Module 12 2019

eCTD - basic rules

Once eCTD always eCTD

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• Folder- and file naming convention for eCTD according to specifications highly recommended, for NeeS mandatory • One way traffic from applicant to authority • Files: ▪ Documents to be submitted in PDF format ▪ • Granularity, folder and file naming convention as defined in the specifications has to be followed (highly recommended) ▪ Empty folders to be removed/deleted ▪ Documents without content are not included (no "not applicable" documents) ▪ ToC’s not allowed (XML backbone) Word documents are not included in the eCTD, but in “working documents” folder

The Organisation for Professionals in Regulatory Affairs

Slide 70