Transcript COMMON TECHNICAL DOCUMENT - PharmaQuesT

COMMON TECHNICAL DOCUMENT
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ORIGIN OF CTD…
ICH
EWG
WAS OFFICIALLY SIGNED
OFF IN NOVEMBER 2000,
CTD
AT 5TH ICH CONFERENCE;
SAN DIEGO,CALIFORNIA.
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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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NOT A PART OF
CTD
MODULE 1
1.REGIONAL INFO.
1.1 ToC
2.1 CTD ToC
PARTS OF CTD
2.2 CTD INTRODUCTION
MODULE 2
2.3
QOS
3
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
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has been replaced
by electronic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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Study questions:
1.
What is CTD?
What are the advantages of it?
(uni. exam…2005)
2.
COMMENT ON:‘CTD is a common guideline for
WHO,ICH,MCA,EMEA & USFDA.’
(uni.exam…2006)
3. What is CTD?
Why it is introduced? Who regulates it?
Give diagrammatic representation, advantages and
exclusions of it.
(uni. exam…2007)
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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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