ICH CTD Seminar

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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

    2

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    WHAT IS CTD???

    3

    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/Europe
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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 %&$

    4

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    SCOPE OF CTD

    5

    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(

    10

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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$

    12

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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'

    25

    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.html
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