Next-generation nanomedicines and nanosimilars: EU regulators%26apos; initiatives relating to the development and evaluation of nanomedicines

作者：Ehmann Falk^*; Sakai Kato Kumiko; Duncan Ruth; de la Ossa Dolores Hernan Perez; Pita Ruben; Vidal Jean Marc; Kohli Ashish; Toth****si Laszlo; Sanh Alan; Tinton Sandrine; Robert Jean Louis; Lima Beatriz Silva; Amati Marisa Papaluca

来源：Nanomedicine, 2013, 8(5): 849-856.

DOI：10.2217/NNM.13.68

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

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 %26apos;follow-on%26apos; nanomedicine products, %26apos;nanosimilars%26apos;. Moreover, drug regulators need to ensure that %26apos;next%26apos;-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.

• 出版日期2013-5