Module 1 – This is not part of the CTD and is not defined by the ICH guidelines. It contains specific regional administrative information such as application forms.
Module 2 – This section introduces the pharmaceutical drug and includes key summaries of the submission data including, for example, the quality overall summary, non-clinical overview, and clinical overview.
Module 3 – This module contains the quality information for the drug substance, drug product and any relevant regional information. Module 3 is also referred to as the Chemistry, Manufacturing and Controls (CMC) section.
Module 4 – This section contains safety information presented in non-clinical study reports.
Module 5 – This contains efficacy information presented in the clinical study reports.