COMMON TECHNICAL DOCUMENT

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ORIGIN OF CTD

ICH
EWG
WAS OFFICIALLY SIGNED
OFF IN NOVEMBER 2000,

CTD
CTD

AT 5TH ICH CONFERENCE;

SAN DIEGO,CALIFORNIA.

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CTD
CTD
CTD IS A JOINT EFFORT OF 3 REGULATORY AGENCIES:
1.European Medicines Agency (EMEA, Europe),
2. Food and Drug Administration (FDA, USA) and
3. Ministry of Health, Labour and Welfare (MHLW,Japan).

CTD is maintained by ICH through EWG.

It has been adopted by several other countries

including Canada and Switzerland.
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 Any guideline which is given by ICH passes through different steps.

These different steps are called STATUS of that GUIDELINE.

Status of CTD
STATUS

FUNCTIONALITY

Step 1

Development of Consensus

Step 2

Text released for consultation

Step 3

Consultation outside ICH

Step 4

ICH guideline finalized

Step 5

Implementation

STEP 4 STATUS ACHIEVED IN

NOV.2000 IN 5TH ICH
CONFERENCE IN SANDIEGO..
STEP 5 STATUS ACHIEVED IN
MAY.2001 IN ICH MEETING IN
TOKYO.
GUIDANCE MADE AVAILABLE
TO INDUSTRY IN OCTOBER
16,2001 BY FDA.

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SIGNIFICANCE OF CTD:
Avoid generating and compiling different registration dossiers
Common format will significantly reduce the time and resources

Facilitates simultaneous submission in three regions

Facilitates exchange of information among regulatory authorities

Faster availability of new medicines.

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STRUCTURE OF CTD:
- Divided into various modules having
different contents.

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MODULE 1

NOT A PART OF
CTD

1.REGIONAL INFO.
1.1 ToC

2.1 CTD ToC

PARTS OF CTD

2.2 CTD INTRODUCTION

MODULE 2
2.3
QOS

Quality

3.1 ToC

Max. 30

Max. 30 pgs.

2.5CO

2.6 NCWTS
100 - 150 pgs.

Max.40 or 80 pgs.

MODULE 3

2.4 NCO

MODULE 4

2.7 CWTS
50 - 400 pgs.

MODULE 5

4 non clinical study reports 5 clinical study reports

4.1 ToC

5.1 ToC
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Paper CTD

1
c
Do
2
c
Do
3
c
Do
4
c
Do

eCTD

File 1

File 2

File 3

File 4

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eCTD:electronic CTD
- Developed by M2 EWG (Multidisciplinary 2 Expert
Working Group) of ICH.

Industry <-----> Message <------> Agency

Paper submission
has been replaced
by electronic
submission

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Characteristics of eCTD:1. Files Referenced in the XML Backbone(s)

(Extensible Markup Language)

REASONS:
1.It manages the large data for the entire submission
and for each document within the submission.
2.This XML backbone allows the eCTD submission to be
viewed via a web browser and can be loaded on a Web
server.
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2.The file formats that can be included

in the eCTD are Portable Document
Format (PDF) and XML.
However other formats can be used for
graphs and images.
JPEG
PNG
GIF
-may be used for higher resolution.
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3. All eCTD Submissions Include Module 1

Module 1 Identifies following important information:

Company Name
Drug Name
Submission Type
Submission Date
Application Number
Sequence Number

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Nomenclature for files and eCTD

submission.
EXAMPLE:- MODULE 2 FILE NOMENCLATURE AND eCTD submission
Description

File Name

2.2 introduction

22-intro

2.3 Quality overall summary

23-qos

2.4 Non clinical Overview

24-nonclin-over

2.5 Clinical Overview

25-clin-over

2.6 Non clinical Written and

Tabulated Summaries

26-nonclin-sum

2.7 Clinical summary

27-clin-sum

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Agency Sites with eCTD

submission Information
FDA

: http://www.fda.gov/cder/regulatory/ersr/ectd.htm

EMEA(EU) : http://esubmission.eudra.org/
MHLW(JP) : http://www.mhlw.go.jp/english/index.html

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Summary
CTD was introduced with the aim to harmonize
submission of technical data for registration of
human use in different regions.
After 5 years of implementation of ctd,we can say
that considerable harmonization has been
achieved in various regions for submission of
technical data.
More and more regulatory agencies have started
association with this implementation generated
actually by ICH before 5 years back.
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FOR EXAMPLE :
TGA (AUSTRALIAN REGULATORY AGENCY) has started
submission of technical data in the form of CTD.
http://www.tga.gov.au/docs/html/eugctd.htm
http://www.tga.gov.au/docs/pdf/euguide/tgamod1.pdf
http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2quality.pdf
http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2safety.pdf
http://www.tga.gov.au/docs/pdf/euguide/ich/ctdm2efficacy.pdf
AND TGA IS NOW WORKING ON A PROJECT TO IMPLEMENT eCTD for
marketing authorization, NDA, ANDA AND DIFFERENT DOSSIER
SUBMISSION.

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1.

What is CTD?
What are the advantages of it?

Study questions:

(uni. exam2005)
2.

COMMENT ON:CTD is a common guideline for

WHO,ICH,MCA,EMEA & USFDA.
(uni.exam2006)

3. What is CTD?
Why it is introduced? Who regulates it?
Give diagrammatic representation, advantages and
exclusions of it.
(uni. exam2007)
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REFERENCES:www.ich.org
http://www.fda.gov/cder/regulatory/ersr/ectd.htm
http://esubmission.eudra.org/
http://www.mhlw.go.jp/english/index.html
http://www.tga.gov.au/docs/html/eugctd.htm

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