FDA and EMA Publish Assessment of QbD for Marketing Applications

FDA and the European Medicines Agency (EMA) have published a joint assessment of quality-by-design (QbD) elements of a marketing authorization application. The joint-published document answers questions on regulatory submissions for quality target product profiles, expectations for critical quality attributes, and classification of criticality for process parameters. The assessment also answers questions in regards to the application of ICH Q8 (R2).

The assessment is the result of a pilot program launched by FDA and EMA in March 2011. The pilot program allows the two agencies to share review findings throughout the review process about QbD elements of applications that were chosen for the pilot. The assessment gives the agency the opportunity to collaborate on regulatory decisions so that quality of pharmaceutical products is consistent in the US and Europe. Experts from the Japanese Pharmaceuticals Medical Device Agency observed the first parallel assessment. FDA and EMA will publish further outcomes of the pilot as more assessments are conducted.