US and European regulatory initiatives to improve R&D performance

Abstract

Both the FDA and the European Medicines Agency recognise that the process of R&D must be changed to improve industry productivity. They also realise that industry cannot do it alone and have crafted initiatives to facilitate industry R&D performance. Some initiatives have been ongoing since the late 1990s, such as scientific interaction between drug sponsors and regulators. Others have emerged more recently in the mid-2000s, such as the FDA's Critical Path and the European Medicines Agency's new medicines legislation and the Road Map to 2010. The overarching purpose is to reinvent the process by which drugs are ushered through the clinical phase of development, as well as providing a better feedback loop from bench to bedside.