eCTD

Module 1: Regional Administrative Information

• 1.0 Cover Letter

• 1.1 Comprehensive Table of Contents

• 1.2 Application Forms

• 1.3 Administrative Information

• 1.4 Information for Regional Use

• 1.5 Labeling

• 1.6 Other Regional Information

Module 2: Common Technical Document Summaries

• 2.1 CTD Table of Contents

• 2.2 Introduction

• 2.3 Quality Overall Summary

• 2.4 Nonclinical Overview

• 2.5 Clinical Overview

• 2.6 Nonclinical Written and Tabulated Summaries

  • 2.6.1 Pharmacology Written Summary

  • 2.6.2 Pharmacology Tabulated Summary

  • 2.6.3 Pharmacokinetics Written Summary

  • 2.6.4 Pharmacokinetics Tabulated Summary

  • 2.6.5 Toxicology Written Summary

  • 2.6.6 Toxicology Tabulated Summary

• 2.7 Clinical Summary

  • 2.7.1 Summary of Biopharmaceutics and Associated Analytical Methods

  • 2.7.2 Summary of Clinical Pharmacology Studies

  • 2.7.3 Summary of Clinical Efficacy

  • 2.7.4 Summary of Clinical Safety

  • 2.7.5 Synopses of Individual Studies

Module 3: Quality

• 3.1 Table of Contents of Module 3

• 3.2 Body of Data

  • 3.2.S Drug Substance

  • 3.2.S.1 General Information

  • 3.2.S.2 Manufacture

  • 3.2.S.3 Characterization

  • 3.2.S.4 Control of Drug Substance

  • 3.2.S.5 Reference Standards or Materials

  • 3.2.S.6 Container Closure System

  • 3.2.S.7 Stability

  • 3.2.P Drug Product

  • 3.2.P.1 Description and Composition of the Drug Product

  • 3.2.P.2 Pharmaceutical Development

  • 3.2.P.3 Manufacture

  • 3.2.P.4 Control of Excipients

  • 3.2.P.5 Control of Drug Product

  • 3.2.P.6 Reference Standards or Materials

  • 3.2.P.7 Container Closure System

  • 3.2.P.8 Stability

  • 3.2.A Appendices

  • 3.2.R Regional Information

Module 4: Nonclinical Study Reports

• 4.1 Table of Contents of Module 4

• 4.2 Study Reports

  • 4.2.1 Pharmacology

  • 4.2.2 Pharmacokinetics

  • 4.2.3 Toxicology

• 4.3 Literature References

Module 5: Clinical Study Reports

• 5.1 Table of Contents of Module 5

• 5.2 Tabular Listing of All Clinical Studies

• 5.3 Clinical Study Reports

  • 5.3.1 Reports of Biopharmaceutic Studies

  • 5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials

  • 5.3.3 Reports of Human Pharmacokinetic (PK) Studies

  • 5.3.4 Reports of Human Pharmacodynamic (PD) Studies

  • 5.3.5 Reports of Efficacy and Safety Studies

  • 5.3.6 Reports of Post-Marketing Experience

  • 5.3.7 Case Report Forms and Individual Patient Listings

• 5.4 Literature References