2011 Scrip 100: Taking drug regulation to a higher level
This article was originally published in Scrip
Executive Summary
The regulation of drug development is moving to a new level, driven by advances in science and the need to better assess the safety profile of new compounds. Regulators will soon be faced with products emerging from areas such as regenerative medicine, gene therapy, personalised or stratified medicine, and nanotechnology. Finding new tools to assess safety, efficacy and quality is vital if these discoveries are to be translated into commercial products.