Results of a previous survey conducted by the EMA showed that 90% of initial MAAs are affected by validation issues.
In order to address this, the Agency is now requesting that Applicants include a new validation checklist as part of the MAA dossier. Use of this checklist should help ensure a greater completeness and consistency of the applications.
The aim is to increase the number of applications that are correct at time of submission, thus reducing the workload of both the Applicant and Agency. Results of an initial five-month pilot study will be published by the EMA towards the end of 2019.
Applicants who use the checklist can submit comments to email@example.com. Feedback will be used to improve the checklist and the overall validation process.
Further information has been included in the Pre-authorisation guidance Q&A on the EMA website.