it is all about CTD-eCTD .

1. CTD AND ECTD
By
Mohit Baghel
M.Pharm 1st year

2. INTRODUCTION
Common Technical Documents was agreed in (Nov 2000) in San Diego,
USA.
It is provide for a harmonized structure and the format for new product
application.
CTD is a type of application dossier for the registration of the medicine and
Designed to be used across Europe, Japan, United State.
CTD was developed by European Medicine Agency (EMEA), Food & Drug
administration (FDA), The Ministry of Health, Labour and Welfare (Japan)

3.  The FDA characterize the CTD as “An Information Package of Clinical, Non clinical,
Manufacturing, Technical data” in the same format and with the same content.

4. CTD Modules
Module 1. Administration information (Region Specific).
Module 2. CTD Summaries (QOS).
Module 3. Quality (CMC).
Module 4. Non clinical Study Report.
Module 5. Clinical Study Report.

5. Module 1. Administration information (Region Specific).
For USA
• Application Form 356H.
• Product Lebel.
• Patient Certificate/Information.
• Department Certificate.
• Labelling Text.
• DMF letter.
For EU
• Application Form.
• Summary of characteristic
product.
• Labelling text and Mock up.
• Information about expert’s.
• Risk management plane.

6. Module 2. CTD Summaries (QOS).
It contain 7 section in the following order.
1. CTD TOC (Module 2-5).
2. CTD introduction.
3. Quality Overall Summary.
4. Non Clinical Overview
5. Clinical Overview.
6. Non Clinical Summary
7. Clinical Summary

7. Module 3. Quality (CMC).
1. TOC of Module 3.
2. Body of data- S- Drug substance
P- Drug product
A- Appendices
R- Regional information
3. Literature References.
Module 4. Non clinical Study Report.
1. TOC of Module 4.
2. Study report – Pharmacology
Pharmacokinetics
Toxicology
3. Literature References.

8. Module 5. Clinical Study Report.
1. TOC of module 5.
2. Tabular listing of clinical studies.
3. Clinical study reports.
• Report of Biopharmaceutical (BA-BE) study.
• Report of Biomaterial study.
• Report of Pharmacokinetic study.
• Report of Pharmacodynamic study.
• Report of Post marketing Experience.
• Case report forms & individual patient listening
4. Literature references.

9. Electronic Common Technical Documents is the standard format for the
summiting application , amendments suppleiments , and report to FDA (CBER)
(CDER).
INTRODUCTION
eCTD composed of two type of specification.
• Content Specification – As defined by ICH
• Technical Specification – Electronic Softwares
• CTD- TOC (pdf) paper
• eCTD- XML software

10. CTD is highly recommended by USFDA for-
• NDA
• BLA
• DMF
• IND
Use for approve new drug.
From the year 2010 European Union also make compulsory for eCTD
submission to all procedure.
CTD Ectd
Module 1 M 1
Module 2 M 2
Module 3 M 3 (code)
Module 4 M 4
Module 5 M 5

11. Structure of eCTD

13. Characteristics of eCTD
Structure
• All module 1 to 5 have granularity options.
• Pdf documents linked via XML backbone.
• Increase document granularity.
• Transparency of entire submission.
• Ease of navigation and review

14. Benefits of eCTD
• Can reduce time to approval.
• Improve handling and archiving of submission ( both sponsor
and FDA).
• Search functionality and increase tracking ability.
• Allows for the repurposing of documents for submission in
other region.
• Improve review efficiency.

15. THANK YOU