UA Region eCTD Validation Criteria

Version 1.0

April 2024

The order of changes appears reverse to the timely manner. The most recent change is listed on the top.

Version Number Date Description

1.0 Apr-24 First version
n the top.
 P/F **Pass/Fail

BP ***Best Practice

* *'Y'-criteria

Number Category
1.1 ICH DTD

1.2 ICH DTD

1.3 ICH DTD

1.4 ICH DTD

2.1 ICH stylesheet

2.2 ICH stylesheet

2.3 ICH stylesheet

3.1 UA M1 DTD

3.2 UA M1 DTD
3.3 UA M1 DTD

3.4 UA M1 DTD

3.5 UA M1 DTD

4.1 UA M1 leaf MOD file

4.2 UA M1 leaf MOD file

4.3 UA M1 leaf MOD file

5.1 UA M1 envelope MOD file

5.2 UA M1 envelope MOD file

5.3 UA M1 envelope MOD file

6.1 UA M1 stylesheet

6.2 UA M1 stylesheet
6.3 UA M1 stylesheet

7.1 Index XML

7.2 Index XML

7.3 Index XML

7.4 Index XML

7.5 Index XML

7.6 Index XML

8.1 Index MD5 txt

8.2 Index MD5 txt

8.3 Index MD5 txt

9.1 UA regional XML

9.2 UA regional XML

9.3 UA regional XML

9.4 UA regional XML

9.5 UA regional XML

9.6 UA regional XML

9.7 UA regional XML

9.8 UA regional XML

10.1 Submission Structure

11.1 leaf attributes

11.2 leaf attributes

11.3 leaf attributes

11.4 leaf attributes

11.5 leaf attributes

 11.6 leaf attributes

11.7 leaf attributes

11.8 leaf attributes

11.9 leaf attributes

11.10 leaf attributes

11.11 leaf attributes

11.12 leaf attributes

11.BP2 leaf attributes

11.BP3 ICH Attributes

12.1 Node extensions

13.1 Sequence number

 13.2 Sequence number

13.3 Sequence number

14.3 Envelope Attributes

14.6 Envelope Attributes

14.7 Envelope Attributes

14.BP6 Envelope Attributes

15.1 Files/Folders

15.2 Files/Folders

15.3 Files/Folders

15.4 Files/Folders

15.5 Files/Folders

15.6 Files/Folders
 15.7 Files/Folders

15.8 Files/Folders

15.9 Files/Folders

15.10 Files/Folders

15.11 Files/Folders

15.12 Files/Folders

15.BP1 Files/Folders

15.BP2 Files/Folders

15.BP3 Files/Folders

16.1 PDF Files

 16.2 PDF Files

16.3 PDF Files

16.4 PDF Files

16.5 PDF Files

16.BP1 PDF Files

16.BP2 PDF Files

16.BP3 PDF Files

16.BP4 PDF Files

16.BP5 PDF Files

16.BP6 PDF Files

16.BP7 PDF Files

16.BP8 PDF Files

16.BP9 PDF Files

16.BP10 PDF Files

UA1.2 UA Custom

UA1.0 UA Custom

UA1.5 UA Custom

UA.BL UA Custom
Description of Type of check
These are validation criteria that can either be passed or failed. eCTDs that fail to meet one or more of these criteria will be
sequence number.

The pass/fail category has been introduced for the possibility of future automation of eCTD validation.
A validation tool that identifies deviations from the validation criteria, that if complied with in the submitted e-application is co
SEC. These criteria assess the factors that affect the ease of use of the eCTD, and therefore eCTD tool vendors should inc
Provided that eCTD fails to meet one or more of the validation criteria identified as good practice, these files are accepted b

Test marked with “Y” needs the relevant former sequences for the specific criterion to be present for the result to be fully re
If these sequences are not present when testing, any FAIL results for these criteria shouldType
be interpreted
of carefully.
Validation Criterion check
The specified filename is used P/F**

The file is placed in the correct folder P/F

A currently acceptable version of the DTD is used (checksum matches the published P/F
value)

The version number of the DTD/specification used in the sequence being tested is P/F
higher than or equal to the version of the DTD used in the sequence numerically
preceding the incoming sequence in the eCTD lifecycle.

The specified filename is used P/F

The file is placed in the correct folder P/F

The checksum for the stylesheet used must match the published checksum for the P/F
stylesheet associated with the DTD used for the sequence

The specified filename is used P/F

The file is placed in the correct folder P/F

A currently acceptable version of the DTD is used (checksum matches the published P/F
value)

The version number of the DTD/specification used in the sequence being tested is P/F
higher than or equal to the version of the DTD used in the sequence numerically
preceding the incoming sequence in the eCTD lifecycle.

