Nanomedicines: addressing the scientific and regulatory gap

Abstract

Nanomedicine is the application of nanotechnology to the discipline of medicine: the use of nanoscale materials for the diagnosis, monitoring, control, prevention, and treatment of disease. Nanomedicine holds tremendous promise to revolutionize medicine across disciplines and specialties, but this promise has yet to be fully realized. Beyond the typical complications associated with drug development, the fundamentally different and novel physical and chemical properties of some nanomaterials compared to materials on a larger scale (i.e., their bulk counterparts) can create a unique set of opportunities as well as safety concerns, which have only begun to be explored. As the research community continues to investigate nanomedicines, their efficacy, and the associated safety issues, it is critical to work to close the scientific and regulatory gaps to assure that nanomedicine drives the next generation of biomedical innovation.

A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements

“…25,26 Depending on the definition used, the number of nanomedicines marketed and under development varies. 10 13 this absence of clinical use of different diagnostic NMPs has been linked to problems of developing NMPs with adequate pharmacokinetic characteristics and reproducible consistency, and considerations on toxicity, biodegradation, and elimination could be other factors. 13 Iron oxide NMPs have been used but are currently no longer on the market.…”

“…For some of these NMPs, mainly liposomes and iron oxides, the patents have expired or will do so in the near future, and follow-on nanomedicines are expected to enter the market soon. 1,10,11,24 These new products have been termed as "nanosimilars". 24 Similarity is determined based on aspects of quality, efficacy, and safety and should be demonstrated before the product is granted market authorization.…”

“…6,8 NMPs that are already used in the clinic include a range of therapeutic products, as well as contrast agents for magnetic resonance imaging (MRI). 7,10 Various types of nanoformulations used in drug delivery are presented in Figure 1. 11 Although one of the major benefits claimed for many NMPs is a reduction in unwanted side effects, the use of NMPs does not guarantee the absence of side effects.…”

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

“…Owing to the enhanced permeability and retention effect, Doxil is also passively targeted to tumors, and its doxorubicin is released and becomes available to tumor cells. 5 Research in nanomedicine and pharmaceutical development is active. For instance, Europe's recent Seventh Framework Programme for Research and Technological Development (FP7, 2007(FP7, -2013, mainly supported by Nanotechnology and Nanosciences, Knowledge-based Multifunctional Materials and New Production Processes and Devices (NMP) (EU), has invested €300 million in nanomedicine projects.…”

“…5 Nanotechnology offers novel potential in pharmaceutical and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, regenerative medicine, implantable materials, and the development of nanodrugs. 6,7 Compared with conventional, poorly stable, or poorly soluble drugs, nanodrugs may improve drug solubility, stability, and permeability, resulting in enhanced bioavailability and efficiency.…”