eCTD Validation Criteria_2011-02-11 v3-1.xls

7/26/2019 eCTD Validation Criteria_2011-02-11 v3-1.xls

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Version Number Date Description

1.0 Jan-2008 First approved version

2.0 Jul-2008

2.1 Apr-2009

3.0 Jan-2011

3.1 Feb-2011

EU Region eCTD Validation Criteria

Version 3.1

February 211

Major revision by TIes !ar"onisation roupadopted by TIes

#o""ent on $%e$& 10.1 deleted and 'ilena"in(

'or )*+ se$tion updated



, e(ion e#T/ alidation #riteriaersion 3.0 January 2011

Number Category Validation Criterion Comments

1.1 I#! /T/ T%e spe$i'ied 'ilena"e is used F File is na"ed i$

1.2 I#! /T/ T%e $orre$t pla$e"ent is used F In t%e 'older 44

1.3 I#! /T/ A $urrently a$$eptable version o' t%e /T/ is used F 5

1.6 I#! /T/ F T%e $%e$&su"

2.1 I#! styles%eet T%e spe$i'ied 'ilena"e is used F File is na"ed e

2.2 I#! styles%eet T%e $orre$t pla$e"ent is used F In t%e 'older 44

2.3 I#! styles%eet A $urrently a$$eptable version o' t%e styles%eet is used F 5

2.6 I#! styles%eet F T%e $%e$&su"

3.1 , M1 /T/ T%e spe$i'ied 'ilena"e is used F File is na"ed e

3.2 , M1 /T/ T%e $orre$t pla$e"ent is used F In t%e 'older 443.3 , M1 /T/ A $urrently a$$eptable version o' t%e /T/ is used F 5

3.6 , M1 /T/ F T%e $%e$&su"

6.1 , M1 lea' M*/ 'ile T%e spe$i'ied 'ilena"e is used F File is na"ed e

6.2 , M1 lea' M*/ 'ile T%e $orre$t pla$e"ent is used F In t%e 'older 44

6.3 , M1 lea' M*/ 'ile A $urrently a$$eptable version o' t%e eu-lea'."od 'ile is used F 5

6.6 , M1 lea' M*/ 'ile F T%e $%e$&su"

.1 T%e spe$i'ied 'ilena"e is used F File is na"ed e

.2 T%e $orre$t pla$e"ent is used F In t%e 'older 44

.3 A $urrently a$$eptable version o' t%e eu-envelope."od 'ile is used F 5

.6 F T%e $%e$&su"

Type o!c"ec#

C"ec# canonly beper!ormed inconte$t o!ot"er eCTDsin t"eli!ecycle%

#urrently a$$epe:a"ple not (%as already be

T%e valid version o' t%e /T/ is used <$%e$&su" "at$%es t%epublis%ed value=


T%e valid version o' t%e styles%eet is used <$%e$&su" "at$%es t%epublis%ed value=


T%e valid version o' t%e /T/ is used <$%e$&su" "at$%es t%epublis%ed value=


T%e valid version o' t%e eu-lea'."od 'ile is used <$%e$&su" "at$%est%e publis%ed value=

, M1 envelopeM*/ 'ile





T%e valid version o' t%e eu-envelope."od 'ile is used <$%e$&su""at$%es t%e publis%ed value=




7.1 , M1 styles%eet T%e spe$i'ied 'ilena"e is used F File is na"ed e

7.2 , M1 styles%eet T%e $orre$t pla$e"ent is used F In t%e 'older 44

7.3 , M1 styles%eet A $urrently a$$eptable version o' t%e styles%eet is used F 5

7.6 , M1 styles%eet F T%e $%e$&su"

