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.
- European Medicines Agency and US Food and Drug Administration release first conclusions of parallel assessment of quality-by-design applications45
EMA press release (8/20/2013)
- Questions and Answers about FDA-EMA Parallel Assessment67
EMA-FDA pilot program for parallel assessment of Quality by Design applications(PDF - 103KB)8
FDA, EMA announce pilot for parallel assessment of Quality by Design applications9
FDA news release (3/16/2011)
International Conference on Harmonisation - Quality10
European Medicines Agency1112
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)1314