Nanopharmaceuticals necessitate rigorous, costly testing to address safety
concerns, including cytotoxic effects. The lack of toxicity testing protocols and
understanding of the interactions of nanomaterials make it difficult to make accurate
assessments of health risks. To meet the purpose of regulating and monitoring nano
products in pharmaceuticals, various nations have devised their suitable regulatory
processes. Approximately two decades are required for drug development, which
includes drug discovery, clinical testing, and production approval. However, only when
a novel pharmaceutical product can be mass manufactured in industrially substantial
quantities is its development considered to be accomplished. At present, nanodrugs
have already been introduced successfully to the market, demonstrating their future
potential. This chapter will provide comprehensive details about the drug development
process covering regulations, development, and commercialization of nano-based drugs
Keywords: Crystalline NPs, Drug development, Drug commercialization, European medicines agency, FDA, Inorganic NPs, lipid-based NPs, Nano-drug regulation, Polymeric NPs.
