Quality-by-design in pharmaceuticals is a method whereby quality elements are evaluated using an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality.

The agencies had already been collaborating on a three-year pilot programme, which will conclude on 31 March 2014 [1]. Under this pilot the agencies assessed in parallel the QbD elements of one marketing authorization application and several scientific advice requests from drug manufacturers. The collaboration also resulted in the agencies publishing Q&A guidance for industry and EMA expects further guidance to be published in 2014.

The programme is open to applications for initial marketing authorizations, type-II variations and scientific advice. Participation in the pilot is voluntary and applicants should express their interest in participating in the programme to both agencies at least three months prior to submission of an application. The original pilot was only open to new chemical entities, however, it is not stated in EMA’s press release if this will be extended to generics or not.

The advantage of taking part in this parallel assessment is that applicants will undergo 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.

With the agreement of the applicants, experts from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) will also participate as observers in the programme. This could possibly be with a view to including the PMDA in this collaboration in the future.

Related article

Quality by design for generics by 2013

Reference

1.   GaBI Online - Generics and Biosimilars Initiative. FDA and EMA to join forces on quality [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 14]. Available from: www.gabionline.net/Guidelines/FDA-and-EMA-to-join-forces-on-quality

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