The version number of the DTD/specification used in the sequence being tested is P/F
lower than or equal to the version of the DTD used in the sequence numerically
succeeding the incoming sequence in the eCTD lifecycle.

The specified filename is used P/F

The file is placed in the correct folder P/F

The checksum for the ua-leaf.mod file used must match the published checksum for P/F
the ua-leaf.mod file associated with the DTD used for the sequence

The specified filename is used P/F

The file is placed in the correct folder P/F

The checksum for the ua-envelope.mod file used must match the published P/F
checksum for the ua-envelope.mod file associated with the DTD used for the
sequence

The specified filename is used P/F

The file is placed in the correct folder P/F

The checksum for the stylesheet used must match the published checksum for the P/F
stylesheet associated with the DTD used for the sequence

The file is placed in the correct folder P/F

The file is named correctly P/F

The file is well formed P/F

The file is valid P/F

The reference to the DTD in index.xml is directed to the DTD provided in the util P/F
folder.

The reference to the stylesheet in index.xml is directed to the stylesheet provided in P/F
the util folder.

The file is placed in the correct folder P/F

The file is named correctly P/F

The regenerated checksum for the index.xml matches the value in the file index- P/F
md5.txt.

The file is placed in the correct folder P/F

The file is named correctly P/F

The file is well formed P/F

The file is valid P/F

The reference to the DTD in ua-regional.xml is directed to the DTD provided in the P/F
util folder.

The reference to the stylesheet in ua-regional.xml is directed to the stylesheet P/F

provided in the util folder.

The UUID is well formed according to ISO/IEC 11578:1996 and ITU-T Rec X.667 | P/F
ISO/IEC 9834-8:2005

If the sequence already submitted numerically preceding the incoming sequence in P/F
the eCTD lifecycle contains a UUID, then the UUID in this incoming sequence must
be identical to the one in the previous sequence.

All the lowest level heading elements in the XML (including node-extensions) P/F
included in the submission contain at least one leaf

The leaf attribute 'checksum-type' has a value of md5 or MD5 P/F

The regenerated checksum for each file matches the value in the leaf attribute P/F
'checksum'

For every leaf the 'title' attribute is not empty P/F

All leaves with an operation attribute value of new, replace or append must have a P/F
value for the cross reference (xlink:href)

All leaves with an operation attribute value of delete must have no value for the cross P/F
reference (xlink:href)
The file referenced by the cross reference (xlink:href) must exist in the same or a P/F
previously submitted sequence within the same eCTD application

All leaves with an operation attribute value of replace, delete or append must have a P/F
value for modified-file

All leaves with an operation attribute value of new must have no value for modified- P/F
file

The leaf referenced by the modified file must exist in a previously submitted P/F
sequence within the same eCTD application.

For all leaves (except leaves within node extensions and leaves in module 3.2.A) P/F
with an operation attribute value of replace, delete or append, the modified file must
be present in the same CTD section of the dossier.
Note: Using the operation attribute 'delete' to remove content placed in m1-additional-
data is exempt from this rule.

Two leaf elements should not have the same leaf ID. P/F

For all leaves with an operation attribute value of replace, delete or append the P/F
modified file must not have been replaced or deleted by any other leaf element in any
sequence including the current one.

For all leaves within node extensions or module 3.2.A with an operation attribute BP**
value of replace, delete or append, the modified file should be present in the same
node extension or attribute-defined section.

ICH attributes must not contain leading or trailing spaces, nor start or end with BP
hyphens.

For every node-extension the 'title' attribute is not empty P/F

The sequence folder name is a 4 digit number P/F

The sequence number (folder name) has not already been used P/F

The sequence folder name matches the sequence number in each envelope in ua- P/F
regional.xml

There is a single country specific envelope if the procedure type is 'national' .