.1 Inde: 4M> T%e 'ile is pla$ed in t%e $orre$t 'older F T%e root 'older

.2 Inde: 4M> T%e 'ile is na"ed $orre$tly F File is na"ed in

.3 Inde: 4M> T%e 'ile is ;ell 'or"ed F ?ell 'or"ed ;i

.6 Inde: 4M> T%e 'ile is valid F

8.1 Inde: M/ t:t T%e 'ile is pla$ed in t%e $orre$t 'older F T%e root 'older

8.2 Inde: M/ t:t T%e 'ile is na"ed $orre$tly F T%e 'ile is na"

8.3 Inde: M/ t:t F

9.1 , re(ional 4M> T%e 'ile is pla$ed in t%e $orre$t 'older F T%e 'older 444

9.2 , re(ional 4M> T%e 'ile is na"ed $orre$tly F File is na"ed e

9.3 , re(ional 4M> T%e 'ile is ;ell 'or"ed F ?ell 'or"ed ;i

9.6 , re(ional 4M> T%e 'ile is valid F

10.1 +ub"ission +tru$ture F

11.1 lea' attributes T%e lea' attribute @$%e$&su"-type@ %as a value o' "d or M/ F ote t%at t%is v

11.2 lea' attributes F 5

11.3 lea' attributes For every lea' t%e @title@ attribute is not e"pty F

11.6 lea' attributes F

11. lea' attributes F


11. lea' attributes F

11.8 lea' attributes F


12.1 ode e:tensions For every node-e:tension t%e @title@ attribute is not e"pty F


T%e valid version o' t%e styles%eet is used <$%e$&su" "at$%es t%epublis%ed value=

alid ;it% respe'older

T%e re(enerated $%e$&su" 'or t%e inde:.:"l "at$%es t%e value int%e 'ile inde:-"d.t:t.

alid ;it% respeutildtd 'older

All t%e lo;est level %eadin( ele"ents in t%e 4M> <in$ludin( node-

e:tensions= in$luded in t%e sub"ission $ontain at least one lea'

T%e re(enerated $%e$&su" 'or ea$% 'ile "at$%es t%e value in t%elea' attribute @$%e$&su"@

ote t%at i' t%e e#T/ appli$atia$$ess to t%is '

T%e M/ $%e$

All leaves ;it% an operation attribute value o' ne; repla$e orappend "ust %ave a value 'or :lin&C%re'

All leaves ;it% an operation attribute value o' delete "ust %ave novalue 'or :lin&C%re'

T%e attribute do;it% a null value

T%e 'ile re'eren$ed by t%e :lin&C%re' "ust e:ist in t%e sa"e or apreviously sub"itted seBuen$e ;it%in t%e sa"e e#T/ appli$ation

All leaves ;it% an operation attribute value o' repla$e delete orappend "ust %ave a value 'or "odi'ied-'ile

All leaves ;it% an operation attribute value o' ne; "ust %ave novalue 'or "odi'ied-'ile

T%e attribute do;it% a null value

T%e lea' re'eren$ed by t%e "odi'ied 'ile "ust e:ist in a previouslysub"itted seBuen$e ;it%in t%e sa"e e#T/ appli$ation




13.1 +eBuen$e nu"ber T%e seBuen$e nu"ber is 6 di(its F i.e. nu"bers be

13.2 +eBuen$e nu"ber T%e seBuen$e nu"ber %as not already been used F 5

13.3 +eBuen$e nu"ber F

16.1 ,nvelope Attributes F T%is s%ould stil

16.2 ,nvelope Attributes F

16.D1 ,nvelope Attributes D

16.D2 ,nvelope Attributes D

1.1 FilesFolders F

1.2 FilesFolders F e'er to I#! e#

1.3 FilesFolders Total 'ile 'older pat% len(t% "ust not e:$eed 180 $%ara$ters F

1.6 Fi lesFolders File na"es in$ludin( t%e e:tension "ust not e:$eed 76 $%ara$ters F

1. FilesFolders Folder na"es "ust not e:$eed 76 $%ara$ters F1.7 FilesFolders *nly valid $%ara$ters are used in 'ile na"es F

