Abstract
Nanotechnology-based products show the tremendous potential to change the course of diagnostics and therapy. Numerous nanosystems are already available in the market and hundreds of products are currently in different stages of the preclinical and clinical development. Although in the last two decades, several nanoformulations have been approved in the market, the guidelines are not very clear and a closer collaboration between regulatory agencies is required. The main hurdle to generate regulation of these nanopharmaceuticals is related to their properties/characteristics. Different regulatory bodies across the globe have released their guidelines to address nanopharmaceuticals aspects that are known to have a profound effect to introduce new nanoformulation in the market. This chapter deals with all these regulatory guidelines need to be followed for the development of nanopharmaceuticals.
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