Module 1 2021

25/06/2021

The NeeS submission format

• The NeeS format was developed in Europe and was intended as a stepping stone to the eCTD • Use the same files and folders as the eCTD but simplify the navigation by using a PDF Table of Contents (TOC) with hyperlinks • What is not available is the lifecycle management information

• But note that the NeeS format is still a good standard! ─ NeeS has also become a term used in many regions

The Organisation for Professionals in Regulatory Affairs

19

Main components of the eCTD

The Organisation for Professionals in Regulatory Affairs

20

10