What is the CTD?
The Common Technical Document (CTD) is the harmonized format used to submit a pharmaceutical marketing authorization application across ICH regions. Five modules cover everything from administrative paperwork to clinical study reports.
Short answer. The CTD is a five-module submission format harmonized under ICH M4. Module 1 is region-specific administrative content. Modules 2-5 are harmonized: summaries (Module 2), Quality / CMC (Module 3), Nonclinical Safety (Module 4), Clinical Efficacy (Module 5). eCTD is the electronic packaging that wraps the CTD content for transmission.
The five modules
- Module 1 — Regional Administrative Information. Not harmonized. FDA's Module 1 differs from EMA's, which differs from Health Canada's. Contains cover letter, application form, labeling, environmental assessment, patent certifications, etc.
- Module 2 — Summaries. CTD Table of Contents, CTD Introduction, Quality Overall Summary (QOS), Nonclinical Overview, Nonclinical Summary, Clinical Overview, Clinical Summary.
- Module 3 — Quality (CMC). 3.2.S drug substance, 3.2.P drug product, 3.2.A appendices (facilities, adventitious agents, excipients), 3.2.R regional information. Governed by ICH M4Q.
- Module 4 — Nonclinical Study Reports. Pharmacology, pharmacokinetics, toxicology. Governed by ICH M4S.
- Module 5 — Clinical Study Reports. Phase I through Phase IV study reports, tabular listings, integrated summaries of efficacy and safety. Governed by ICH M4E.
Regional variants
The CTD itself is harmonized, but specific regional filings sit on top of it:
- United States (FDA): NDA (new drug), BLA (biologics), ANDA (generics), IND (investigational).
- European Union (EMA): centralized procedure, decentralized procedure, mutual recognition procedure.
- Canada (Health Canada): ANDS (generic), NDS (new drug), Supplemental NDS, Notifiable Change.
- Japan (PMDA): JNDA.
CTD vs eCTD
The CTD specifies what content goes where. The eCTD (electronic CTD) specifies the XML backbone, folder hierarchy, and PDF formatting requirements for electronic transmission. FDA, EMA, Health Canada, and PMDA all require eCTD for most application types. Validated publishers (Veeva Vault RIM Publishing, Lorenz docuBridge, EXTEDO eCTDmanager) package CTD content into eCTD before submission.
Related glossary entries
Frequently asked questions
What is the CTD?
The Common Technical Document is the harmonized format for pharmaceutical product applications across ICH regions (FDA, EMA, PMDA, Health Canada, Swissmedic, and others). It was developed under ICH M4 to eliminate region-specific submission formats.
How many modules does the CTD have?
Five. Module 1 (region-specific admin), Module 2 (summaries: QOS, Nonclinical Overview, Clinical Overview, Clinical Summary), Module 3 (Quality / CMC), Module 4 (Nonclinical Safety), Module 5 (Clinical Efficacy and Safety).
What is the difference between CTD and eCTD?
CTD refers to the content structure. eCTD is the electronic format (XML backbone, PDFs, folder hierarchy) used to transmit CTD content to agencies. FDA, EMA, Health Canada, and PMDA now require eCTD for most submissions.
Which ICH guideline covers the CTD?
ICH M4 overall, with M4Q for Quality (Module 3), M4S for Safety (Module 4), and M4E for Efficacy (Module 5). Current versions: M4(R4), M4Q(R2) (2025 revision), M4S(R2), M4E(R2).