1. FilesFolders *nly valid $%ara$ters are used in 'older na"es F

1.8 FilesFolders T%ere are no unre'eren$ed 'iles in M1 M2 M3 M6 and M 'olders F

1.9 FilesFolders F

1.10 FilesFolders T%ere are no e"pty 'olders F

1.11 FilesFolders F T%e 'older 444

1.12 FilesFolders F

1.D1 FilesFolders Individual 'iles do not e:$eed 100 MD in siEe D

1.D2 FilesFolders D

T%e seBuen$e 'older na"e "at$%es t%e seBuen$e nu"ber in t%eenvelope in eu-re(ional.:"l

T%ere is a sin(le envelope ;it% t%e $ountry attribute value o' e"ea i't%e pro$edure type $entralised

T%ere is a envelope ele"ent ;it% a "at$%in( $ountry attribute value'or every $ountry spe$i'i$ lea' <e:$ept @$o""on@= in$luded in Module

1

I' all $ontent is envelopes 'or e

t%at t%ere is no

I' t%e sub"ission type is supple"ental-in'o or $orri(endu" t%en t%erelated-seBuen$e attribute "ust %ave a value

I' t%e sub"ission type is not supple"ental-in'o or $orri(endu" t%ent%ere "ust not be related seBuen$e attribute

T%e 'iles provided in t%e 'olders 'or Module 1 are in a$$eptable'or"ats

e'er to table inTF ;ill be re"re'eren$ed by l

T%e 'iles provided in t%e 'olders 'or Module 2- are in a$$eptable'or"ats

#ountin( startsseBuen$e nu"

lo;er $ase $%ado$u"ented in

lo;er $ase $%ado$u"ented in

In$ludin( all su'older and sub'

T%e only 'iles in t%e seBuen$e 'older <4444= are t%e inde:.:"land inde:-"d.t:t

<I' t%e pro$edure type in t%e envelope is @de$entralised@ or @"utual-re$o(nition@= T%e tra$&in( table 'ile is present in t%e $orre$t lo$ation

<I' t%e pro$edure type in t%e envelope is @de$entralised@ or @"utual-re$o(nition@= T%e tra$&in( table 'ile is $orre$tly na"ed

File is na"ed $tra$&in(.:"l

Any deviation s

Files lar(er t%ae:$eed t%is li"

T%e re$o""ended 'older stru$ture and 'older na"es in t%e I#! and, spe$i'i$ations are used

Any deviation reported by t%e




1.D3 FilesFolders D

17.1 /F Files o /F %as been $reated and saved as version 1.3 or earlier F

17.2 /F Files T%ere is no se$urity settin( to open any individual 'ile F

17.3 /F Files F

17.D1 /F Files Files %ave been $reated and saved as /F 1.6 D

17.D2 /F Files D

17.D3 /F Files D

17.D6 /F Files D 5

T%e re$o""ended 'ile na"es 'ro" t%e I#! and , spe$i'i$ationsare used 'or all 'iles

Any deviation s

ote t%at t%e $ot%e I#! e#T/ st%is is variable tIn , Module 1%yp%ens. otein t%e ariable

Appli$ants usin A+MF are re"@ap@ and @rp@ prpart respe$tivepre'i:es in Mod

T%e ## $ode oo' t%e lea' attrib

/F 1.3 or eare:$eptions ;ill re$eived in /F/F 1.6 even

Furt%er (uidan

/F version.

T%is in$ludes psettin(s et$.

T%ere are no 'urt%er se$urity settin(s applied to any individual 'ile<e:$ept 'or 'iles in Modules 3.3 6.3 and .6=

All @restri$tionsre'eren$es +

I' t%e use o' lats%ould $%e$& t%versions t%an 1and t%us potendo$u"ent.

Furt%er (uidan/F version.

