FDA and EMA Extend QbD Parallel-Assessment Pilot Program

FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the United States.

The extension follows what FDA and EMA have called a successful program that has created inter-agency agreement on a wide range of QbD topics. The program has resulted in the publication of two question-and-answer documents and has created joint research efforts on QbD-related topics. The agencies have agreed that there are further QbD areas that warrant additional inter-agency harmonization and expect to publish more guidance documents in 2014.

The program is open to applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot is voluntary, and applicants should contact both FDA and EMA at least three months prior to submitting an application. According to EMA, “applicants volunteering for this parallel assessment benefit from a harmonized evaluation of their application and receive a common list of questions/information requests or an agreed list of issues to be addressed from the two agencies for the parts of the application subject to the pilot.”