ABSTRACT
Many nanomedicines work by direct interaction with genetic materials or by interaction with biomolecules that are required for normal genome function and cell division, all of which can cause genotoxicity and mutagenicity. Such toxicity to nanomedicines is mediated by the inflammatory response of neutrophils and macrophages by the production of reactive oxygen and nitrogen species which cause oxidative and nitrosative stress. The accumulation of such free radicals can cause extensive damage to the body. Currently, the precise interactions of many nanomedicines with biological systems are not yet fully understood; therefore, making, understanding, identifying, or drawing conclusions about nanomedicines physicochemical and toxicological properties is challenging. However, very little is set to change without standardized regulatory guidance in this area. It also has to be acknowledged that “one-size” certainly does not fit all in this process as the unique properties observed at the nanoscale are highly dependent upon nanoparticle type, surface properties, administration route, and importantly, nanoparticle morphology which can be diverse – something that is undoubtedly holding up the regulatory process. This chapter aims to discuss the use of nanomaterials within the clinical setting, the significance of regulating these materials, and the challenges faced generally, along with the current regulation used in different nations.
