EMA & FDA Team on QbD Parallel Evaluation Pilot Scheme

The EMA and the US FDA will conduct parallel assessment of QbD development and manufacturing data for new drug submissions.

The U.S. FDA and the European Medicines Agency (EMA) have initiated 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 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 (NDAs) submitted to the FDA and marketing authorization applications (MAAs) submitted to the EMA.  However, there will be regular communication and consultation between European regulators and their U.S. colleagues throughout the review process relevant to QbD aspects of the applications.