation
  • nanomedicine
  • nanosimilar
  • next-generation nanomedicine
  • regulatory science

ASJC Scopus subject areas

  • Materials Science(all)
  • Bioengineering
  • Biomedical Engineering
  • Medicine (miscellaneous)
  • Development

Cite this

Ehmann, F., Sakai-Kato, K., Duncan, R., Pérez De La Ossa, D. H., Pita, R., Vidal, J. M., ... Amati, M. P. (2013). Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines. Nanomedicine, 8(5), 849-856. https://doi.org/10.2217/nnm.13.68

Next-generation nanomedicines and nanosimilars : EU regulators' initiatives relating to the development and evaluation of nanomedicines. / Ehmann, Falk; Sakai-Kato, Kumiko; Duncan, Ruth; Pérez De La Ossa, Dolores Hernán; Pita, Ruben; Vidal, Jean Marc; Kohli, Ashish; Tóthfalusi, L.; Sanh, Alan; Tinton, Sandrine; Robert, Jean Louis; Silva Lima, Beatriz; Amati, Marisa Papaluca.

In: Nanomedicine, Vol. 8, No. 5, 05.2013, p. 849-856.

Research output: Contribution to journalArticle

Ehmann, F, Sakai-Kato, K, Duncan, R, Pérez De La Ossa, DH, Pita, R, Vidal, JM, Kohli, A, Tóthfalusi, L, Sanh, A, Tinton, S, Robert, JL, Silva Lima, B & Amati, MP 2013, 'Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines', Nanomedicine, vol. 8, no. 5, pp. 849-856. https://doi.org/10.2217/nnm.13.68
Ehmann, Falk ; Sakai-Kato, Kumiko ; Duncan, Ruth ; Pérez De La Ossa, Dolores Hernán ; Pita, Ruben ; Vidal, Jean Marc ; Kohli, Ashish ; Tóthfalusi, L. ; Sanh, Alan ; Tinton, Sandrine ; Robert, Jean Louis ; Silva Lima, Beatriz ; Amati, Marisa Papaluca. / Next-generation nanomedicines and nanosimilars : EU regulators' initiatives relating to the development and evaluation of nanomedicines. In: Nanomedicine. 2013 ; Vol. 8, No. 5. pp. 849-856.
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