What it checks. File is named whopqt-regional.dtd

What it checks. In the folder /XXXX/util/dtd

What it checks. A currently acceptable version of the DTD is used, with reference to any transition guidance. The checksum for the DTD for WHO-PQT M1 v1.0 is correct.

What it checks. With reference to any transition guidance, going back to an earlier version WHO-PQT M1 DTD 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 0086 used DTD 1.0, 0087 was DTD 1.1, then 0088 must be built in either DTD 1.1 or higher. The criterion should only be tested if there are sequences with lower sequence numbers present.

What it checks. 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 1.0, and 0012 was DTD 1.1, then 0011 must be built in either DTD 1.0 or 1.1. The criterion should only be tested if there are sequences with higher sequence numbers present.

What it checks. File is named whopqt-leaf.mod

What it checks. In the folder /XXXX/util/dtd

What it checks. The checksum for whopqt-leaf.mod must match the current version from WHO-PQT eCTD Module 1 v1.0.

What it checks. File is named whopqt-envelope.mod

What it checks. In the folder /XXXX/util/dtd

What it checks. The checksum for whopqt-envelope.mod must match the current version from WHO-PQT eCTD Module 1 v1.0

What it checks. File is named ich-ectd-3-2.dtd

What it checks. In the folder /XXXX/util/dtd

What it checks. 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)

What it checks. 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.

What it checks. 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. The criterion should only be tested if there are sequences with higher sequence numbers present.

What it checks. The root folder /XXXX

What it checks. The file is named index-md5.txt

What it checks. The root folder /XXXX

What it checks. File is named index.xml

What it checks. Well formed with respect to the rules of the XML specification

What it checks. Valid with respect to the ICH eCTD DTD file included in the util/dtd folder

What it checks. This is the ICH DTD in /XXXX/util/dtd, and tested for validity by rules A.12 - A.16. 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).

What it checks. The folder /XXXX/m1/whopqt

What it checks. File is named whopqt-regional.xml

What it checks. Well formed with respect to the rules of the XML specification

What it checks. Valid with respect to the WHO-PQT Module 1 DTD file included in the util/dtd folder.

What it checks. This is the WHO-PQT Regional DTD and tested for validity by rules A.01 - A.05 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)

What it checks. 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.

What it checks. 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).

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

What it checks. The link within the XML leaf element is valid, i.e. the target exists.

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

What it checks. 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.

What it checks. ID must be unique within each sequence.

What it checks. 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.

What it checks. The definition of 'same CTD section' is as in criterion C.10. If the node extension is not in the same section the criterion C.10 still applies.

What it checks. 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.

What it checks. 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 D.06

What it checks. This includes passwords, certificate security, or adobe policy server settings. This test should not be used to test for corrupted files, instead see D.05 corrupted files.

What it checks. 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 m1.2.1 are tested in criterion (D.04. security setting)

What it checks. These limited security settings are allowable for the application form, because they are necessary for the functioning of the application form and similar forms.

What it checks. 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.

What it checks. 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 and read by assessors.

What it checks. 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.

What it checks. 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.

What it checks. 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.

What it checks. The use of 'Fast Web View' helps ensure optimum performance of the review system. However, application form files are exempt from this rule as they cannot be provided as fast web view version.

What it checks. 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.

What it checks. 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.

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

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

What it checks. 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 is important because links who are not according to section 7.11.2.3 may not work on certain devices, such as non-Windows operating systems or tablets.

What it checks. This criterion will test whether the UUID is well formed.

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

What it checks. Refer to WHOPQT Module 1 eCTD 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.

What it checks. Refer to WHOPQT Module 1 eCTD 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.

What it checks. i.e. numbers between 0000 and 9999

What it checks. Refer to table in WHOPQT Module 1 eCTD Specification: this is XML (where a specification exists), PDF, JPEG/JPG, PNG, SVG and GIF.

What it checks. ICH eCTD Specification 3.2.2 (Appendix 7: Specification for Submission Format) lists the documents allowed in Module 2-5: PDF, SVG (for graphics) and XML for the backbone (index.xml and whopqt-regional.xml) used in eCTD

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

What it checks. 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 C.04.

What it checks. 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 C.04.

What it checks. Including all subfolders within the m1-m5 folders but excluding 'util' folder and subfolders

What it checks. Any deviation should always be reported by the validating tool. Files larger than 500 MB should be avoided due to potential archiving issues and to make the assessment easier.

What it checks. 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 WHOPQT naming guidance.

What it checks. 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 WHOPQT naming guidance.

What it checks. The Application Type attribute value must be a valid version according the Application-Type.xml code definition file

What it checks. The Application Type attribute value must be a valid version according the Application-Sub-Type.xml code definition file

What it checks. The Product Type attribute value must be a valid version according the Product-Type.xml code definition file

What it checks. The Product Sub Type attribute value must be a valid version according the Product-Sub-Type.xml code definition file.

What it checks. The Submission Unit Type attribute value must be a valid version according the Submission-Unit-Type.xml code definition file

What it checks. Allowed combinations from WHO's ePQS matrix of Product and Application types, 18 October 2024 (extranet.who.int/prequal/node/31509). SRA-IN is struck through in that matrix and is not allowed. '-' means no value is expected.

What it checks. All applications to re-format an existing product to the eCTD format must be submitted as application type "Post-PQ change", application subtype "eCTD baseline" and submission unit type "reformat".