Module 12 2019

eCTD eCTD = Electronic Common Technical Document

An eCTD application is a CTD application, but then electronically.

Electronically means for eCTD: • Complete dossier in electronic format • XML files (XML backbone) • Specifications followed for the Granularity, folder- & filename convention of the dossier • Navigation through the dossier by means of hyperlinks and bookmarks

The Organisation for Professionals in Regulatory Affairs

Slide 9