Pfizer transfers first QbD Dossier within the FDA/EMA Project

On 1 April 2011 the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA) started a pilot project (see our GMP News from 6 April 2011) for the evaluation of Quality by Design (QbD) applications. On 17 June the two authorities informed about the first dossier within the pilot programme which was issued by Pfizer.

The pilot programme is supposed to facilitate the implementation of QbD. Companies benefit from the fact that both authorities review the dossier together. This reduces the effort for the authorities as well as for the participating companies. In addition it can be expected that the joint evaluation of the dossiers speeds up the approval process. For all pharmaceutical companies operating internationally it is extremely important that the time until the authorisation is granted can be reduced within the scope of optimising the "time to market".

With the publication of ICH Q8 Pharmaceutical Development harmonised standards have been established in the regions Japan, USA and Europe. Due to the pilot project it is now possible to optimally process QbD applications.

Examples for implementing QbD projects are also part of the QbD/PAT Conference organised by the University of Heidelberg together with the ECA.

Source: EMA Webseite

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