The document discusses the Common Technical Document (CTD) format, which is used for new drug applications submitted to regulatory agencies in Europe, Japan, and the United States. The CTD format aims to increase harmonization across regions. It is organized into five modules covering administrative information, summaries, quality information, nonclinical study reports, and clinical study reports. An electronic version of the CTD (eCTD) uses XML formatting to improve the submission and review process. The eCTD allows for increased accuracy, reduced costs and time to market, and easier navigation compared to the paper CTD format.

1. CTD & eCTD
AKSHAY TRIVEDI
M.PHARM
DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE

2. Content
 Introduction to CTD
 Structure of CTD
 Organization of CTD
 Module of CTD
 eCTD
 Characteristics of eCTD
 Format of eCTD
 Advantage of eCTD
 Difference between eCTD and CTD
 Reference

3. Objective of CTD
 The objective is to increase international harmonization of
technical requirements to ensure that safe, effective, and high
quality medicines are developed and registered in the most
efficient and costeffective manner.

4. CTD
 CTD is a joint effort of three Regulatory Agencies
 European Medicines Agency (EMEA, Europe)
 Food and Drug Administration (FDA, USA)
 Ministry of Health, Labour and Welfare (MHLW Japan).

5. CTD
 The Common Technical Document (CTD) is a set of
specification for application dossier for the registration of
Medicines and designed to be used across Europe, Japan
and the United States

6. CTD
 The FDA characterized the CTD as “An information package
of clinical, non clinical , manufacturing , technical data in the
same content that would be submitted for registering new
drugs in all 3 ICH regions i.e. U.S , European Union and
Japan

7. General consideration
 All sentences should blue Italic fonts
 Font Size 12 in Times new roman ( Descriptive Text )
 Font size 9 in Times new roman ( Table content and Text)
 Text and tables should be prepared using margins.(Prevent
binding problem )
 All pages of a document should include a unique header or
footer

8.  Hard copy: front and side of each volume / file / binder must
contain Name of applicant , file no , date of submission and
drug name . E.g- file No 6/10 (file no / total file )
 Thickness of file should not more then 3 inches
 CDs should be labeled using marker (Name of applicant , file
no , date of submission and drug name )
 Applicant should preserve duplicate copy for future reference
 Submit ONE hard copy and THREE soft copies

9. CTD Triangle

10. Organizations of CTD
 Module 1 – Administrative Information [Region Specific]
 Module 2 – CTD Summaries [QOS]
 Module 3 – Quality [CMC]
 Module 4 – Non clinical study reports
 Module 5 – Clinical study reports

11. Module 1 : Administrative Information
(Region Specific )
 This module should contain documents specific to each region
 Ex : Application form regarding the prescribing information,
proposed label
 This module is not part of the CTD.
 The content & format of this module can be specified by the
relevant regulatory authorities.

12. Module 2 : CTD Summaries
(QOS)
 It should begin with a general introduction to the
pharmaceutical , including its pharmacological class , mode of
action & proposed clinical use. i.e. information should not
exceed one page

13. Module 2
 It contain 7 sections in the following order
 2.1 CTD TOC
 2.2 CTD Introduction
 2.3 Quality Overall Summary
 2.4 Nonclinical overview
 2.5 Clinical overview
 2.6 Non clinical summary
 2.7 Clinical summary

14. Module 3 : Quality [CMC]
 3.1 TOC of Module 3
 3.2 Body of Data
 3.2.SDrug substance
 3.2.P Drug product
 3.2.A Appendices
 3.2.R Regional information
 3.3 Literature references

15. Module 4 : Non Clinical Study Reports
 4.1 TOC of Module 4
 4.2 Study reports
 4.2.1 Pharmacology
 4.2.2 Pharmacokinetics
 4.2.3 Toxicology
 4.3 Literature References

16. Module 5 : Clinical Study Reports
 5.1 TOC of Module 5
 5.2 Tabular listing of clinical studies
 5.3 Clinical study reports

17. Module 5 : Clinical Study Reports
 5.3 Clinical study reports
 5.3.1 Repots of biopharmaceutical study[BA-BE]
 5.3.2 Reports of PK [biomaterial] study
 5.3.3 Reports of PK studies
 5.3.4 Reports of 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 & Individual patient listings

18. eCTD
 It is electronic version of CTD , so called as electronic
common technical document
 e CTD composed of 2 types of specification
1. Content specification – As defined by ICH
2. Technical specification- Electronic software's
 CTD - TOC[pdf]
 e CTD - [paper] XML Backbone

19.  eCTD highly recommended by USFDA for NDAs, DMFs, and
NDAs filing
 From 2010 EU also make compulsory eCTD to all procedure

20. Why electronic?
 Improve the submission and review process
 Increase accuracy of the submission Decrease total costs
 This specification has been developed by the
 ICH M2 Expert Working group and maintained by the eCTD
Implementation Working group in accordance with the ICH
Process.

21. e CTD Characteristics
 Structure
 All Modules 1 to 5 have granularity options
 PDF documents linked via XML backbone
 Increased document granularity.
 Transparency of entire submission
 Ease of navigation and review

22. Advantage of eCTD
 Improved handling and archiving of submissions
 Large reduction in dossier duplication time and expense .
 Ease of archiving and distribution
 Immediate Access to complete and up‐to‐date information

23.  Ease of navigation during review using hyperlinks and
bookmarks .
 Facilitated evaluation and better visibility of the process
 Reduced workload and reuse of information for assessment
reports
 Reduced the time for filing submissions and reduce time to
market

24. THANK YOU