P/F

If the submission unit type is ‘initial’ or ‘reformat' then the related-sequence attribute
must have a value equal to the current sequence.
P/F

If the submission unit type is not equal to ‘initial’ or ‘reformat' then the entry for
related sequence must not be equal to the value for the current sequence.
P/F

The procedure-tracking element of the envelope should be filled in with the BP

procedure number for the regulatory activity if available

The files provided in the folders for Module 1 are in acceptable formats P/F

The files provided in the folders for Module 2-5 are in acceptable formats P/F

Total file folder path length must not exceed 180 characters P/F

File names, including the extension, must not exceed 64 characters P/F

Folder names must not exceed 64 characters P/F

Only valid characters are used in file names P/F

Only valid characters are used in folder names P/F

There are no unreferenced files in M1, M2, M3, M4 and M5 folders P/F

The only files in the sequence folder (/XXXX/…) are the index.xml and index-md5.txt P/F

There are no empty folders P/F

Tracking table file is present in the correct location P/F

Tracking table file is correctly named P/F

Individual files do not exceed 200 MB in size BP

The recommended folder structure and folder names in the ICH and UA BP
specifications are used

The recommended file names from the ICH and UA specifications are used for all BP
files

No PDF has been created and saved as version 1.3 or earlier P/F
There is no security setting to open any individual file P/F

There are no further security settings applied to any individual file (except for files in P/F
Modules 1.0, 1.2, 3.3, 4.3 and 5.4)

Individual files in section 1.0 and 1.2 have no security settings except for the P/F
following:
1) Changing the document
2) Document assembly
3) Page extraction
4) Commenting
5) Creation of template pages.
The submission does not contain corrupted files P/F

Files have been created and saved as PDF 1.4, 1.5, 1.6, or PDF 1.7 BP

Hyperlinks and bookmarks within documents, or between documents within the same BP
sequence, have a valid target.

Hyperlinks and bookmarks to destinations in a different sequence in the same eCTD BP

have a valid target.

All hyperlinks and bookmarks are set to 'inherit zoom' BP

PDFs except the files from section 1.0 and 1.2 must have 'Fast Web View' active BP

PDF Document Properties for the Initial View are set for 'Page Layout = Default' and BP
'Magnification = Default'
All PDF hyperlinks and bookmarks are relative BP

The bookmarks pane should be visible if bookmarks are included within a PDF BP
document

The bookmarks pane should not be visible if there are no bookmarks included within BP
a PDF document

All hyperlinks and bookmarks between two PDFs must be configured as specified in BP
ISO 32000-1:2008

Files in M1.0, M1.2 with name "form", "annex", "letter" should be signed with P/F
Ukrainian electronic signature.

File cover letter is required in M1.0 section. P/F

Forbiddent to submit sequence number lower (or the same), than it was submitted P/F
before for this dossier.

Minimal required elements of eCTD structure, while submmiting first baseline. P/F
m1-0-cover
m1-3-2-labeling
m1-3-3-instructions
m1-8-1-pharmacovigilance-system
m1-8-2-risk-management-system
m3
one or more of these criteria will be returned to the applicant for fixing and resubmission as the same

D validation.
in the submitted e-application is considered good practice, when an eCTD is submitted by an applicant to the
fore eCTD tool vendors should include these validation criteria in the validation tools for eCTD creation.
practice, these files are accepted by the SEC during technical validation.

present for the result to be fully reliable.

Lifecycle
d be interpreted carefully.
needed?
'YES' (Y) * Comments
File is named ich-ectd-3-2.dtd

In the folder /XXXX/util/dtd

Currently acceptable versions are described in the current ICH eCTD Specification.
(The checksum for the DTD in eCTD v3.2 (ich-ectd-3-2.dtd) is
1d6f631cc6b6357f0f4fe378e5f79a27)

Y With reference to any transition guidance, going back to an earlier version is not
allowed when a newer version has already been used for that eCTD. ‘The sequence
numerically preceding the incoming sequence in the eCTD lifecycle‘ refers to the
highest numbered sequence that is numerically lower than the incoming sequence.

The criterion should only be tested if there are sequences with lower sequence
numbers present.
File is named ectd-2-0.xsl

In the folder /XXXX/util/style

For example, the checksum corresponding to the stylesheet from eCTD specification
v3.2 (ectd-2-0.xsl) is 3a07a202455e954a2eb203c5bb443f77

File is named ua-regional.dtd

In the folder /XXXX/util/dtd

 Currently acceptable with reference to any transition guidance. The checksum for the
DTD for UA m1 corresponds the one published on dec.gov.ua

Y With reference to any transition guidance, going back to an earlier version is not
allowed when a newer version has already been used for that eCTD. ‘The sequence
numerically preceding the incoming sequence in the eCTD lifecycle‘ refers to the
highest numbered sequence that is numerically lower than the incoming sequence.
For example if 0109 used DTD 1.4, 0110 was DTD 2.0, and 0111 is not present,
then 0112 must be built in either DTD 2.0 or higher.
Y This rule specifically tests in situations where sequences have been submitted out of
order. ‘The sequence numerically succeeding the incoming sequence in the eCTD
lifecycle‘ refers to the lowest numbered sequence that is numerically higher than the
incoming sequence. For example if 0010 used DTD 1.4, and 0012 was DTD 2.0,
then 0011 must be built in either DTD 2.0 or 1.4.
The criterion
File is namedshould only be tested if there are sequences with higher sequence
ua-leaf.mod
numbers present.

