The new pilot programme to evaluate the pervasiveness of a Quality by Design (QbD) approach to developing products will be launched on April 1st and will involve an assessment of a number of areas relevant to QbD, such as development, design space and real-time testing.
New marketing authorisation applications and scientific advice requests will also fall under the pilot, which will only include chemical entities and is set to run until March 31st 2014.
Both organisations will publish the outcomes of the programme following its conclusion in three years time.
However, the two groups could extend this to include other areas.
Applicants and sponsors interested in being involved in this voluntary scheme have been asked to notify both agencies three months prior to submitting an application.
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