EMA and FDA extend pilot programme for parallel assessment of quality-by-design applications

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06/03/2014

EMA and FDA extend pilot programme for parallel assessment of quality-by-design applications

As of 1 April 2014 the European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have agreed on a two-year extension of their joint pilot programme for the parallel evaluation of quality-by-design (QbD) applications.

This follows the success of the first phase of this programme initiated in April 2011 during which the agencies assessed in parallel the QbD elements of one marketing authorisation application and several scientific advice requests submitted by medicines developers. 

Both agencies found these parallel assessments extremely useful and reached agreement on a wide range of QbD aspects leading to the publication of two guidance documents for the industry. Further guidance is being developed and is expected to be published in 2014.

Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of the medicines; these concepts are described in the international guidelines ICH Q8, Q9, Q10 and Q11.

The objective of this parallel assessment is to share knowledge, facilitate a consistent implementation of the international guidelines on QbD aspects and promote the availability of pharmaceutical products of consistent quality throughout the European Union and the United States.

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.

Applicants volunteering for this parallel assessment benefit from a harmonised 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.

With the agreement of the applicants, experts from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) participate as observers in the programme.