Do I need to know about XML in order to build an eCTD?
No. A number of vendors provide electronic publishing software that generates the XML backbone automatically. Integrated document management and publishing solutions are available available commercially from numerous vendors (see our vendor links page). These tools provide intuitive graphical environments for working with eCTDs, and the XML processing is done automatically “under the hood”. Thus there is no need for the users to have any specific knowledge of XML.