ABSTRACT
The field of nanomedicines has expanded significantly in recent years in the breadth of compounds under development as well as in the types of technology that are being applied to generate nanomedicines. The history of licensed nanomedicines dates back to 1989, with the introduction of propofol liposomes for anesthesia and later additional liposomal, colloidal suspensions, and pegylated forms of active ingredients have followed in oncology, infectious disease, and ophthalmology. The Nanomedicines Alliance is an organization of pharmaceutical and biotechnology companies formed in 2010 that occupies a unique place in the global pharmaceutical industry. This group of companies focuses its energy on promoting the scientific development, safe use, regulatory and legislative advancement, and expanding public knowledge of nanomedicines and nanotechnology-enabled medical devices. Members are representative of both large, intermediate, and small companies from the US, Europe, and Japan. The existing regulatory framework allows specific considerations of each candidate on a case-by-case basis.
