EMA: European Medicines Agency and U.S. Food and Drug Administration announce pilot program for parallel assessment of Quality by Design applications

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are launching a three-year pilot program that will allow parallel evaluation of relevant quality data components, known as Quality by Design (QbD), of selected applications that are submitted to both agencies at the same time. The pilot will be starting on 1 April 2011.