Review Regulatory aspects on nanomedicines Vanessa Sainz 1 , Jo ~ ao Conniot 1 , Ana I. Matos, Carina Peres, Eva Zupan  ci  c, Liane Moura, Liana C. Silva, Helena F. Florindo, Rog  erio S. Gaspar * Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Lisbon, Portugal article info Article history: Received 3 August 2015 Accepted 5 August 2015 Available online xxx Keywords: Nanotechnology Regulatory sciences Nanomedicine Biocompatibility “Quality-by-design” Manufacturing abstract Nanomedicines have been in the forefront of pharmaceutical research in the last decades, creating new challenges for research community, industry, and regulators. There is a strong demand for the fast development of scientific and technological tools to address unmet medical needs, thus improving hu- man health care and life quality. Tremendous advances in the biomaterials and nanotechnology fields have prompted their use as promising tools to overcome important drawbacks, mostly associated to the non-specific effects of conventional therapeutic approaches. However, the wide range of application of nanomedicines demands a profound knowledge and characterization of these complex products. Their properties need to be extensively understood to avoid unpredicted effects on patients, such as potential immune reactivity. Research policy and alliances have been bringing together scientists, regulators, industry, and, more frequently in recent years, patient representatives and patient advocacy institutions. In order to suc- cessfully enhance the development of new technologies, improved strategies for research-based corporate organizations, more integrated research tools dealing with appropriate translational re- quirements aiming at clinical development, and proactive regulatory policies are essential in the near future. This review focuses on the most important aspects currently recognized as key factors for the regu- lation of nanomedicines, discussing the efforts under development by industry and regulatory agencies to promote their translation into the market. Regulatory Science aspects driving a faster and safer development of nanomedicines will be a central issue for the next years. © 2015 Elsevier Inc. All rights reserved. Contents 1. Opportunities and challenges of nanotechnology ....................................................................................... 00 2. Regulatory perspective on the development of nanomedicines ........................................................................... 00 3. Nanomedicines in the market ....................................................... ................................................ 00 4. Regulatory development for “next-generation” of nanomedicines ...................................... ................................. 00 Conflict of interest ............................................................. .................................................... 00 Acknowledgments ................................................................................................................. 00 References ........................................................................................................................ 00 1. Opportunities and challenges of nanotechnology Nanotechnology has been largely explored over the last two decades, emerging as a “new technological revolution”. The field provides a multitude of possibilities across several traditional research areas, such as physics, chemistry, engineering, * Corresponding author. Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-003 Lisbon, Portugal. E-mail address: rgaspar@ff.ulisboa.pt (R.S. Gaspar). 1 Equally contributing authors. Contents lists available at ScienceDirect Biochemical and Biophysical Research Communications journal homepage: www.elsevier.com/locate/ybbrc http://dx.doi.org/10.1016/j.bbrc.2015.08.023 0006-291X/© 2015 Elsevier Inc. All rights reserved. Biochemical and Biophysical Research Communications xxx (2015) 1e7 Please cite this article in press as: V. Sainz, et al., Regulatory aspects on nanomedicines, Biochemical and Biophysical Research Communications (2015), http://dx.doi.org/10.1016/j.bbrc.2015.08.023