Clinical Aspects and Regulatory Requirements for Nanomedicines

The last few decades witnessed the emergence of nanotechnology in the pharmaceutical sector and the reason for the expansion and evolution of nanomedicines. Nowadays, nanoscale modalities are leading the healthcare sector from the front. However, this emerging field of science creating new challenges for the research community, industry, and regulators. The major problem in using nanomedicines is the complex characterization procedure that also varies from product to product. The characteristics of nanomedicines are required to be understood in such a way to minimize their unwanted effects for better patient compliance. This chapter emphasizes the current updates on various regulatory bodies such as US FDA, TGA, and EMA in relation to the regulatory requirement for the suitable use of nanomedicines.