In the folder /XXXX/util/dtd

The checksum corresponds the one published on dec.gov.ua

File is named ua-envelope.mod

In the folder /XXXX/util/dtd

The checksum corresponds the one published on dec.gov.ua

File is named ua-regional.xsl

In the folder /XXXX/util/style

The checksum corresponds the one published on dec.gov.ua

The root folder /XXXX

File is named index.xml

Well formed with respect to the rules of the XML specification

Valid with respect to the ICH eCTD DTD file included in the util/dtd folder

This is the ICH DTD in /XXXX/util/dtd, and tested for validity by rules 1.1 - 1.5. A
valid reference means a URI - see http://www.w3.org/TR/xml/ and
http://www.ietf.org/rfc/rfc3986.txt (version 2005 page 22, section 3.3).

This is the ICH stylesheet in /XXXX/util/style and tested for validity by rules 2.1 - 2.3.
A valid reference means a URI - see http://www.w3.org/TR/xml/ and
http://www.ietf.org/rfc/rfc3986.txt (version 2005 page 22, section 3.3).

The root folder /XXXX

The file is named index-md5.txt

The folder /XXXX/m1/ua

File is named ua-regional.xml

 Well formed with respect to the rules of the XML specification

Valid with respect to the UA Module 1 DTD file included in the util/dtd folder.

This is the UA Regional DTD in /XXXX/util/dtd, and tested for validity by rules 3.1-
3.5. A valid reference means a URI - see http://www.w3.org/TR/xml/ and
http://www.ietf.org/rfc/rfc3986.txt (version 2005 page 22, section 3.3)

This is the stylesheet in /XXXX/util/style, and tested for validity by rules 6.1-6.3. A
valid reference means a URI - see http://www.w3.org/TR/xml/ and
http://www.ietf.org/rfc/rfc3986.txt (version 2005 page 22, section 3.3).

This criterion will test whether the UUID is well formed.

Y This rule checks that the UUID is correct and the sequence is being loaded into the
correct eCTD Application.

Note that this value is not case sensitive.

Y Note that if the content file is in an earlier sequence within the same eCTD
application then the checksum can only be regenerated if access to this file is
available.

The MD5 checksum is not case sensitive.

The value for the cross reference (xlink:href) should be valid, and not contain any
illegal characters. (Legal characters are lower case characters a-z, digits 0-9 and
hyphens, as documented in the ICH eCTD specification). A valid reference means a
URI - see http://www.w3.org/TR/xml/ and http://www.ietf.org/rfc/rfc3986.txt (version
2005 page 22, section 3.3).
The attribute does not need to be included, or can be declared but with a null value.
Y The link within the XML leaf element is valid, i.e. the target exists.

The attribute does not need to be included, or can be declared but with a null value.

Y This test applies to all procedures. Applicants should avoid replacing, deleting or
appending to content submitted in national sequences (other than the first national
phase before MRP), and vice versa.

Y 'Same CTD section' refers to the position in the table of contents. Sections are
defined by the CTD and also by attributes in the eCTD. For example, applicants
cannot replace content in the application form section with revised content that is
being provided in the cover letter section. eCTD attributes also create applicant
defined sections. For example, each 'substance' or 'manufacturer' attribute in m3-2-
s-drug-substance, or 'product-name' attribute in m3-2-p–drug-product will create a
new CTD section, and lifecycle between these sections is also not allowed. For
further details refer to Section 2.9.6 on page 13 of the Harmonised Technical
Guidance for eCTD Submissions in the EU.
Due to inconsistency between tools how attributes are handled in the past, attributes
ID must be3.2.A
in module unique withinbeeach
should sequence.
allowed to be edited or not automatically copied. To avoid
unnecessary errors these modules are exempt as well.

Y Documents can be replaced or deleted just once.

The modified file must not have been subject to another replace or delete operation
in any of the available sequences.

Y The definition of ‘same CTD section’ is as in criterion 11.10. If the node extension is
not in the same section the criterion 11.10 still applies.

