CTD and ECTD Document

Nirmal Morya
M.Pharm (1st
Sem )
(Dept. of Pharmaceutical Science)
BBAU Lucknow
CTD & eCTD
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CONTENT :
 Introduction to CTD
 Structure of CTD
 Orgnization of CTD
 Module of CTD
 eCTD
 Characterstics of eCTD
 Format of eCTD
 Advantage of eCTD
 Difference between eCTD and CTD
 Reference
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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 cost‐
effective manner.
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 European Medicines Agency (EMEA, Europe)
 Food and Drug Administration (FDA, USA)
 Ministry of Health, Labour and Welfare
(MHLW Japan).
CTD
CTD is a joint effort of 3 Regulatory
Agencies-
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 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
CTD
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 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
CTD
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 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.(Pravent binding
problem )
 All pages of a document should include a unique header or footer
GENERAL CONSIDERATION
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GENERAL CONSIDERATION
 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
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ORGANISATIONS 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
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Module 1
 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.
Administrative Information (Region
Specific )
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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
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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
Module 2
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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 *

Module 4
Non Clinical Study Reports
 4.2 Study reports
 4.2.1 Pharmacology
 4.2.2 Pharmacokinetics
 4.2.3 Toxicology
 4.3 Literature References
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 5.2 Tabular listing of clinical studies
 5.3 Clinical study reports
Module 5
Clinical Study Reports
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• 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
Module 5
Clinical Study Reports
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e CTD
 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
softwares
CTD
e CTD
TOC[pdf]
[paper] XML
Backbone *

 eCTD highly recommended by USFDA for
NDAs, DMFs, and NDAs filing
 From 2010 EU also make compulsory
eCTD to all procedure
CTD eCTD
Module 1 m1
Module 2 m2
Module 3 m3
Module 4 m4
Module 5 m5
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.
 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.
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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
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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
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Advantage of eCTD
 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
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CTD eCTD
Compiled electronically with volumes ,
tabs , slipsheets then printed to paper
Compiled electronically with e documents
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
section number
Cross references are hyperlinked to
targets
Manual document navigation by TOC s,
page numbers, and caption cross
references
Electronic document navigation by TOC s
,bookmarks and hyperlinks
Submitted in binders in boxes on pallets
by trucks
Submitted on CD[ or DVD] or by email or
portal
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REFERENCE
 Patel R.C. et.al. An eCTD filing for generic drug application in USA
JOURNAL OF PHARMACEUTICAL SCIENCE AND BIOSCIENTIFIC
RESEARCH (JPSBR )Volume 4, Issue 4: 2014(228-236)
 Jordan D. An overview of the Common Technical Document (CTD)
regulatory dossier The European Medical Writers Association Volume 23
2014 (101-105)
 ICH M4 Guidelines Organization of Common Technical Document for the
registration of Pharmaceuticals for human use (R3) [cited 2004 Jan 13]
 ICH M8 Guidelines : Electronic common technical document [cited 2010
Nov 8]
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CTD and ECTD Document

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