Conclusions of FDA-EMA Parallel Assessment of Quality-By-Design Elements of Marketing Applications

August 20, 2013

Today the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint question-and-answer document¹

² that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application.

In March 2011, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a pilot program³ in which both agencies communicated review findings about quality-by-design (QbD) elements of applications chosen for the pilot.

QbD is a science and risk-based approach to pharmaceutical development and manufacturing. QbD in pharmaceuticals involves designing and developing pharmaceutical formulations and manufacturing processes to help ensure product manufacturing quality.

As part of this pilot program, U.S. and European regulators communicate and consult throughout the review process relevant to QbD aspects of the new drug and supplement applications. This parallel assessment aids sharing of regulatory decisions and facilitates the availability of consistent quality pharmaceutical products throughout the United States and the European Union.

Both agencies found the parallel assessment useful and reached agreement on a wide range of QbD aspects. At the request of the applicant, experts from the Japanese Pharmaceuticals Medical Devices Agency also participated as observers in this first parallel assessment.

One of the projected outcomes of this pilot was to share key findings with the public. The FDA and EMA will publish further conclusions on other QbD-related topics as the pilot program continues and more parallel assessments are conducted.