Y The problem is with attributes in the XML that define re-useable sections. Hyphens
or spaces at the beginning or end of a attribute name are not allowed.

i.e. numbers between 0000 and 9999

Y

The country attribute value must be from the dictionary in specification.

Refer to UA M1 specification. When submitting a first submission initialising a

regulatory activity or proving a reformatted application, the related sequence attribute
should be populated with the same number of that current sequence.

Refer to UA M1 specification. When submitting additional lifecycle sequences within

an ongoing regulatory activity, the related sequence attribute should be populated
with the number of the sequence that started this regulatory activity.

Refer to table in UA Module 1 specification: this is XML (where a specification exists)

and PDF.

Refer to table in UA Module 1 specification: this is XML (where a specification exists)

and PDF.

Counting starts from the first digit of the sequence number in the sequence number
folder name, and includes the filename.

Lower case characters a-z, digits 0-9 and hyphens are allowed (as documented in
the ICH eCTD specification). This test should only be applied to the file names in the
file system, for checks on the XML see test 11.4.
Lower case characters a-z, digits 0-9 and hyphens are allowed (as documented in
the ICH eCTD specification). This test should only be applied to the folder names in
the file system, for checks on the XML see test 11.4.

Including all subfolders within the m1-m5 folders but excluding ‘util’ folder and
subfolders

The folder is:

/XXXX/m1/ua/10-cover

File is named tracking-var.pdf

Note that the use of XML format for the Tracking table is not acceptable.

Any deviation should always be reported by the validating tool.

Files larger than 200 MB should be avoided due to potential archiving issues and to
make the assessment easier.
Any deviation, including additional subfolders, should always be reported by the
validating tool.

Although navigation of an eCTD is typically carried out via the XML backbone, it is
also helpful if the underlying files and folders follow the ICH and UA naming
guidance.
Any deviation should always be reported by the validating tool.

Note that the components of the file names in italics in Appendix 4 of the ICH eCTD
specification are to be specified by the applicant (i.e. this is variable text).

The potential presence of STF files in m4 or m5 should not be tested.

Although navigation of an eCTD is typically carried out via the XML backbone, it is
also helpful if the underlying files and folders follow the ICH and UA naming
guidance.

PDF 1.3 or earlier is not acceptable for technical reasons. No exceptions will be
made. For example, if a literature reference is received in PDF 1.3 or earlier, then
the applicant must provide it in PDF 1.4, 1.5, 1.6 or 1.7, even if this means copying
the full text into a new document or even getting a paper copy and scanning it.

Further guidance is provided about the best ways to check the PDF version in the
comment to rule 16.BP1.
 This includes passwords, certificate security, or adobe policy server settings. This
test should not be used to test for corrupted files, instead see 16.5.

All 'restrictions' should be 'allowed' when viewing the Document Preferences >
Security settings. This includes any of the following document restrictions: printing,
changing the document, document assembly, content copying, content copying for
accessibility, page extraction, filling of form fields, signing, creation of template
pages.
Specific security settings of files in m1.0 and m1.2 are tested in criterion 16.4.

This can be achieved by opening a PDF file in software which is compliant to ISO
32000-1; if the file opens without error, the PDF file is considered to be conformant.
Absence of detection of conformance means corrupted PDF.

For PDF files with apparent versions of 1.3 or earlier, the version information should
be taken from the first eight characters from the first line of the header in the file. For
versions 1.4 and higher, the version should be taken from the document catalogue
dictionary, if present. If both the header information and the catalogue information
are present, then the document catalogue dictionary information takes precedent,
see PDF 32000-1:2008 specification, chapter 7.5.2 for further details.

Only the PDF versions specified are recommended by ICH.

This test is important due to archiving and also that PDF files can be correctly open
Only linksby
and read that open in the same software application are tested. Other links (e.g.
assessors.
web links and e-mail addresses) are not considered to link to essential content and
should not be tested.

If this BP criterion is not met, the assessor might not be able to conveniently find the
relevant documents and read the submission as intended by the applicant.
Y Only links that open in the same software application are tested. Other links (e.g.
web links and e-mail addresses) are not considered to link to essential content and
should not be tested.

If this BP criterion is not met, the assessor might not be able to conveniently find the
relevant documents and read the submission as intended by the applicant.
Using 'inherit zoom' ensures that assessors do not need to spend time repeatedly
setting the view when using the links for navigation to new documents.

