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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

Ctd triangle

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Page 1: Ctd triangle

Module 1

Regionaladministrative

information

Not partof the CTD

The CTD

Module 3

Module 2

Quality

Module 4

Non-clinicalstudy reports

Module 5

Clinical studyreports

Quality overallsummary

Non-clinicaloverview

Non-clinicalsummary

Clinicalsummary

Clinicaloverview

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