!yperlin&s ;it%in do$u"ents or bet;een do$u"ents ;it%in t%esa"e seBuen$e %ave a valid tar(et

>in&s to destinaaddresses et$

Doo&"ar&s to destinations ;it%in t%e sa"e seBuen$e %ave a validtar(et

Doo&"ar&s to daddresses et$

!yperlin&s to tar(ets ;it%in do$u"ents in a di''erent seBuen$e in t%esa"e appli$ation %ave a valid tar(et

>in&s to destinaaddresses et$




17.D /F Files D 5

17.D7 /F Files All boo&"ar&s and lin&s are set to @in%erit Eoo"@ D

17.D /F Files /Fs "ust %ave @Fast ?eb ie;@ a$tive D

17.D8 /F Files D

17.D9 /F Files All /F %yperlin&s are relative D

17.D10 /F Files All /F boo&"ar&s are relative D

17.D11 /F Files D

Description o! Type o! c"ec#

F assFail

D Dest ra$ti$e

Doo&"ar&s to destinations in a di''erent seBuen$e in t%e sa"eappli$ation %ave a valid tar(et

Doo&"ar&s to daddresses et$.=

/F /o$u"ent roperties 'or t%e Inital ie; are set 'or @a(e>ayout /e'ault@ and @Ma(ni'i$ation /e'ault@

T%e boo&"ar&s pane s%ould be visible i' boo&"ar&s are in$luded;it%in a /F do$u"ent

T%ese are validation $riteria t%at $an eit%er be passed or 'ailed.e#T/s t%at 'ail to "eet one or "ore o' t%ese $riteria ;ill be returnedto t%e appli$ant 'or 'i:in( and resub"ission as t%e sa"e seBuen$enu"ber.

T%e pass'ail $ate(ory %as been introdu$ed 'or t%e possibility o''uture auto"ation o' e#T/ validation.

Any deviation 'ro" t%e $riterion s%ould al;ays be reported by t%evalidatin( tool.

T%ese are validation $riteria t%at it is $onsidered (ood pra$ti$e toensure are $orre$t in t%e sub"itted e#T/. T%e appli$ant s%ould"a&e every e''ort to address t%ese areas be'ore t%e e#T/ issub"itted to t%e a(en$y. T%e appli$ant s%ould be prepared toin$lude justi'i$ation 'or any Dest ra$ti$e $riteria not "et in t%esub"ission $over letterrevie;erKs (uide.

e#T/s t%at 'ail to "eet one or "ore o' t%ese $riteria ;ill still bea$$epted by t%e a(en$y durin( te$%ni$al validation and it is possiblet%at a(en$ies "ay not even $%e$& t%ese $riteria durin( te$%ni$alvalidation.

T%ese $riteria assess 'a$tors t%at a''e$t t%e overall ease o' use o't%e e#T/. All tool vendors s%ould in$lude t%ese $riteria in t%eirvalidation tools so t%at appli$ants $an produ$e e#T/s t%at areeasier to use. sers o' t%e validation tool s%ould also be able to

$%e$& t%e e#T/ ;it%out $%e$&in( 'or t%e Dest ra$ti$e $riteria.



&E'END

Dla$& T%ese entries are 'i:ed te:t 'or 'older and 'ile na"es a$$ordin( to

ed T%ese entries are variable te:t 'or 'older and 'ile na"es a$$ordin

reen T%ese entries are pi$&list values a$$ordin( to t%e , spe$i'i$atio

Dlue <ee+= T%ese entries 'or 'ilena"es are only appli$able 'or a ee+ 'or"a

in& <e#T/= T%ese entries 'or 'olders and 'ilena"es are only appli$able 'or an

Dro;n <$o"pendial= I' t%e 'older na"e starts ;it% t%is te:t t%en $o"ponent 'ilena"es

(old) no !ile e$tension T%ese entries indi$ate 'older na"es and are $oloured in a$$orda

e(ular ;it% 'ile e:tension <.pd'= T%ese entries indi$ate 'ile na"es and are $oloured in a$$ordan$

product*name

$td-to$.pd'

inde:.:"l

inde:-"d.t:t

m1"1-to$.pd'

eu

eu-re(ional.:"l

1*co+er

cc

12*!orm

cc

13*pi

131*spclabelpl

cc ll

132*moc#up

cc

133*specimen

cc

13,*consultation

cc

13-*appro+ed

cc

13*braille

1,*e$pert

1,1*/uality

1,2*nonclinical

1,3*clinical

1-*speci!ic

$$-$over -var .pd'

$$-'or"-var .pd'

$$-pido$-var .pd'

$$-"o$&up-var .pd'

$$-spe$i"en-var .pd'

$$-$onsultation-var .pd'

$$-approved-var .pd'

braille-var .pd'