The use of 'Fast Web View' helps ensure optimum performance of the review
system. However, e.g. PAM form and eAF PDF files are exempt from this rule as
they cannot be provided as fast web view version.

Setting page layout and magnification to default allows the assessor to set his/her
own preferences to define how the PDF is displayed, rather than the settings being
taken from each individual PDF file.
Relative links and bookmarks will continue to work when the submission is copied
and loaded into new a environment at the agency side. Absolute (rooted) links and
bookmarks will not.

Fulfilling this BP criterion make it more convenient for the assessor in knowing there
are bookmarks without opening the pane.

Fulfilling this BP criterion makes it more convenient for the assessor in knowing there
are no bookmarks without opening the pane to check.

Consult the PDF specifications as in ISO 32000-1:2008 for section 7.11.2.3 on how
the paths need to be written in PDF. The paths cannot contain back slashes, only
forward slashes. See also 12.6.4.3 for the remote goto action. The link to another
PDF cannot be made with javascript code in the PDF.

Please note, not all PDF tools display the path for the link with forward slashes.
However, the presence of a backslash in a link as displayed in a PDF viewer or
editor does not necessarily mean that the link is NOT according to the ISO
specifications. Therefore, tests for backslashes must be performed in eCTD
validation software.

This BP criterion
Signature should is
beimportant
done withbecause
standartlinks who are not according to section
PAdES.
7.11.2.3 may not work on certain devices, such as non-Windows operating systems
or tablets.

Cover letter should be present with operation = new, in every sequence.

Sequence number should always be increased from previous submission.

During submission of first baseline, all xml nodes should be filled with correct eCTD
structure
LEGEND
Black These entries are fixed text for folder and file names according to the UA and ICH spe
Red These entries are variable text for folder and file names according to the UA and ICH s
Green These entries are picklist values according to the UA specification, refer to separate w
Pink (eCTD) These entries for folders and filenames are only applicable for an eCTD format submis
Brown (compendial) If the folder name starts with this text, then component filenames below are entirely va

Bold, no file extension These entries indicate folder names, and are coloured in accordance with the legend a
Regular, with file extension (.pdf) These entries indicate file names, and are coloured in accordance with the legend abo

Use of Additional Folders

multiple branches possible At these locations, a complete branch of the table of contents can be added
optional folder At these locations, one or more optional subfolders may be used, (also as nested folde
folder required and At these locations, there must be a subfolder if content is provided. Optional additiona
additional folders optional
In all other locations, additional folders are not allowed.

