CTC & eCTD Structure (Common Technical Document)
In regulatory affairs, drug approval submissions follow a globally accepted format called CTC (CTD).
CTC = Common Technical Document
eCTD = electronic Common Technical Document (digital submission format)
This structure helps regulators review drug applications in a standard, organized, and systematic way.
CTC / eCTD Has 5 Modules
The CTD is divided into 5 modules, and each module contains specific data.
Module 1: Regional / Administrative Information
This module contains country-specific requirements (varies by USFDA, EMA, CDSCO, etc.)
Includes:
- Cover letter
- Application forms
- Labeling (package insert, carton, prescribing info)
- Certificates & legal documents
- Risk management plan
Note: Module 1 is not common globally because it depends on the region.
Module 2: CTD Summaries
This module provides summaries of Modules 3, 4, and 5 for quick understanding.
Includes:
- Quality Overall Summary (QOS)
- Nonclinical Overview & Summary
- Clinical Overview & Summary
It gives a complete overview of the product data in a concise format.
Module 3: Quality (CMC)
CMC = Chemistry, Manufacturing & Controls
This module focuses on product quality and manufacturing consistency.
Includes:
- API (Drug Substance) details
- Finished Product (Drug Product) details
- Manufacturing process
- Specifications & testing methods
- Stability studies
- Packaging information
This module proves the product is stable, consistent, and well-controlled.
Module 4: Nonclinical (Preclinical Studies)
This module contains laboratory and animal study data.
Includes:
- Pharmacology studies
- Toxicology studies
- ADME studies (Absorption, Distribution, Metabolism, Excretion)
It ensures the drug is safe before human trials.
Module 5: Clinical Studies
This module contains human clinical trial data.
Includes:
- Clinical Study Reports (CSR)
- Safety & efficacy results
- Biostatistics and analysis
- Protocols and trial documentation
This module confirms the medicine is effective and safe in humans.
CTC vs eCTD
CTC = Standard submission format
eCTD = Electronic submission with structured folders + hyperlinks + XML backbone
Today, most global submissions are done through eCTD.
Conclusion
The CTC/eCTD structure plays a major role in ensuring drug approval submissions are complete, well-organized, and globally accepted, supporting faster and smoother regulatory review
MBH/PS