In the EU, which type of documentation should NOT be included in Module 1 of a submitted dossier?

The reason the Quality Overall Summary should not be included in Module 1 of a submitted dossier lies in the specific structural requirements outlined by the European Medicines Agency (EMA) for the Common Technical Document (CTD) format. Module 1 of the CTD primarily serves as the administrative and legislative backbone of the application, containing documents like the application form, Labeling text, and the Summary of Product Characteristics (SmPC).

In contrast, the Quality Overall Summary is part of Module 3, which focuses on the quality section of the drug application. This section is intended to provide detailed information about the drug substance and drug product, including their quality attributes and manufacturing processes. By delineating the Quality Overall Summary to Module 3, the regulatory authorities ensure that quality information is organized in a cohesive manner that aligns with other technical data relevant to the product's chemistry, manufacturing, and controls (CMC). This organization allows for a comprehensive and systematic review process by the regulatory entities.