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New EMA pilot project helps to facilitate validation of initial marketing authorisation applications

Europe

EMA launched a five-month pilot study to increase the correct submissions of initial marketing authorisations applications (MAAs). The pilot is a result of the 2016 EMA survey that showed validation issues occur in 90% of all initial applications.

The pilot study consists of an authomated checklist that will help companies assess the level of completion and consistency of the various sections in their application. EMA encourages applicants to submit the validation checklist as part of the MAA dossier. In addition, comments to the checklist may be sent to checklist_ima@ema.europa.eu for further evaluation and improvement of the current validation process.

More information can be found here.

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