An Initiative Under The ICH: Europe, Japan and USA

Common Technical Document
)CTD(
An initiative under the ICH: Europe, Japan

and USA.
Structure of dossier of medicinal products,
information on the CTD format (1)
 A common format for the technical documentation:
– significantly reduces the time and resources needed to compile
applications for registration of human pharmaceuticals
– eases the preparation of electronic submissions
– Facilitates regulatory reviews and communication with the
applicant by a standard document of common elements
– Simplifies exchange of regulatory information between
Regulatory Authorities
 This guideline is not intended to indicate what studies are

required. It merely indicates an appropriate format for the
data that have been acquired.
CTD format (2)
 GENERAL PRINCIPLES
– Text and tables should be prepared using margins that allow the document
to be printed on A4 paper.
– The left-hand margin should be sufficiently large that information is not
obscured by the method of binding.
– Font sizes for text and tables should be easily legible, even after
photocopying. Times New Roman, 12-point font, is recommended for
narrative text.
– Every page should be numbered.
– Acronyms and abbreviations should be defined the first time they are used
in each module.
– References should be cited in accordance with the current edition of the
Uniform Requirements for Manuscripts Submitted to Biomedical Journals,
International Committee of Medical Journal Editors (ICMJE)1.
The CTD is organized into five modules:
Module 1.
 Administrative, Regional or National information provided
Module 2.
 Contain High level summaries (the quality overall summary, Nonclinical over
view/Summaries
Module 3.
 Chemical, Pharmaceutical and biological documentation is provided
Module 4.
 The documentation on the Toxicological and Pharmaceutical tests performed in
the nonclinical written summaries (from Module 2) and non clinical study reports
Module 5.
 The documentation on the clinical trials performed on the drug/medical product
is provided in the clinical written summaries (from Module 2) and in the clinical
study reports
CTD format: Overall Table of Contents (ToC)
1.1
ToC of Module 1
or overall ToC,
2.1 including Module 1
ToC of the CTD Module 1
(Mod 2,3,4,5)
2.1
2.2
Module 2
2.4 2.5
2.3
2.6 2.7
Module 3 Module 4 Module 5
3.1 4.1 5.1

ToC for Module 3 ToC for Module 4 ToC for Module 5
CTD format: Numbering System
1.0 Regional Administrative Information
1.1 ToC of Module 1 or overall ToC,
including Module 1
Module 1
1.0 2.1 ToC of the CTD (Mod 2,3,4,5)
2.1 2.2 Introduction
Module 2 2.3 Quality Overall Summary
2.2
2.4 Non-clinical Overview
2.4 2.5
2.5 Clinical Overview
2.3
2.6 2.7 2.6 Non-clinical Written and
Tabulated Summaries
Module 3 Module 4 Module 5 2.7 Clinical Summary
Nonclinical Clinical
Quality
Study Reports Study Reports
CTD format: Numbering System: Module 2
Module 2
2.1 OVERALL CTD TABLE OF CONTENTS OF MODULES 2, 3, 4, AND 5
2.2 INTRODUCTION
2.3 QUALITY OVERALL SUMMARY
2.3.S DRUG SUBSTANCE
2.3.S.1 General Information
2.3.S.2 Manufacture
2.3.S.3 Characterization
2.3.S.4 Control of Drug Substance
2.3.S.5 Reference Standards or Materials
2.3.S.6 Container Closure System
2.3.S.7 Stability
2.3.P DRUG PRODUCT
2.3.P.1 Description and Composition of the Drug Product
2.3.P.2 Pharmaceutical Development
2.3.P.3 Manufacture
2.3.P.4 Control of Excipients
2.3.P.5 Control of Drug Product
2.3.P.6 Reference Standards or Materials
2.3.P.7 Container Closure System
2.3.P.8 Stability
Module 2 (Cont.) Module 2 (Cont.)
2.3.A APPENDICES 2.6 CONTENT OF NONCLINICAL WRITTEN AND
2.3.A.1 Facilities and Equipment TABULATED SUMMARIES
2.3.A.2 Adventitious Agents Safety Evaluation 2.6.1 Introduction
2.3.A.3 Novel Excipients 2.6.2 Pharmacology Written Summary
2.3.R REGIONAL INFORMATION 2.6.3 Pharmacology Tabulated Summary
2.4 NONCLINICAL OVERVIEW (Appendix B)
2.4.1 Overview of the Nonclinical Testing Strategy 2.6.4 Pharmacokinetics Written Summary
2.4.2 Pharmacology 2.6.5 Pharmacokinetics Tabulated Summary
2.4.3 Pharmacokinetics (Appendix B)
2.4.4 Toxicology 2.6.6 Toxicology Written Summary
2.4.5 Integrated Overview and Conclusions 2.6.7 Toxicology Tabulated Summary (Appendix B)
2.4.6 List of Literature Citations 2.7 CLINICAL SUMMARY
2.5 CLINICAL OVERVIEW 2.7.1 Summary of Biopharmaceutics and
Associated Analytical Methods
2.5.1 Product Development Rationale
2.7.2 Summary of Clinical Pharmacology Studies
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.7.3 Summary of Clinical Efficacy
2.5.4 Overview of Efficacy 2.7.4 Summary of Clinical Safety
2.5.5 Overview of Safety 2.7.5 References
2.5.6 Benefits and Risks Conclusions 2.7.6 Synopses of Individual Studies
2.5.7 References
Module 3
3.1 MODULE 3 TABLE OF CONTENTS
3.2 BODY OF DATA
3.2.S DRUG SUBSTANCE
3.2.S.1 General Information
3.2.S.2 Manufacture Module 3 (Cont.)
3.2.S.3 Characterisation 3.2.A APPENDICES
3.2.S.4 Control of Drug Substance 3.2.A.1 Facilities and Equipment
3.2.S.5 Reference Standards or Materials 3.2.A.2 Adventitious Agents Safety Evaluation
3.2.S.6 Container Closure System 3.2.A.3 Novel Excipients
3.2.S.7 Stability 3.2.R REGIONAL INFORMATION
3.2.P DRUG PRODUCT 3.3 LITERATURE REFERENCES
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
Module 4
4.2 STUDY REPORTS
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 LITERATURE REFERENCES
Module 5
5.2 TABULAR LISTINGS 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
Electronic Submissions
The equivalent of 50,000 paper pages of data..

Summary-Influence of the CTD/eCTD
 The CTD format of a submission influences the content of a review

by imposing a consistent order of information and data provided
 Consistency of CTD format should promote consistent review

practices (GRPs) and efficiency
 As more countries utilize ICH guidelines and the CTD format a

common regulatory language will evolve promoting interactions
between regulatory authorities

An Initiative Under The ICH: Europe, Japan and USA

Uploaded by

Copyright:

Available Formats

An Initiative Under The ICH: Europe, Japan and USA

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

An Initiative Under The ICH: Europe, Japan and USA

Uploaded by

Copyright:

Available Formats

Common Technical Document

An initiative under the ICH: Europe, Japan

 This guideline is not intended to indicate what studies are

Module 3 Module 4 Module 5

3.1 4.1 5.1

The equivalent of 50,000 paper pages of data..

 The CTD format of a submission influences the content of a review

 Consistency of CTD format should promote consistent review

 As more countries utilize ICH guidelines and the CTD format a

You might also like