Definition
CTD (Common Technical Document) is the internationally standardized format for organizing pharmaceutical regulatory applications. Developed by ICH, CTD provides a common structure accepted by FDA, EMA, PMDA, and other major regulatory agencies.
How CTD Format Works
CTD organizes drug application content into five modules, with Module 1 being region-specific and Modules 2-5 common across all regions. This harmonization enables global regulatory submissions.
CTD Modules
| Module | Title | Content |
|---|---|---|
| 1 | Administrative | Regional requirements, forms, labeling |
| 2 | Common Technical Document Summaries | Quality, nonclinical, clinical overviews |
| 3 | Quality | Drug substance and product CMC data |
| 4 | Nonclinical Study Reports | Pharmacology and toxicology studies |
| 5 | Clinical Study Reports | Clinical trial data and analysis |
Module 2 Summaries
Module 2 provides critical summaries for reviewers:
- 2.2: CTD Introduction
- 2.3: Quality Overall Summary
- 2.4: Nonclinical Overview
- 2.5: Clinical Overview
- 2.6: Nonclinical Summaries
- 2.7: Clinical Summaries
Why BD Teams Track CTD Format
For business development professionals, CTD organization affects development:
- Deal Implication: Well-organized CTD dossiers reduce regulatory risk
- Due Diligence Focus: Review CTD completeness and gaps
- Opportunity Signal: Partners with CTD expertise enable faster global submissions