Question 4 of 6 Intermediate Concept
What is the purpose of each CTD module?
Short answer
Module 1 covers regional administrative material, Module 2 summarizes the evidence, Module 3 covers quality, Module 4 nonclinical reports and Module 5 clinical study reports.
Why
Use the CTD as a map of what the regulator needs to review. Module 1 can contain region-specific forms and prescribing information. Module 2 contains the quality overall summary and nonclinical and clinical overviews and summaries.
Module 3 details chemistry, manufacturing and controls, including product and process information. Module 4 provides nonclinical pharmacology and toxicology study reports, while Module 5 contains clinical study reports and relevant clinical information. For a therapeutic antibody, manufacturing characterization and control strategy are primarily presented in Module 3, while pivotal clinical efficacy reports appear in Module 5 and are synthesized in Module 2.
Scientific modules 2 to 5 use a harmonized outline, but national administrative requirements and submission validation differ. eCTD organizes the electronic delivery and lifecycle of these materials.
Common mistakes
- Putting all efficacy data in Module 2 or claiming that Module 1 is identical in every country
The interviewer might ask next
Which modules would be impacted if a stability concern triggers a formulation change?