The document discusses the Common Technical Document (CTD), which is a standardized format for submitting documentation to regulatory agencies in Europe, Japan, and the United States. It describes the CTD's five modules, which contain administrative information, summaries, quality data, nonclinical study reports, and clinical study reports. The CTD format was developed by international drug regulatory bodies to harmonize the technical requirements for marketing new pharmaceuticals. It has been adopted as the standard application dossier across major global drug markets.

1. SHASHANK MISHRA
B Pharma HONS M PHARM 1ST Year
DR APJ ABDUL KALAM TECHNICAL UNIVERSITY
Common
technical
document

2. 1-CTD is application dossier for the
registration of new product used across
Europe, Japan and US.
2-It is maintained by the ICH (International
conference on Harmonization ).
3-A/c to FDA CTD is an information package
of nonclinical, clinical, manufacturing,
technical data in the same format and with
the same content that would be submitted
for registering new drugs in all three ICH
regions i.e. US, European union and Japan.

3. CTD was developed by Food and Drug
Administration (FDA),EMEA European
medicines agency, the ministry of health
labour and welfare (japan).
CTD Triangle
Module 1 Administrative information
Module 2 CTD Summaries
Module 3 Quality( CMC)
Module 4 Non clinical study Reports
Module 5 Clinical study Reports

4. Module 1 Administrative information
It is region specific ,prescribing information
Covering letter
Application form
Labeling
Product info
Labeling text
Patent certification
Note Module 1 data differ with Regulatory bodies

5. Module 2 -CTD summaries (QOS)
It contain 7 sections in following order
2.1 CTD TOC
2.2 CTD Introduction
2.3 Quality Overall Summary
2.4 Non clinical Overview
2.5 Clinical Overview
2.6 Non Clinical Summary
2.7 Clinical Summary

6. Module 3 Quality (CMC)
 3.1 TOC of Module 3
 3.2 Body of Data –
 DRUG SUBSTANCE
 DRUG PRODUCT
 APPENDICES
 REGIONAL INFORMATION
 3.3 Literature References

7. 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

8. Module 5 Clinical Study Reports
 5.1 TOC OF MODULE
 5.2 Tabular listing of Clinical Trials
 5.3 Clinical Study reports
 5.3.1 Reports of Biopharmaceutical (BA-BE) Study
 5.3.2 Reports of Pharmacokinetics (Biomaterial)Study
 5.3.3 Reports of Pharmacokinetic(PK) Studies
 5.3.4 Reports of Pharmacodynamics (PD) Studies
 5.3.5 Reports of Efficacy and Safety Studies
 5.3.6 Reports of Post –Marketing experience
 5.3.7 Case Reports Forms Individual patient listing5.
 5.4 Literature References

9. eCTD- electronic common Technical
Document
 It is electronic submission of CTD ,electronic versions of Toc pdf paper
to XML Backbone
 Content Specifications defined by ICH
 eCTD is highly recommended by USFDA for NDA,BLAs,DMFs,and INDs
filling
 From year 2010 EU also make compulsory for eCTD submissions to all
procedures
 CTd modules are
 M1------------m1
 M2 ------------m2
 M3--------------m3
 M4-------------m4
 M5-------------m5

10. BY IMAGE UNDERSTAND eCTD
Before

11. Characteristics of eCTD
 All modules have granularity options
 Increased documents granularity
 Transparency of entire submission
 Ease of navigation and review
 Pdf linked via Xml backbone
 Review ,life cycle management and archival of the
electronic

12. Benefits of eCTd
1 ectD save tree

13. 2 Better Quality easy stored
3 Cost Reduced
4 faster ,more efficient review
5 life cycle covered
6 Easy Readable

14. Thanks you