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CTD Modules with Diagrammatic representation

Updated

CTD Modules with Diagrammatic Representation provide a clear way to understand how regulatory information is organised within the Common Technical Document (CTD). The CTD consists of five modules: Module 1 contains region-specific information, while Modules 2–5 follow the harmonised structure established by the International Council for Harmonisation (ICH).

For an overview of the complete CTD and electronic submission framework, see Common Technical Document and eCTD.

The CTD can be visualised as a hierarchy in which Module 2 provides summaries and overviews of the detailed quality, nonclinical and clinical information contained in Modules 3, 4 and 5.

The official five-module structure is defined in the ICH Common Technical Document guidance.

CTD Module Structure

Module 1 – Regional Administrative and Prescribing Information

Contains region-specific administrative documents, application forms, prescribing information and other information required by the relevant regulatory authority.

Module 2 – Common Technical Document Summaries

Provides summaries and overviews of the technical information contained in Modules 3–5.

Module 2 includes:

  • 2.1 – CTD Table of Contents
  • 2.2 – CTD Introduction
  • 2.3 – Quality Overall Summary
  • 2.4 – Nonclinical Overview
  • 2.5 – Clinical Overview
  • 2.6 – Nonclinical Written and Tabulated Summaries
  • 2.7 – Clinical Summary

Module 3 – Quality

Contains detailed information relating to the quality of the drug substance and drug product, including manufacturing, characterisation, controls, specifications, analytical procedures and stability.

The Quality Overall Summary is not located in Module 3. It is provided in Module 2.3 and summarises the detailed quality information contained in Module 3.

Module 4 – Nonclinical Study Reports

Contains detailed reports from nonclinical studies, including relevant pharmacology, pharmacokinetic and toxicology studies.

Module 5 – Clinical Study Reports

Contains clinical study reports and related clinical information supporting the safety and efficacy of the medicinal product.

Diagrammatic Relationship of CTD Modules

The relationship between the modules can be represented as:

Module 1
Regional Administrative and Prescribing Information

↓

Module 2
CTD Summaries and Overviews

↓

Module 3 | Module 4 | Module 5
Quality | Nonclinical Study Reports | Clinical Study Reports

Module 2 acts as the summary layer for the detailed technical documentation contained in Modules 3–5.

Relationship Between Module 2 and Technical Modules

The CTD structure allows regulatory reviewers to move from high-level summaries to detailed supporting information.

The Quality Overall Summary in Module 2.3 summarises Module 3. The Nonclinical Overview and Summaries in Modules 2.4 and 2.6 relate to the detailed nonclinical reports in Module 4. The Clinical Overview and Clinical Summary in Modules 2.5 and 2.7 relate to the detailed clinical information in Module 5.

This hierarchical structure helps maintain consistency between regulatory summaries and the underlying quality, nonclinical and clinical evidence.

Here is a diagrammatic representation of the modules included in the Common Technical Document (CTD):

Common Technical Document (CTD)
+—————————————————–+
| Module 1: Administrative Information |
| |
| +————————————————-+ |
| | Application Form | |
| +————————————————-+ |
| | Table of Contents | |
| +————————————————-+ |
| | Summaries of the Drug Characteristics | |
| +————————————————-+ |
| | Product Labeling | |
| +————————————————-+ |
| |
+—————————————————–+
|
|
+—————————————————–+
| Module 2: Summaries |
| |
| +————————————————-+ |
| | Quality Overall Summary (QOS) | |
| +————————————————-+ |
| | Nonclinical Overview | |
| +————————————————-+ |
| | Clinical Overview | |
| +————————————————-+ |
| | Clinical Summary of Efficacy | |
| +————————————————-+ |
| | Clinical Summary of Safety | |
| +————————————————-+ |
| |
+—————————————————–+
|
|
+—————————————————–+
| Module 3: Quality |
| |
| +————————————————-+ |
| | Quality Overall Summary (QOS) | |
| +————————————————-+ |
| | Drug Substance (Active Substance) | |
| +————————————————-+ |
| | Drug Product (Finished Product or Formulation) | |
| +————————————————-+ |
| | Stability Data | |
| +————————————————-+ |
| |
+—————————————————–+
|
|
+—————————————————–+
| Module 4: Nonclinical Study Reports |
| |
| +————————————————-+ |
| | Introduction and Study Reports | |
| +————————————————-+ |
| | Pharmacology | |
| +————————————————-+ |
| | Pharmacokinetics | |
| +————————————————-+ |
| | Toxicology | |
| +————————————————-+ |
| |
+—————————————————–+
|
|
+—————————————————–+
| Module 5: Clinical Study Reports |
| |
| +————————————————-+ |
| | Introduction and Study Reports | |
| +————————————————-+ |
| | Clinical Study Reports | |
| +————————————————-+ |
| | Clinical Study Reports Appendices | |
| +————————————————-+ |
| |
+—————————————————–+

Understanding CTD Modules with Diagrammatic Representation helps illustrate the relationship between regulatory summaries and the underlying quality, nonclinical and clinical evidence, while making the five-module CTD hierarchy easier to navigate.

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