Nanotechnology-based medicines and regulatory affairs: where are we

Abstract

The application of nanotechnology to pharmaceutical sciences is creating drug formulations with novel properties that can improve and innovate the therapeutic arsenal to treat, prevent and diagnose diseases with great benefits for the public health. These nanomedicines are complex in their nature and therefore difficult to correctly evaluate using old methodologies. Also, follow-on versions of current nanomedicines called nanosimilars need to be safely introduced into the market. This shows the importance that regulatory agencies have in evaluating their safety, efficacy and quality. We are going to discuss some of the different types of nanomedicine formulations available, while discussing the current regulatory approachs taken by the agencies and the current limitations to the commercialization of this type of products.