Regulatory pathway to introduce a nanomedicine product in the market at international level

Nanotechnology-enabled medical technologies will have a huge impact on human disease detection, prevention, and treatment over the next couple of decades. Nanomedicines have new properties designed to improve their bioavailability and can be activated by external stimuli. The number of approved nano-based pharmaceutical products has been significantly increasing since 1980. The market for nanomedicine consists of nanoparticles, liposomes, nanocrystals, nanoemulsions, conjugates of polymeric proteins, and nanocomplexes. The worldwide approval of pharmaceutical and medical products is well regulated, with relevant literature, guidelines, and legislation to ensure that appropriate procedures were followed to ensure confidence in product safety. This chapter discusses the current international pathways of nanomedicines and the significance for this perspective.