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ICHCTD By S.Neelima
Reddy M.Pharm 1st
DEPARTMENT OF PHARMACE"TICS
REGULATORY AFFAIRS
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y
CTD
INTRODUCTION
IMPLEMENTATION DATES
SCOPE OF C T D
OVERALL TABLE OF CONTENTS NUMBERING SYSTEM
ectd
SCOPE
HISTORY CHALLENGES
FUTURE
CONTENTS
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WHAT IS CTD???
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The C#mm#$ Te%h$i%al D#%&me$t(CTD) is a set ofspecication for application dossier for the registration ofMedicines and designed to be used across Europe,Japanandthe United States.
t !as de"eloped b# the European Medicines $genc#(EM$,Europe), the %ood and &rug $d'inistration(%&$, U.S.) andthe Ministr# of ealth, abour and *elfare(Japan).
The +T& is 'aintained b# thenternational +onference on ar'onisation of Technical e-uire'ents for egistration of har'aceuticals forH&ma$ "se'ICH(.
http://en.wikipedia.org/wiki/Europehttp://en.wikipedia.org/wiki/Japanhttp://en.wikipedia.org/wiki/United_Stateshttp://en.wikipedia.org/wiki/European_Medicines_Agencyhttp://en.wikipedia.org/wiki/Europehttp://en.wikipedia.org/wiki/Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/U.S.http://en.wikipedia.org/wiki/Ministry_of_Health,_Labour_and_Welfarehttp://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Usehttp://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Usehttp://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Usehttp://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Usehttp://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Usehttp://en.wikipedia.org/wiki/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Usehttp://en.wikipedia.org/wiki/Ministry_of_Health,_Labour_and_Welfarehttp://en.wikipedia.org/wiki/U.S.http://en.wikipedia.org/wiki/Food_and_Drug_Administrationhttp://en.wikipedia.org/wiki/Europehttp://en.wikipedia.org/wiki/European_Medicines_Agencyhttp://en.wikipedia.org/wiki/United_Stateshttp://en.wikipedia.org/wiki/Japanhttp://en.wikipedia.org/wiki/Europe7/24/2019 ICH CTD Seminar
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IMPLEMENTATION DATESOF CTD
/ptional
Jul# 2001 EU, %&$, M*
(+anada, S!iterland)
Mandator#Jul# 2003 EU, M*
(+anada, S!iterland)
ighl# reco''ended
Jul# 2003 %&$
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SCOPE OF CTD
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Ty)e #* Dr&+
Pr#d&%t
E" FDA MHL,
6e! che'icalentities
included included included
6e! 7iologic included included included
6e! ndication included included included
6e! &osage for' included included included
6e! oute ofad'inistration
included included included
8enerics included included 6ot included
/T+ included
included 6ot included
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1.1
To+ of Module 1
or o"erall To+,
including Module 1
2.1
To+ of the +T&
(Mod 2,3,4,5)
Module 1
Module - Module Module /
2.1
2.2
2.3 2.4 2.5
2.9 2.:
Module
3.1
To+ for Module 3
4.1
To+ for Module 4
5.1
To+ for Module 5
:
STR"CT"RE OF CTD
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Module 2
2.1 '/0RA CTD TA0 '3 C')T0)T( '3 M'D40( 2, !, ", A)D #
2.2 I)TR'D4CTI')
2.! %4AIT5 '/0RA (4MMAR5
2.!.( DR46 (4(TA)C02.!.(.1 6eneral Information
2.!.(.2 Manufacture
2.!.(.! Characteri7ation
2.!.(." Control of Drug (ustance
2.!.(.# Reference (tandards or Materials
2.!.(. Container Closure (&stem
2.!.(.+ (tailit&
2.!.8 DR46 8R'D4CT
2.!.8.1 Descri9tion and Com9osition of the Drug 8roduct
2.!.8.2 8harmaceutical Develo9ment
2.!.8.! Manufacture
2.!.8." Control of 0:ci9ients
2.!.8.# Control of Drug 8roduct
2.!.8. Reference (tandards or Materials
2.!.8.+ Container Closure (&stem
2.!.8.; (tailit& ;
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Module 2 (Cont.)
