Regulatory aspect of nanomedicines and nanobiosystems development

Nanotechnology has offered several advantages over conventional drug delivery systems, mostly related to their site-specific release in oncology treatment. However, the developed nanomedicines have always a concern about their stability and clinical toxicity. Many regulatory agencies have brought forward various scientists and industrialists to successfully develop and implement these technologies. Mainly, European Union and United States Food and Drug Administration are the key agencies that have taken initiatives to regulate the market of nanoparticles. These two regulatory agencies mainly deal with issues related to the safety, efficacy, and stability of nanomedicines on a case-to-case basis. However, they have found limited success in implementing their regulations due to significant variations in the type of nanoparticles produced. Hence, developing a strict regulatory framework to regulate their safety, efficacy, and stability is still in progress. This chapter covers various aspects related to regulatory framework for nanomedicines and, in particular, to various dosage forms.