The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are publishing a series of joint question-and-answer documents that outline the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application.
One of the projected outcomes of this pilot was to share key findings with the public. FDA and EMA will publish additional question-and-answer documents on other QbD-related topics as the pilot program continues and more parallel assessments are conducted.
In March 2011, FDA and EMA launched a pilot program, in which both agencies communicated review findings about 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 quality.
As part of this pilot program, U.S. and European regulators communicate and consult throughout the review process relevant 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.
- Questions and answers on level of detail in the regulatory submissions
Questions and Answers on Design Space Verification
- European Medicines Agency and US Food and Drug Administration release first conclusions of parallel assessment of quality-by-design applications
- Questions and Answers about FDA-EMA Parallel Assessment
International Council for Harmonisation-Quality Q8, Q9, and Q10 Questions and Answers(PDF - 185KB) Q8, Q9, & Q10 Questions and Answers -- Appendix: Q&As from Training Sessions (Q8, Q9, & Q10 Points to Consider) European Medicines Agency