product-name
0000
index.xml
index-md5.txt
m1
ua
ua-regional.xml
10-cover
ua
ua-cover-var.pdf
ua-tracking-var.pdf
ua-letter-var.pdf
12-form
ua
ua-form-var.pdf
ua-form-annex-var.pdf
ua-letter-var.pdf
13-pi
131-approved
ua
ua-approved-var.pdf
132-labeling
ua
ua-label-var.pdf
133-instructions
ua
ua-instructions-var.pdf
134-spc
ua
ua-spc-var.pdf
14-expert
141-quality
quality-var.pdf
142-nonclinical
 nonclinical-var.pdf
143-clinical
clinical-var.pdf
15-specific
151-well-established
well-established-var.pdf
152-generic-hybrid-bio-similar
biosimilar-var.pdf
generic-var.pdf
hybrid-var.pdf
16-environrisk
environment-var.pdf
17-orphan
orphan-var.pdf
18-pharmacovigilance
181-phvig-system
phvigsystem-var.pdf
182-riskmgt-system
riskmgtsystem-var.pdf
additional-data
ua
ua-additionaldata-var.pdf
responses
ua
ua-responses-var.pdf
m2
22-intro
introduction-var.pdf
23-qos
qos-var.pdf
OR
introduction-var.pdf
drug-substance-var.pdf
drug-product-var.pdf
appendices-var.pdf
regional-information-var.pdf
24-nonclin-over
nonclinical-overview-var.pdf
25-clin-over
clinical-overview-var.pdf
26-nonclin-sum
introduction-var.pdf
pharmacol-written-summary-var.pdf
pharmacol-tabulated-summary-var.pdf
pharmkin-written-summary-var.pdf
pharmkin-tabulated-summary-var.pdf
toxicology-written-summary-var.pdf
toxicology-tabulated-summary-var.pdf
27-clin-sum
summary-biopharm-var.pdf
summary-clin-pharm-var.pdf
 summary-clin-efficacy-var.pdf
summary-clin-safety-var.pdf
literature-references-var.pdf
synopses-indiv-studies-var.pdf
m3
32-body-data
32s-drug-sub
drug-substance multiple branches possible
32s1-gen-info
nomenclature-var.pdf
structure-var.pdf
general-properties-var.pdf
32s2-manuf
manufacturer-var.pdf
manuf-process-and-controls-var.pdf
control-of-materials-var.pdf
control-critical-steps-var.pdf
process-validation-var.pdf
manuf-process-development-var.pdf
32s3-charac
elucidation-of-structure-var.pdf
impurities-var.pdf
32s4-contr-drug-sub
ctrlstrat-var.pdf
32s41-spec
specification-var.pdf
32s42-analyt-proc
analytical-procedure.pdf
32s43-val-analyt-proc
validation-analyt-procedure.pdf
32s44-batch-analys
batch-analyses-var.pdf
32s45-justif-spec
justification-of-specification-var.pdf
32s5-ref-stand
reference-standards-var.pdf
32s6-cont-closure-sys
container-closure-system-var.pdf
32s7-stab
stability-summary-var.pdf
postapproval-stability-var.pdf
stability-data-var.pdf
32p-drug-prod
drug-product multiple branches possible
32p1-desc-comp
description-and-composition-var.pdf
32p2-pharm-dev
pharmaceutical-development-var.pdf
32p3-manuf
manufacturers-var.pdf
batch-formula-var.pdf
 manuf-process-and-controls-var.pdf
control-critical-steps-var.pdf
process-validation-var.pdf
32p4-contr-excip
excipients.pdf
excipient multiple branches possible
specifications-var.pdf
analytical-procedures-var.pdf
validation-analyt-procedures-var.pdf
justification-of-specifications-var.pdf
compendial-excipients
multiple branches possible
specifications.pdf
analytical-procedures.pdf
validation-analyt-procedures.pdf
justification-of-specifications.pdf
excipients-human-animal-var.pdf
novel-excipients-var.pdf
32p5-contr-drug-prod
ctrlstrat-var.pdf
32p51-spec
specifications-var.pdf
32p52-analyt-proc
analytical-procedure.pdf
32p53-val-analyt-proc
validation-analytical-procedures.pdf
32p54-batch-analys
batch-analyses-var.pdf
32p55-charac-imp
characterisation-impurities-var.pdf
32p56-justif-spec
justification-of-specifications-var.pdf
32p6-ref-stand
reference-standards-var.pdf
32p7-cont-closure-sys
container-closure-system-var.pdf
32p8-stab
stability-summary-var.pdf
postapproval-stability-var.pdf
stability-data-var.pdf
32a-app
32a1-fac-equip
manufacturer optional folder
facilities-and-equipment-report.pdf
32a2-advent-agent
substance optional folder
adventitious-agents-report.pdf
32a3-excip-substance multiple branches possible
folder optional folder
substance.pdf
32r-reg-info
folder optional folder
 process-val-scheme.pdf
medical-device.pdf
certificate-suitability.pdf
materials-animal-human-origin.pdf
33-lit-ref
folder optional folder
reference.pdf
m4
42-stud-rep
421-pharmacol
4211-prim-pd
study-report optional folder
study-report.pdf
4212-sec-pd
study-report optional folder
study-report.pdf
4213-safety-pharmacol
study-report optional folder
study-report.pdf
4214-pd-drug-interact
study-report optional folder
study-report.pdf
422-pk
4221-analyt-met-val
study-report optional folder
study-report.pdf
4222-absorp
study-report optional folder
study-report.pdf
4223-distrib
study-report optional folder
study-report.pdf
4224-metab
study-report optional folder
study-report.pdf
4225-excr
study-report optional folder
study-report.pdf
4226-pk-drug-interact
study-report optional folder
study-report.pdf
4227-other-pk-stud
study-report optional folder
study-report.pdf
423-tox
4231-single-dose-tox
study-report optional folder
study-report.pdf
4232-repeat-dose-tox
study-report optional folder
study-report.pdf
4233-genotox
42331-in-vitro
study-reportoptional folder
study-report.pdf
42332-in-vivo
study-reportoptional folder
study-report.pdf
4234-carcigen
42341-lt-stud
study-reportoptional folder
study-report.pdf
42342-smt-stud
study-reportoptional folder
study-report.pdf
42343-other-stud
study-reportoptional folder
study-report.pdf
4235-repro-dev-tox
42351-fert-embryo-dev
study-reportoptional folder
study-report.pdf
42352-embryo-fetal-dev
study-reportoptional folder
study-report.pdf
42353-pre-postnatal-dev
study-reportoptional folder
study-report.pdf
42354-juv
study-reportoptional folder
study-report.pdf
4236-loc-tol
study-report optional folder
study-report.pdf
4237-other-tox-stud
42371-antigen
study-reportoptional folder
study-report.pdf
42372-immunotox
study-reportoptional folder
study-report.pdf
42373-mechan-stud
study-reportoptional folder
study-report.pdf
42374-dep
study-reportoptional folder
study-report.pdf
42375-metab
study-reportoptional folder
study-report.pdf
42376-imp
study-reportoptional folder
 study-report.pdf
42377-other
study-reportoptional folder
study-report.pdf
43-lit-ref
folder optional folder
reference.pdf
m5
52-tab-list
tabular-listing-var.pdf
53-clin-stud-rep
531-rep-biopharm-stud
5311-ba-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5312-compar-ba-be-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5313-in-vitro-in-vivo-corr-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5314-bioanalyt-analyt-met
study-report folder required and additional folders optional
study-report.pdf
532-rep-stud-pk-human-biomat
5321-plasma-prot-bind-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5322-rep-hep-metab-interact-stud
study-report folder required and additional folders optional
study-report.pdf
5323-stud-other-human-biomat
study-report folder required and additional folders optional
study-report.pdf
533-rep-human-pk-stud
5331-healthy-subj-pk-init-tol-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5332-patient-pk-init-tol-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5333-intrin-factor-pk-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5334-extrin-factor-pk-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5335-popul-pk-stud-rep
study-report folder required and additional folders optional
study-report.pdf
534-rep-human-pd-stud
 5341-healthy-subj-pd-stud-rep
study-report folder required and additional folders optional
study-report.pdf
5342-patient-pd-stud-rep
study-report folder required and additional folders optional
study-report.pdf
535-rep-effic-safety-stud
indication multiple branches possible
5351-stud-rep-contr
study-reportfolder required and additional folders optional
study-report.pdf
5352-stud-rep-uncontr
study-reportfolder required and additional folders optional
study-report.pdf
5353-rep-analys-data-more-one-stud
study-reportfolder required and additional folders optional
study-report.pdf
5354-other-stud-rep
study-reportfolder required and additional folders optional
study-report.pdf
536-postmark-exp
folder optional folder
study-report.pdf
537-crf-ipl
study optional folder
filename.pdf
54-lit-ref
folder optional folder
reference.pdf
util
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ua-regional.dtd
ua-envelope.mod
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ua-regional.xsl
entries are fixed text for folder and file names according to the UA and ICH specifications. The level of adherance to these names is sp
entries are variable text for folder and file names according to the UA and ICH specifications. In all folder locations containing file name
entries are picklist values according to the UA specification, refer to separate worksheet of UA M1 specification.
entries for folders and filenames are only applicable for an eCTD format submission.
older name starts with this text, then component filenames below are entirely variable. If the foldername does not start with this word, th

