1. CTD Triangle
Regional
administrative
information
Module 1
Non-clinical
overview
Module 2
Not part
of the CTD
Clinical
overview
The CTD
Quality overall
summary
Quality
Module 3
Non-clinical
summary
Clinical
summary
Non-clinical
study reports
Clinical study
reports
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.