Regulatory Considerations of Nanotechnological Products in Developed Countries
Nanotechnology is a revolutionary field of micro-manufacturing involving manipulation by chemical or physical processes of individual atoms and molecules. It is important that safety regulations of nanotherapeutics keep pace with this growing level of pharmaceutical industry interest. Current and potential applications of nanotechnology in medicine range from research involving diagnostic devices, drug delivery vehicles to enhanced gene therapy and tissue engineering procedures. Safety regulations of nanotherapeutics may present unique risk assessment challenges, given the novelty and variety of products, high mobility and reactivity of engineered nanoparticles, and blurring of the diagnostic and therapeutic medicines. Major efforts are underway, however, very little attention is devoted to assessment of health risks to human or to the ecosystem. Inhaled nanoparticles have already been related to lung injury. It is recognized that physico-chemical properties in conjunction with environmental factors and stability of the nanomaterial all contribute to the overall toxicological responses. Nanotoxicological information, currently insufficient, will be vital in aiding regulatory bodies in elucidating the mechanisms of action, balancing its risk and benefit and thus to lay down the regulations. The present work is aimed at the regulatory considerations of nanoparticulate systems in various regions such as United States, European Union and Australia