entries indicate folder names, and are coloured in accordance with the legend above
entries indicate file names, and are coloured in accordance with the legend above

e locations, a complete branch of the table of contents can be added

e locations, one or more optional subfolders may be used, (also as nested folders, i.e. folders within folders) but files can also be placed
e locations, there must be a subfolder if content is provided. Optional additional subfolders are also allowed.

ther locations, additional folders are not allowed.

e branches possible

controls-var.pdf

lopment-var.pdf

procedure.pdf

ecification-var.pdf

stem-var.pdf

e branches possible

position-var.pdf

elopment-var.pdf
 controls-var.pdf

e branches possible

ures-var.pdf
procedures-var.pdf
ecifications-var.pdf
e branches possible

procedures.pdf
ecifications.pdf
nimal-var.pdf

cal-procedures.pdf

mpurities-var.pdf

ecifications-var.pdf

stem-var.pdf

ment-report.pdf

e branches possible
man-origin.pdf
equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

-tol-stud-rep
equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

equired and additional folders optional

e branches possible

equired and additional folders optional

equired and additional folders optional

more-one-stud
equired and additional folders optional

equired and additional folders optional

 of adherance to these names is specified in the eCTD validation criteria.
older locations containing file names entirely in red text or files with -var components, multiple files are accepted.
pecification.

ame does not start with this word, then the fixed filenames should be followed.

folders) but files can also be placed directly at this location. The subfolders and single files can also be used beside each other at the
are accepted.

o be used beside each other at the same level.