CTD Modules with Diagrammatic representation
CTD Modules with Diagrammatic representation
Here is a diagrammatic representation of the modules included in the Common Technical Document (CTD):
Common Technical Document (CTD)
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| Module 1: Administrative Information |
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| | Application Form | |
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| | Table of Contents | |
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| | Summaries of the Drug Characteristics | |
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| | Product Labeling | |
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| Module 2: Summaries |
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| | Quality Overall Summary (QOS) | |
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| | Nonclinical Overview | |
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| | Clinical Overview | |
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| | Clinical Summary of Efficacy | |
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| | Clinical Summary of Safety | |
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| Module 3: Quality |
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| | Quality Overall Summary (QOS) | |
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| | Drug Substance (Active Substance) | |
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| | Drug Product (Finished Product or Formulation) | |
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| | Stability Data | |
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| Module 4: Nonclinical Study Reports |
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| | Introduction and Study Reports | |
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| | Pharmacology | |
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| | Pharmacokinetics | |
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| | Toxicology | |
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| Module 5: Clinical Study Reports |
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| | Introduction and Study Reports | |
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| | Clinical Study Reports | |
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| | Clinical Study Reports Appendices | |
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This diagram provides a visual representation of the five modules included in the CTD, along with their respective contents. It highlights the organization and structure of the CTD, which is designed to provide a comprehensive overview of the data generated during the drug development process, and facilitate the regulatory review and approval of pharmaceuticals for human use.
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