EMA and FDA Release QbD Guidance

FDA and the European Medicines Agency (EMA) have published a second joint question-and-answer document that provides guidance on the quality-by-design (QbD) concept. The guidance focuses on design space verification and reflects the conclusions reached by European Union and US regulators.

In March 2011, FDA and EMA launched a three-year pilot program for the parallel assessment of certain quality or chemistry manufacturing and control (CMC) sections of applications that are relevant to QbD. The objective of the program is to share knowledge and harmonize implementation of the QbD concept. Experts from the Japanese Pharmaceuticals and Medical Devices Agency participate as observers in the program.

According to EMA, the pilot program is open to selected procedures, including applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot program is voluntary. Interested applicants and sponsors should notify both agencies three months prior to submission of an application.

To access the document, see FDA/EMA.

Posted by Tim Sandle