EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications

The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications.

Quality-by-design is a science- and risk-based approach to pharmaceutical development and manufacturing that was introduced a few years ago in international guidelines intended for the pharmaceutical industry. QbD involves the use of statistical, analytical and risk-assessment methods to design and develop pharmaceutical compounds and manufacturing processes to ensure the quality of the manufactured product.

In March 2011, the EMA and the US FDA launched a three-year pilot programme for the parallel assessment of certain quality or chemistry, manufacturing and control (CMC) sections of applications that are relevant to QbD.

The objective of this parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on the implementation of the QbD concept (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines Q8, Q9, Q10 and Q11) and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the US.

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

Both agencies found the first parallel assessment extremely useful and reached agreement on a wide range of QbD aspects, as reflected in the question-and-answer document. Experts from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) participated as observers in this first parallel assessment, with the agreement of the applicant.

The EMA and the US FDA will publish further conclusions on other QbD-related topics as the pilot programme continues and more parallel assessments are conducted.