CTD Triangle

Not part
of the CTD
Regional
administrative
information
Module 1

Non-clinical
overview Clinical
Module 2
overview

The CTD
Quality overall Non-clinical Clinical
summary summary summary

Quality Non-clinical Clinical study

study reports reports
Module 3 Module 4 Module 5

The CTD triangle. The Common Technical Document is organized into five modules. Module 1is
region specific and modules 2, 3, 4 and 5 are intended to be common for all regions.