How many modules is the CTD divided into?

The Common Technical Document (CTD) is divided into five modules. This structure is designed to facilitate the review of applications for pharmaceuticals and biologics by regulatory agencies.

Module 1 contains administrative information and prescribing information which varies by region, particularly the United States and the European Union. Module 2 includes summaries of the entire application and is intended to provide a comprehensive overview of the more detailed findings found in the subsequent modules. Module 3 focuses specifically on quality, covering the chemistry, manufacturing, and controls of the drug. Module 4 deals with non-clinical studies, providing safety and efficacy data from animal studies. Finally, Module 5 presents clinical study reports, which include all clinical data collected during trials.

The five-module structure of the CTD is standardized to ensure consistency and efficiency in regulatory submissions globally, aiding both applicants and regulatory reviewers in the evaluation process.