CTD AND ECTD
FORMAT
By bashaant kumar sah ,1st mpharm
NARGUND COLLEGE OF PHARMACY
CTD
• Common Technical Document [CTD]: It is an
format set by ICH which was agreed by the
Regulatory Agencies of Europe , Japan & the U.S.
• 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
ORGANISATIONS OF CTD:
• It should be organized into 5 modules
- 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
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.
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
• It contain 7 sections in the following order:
- 2.1 CTD TOC [Module 2 – 5] [Table Of
Content]
- 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
• The organization of these summaries is
described in 3 separate documents:
A] M4 Q – The CTD quality
B] M4 S - The CTD Safety
C] M4 E - The CTD Efficacy
Module 3
Quality [CMC]
• 3.1 TOC of Module 3
• 3.2 Body of Data
- 3.2.S -Drug substance
- 3.2.P – Drug product
- 3.2.A – Appendices
- 3.2.R – Regional information
• 3.3 Literature references
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
Module 5
Clinical Study Reports
• 5.1 TOC of Module 5
• 5.2 Tabular listing of clinical studies
• 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
• 5.4 Literature References
e CTD
• It is electronic version of CTD , so called as
electronic common technical document
[e CTD]
• e CTD composed of 2 types of specification
- Content specification – As defined by ICH
- Technical specification- Electronic softwares
CTD TOC [pdf] [paper]
e CTD XML Backbone
e CTD Characteristics
• Structure
-All Modules 1 to 5 have granularity options[
level of detail a document has ]
-PDF documents linked via XML backbone
-Increased document granularity.
-Transparency of entire submission
-Ease of navigation and review
COMPARING PAPER CTD AND e CTD
Paper CTD e CTD
Compiled electronically with volumes , Compiled electronically with e documents
tabs , slipsheets then printed to paper in folders
Paper volumes must be A4 e Documents can be A4 or US letter size
CTD navigation by TOC s and volume e CTD navigation by XML backbone
Cross references includes target CTD Cross references are hyperlinked to
section number targets
Manual document navigation by TOC s, Electronic document navigation by TOC s
page numbers, and caption cross ,bookmarks and hyperlinks
references
Submitted in binders in boxes on pallets Submitted on CD[ or DVD] or by email or
by trucks portal
THANK YOU
