QbD in pharmaceuticals involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality.

Under the programme, both agencies will assess the parts of the applications relevant to QbD, such as development, design space and real-time release testing; separately but with regular communication, leading to a common list of questions for the applicants and a harmonised evaluation of their responses.

In Europe, the pilot programme currently applies only to new marketing authorisation applications and quality-related scientific advice requests. Type II variations may be included on a case-by-case basis. In the US the programme will cover new drug marketing applications, prior approval supplements and chemistry manufacturing control meeting requests. The pilot programme will only include chemical entities. However, who knows—generics may be next.

Participation in the pilot programme is voluntary, and interested applicants/sponsors are asked to notify both agencies three months prior to submission of an application. The pilot programme will conclude on 31 March 2014, when both agencies will jointly assess and publish the outcome of the pilot programme.