Update of the BfArM-websites in the section eSubmission including an update of the eValidator
The BfArM updated its websites in the section eSubmission due to the use of electronic application forms (eAF) as of 1 January 2016.
In addition the BfArM offers an updated version of a tool which checks your dossier against validation criteria for the eCTD format as well as for NeeS compilations and PDF files (file size, PDF version, configuration, hyperlinks, bookmarks, naming conventions) which can be downloaded and used free of cost. The current changes cover e.g. a check of opening the new eAF PDF files (in line with the criterion 16.5). Therefore, the update is highly recommended.