The document discusses the Common Technical Document (CTD) and electronic CTD (eCTD) formats for submitting information on medicines to regulatory authorities. The CTD format was introduced in 2000 to harmonize dossier submissions across regions. It organizes information into five modules covering administrative data, quality and safety summaries, nonclinical and clinical study reports. The eCTD is the electronic version that allows electronic submission to improve the review process. Requirements for the eCTD include PDF version, formatting, hyperlinks and file naming conventions. Overall, the CTD and eCTD were created to standardize submissions and facilitate review of medicines by regulatory bodies.

1. CTD and eCTD Submission

2. CTD and eCTD Submission
• CTD (Common Technical Document):- is a
harmonized format for submission of detailed
information on medicines to regulatory authorities
and agencies for the purposes of obtaining
approval to market a product.
• eCTD (Electronic Common Technical
Document): is the electronic version of CTD.
• An eCTD is simply a standard electronic format
for sending data from the applicant to the
regulatory authority.

3. History of CTD
• The Concept of CTD was introduced by ICH in
the year of 2000 for the public consultation.
• Before 2000 there was no uniformity to submit
dossier in regulatory authority. This creates many
hassles for applicant as well as auditors to submit
and reviewing the dossier information in an
organized manner. Hence concept of CTD was
come for harmonization in dossier submission.
• It is important to note that on July 1, 2003 use of
the CTD format will become mandatory across all
three regions like EU, FDA and Japan.

4. Impact of CTD
• The ICH CTD represents one of the most
ambitious and successful international
harmonization activities undertaken for
medicines product of human use.
• It will significantly reduce time and resources
needed by industry to compile applications for
global registration.
• Applies to all NDAs, ANDAs, BLAs and
INDs application.

5. Benefits of CTD
• Easy “Reviewable” applications.
• Complete, well-organized submission.
• More predictable format.
• More consistent reviews.
• Easier analysis across application.
• Easier Exchange of information.
• Facilitates electronic submission.

6. CTD Triangle

7. CTD Dossier
The CTD is organized into FIVE modules:
1.0 Module 1:- Regional Administrative Information
2.0Module 2:- Introduction, Quality Overall
Summary, Nonclinical Overview, Clinical
Overview, Nonclinical Written and Tabulated
summaries, Clinical Summary
3.0 Module 3:- Quality
4.0 Module 4:- Nonclinical Study Reports
5.0 Module 5:- Clinical Study Reports

8. 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

9. 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

10. 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

11. 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

12. Module 5: Clinical Study Reports
• 5.1- Table of Content
• 5.2- Tabular Listing of All Clinical Studies
Like Type of Study, Study Identifier, Location
of Study Reports, Objective of the Study,
Number of Subjects, Study design, Test
Product; Dosage Regimen; Route of
administration, Healthy Subjects, Duration of
Treatment, Study Status, Type of Report.
. 5.3 Clinical Study Reports
. 5.4 Literature References

13. Module 5.3 Clinical Study Report
ICH E3
• 1-3-15, Study report
• 2-Study Synopsis
• 16.0 Appendices
• 16.1.1 Protocol and its amendment
• 16.1.2 Sample Copy of CRF
• 16.1.3 List of IEC, their CVs and Informed Consent
Form
• 16.1.4 List of Investigator and their CVs
• 16.1.5 Compliance Statement
• 16.1.6 Listing of Subject Receiving Test and Reference
Product From Specific batches

14. Module 5.3 Clinical Study Report
ICH E3
• 16.1.7 Randomization scheme and codes
• 16.1.8 Audit Cert.
• 16.1.9 Documentation of statistical Method
• 16.1.10 QA Statement
• 16.1.11 Publication based on the study
• 16.1.12 Important reference used in the Study
• 16.2 Subject Data Listing
• 16.2.1 DS Subject
• 16.2.2 Protocol deviation

15. Module 5.3 Clinical Study Report
ICH E3
• 16.2.3 Subject excluded from efficacy Analysis
• 16.2.4 Demographic Details
• 16.2.5 Drug Concentration data
• 16.2.6 Individual Efficacy Data
• 16.2.7 AE Table
• 16.2.8 Individual Abnormal Lab Parameter
• 16.3 Case Report Form
• 16.3.1 CRF of withdrawn subject due to AE or death or
other serious AE
• 16.3.2 Other CRFs
• 16.4 Individual Subject Data Listings

16. eCTD
• The electronic Common Technical Document
(eCTD) is the electronic equivalent of the
Common technical document, which is standard
format for submissions to the authorities and
agencies responsible for regulation of
pharmaceutical of products in US, Europe and
Japan.
• Why Electronic?
- Improve the submission and review process.
- Increase accuracy of the Submission.
- Decrease total costs.

