Regulatory Framework for Nanomedicines

Abstract

The nanotechnological products that are released in market are carefully evaluated in the United States by the National Agency for Food and Drugs that is called the Food and Drug Administration (FDA), while in Europe by the European Medicines Agency (EMA). These organizations act according to proposals and recommendations of scientific committees that suggest changes and modifications of the regulatory framework according to scientific, technological, and social facts keeping into consideration as the main concern, the public health. These organizations develop the regulations for law applications related to medicines and medicinal products. The "copies" of nanotechnological medicines that are candidates to release in market are called as nanosimilars. They are off-patent nanotechnological products, and their similarity is considered as an emerging issue to be discussed within the scientific community and moreover in the regulatory bodies which are responsible for their approval. An important issue from the regulatory point of view is innovative excipients that include the self-assembled nanostructures such as liposome, micelles, dendrimers, etc. incorporating bioactive molecules.