Module 1 — Regional administrative
Scope: Region-specific forms, labeling, patent/certification (US), application forms (EU)
Examples: FDA forms, SPL labeling, environmental assessment, REMS (US); application form, SmPC, artwork (EU)
Regulatory Reference
eCTD Structure Guide
Common Technical Document (CTD) modules 1–5 as used in electronic submissions (eCTD) to FDA and EMA — folder logic, regional differences, and validation expectations.
CTD vs eCTD
The CTD is the ICH-organized content structure for marketing applications. The eCTD is the electronic implementation: XML backbone, leaf attributes, lifecycle operations (new, replace, delete), and regional validation rules.
NDAs, BLAs, ANDAs, and major supplements are filed in eCTD format for FDA. EMA centralized procedures use eCTD via the Common European Submission Platform (CESP).
Modules 1–5 overview
Module 2 — Common technical document summaries
Scope: Overviews and summaries across quality, nonclinical, and clinical
Examples: 2.2 QOS, 2.3–2.7 quality/nonclinical/clinical overviews and written summaries
Module 3 — Quality (CMC)
Scope: Drug substance, drug product, facilities, appendices
Examples: 3.2.S API, 3.2.P drug product, 3.2.A appendices, 3.2.R regional info
Module 4 — Nonclinical study reports
Scope: Pharmacology, PK, toxicology study reports and literature
Examples: 4.2.1 primary pharmacodynamics, 4.2.3 toxicology, 4.3 literature references
Module 5 — Clinical study reports
Scope: Clinical efficacy and safety reports, synopses, datasets
Examples: 5.2 study reports, 5.3 literature, ISS/ISE summaries in 2.7
Module 1 — US vs EU
| Element | FDA (US) | EMA (EU) |
|---|---|---|
| Application form | Form FDA 356h and regional forms | EU application form per procedure type |
| Labeling | US Prescribing Information (SPL) | SmPC, labeling, mock-ups, specimens |
| Patents / exclusivity | Orange Book certifications, exclusivity claims | IP and data exclusivity statements per EU law |
| Risk management | REMS (when required) | RMP (Risk Management Plan) |
Leaf titles, STF & validation
- Leaf title — each document node carries a controlled title (e.g. 3.2.P.1 Description) in the eCTD backbone
- Study Tagging Files (STF) — XML wrappers linking nonclinical and clinical study reports in Modules 4 and 5
- Technical validation — FDA eCTD validation criteria (file naming, PDF versions, bookmarks, hyperlinks) before submission gateway acceptance
- Lifecycle — submissions are sequences; supplements append or replace prior leaves with operation attributes
Frequently asked questions
Modules 2–5 follow ICH CTD structure and are largely common across regions. Module 1 is
region-specific — FDA and EMA each define their own Module 1 granularity and required forms.
Full study reports and synopses are filed in Module 5. Integrated summaries (ISS/ISE) appear in
Module 2.7. Study Tagging Files associate each report with study identifiers for reviewer navigation.