A regulatory framework for the development of topical nanomedicines

In the past decade, the field of nanomedicine has considerably matured with several products under clinical trials, and some already commercially available. Nevertheless, advancing nanomedicines from concept to clinic can be challenging as there are several scientific, toxicological, and scale-up hurdles. However, several regulatory initiatives have been directed to overcome this situation. Some examples include the nanotechnology characterization lab, the European technology platform on nanomedicines, as well as several FDA and EMA-specific guidelines. One of the key clinical applications of nanomedicines regards dermatology. Topical nanomedicines offer a noninvasive and painless route for drug administration, which reinforces patient compliance. Moreover, nanoparticles due to their small size, high surface area, high deformation ability, and occlusive effect are able to enhance drug permeation and consequently increase the therapeutic effect. In this context, this chapter outlines a regulatory-oriented framework for the pharmaceutical development of topical semisolid nanomedicines.