EMA and US FDA get first parallel QbD application; FDA beats EMA on cancer drug appros

The European Medicines Agency (EMA) and the US Food and Drug Administration have agreed to accept the first application under their pilot program for the parallel evaluation of marketing authorization applications involving “quality by design” (QbD).

The application, from US drugs behemoth Pfizer (NYSE: PFE), will allow the two agencies to assess the parts of the application related to QbD in parallel. The agencies, which did not reveal the identity of the product to be evaluated, will communicate with and consult each other regularly during the evaluation process, resulting, if possible, in a common list of questions to the applicant and harmonised evaluation of the applicant's responses.

QbD is a methodology that involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure the quality of medicines. The agencies started the three-year pilot of parallel QbD evaluation in April 2011. The pilot is being operated under the EMA's confidentiality arrangements with the FDA.