EMA and FDA extend pilot for parallel assessment of quality-by-design applications
Further guidance on QbD should be published later this year
As of 1 April, the European Medicines Agency (EMA) and the US Food and Drug Administration (US FDA) have agreed a two-year extension of their joint pilot programme for the evaluation of quality-by-design (QbD) applications.
This follows the success of the first phase of the programme, started in April 2011, during which the agencies assessed in parallel the QbD elements of a marketing authorisation application and several scientific advice requests submitted by drug developers.
The agencies found these parallel assessments useful and agreed on a range of QbD aspects, resulting in the publication of two guidance documents for the industry. Further guidance is being developed and should be published this year.
QbD aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.
The parallel assessment aims to share knowledge, facilitate a consistent implementation of the international guidelines on QbD 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. Applicants and sponsors should express their interest in participating in the programme to both agencies at least three months prior to submission of an application.