17. How are eCTD built?
• An eCTD can be built manually or automatically,
using integrated document management and
publishing software. Such Solutions are available
commercially from numerous vendors.
• Example of eCTD Software:-
1.0 ROSETTA Regulatory Software
2.0 Pharmaready eCTD Product which is fully
validated, international regulatory Compliant
software that is 21 CFR Part 11 compliant.

18. Benefit of eCTD
• Improve handling and archiving of
submission.
• Support Life cycle Management.
• Immediate access to complete and Up to date
information.
• Search functionally for assessors and increased
tracking ability.
• Reduced Workload.
• Better communication with industry.

19. Benefits of eCTD

20. Requirement of eCTD
• PDF Version should be 5.0 or higher
• Optimize pdf files for fast web view.
• The Print area for pages should fit on a sheet
of A4 and letter (8.5” X 11”) paper.
• A sufficient margin (at least 2.5 cm) on the left
side of each page should be provided to avoid
obscuring information.
• Header and footer information can appear
within these margins.

21. Requirement of eCTD
• Fonts and Font Size
Times New Roman, Arial, Courier and Fonts supported in
the Acrobat set itself.
12- point font
. Use of Color fonts
Black font color is recommended. Blue color can be used
for hypertext link.
. Page Orientation
Page Should be properly oriented so that all portrait pages
are presented in portrait and all landscape pages are
presented in landscape.
. Headers and Footers
Unique header or footer that identifies its subject matter.

22. Requirement of eCTD
• Source of Electronic Document
Scanning should be avoided where possible.
Document Should be generated from electronic source
documents and not from scanned material, except where
access to the source electronic file is unavailable or where a
signature is called for.
All scanned documents should be OCR. (Optical Character
Recognition).
. Methods for creating PDF documents and Images
It is recommended that scanning be undertaken at a
resolution of 300 dpi (dots per inch) to balance
legibility and file size.

23. Requirement of eCTD
• Hypertext Linking and Bookmarks
1.0 Improve navigation through PDF documents.
2.0 Use- to support annotations, related sections,
references, appendices, tables or figures that are located
on the same page are helpful and improve navigation
efficiency.
3.0 Hyperlink- Designated by rectangles using thin lines
or by blue.txt as appropriate.
4.0 Bookmark- Hierarchical level. No more that 4 levels
in hierarchy is recommended.
5.0 The magnification setting Inherit Zoom should be
used.

24. Requirement of eCTD
• Page Numbering:- The first page of the document
should be numbered 1, and all subsequent pages
should be numbered consequentially with Arabic
numbers.
• Open Dialog Box:-
The initial view of the PDF files should be set as
Bookmarks and Page.
If there are no bookmarks, the initial view as page
only should be set.
The Magnification and Page layout should be set
as default.

25. Requirement of eCTD
• Folder and file Naming Conventions
 The maximum length of the name of a single folder or file is
64 character including file extension.
 Only lower case letters should be used in all file and
directory names.
 The maximum length of a path is 230 characters, including
file name, and extension.
 Name is a taken composed of the following characters.
1.0 Letters “a” to “z”
2.0 Digits “0” to “9”
3.0 hyphens “-”
> Security:- No security settings or password protection for
PDF files should be included.

26. Other files that has been Submitted to
Regulatory
1.0 xpt files:- For USFDA
2.0 INF and DAT files:- For CANADA (TPD
and HPFB)
3.0 EXCEL of drug Concentration and
Pharmacokinetic parameter of each Subject:-
For ANVISA

27. Thank You