What is the purpose of Module 2 in the CTD?

Module 2 of the Common Technical Document (CTD) serves as an overview and provides a critical synthesis of the information presented in Modules 3 to 5. It is aimed at summarizing quality-related data, clinical data, and non-clinical data in a coherent manner, allowing regulatory authorities to gain a comprehensive understanding of the information presented in the detailed modules. This module helps to position the detailed data within the broader context of the submission, facilitating the evaluation process for the regulatory reviewers.

By including summaries and overviews, Module 2 aids in the identification of key findings and conclusions from the more technical details provided in the subsequent modules. This structured approach not only enhances clarity but also ensures that the reviewer can focus on significant aspects of the submission without getting overwhelmed by extensive data. Thus, the integration of summaries and overviews aligns with regulatory goals for efficient review and evaluation of pharmaceutical submissions.