In which module of the CTD is the quality information of a medicinal product displayed?

The quality information of a medicinal product is contained in Module 3 of the Common Technical Document (CTD). This module focuses specifically on the quality aspect of the drug substance and drug product, including detailed information about the production process, specifications, and control measures. It is crucial for regulatory authorities to evaluate the quality of a medicinal product to ensure that it is safe and effective for consumer use.

Module 1 is designated for regional administrative information, including country-specific requirements, and does not focus on the product's quality attributes. Module 2 provides a summary of the data found in the other modules but does not contain detailed quality data itself. Module 4 is related to nonclinical study reports. Thus, Module 3 is the dedicated section where all pertinent quality information is comprehensively presented.