Module 1

Regional
administrative
information
Not part
of the CTD
The CTD
Module 3
Module 2
Quality
Module 4
Non-clinical
study reports
Module 5
Clinical study
reports
Quality overall
summary
Non-clinical
overview
Non-clinical
summary
Clinical
summary
Clinical
overview
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.
CTD Triangle