eCTD is the standard format for submitting original applications, amendments, supplements, and registration changes to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.
May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.

Please refer to the eCTD Guidance for the complete details to meet the eCTD requirement.

Now paper based dossier submission companies will have no choice and must quickly move to create and publish their dossier with new FDA’s regulations and requirments in eCTD format. So, to help submitting dossiers in electronic format KnowledgeNET an eCTD software can easily save a company thousands of dollars by effectively utilising the software features, for generating dossiers in eCTD format