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

@article{Ehmann2013NextgenerationNA,
  title={Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines.},
  author={Falk Ehmann and Kumiko Sakai-Kato and Ruth Duncan and Dolores Hern{\'a}n P{\'e}rez de la Ossa and Ruben Pita and J. Vidal and Ashish Kohli and Laszlo Tothfalusi and Alan Sanh and Sandrine A. Tinton and J. Robert and Beatriz Silva Lima and Marisa Papaluca Amati},
  journal={Nanomedicine},
  year={2013},
  volume={8 5},
  pages={849-56}
}
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… CONTINUE READING
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