What is a NEES submission?
NEES stands for “non-eCTD electronic submission”. A NEES submission is essentially an eCTD without any XML backbones. In a NEES submission, the XML backbone is replaced with hyperlinked Tables of Contents in PDF format (Sections 1.1, 2.1, 3.1, 4.1 and 5.1). These sections are not needed in an eCTD, because the XML backbone functions as a hyperlinked Table of Contents. The XML backbone also includes lifecycle management information that describes how the files being submitted relate to those submitted in previous submissions (sequences). In a NEES submission, the covering letter must include a detailed description of how the files submitted in the current submission relate to what has been submitted previously, since there is no XML backbone containing this information. Guidance on NEES in Europe is available on the EMEA website. In Europe, NEES can be viewed as analternative to eCTD which is especially valuable for authorised products for which paper submissions have been used previous
