What does Module 4 of the CTD focus on?

Module 4 of the Common Technical Document (CTD) specifically focuses on Non-Clinical Study Reports. This module is critical as it provides a comprehensive summary and presentation of the non-clinical studies used to assess the safety of a drug product before it is tested in humans. Typically, this includes data from toxicity studies, pharmacology studies, and other preclinical evaluations that are vital for demonstrating the safety profile of the investigational product to regulatory bodies.

In this module, companies are required to submit a detailed account of their findings, including methodologies, results, and analyses of the studies conducted. This information is crucial in addressing the regulatory requirements pertaining to the development of new drugs, as it helps establish the foundational safety data upon which clinical trials rely.

Understanding the structure and content of Module 4 is essential for regulatory affairs professionals, as it directly impacts the submission process and the approval pathway for new drug applications.