Recent Interventions for Nanotechnology Based Drug Products: Insights into the Regulatory Aspects

Abstract

Background : Nanotechnology has been one of the most prominent forefront grounds in several traditional research areas of science and technology, and development of medicines at nanoscale can be reflected by the tremendous surge in market interest. Present outlook: Its applications include various research areas of medicine, drug delivery technology, diagnostic devices, tissue engineering and gene therapy. Along with immense advances, this technology comes with major limitations including potential immune reactivity and complex characterization of these products. Regulatory Challenges: The lack of a proper regulatory perspective due to infidelities in scientific findings have led to further uncertainties and vagueness of the nanoscale domain, particularly its safety implications. Guideline Scenario: Early development pathways and regulations should be a top-notch priority to help researchers fail faster and more economically. This would facilitate the peaking utility of these materials in medicine without compromising public health and environmental integrity. This review attempts to emphasize the regulatory rationales of key considerations in nanotechnology along with a portray of the present scenario.