European Medicines Agency and US Food and Drug Administration receive first parallel quality-by-design application

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17/06/2011

European Medicines Agency and US Food and Drug Administration receive first parallel quality-by-design application

The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have agreed to accept the first application under their pilot programme for the parallel evaluation of marketing-authorisation applications involving 'quality by design' (QbD).

The application, from Pfizer, will allow the two agencies to assess the parts of the application related to QbD in parallel. The agencies 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.

Related information

Contact point:

info@ema.europa.eu