1. Last Update June 13 '02
Common Technical Document (CTD)
Implementation Coordination Group
presenting
General Information on the CTD
organized by:
Implementation Coordination Group Members
plus members in CTD-Q, CTD-S, CTD-E & eCTD
2. Last Update June 13 '02
1) Implementation Dates
2) Scope of CTD
3) Overall Table of Contents
4) Numbering System
5) Pagination (under discussion)
6) Transitional Arrangements
7) Regional Specificities
8) Line Extensions, Variations & Supplements
9) Questions about the CTD
10) Meeting Plans
Issues addressed
3. Last Update June 13 '02
1) Implementation Dates of CTD
Optional
July 2001: EU, FDA, MHLW
(Canada, Switzerland)
Highly recommended
July 2003: FDA
Mandatory
July 2003: EU, MHLW
(Canada, Switzerland)
4. Last Update June 13 '02
2) Scope of CTD
New chemical entities
New biologic
New indication
New dosage forms
New route of administration
Generics
OTC
EU FDA MHLW
included
included
included
included
included
included
included
included
included*
included
included
included
included
included
included
included
included
included
included
not included
not included
* with the exception of blood and blood components
5. Last Update June 13 '02
3) Overall Table of Contents (ToC)
1.1
ToC of Module 1
or overall ToC,
including Module 1
2.1
ToC of the CTD
(Mod 2,3,4,5)
Module 1
Module 3 Module 4 Module 5
2.1
2.2
2.3
2.4 2.5
2.6 2.7
Module 2
3.1
ToC for Module 3
4.1
ToC for Module 4
5.1
ToC for Module 5
6. Last Update June 13 '02
4) Numbering System
1.0 Regional Administrative Information
1.1 ToC of Module 1 or overall ToC,
including Module 1
2.1 ToC of the CTD (Mod 2,3,4,5)
2.2 Introduction
2.3 Quality Overall Summary
2.4 Nonclinical Overview
2.5 Clinical Overview
2.7 Clinical Summary
2.6 Nonclinical Written and
Tabulated Summaries
Module 1
Module 3 Module 4 Module 5
2.1
2.2
2.3
2.4 2.5
2.6 2.7
1.0
Quality
Nonclinical
Study Reports
Clinical
Study Reports
Module 2
7. Last Update June 13 '02
4) 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
8. Last Update June 13 '02
4) Numbering System: Module 2
Module 2 (Cont.)
2.3.A APPENDICES
2.3.A.1 Facilities and Equipment
2.3.A.2 Adventitious Agents Safety Evaluation
2.3.A.3 Novel Excipients
2.3.R REGIONAL INFORMATION
2.4 NONCLINICAL OVERVIEW
2.4.1 Overview of the Nonclinical Testing Strategy
2.4.2 Pharmacology
2.4.3 Pharmacokinetics
2.4.4 Toxicology
2.4.5 Integrated Overview and Conclusions
2.4.6 List of Literature Citations
2.5 CLINICAL OVERVIEW
2.5.1 Product Development Rationale
2.5.2 Overview of Biopharmaceutics
2.5.3 Overview of Clinical Pharmacology
2.5.4 Overview of Efficacy
2.5.5 Overview of Safety
2.5.6 Benefits and Risks Conclusions
2.5.7 References
Module 2 (Cont.)
2.6 CONTENT OF NONCLINICAL WRITTEN AND
TABULATED SUMMARIES
2.6.1 Introduction
2.6.2 Pharmacology Written Summary
2.6.3 Pharmacology Tabulated Summary
(Appendix B)
2.6.4 Pharmacokinetics Written Summary
2.6.5 Pharmacokinetics Tabulated Summary
(Appendix B)
2.6.6 Toxicology Written Summary
2.6.7 Toxicology Tabulated Summary (Appendix B)
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 References
2.7.6 Synopses of Individual Studies
9. Last Update June 13 '02
4) Numbering System: Module 3
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
3.2.S.3 Characterisation
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
Module 3 (Cont.)
3.2.A APPENDICES
3.2.A.1 Facilities and Equipment
3.2.A.2 Adventitious Agents Safety Evaluation
3.2.A.3 Novel Excipients
3.2.R REGIONAL INFORMATION
3.3 LITERATURE REFERENCES
10. Last Update June 13 '02
4) Numbering System: Module 4
Module 4
4.1 MODULE 4 TABLE OF CONTENTS
4.2 STUDY REPORTS
4.2.1 Pharmacology
4.2.2 Pharmacokinetics
4.2.3 Toxicology
4.3 LITERATURE REFERENCES
11. Last Update June 13 '02
4) Numbering System: Module 5
Module 5
5.1 MODULE 5 TABLE OF CONTENTS
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
12. Last Update June 13 '02
5) Pagination
http://www.ich.org/pdfICH/CTDPagination.pdf
Please consult our CTD Pagination document at:
13. Last Update June 13 '02
6) Transitional Arrangements
For EU, please consult their Q&A on Mixed Application at:
http://pharmacos.eudra.org/F2/eudralex/vol-2/B/CTD-QA.pdf
For further details, please consult the following Web sites:
http://www.fda.gov/cber/ich/ichguid.htm
http://www.fda.gov/cder/guidance/4539O.htm
http://pharmacos.eudra.org/F2/eudralex/vol-2/home.htm
http://www.nihs.go.jp/dig/ich/m4index.html
FDA & MHLW agreed as follows:
acceptance of application using a combination of the CTD and non-
CTD formats within the CTD but not within a module.
14. Last Update June 13 '02
7) Regional Specificities
Module 1
Regional Administrative Information (EU, FDA, MHLW)
Environmental Assessment
(GMO & Non-GMO), as an Annex
Modules 2 & 3 Regional Information (in Sections 2.3.R & 3.2.R)
Modules 4 & 5 No Specific Regional Section
Module 5
(place foreseen, if required)
ISE, ISS (may be required by US law &/or regulations)
Case Report Form (FDA)
Tabulated List of Trial Subjects (MHLW)
15. Last Update June 13 '02
8) Line Extensions, Variations & Supplements
EU, FDA & MHLW agreed as follows:
For New products,
new CTD format should be used
For Old products,
cross-reference to old format is acceptable
(no requirement to reformat existing dossier)
16. Last Update June 13 '02
Please send your CTD Questions to:
CTD-related.question@ifpma.org
9) Questions about the CTD
17. Last Update June 13 '02
10) Meeting Plan
Next CTD Implementation Coordination Group (CTD-ICG)
meeting will be held on September 9 to 12, 2002, in Washington.
CTD-ICG will continue their discussion to promote smooth
implementation.
eCTD is expected to reach Step 4 in Washington.