2., C')T0)T '3 )')CI)ICA -RITT0) A)DTA4AT0D (4MMARI0(
2.,.1 Introduction
2.,.2 8harmacolog& -ritten (ummar&
2.,.! 8harmacolog& Taulated (ummar&A99endi: $
2.,." 8harmaco
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Module 3
!.1 M'D40 ! TA0 '3 C')T0)T(
!.2 'D5 '3 DATA
!.2.( DR46 (4(TA)C0
!.2.(.1 6eneral Information
!.2.(.2 Manufacture
!.2.(.! Characterisation
!.2.(." Control of Drug (ustance
!.2.(.# Reference (tandards or Materials
!.2.(., Container Closure (&stem
!.2.(.+ (tailit&!.2.8 DR46 8R'D4CT
!.2.8.1 Descri9tion and Com9osition of the Drug8roduct
!.2.8.2 8harmaceutical Develo9ment
!.2.8.! Manufacture
!.2.8." Control of 0:ci9ients
!.2.8.# Control of Drug 8roduct
!.2.8., Reference (tandards or Materials
!.2.8.+ Container Closure (&stem
!.2.8.; (tailit&
Module 3 (Cont.)
!.2.A A880)DIC0(
!.2.A.1 3acilities and 0=ui9ment
!.2.A.2 Adventitious Agents (afet& 0valuation
!.2.A.! )ovel 0:ci9ients
!.2.R R06I')A I)3'RMATI')
!.! IT0RAT4R0 R030R0)C0(
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Module 4
".1 M'D40 " TA0 '3 C')T0)T(
".2 (T4D5 R08'RT(
".2.1 8harmacolog&
".2.2 8harmaco
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LINE ETENSIONS! 2ARIATIONS 3S"PPLEMENTS
4, 3DA M>- agreed as follo*sB
3or )e* 9roducts,
ne* CTD format should e used
3or 'ld 9roducts, cross@reference to old format is acce9tale no re=uirement to reformat
e:isting dossier$
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eCTD
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6T/&U+T/6
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n 6o"e'ber 2010, the + Steering +o''ittee endorsed
the establish'ent of an E4ert ,#r5i$+ Gr#&) 'E,G( 6Im)leme$tati#$ ,#r5i$+ Gr#&) 'I,G( for the e+T&and assigned the topic code 7M87. *or= in relation to thee+T& had pre"iousl# been underta=en b# the M0 E*8.
Under the M; re'it is the support of the progression of thee+T& through the Sta$dards De9el#)me$tOr+a$isati#$ 'SDO( process to de"elop the e+T& as annternational Standard. This is in accordance !ith the 200;
Steering +o''ittee decision that the ne>t 'a?or "ersionof the e+T& be de"eloped in collaboration !ith S&/s, !ithde"elop'ent rst as a ealth e"el Se"en (:) standard,and then as an nternational /rganiation forStandardiation (S/) standard.
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e+T&
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WH! "S eC!#$
%lectronic Co&&on !ec'nical #ocu&ent+o''on Technical &ocu'ent +o''on for'at for @ualit#,Safet#, and EAcac# infor'ation
Electronic CTD = ectd An interface for industry to agency transfer of
regulatory information
It is composed of:
Directory structure Content files XML eCTD instance
lectronic
sumission
1:
eCTD
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1;
SC()% (* eC!#
C!# scope + Module 1C!#, Registration a99lications for ne* 9harmaceuticals including
iotechnolog&@derived 9roducts$
Module 1B Regional Administrative Information and 8rescriingInformation
Regional sco9e ma& var& e&ond CTD sco9e Investigational )e* Drug,
Drug Master 3ile Active (ustance Master 3ile, and etc.
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1+ EI('C) EIC>$ 8lan (te9 2 in 201! Develo9ment de9ends on schedule of (D's >+, I(', C)$
(9ecification >+ R8( Regulated 8roduct (umission$ *ill e used for
message e:change IC> M" CTD and 6ranularit& Document *ill remain as dossier
structure 8D3 *ill remain as maFor document format
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eCTD 9.:
8eneits1. roader sco9e and standardi7ation
2. Intero9erailit&
C'allen-es
!. )eed to understand >+ 9rocess methodolog&". -ill re=uire ne* tools
#. Regional re=uirements in the sco9e of (D' standardi7ation
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S#(@ (tandards Develo9ment 'rganisation
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E%EE6+ES
httpBB!!!.ich.orgBproductsBguidelinesB'ultidisciplinar#BarticleB'ultidisciplinar#Cguidelines.ht'l
CTD +www.ich.org/products/ctd.html
!!!.google.co'
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http://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.htmlhttp://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.htmlhttp://www.ich.org/products/ctd.htmlhttp://www.ich.org/products/ctd.htmlhttp://www.google.com/http://www.google.com/http://www.ich.org/products/ctd.htmlhttp://www.ich.org/products/ctd.htmlhttp://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.htmlhttp://www.ich.org/products/guidelines/multidisciplinary/article/multidisciplinary-guidelines.html7/24/2019 ICH CTD Seminar
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