Posted by Michael Wonder on 08 Feb 2019
EMA launches checklist to facilitate validation for initial marketing authorisation applications
8 February 2019 - A survey launched by EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications.
They create additional workload for companies and potential delays at a critical moment for the timely start of the procedure. To make the validation process more efficient, predictable and easier to navigate, EMA is encouraging applicants to submit a new validation checklist as part of the MAA dossier.
The initiative is launched as a five-month pilot and is expected to increase the number of ‘first time right’ submissions significantly. Applicants who use the checklist are invited to submit their comments to checklist_ima@ema.europa.eu. EMA will use this feedback and the information collected on the quality of submissions using the new checklist to improve the validation process itself.
