Nano-Oncologicals: Regulatory Aspects and Safety Issues

Background: Nanotechnology has touched almost all the spheres of life and all fields of science globally. It has become a part of everyday routine. Many nanoproducts have already reached the market. Over the last decade extensive research has been done to develop nanomedicines for prevention, diagnosis and treatment of various ailments. The reduced side effects associated with the targeted delivery of nanotherapeutics has increased the focus of researchers in developing drugs for the diagnosis and treatment of many diseases including cancer. Nano-oncology has resulted in successful treatment of topical as well as invasive cancers and has therefore been an area of interest and investment by pharmaceutical industries worldwide. The rapid development of nanopharmaceuticals has created challenges for regulatory agencies, formulators as well as for the academicians. Objective: The present review gives an insight into the different nanoformulations used for treatment of cancers. It also focuses on the regulatory aspects underlying the formulation and use of the nano-onchologicals. Besides this, the safety issues related to their use will also be discussed. Discussion: The extensive formulation of anticancer therapeutics by nanotechnological intervention has been a concern for regulatory agencies worldwide. They have the challenge to frame regulations such that the benefits of these formulations reach the patients but at the same time the safety aspects of these pharmaceuticals are not compromised.