Buality-var .pd'

non$lini$al-var .pd'

$lini$al-var .pd'



1-1*bibliograp"ic

1-2*generic*"ybrid*bio*similar

1-3*data*mar#et*e$clusi+ity

1-,*e$ceptional

1--*conditional*ma

1*en+ironris#

11*nongmo

12*gmo

10*orp"an 101*similarity

102*mar#et*e$clusi+ity

1*p"armaco+igilance

11*p"+ig*system

12*ris#mgt*system

1*clinical*trials

11*paediatrics

additional*data

cc

responses

cc

m2

"2-to$.pd'

22*intro

23*/os

*

2,*nonclin*o+er

2-*clin*o+er

2*nonclin*sum

biblio(rap%i$-var .pd'

biosi"ilar -var .pd'

(eneri$-var .pd'

%ybrid-var .pd'

data"ar&ete:$lusivity-var .pd'

e:$eptional-var .pd'

$onditional"a-var .pd'

non("o-var .pd'

("o-var .pd'

si"ilarity-var .pd'

"ar&ete:$lusivity-var .pd'

p%vi(syste"-var .pd'

ris&"(tsyste"-var .pd'

$lini$altrials-var .pd'

paediatri$s-var .pd'

$$-additionaldata-var .pd'

$$-responses-var .pd'

introdu$tion-var .pd'

Bos-var .pd'


dru(-substan$e-var .pd'

dru(-produ$t-var .pd'

appendi$es-var .pd'

re(ional-in'or"ation-var .pd'

non$lini$al-overvie;-var .pd'

$lini$al-overvie;-var .pd'



20*clin*sum

m3

"3-to$.pd'

32*body*data

32s*drug*sub drug*substance

32s1*gen*in!o

32s2*manu!

32s3*c"arac

32s,*contr*drug*sub

32s,1*spec

32s,2*analyt*proc

32s,3*+al*analyt*proc

32s,,*batc"*analys

32s,-*usti!*spec

32s-*re!*stand

32s*cont*closure*sys

32s0*stab

32p*drug*prod drug*product


p%ar"a$ol-;ritten-su""ary -var .pd'

p%ar"a$ol-tabulated-su""ary -var .pd'

p%ar"&in-;ritten-su""ary -var .pd'

p%ar"&in-tabulated-su""ary -var .pd'

to:i$olo(y-;ritten-su""ary -var .pd'

to:i$olo(y-tabulated-su""ary -var .pd'

su""ary-biop%ar"-var .pd'

su""ary-$lin-p%ar"-var .pd'

su""ary-$lin-e''i$a$y-var .pd'

su""ary-$lin-sa'ety-var .pd'

literature-re'eren$es-var .pd'

synopses-indiv-studies -var .pd'

no"en$lature-var .pd'

stru$ture-var .pd'

(eneral-properties-var .pd'

"anu'a$turer -var .pd'

"anu'-pro$ess-and-$ontrols-var .pd'

$ontrol-o'-"aterials-var .pd'

$ontrol-$riti$al-steps-var .pd'

pro$ess-validation-var .pd'

"anu'-pro$ess-develop"ent-var .pd'

elu$idation-o'-stru$ture-var .pd'

i"purities-var .pd'

spe$i'i$ation-var .pd'

analyti$al-pro$edure.pd'

validation-analyt-pro$edure .pd'

bat$%-analyses-var .pd'

justi'i$ation-o'-spe$i'i$ation-var .pd'

re'eren$e-standards-var .pd'

$ontainer-$losure-syste"-var .pd'

stability-su""ary-var .pd'

postapproval-stability-var .pd'

stability-data-var .pd'



32p1*desc*comp

32p2*p"arm*de+

32p3*manu!

