US and European drug regulators pilot program for parallel assessment of quality by design applications

The US Food and Drug Administration and the European Medicines Agency (EMA) have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design (QbD), of new drug marketing applications that are submitted to both agencies. The program will start on April 1.

The parallel evaluation within this voluntary pilot program means that reviewers from both agencies will separately assess the quality/chemistry, manufacturing and control (CMC) section of the New Drug Applications submitted to the FDA and Marketing Authorization Applications filed with the EMA. However, there will be regular communication and consultation between European regulators and their US colleagues throughout the review process relevant to QbD aspects of the applications.

QbD in pharmaceuticals involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product manufacturing quality. Several guidelines have been developed by the International Conference on Harmonisation (ICH) to harmonize and facilitate the implementation of QbD. This pilot program began out of concern that certain ICH guidelines were being interpreted differently in Europe and the USA, the agencies noted. Goals of the pilot program include: