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1. CTD & ECTD
PRESENTED BY - KAJAL PRASAD
[M.PHARM] 1ST YEAR
DEPARTMENT OF PHARMACEUTICS
PRIYADARSHINI J L. COLLEGE OF PHARMACY
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2. CONTENT :
1. INTRODUCTION
2. Common Technical Document
3. CTD Triangle
4. CTD Modules
5. Electronic Common Technical Document
6. ECTD structure
7. Benefits of ECTD
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3. INTRODUCTION
 CTD was agreed in November 2000 in San Diego, USA.
 It provides for a harmonized structure and format for new product applications.
 CTD is a set of specification for application dossier for the registration of
medicines and designed to be used across Europe, Japan & US .
 CTD was developed by the European medicines agency(EMEA),Food& Drug
Administration(FDA),the ministry of health, labour & welfare(Japan).
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5. NEED OF CTD
All regulatory authority had there own guidelines to submit regulatory dossier to get
marketing approval of the drug.
Thus approval process was slow and time consuming
Thus, the three ICH region ( US, EUROPE & JAPAN) collaborated and developed CTD
format for regulatory submissions
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6. C0MM0N TECHNICAL DOCUMENT
 CTD is maintained by the ICH (International Conference
on Harmonization) of technical requirement for
registration of pharmaceuticals for human use.
 The FDA characterized the CTD as “An information
of clinical ,non-clinical, manufacturing, technical data in
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.
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7. CTD Modules
 Module 1 – Administrative Information (Region Specific)
 Module 2 – CTD Summaries
 Module 3 – Quality
 Module 4 – Non-Clinical Study Reports
 Module 5 – Clinical Study Reports
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8. THE CTD TRIANGLE
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9. MODULE 1 Administrative Information
 It should contain document (Specific to Region)
• For USA :
• Application form
• Product label
• Patient Information
• Department certificate
• Letter of authorization
• Labelling text
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10. • FOR EUROPE UNION
• Application form
• Summary of characteristic product.
• Labelling text
• Information about experts
• Risk management plan
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11. MODULE 2 CTD SUMMARIES
 It contain 7 sections 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
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12. 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
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13. MODULE 4 NON –CLINICAL STUDY
REPORTS
 TOC of Module 4
 Study reports
Pharmacology
Pharmacokinetics
Toxicology
 Literature References
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14. MODULE 5 CLINICAL STUDY REPORTS
 TOC of Module
 Tabular listing of Clinical Studies
 Clinical study reports
1. Reports of Biopharmaceutical Study
2. Reports of Pharmacokinetic study
3. Reports of Efficacy and Safety studies
4. Reports of Post-Marketing experience
5. Case Report Forms & Individual patient
listings
 Literature References.
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15. ELECTRONIC COMMON TECHNICAL
DOCUMENT
 eCTD Its electronic version of CTD so called as CTD, electronic
Common Technical Document (eCTD).
 eCTD composed of two types of specification
 Content specification – As defined by ICH
 Technical specification – Electronic software
CTD TOC (Paper)
eCTD XML Backbone
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16.  CTD is highly recommended by USFDA for NDAs, BLAs,
DMFs and INDs filing.
 From year 2010 European Union also make compulsory for
electronic CTD submission to all procedures.
CTD eCTD
Module 1 m1
Module 2 m2
Module 3 m3
Module 4 m4
Module 5 m5
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17. eCTD Characteristics Structure
 All Modules 1 to 5 have granularity options.
 PDF documents linked via XML backbone.
 Increased document granularity.
 Transparency of entire submission.
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19. BENEFITS OF eCTD
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Benefits of
eCTD
Reduce
time
approval
Improved
handling
Search
functionally
and increased
tracking
ability
Allows
repurposing
of docs for
submission in
other region
Submission
allows
immediate
receipt by
FDA
Improve
reviewers
efficiency

20. Comparing paper CTD and eCTD
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CTD eCTD
1.Compiled electronically with volume, tabs,
slip-sheets than printed to paper
1.Compiled electronically with e
documents in Folder
2.Paper volume must be A4 in size. 2. Paper volume must be A4 or US
letter size.
3.CTD navigation by TOCs and volume 3. eCTD navigation by XML
Backbone
4.Cross reference include target CTD section
number.
4.Cross reference are hyperlinked to targets.
5.Manual Document navigation by TOC s, Pg.
Number and caption cross the references
5. Electronic Document navigation by TOC s,
Bookmarks and hyperlinks.
6.Sumitted in binders in boxes on pallets by
trucks.
6.Submitted by (CD /DVD) or by email or
portal

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