32p,*contr*e$cip

e$cipient

32p-*contr*drug*prod

32p-1*spec

32p-2*analyt*proc

32p-3*+al*analyt*proc

32p-,*batc"*analys

32p--*c"arac*imp

32p-*usti!*spec

32p*re!*stand

32p0*cont*closure*sys

32p*stab

32a*app

32a1*!ac*e/uip

32a2*ad+ent*agent

32r*reg*in!o

des$ription-and-$o"position-var .pd'

p%ar"a$euti$al-develop"ent -var .pd'

"anu'a$turers-var .pd'

bat$%-'or"ula-var .pd'

"anu'-pro$ess-and-$ontrols-var .pd'

$ontrol-$riti$al-steps-var .pd'

pro$ess-validation-var .pd'

spe$i'i$ations-var .pd'

analyti$al-pro$edures-var .pd'

validation-analyt-pro$edures -var .pd'

justi'i$ation-o'-spe$i'i$ations-var .pd'

compendial*e$cipients

spe$i'i$ations.pd' analyti$al-pro$edures.pd'

validation-analyt-pro$edures .pd'

justi'i$ation-o'-spe$i'i$ations.pd'

e:$ipients-%u"an-ani"al -var .pd'

novel-e:$ipients-var .pd'

spe$i'i$ations-var .pd'

analyti$al-pro$edure.pd'

validation-analyti$al-pro$edures .pd'

bat$%-analyses-var .pd'

$%ara$terisation-i"purities-var .pd'

justi'i$ation-o'-spe$i'i$ations-var .pd'

re'eren$e-standards-var .pd'

$ontainer-$losure-syste"-var .pd'

stability-su""ary-var .pd'

postapproval-stability-var .pd'

stability-data-var .pd'

'a$ilities-and-eBuip"ent-report.pd'

adventitious-a(ents-report .pd'

32a3*e$cip*substance

substan$e.pd'

pro$ess-val-s$%e"e.pd' "edi$al-devi$e.pd'



33*lit*re!

m,

"6-to$.pd'

,2*stud*rep

,21*p"armacol

,211*prim*pd

,212*sec*pd

,213*sa!ety*p"armacol

,21,*pd*drug*interact

,22*p#

,221*analyt*met*+al

,222*absorp

,223*distrib

,22,*metab

,22-*e$cr

,22*p#*drug*interact

,220*ot"er*p#*stud

,23*to$

,231*single*dose*to$

,232*repeat*dose*to$

,233*genoto$

,2331*in*+itro

,2332*in*+i+o

,23,*carcigen

,23,1*lt*stud

,23,2*smt*stud

,23,3*ot"er*stud

,23-*repro*de+*to$

,23-1*!ert*embryo*de+

,23-2*embryo*!etal*de+

,23-3*pre*postnatal*de+

$erti'i$ate-suitability.pd'

"aterials-ani"al-%u"an-ori(in .pd'

re'eren$e.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'

study-report.pd'



,23-,*u+

,23*loc*tol

,230*ot"er*to$*stud

,2301*antigen

,2302*immunoto$

,2303*mec"an*stud

,230,*dep

,230-*metab

,230*imp

,2300*ot"er

,3*lit*re!

m-

"-to$.pd'

-2*tab*list

-3*clin*stud*rep

-31*rep*biop"arm*stud

-311*ba*stud*rep

study*report

-312*compar*ba*be*stud*rep

study*report

-313*in*+itro*in*+i+o*corr*stud*rep

study*report

-31,*bioanalyt*analyt*met

study*report

-32*rep*stud*p#*"uman*biomat

-321*plasma*prot*bind*stud*rep

study*report

-322*rep*"ep*metab*interact*stud

study*report

-323*stud*ot"er*"uman*biomat

study*report

-33*rep*"uman*p#*stud

-331*"ealt"y*sub*p#*init*tol*stud*rep

study*report

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eCTD Validation Criteria_2011-02-11 v3-1.xls

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