Notice - Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

April 18, 2013

Our file number: 13-106338-113

Health Canada is pleased to announce the revised validation rules for regulatory transactions in the electronic Common Technical Document (eCTD) format. These revised validation rules are being posted to provide further information to stakeholders to assist them in the preparation of regulatory transactions in eCTD format. The revised rules also build on the information provided in the Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format as well as specifications for the regional administrative module (Module1) of the eCTD standard defined in Guidance for Industry: Creation of the Canadian Module 1 Backbone (eCTD) and the International Conference on Harmonization (ICH) Electronic Common Technical Document Specification (Version 3.2.2).

Since October 1, 2011, Health Canada no longer provides the Validation Reports or email notifications for regulatory transactions that have passed validation. When a regulatory transaction fails validation or has warning(s), a validation report will be provided.

Please refer to the table below for Health Canada's revised validation rules.

Although the software and profile may be updated without further notice, as of August 1^st, 2013, Health Canada will be validating regulatory transactions in eCTD format using the following versions

• software: docuBridge^® eCTD Validator 5.1 HF1
• profile: eCTD Validator - Profile HC-SC-3.0

Should you have any questions regarding the content of the notice, please contact:

Office of Submissions and Intellectual Property (OSIP)
Therapeutic Products Directorate
Health Products and Food Branch
Finance Building 2,
Address Locator 0201A1
101 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9

Email: ereview@hc-sc.gc.ca

Health Canada eCTD Validation Rules

eCTD Validator - Profile HC-SC-3.0

ID #	Rule Name	Rule Description	Severity
A - General
A01	Empty Folders	Checks the sequence folder structure for any empty folders (folders without any files or subfolders).	Error
A02	File and Folder Security	Checks the sequence folder structure for any files or folders the user does not have access permission to.	Error
A03	File Size	This rule’s implementation checks for files that exceed the configured maximum size. (Max.size 100MB, xpt files up to 1GB)	Error
A05a	Sequence Folder  Requirements	Checks the sequence folder name. Furthermore the rule will report a finding if the sequence seems to be the initial sequence for the application but its name is not 0000.	Error
A05b	Higher sequences found	Reports error if the validated sequence is not the highest in the application folder.	Error
A06a	XML Backbones Identification	Identifies all ICH and regional index files found in the sequence folder. Previous sequences found in the application folder structure will also be listed.	Error
A06b	STF Identification	Identifies all STF files found in the sequence folder. Previous sequences found in the application folder structure will also be listed.	Error
B - PDF Analysis
B01	Corrupt or unreadable PDF documents	Checks for any corrupt/unreadable PDF documents (documents, which cannot be opened because the content is invalid or the page count is 0 or the encryption is too strong).	Error
B02	Bookmarks - Absolute (Rooted)	Retrieves all non-relative bookmarks in PDF documents and prints the total count, including the broken ones.	Error
B03a	Bookmarks – External (www, e-mail)	Retrieves all web link bookmarks and e-mail bookmarks in PDF documents and prints the total count.	Error
B03b	Bookmarks – External (other)	Retrieves all external bookmarks other than web links and e-mail links from PDF documents and prints the total count	Error
B04	Bookmarks - Inactive	Retrieves all inactive bookmarks in PDF documents and prints the total count.	Error
B06	Bookmarks - Inter Application, broken	Retrieves all broken inter-application bookmarks in PDF documents and prints the total count.	Error
B08	Bookmarks - Intra Application, broken	Retrieves all broken intra-application bookmarks in PDF documents and prints the total count.	Error
B10	Bookmarks - Intra Sequence, broken	Retrieves all broken intra-sequence bookmarks from PDF documents and prints the total count.	Error
B11	Bookmarks - Other	Retrieves all unknown bookmarks (links that could not be identified) from PDF documents and prints the total count.	Warning
B12	Bookmarks - Count	Reports the number of bookmarks per document and the total number of bookmarks in the sequence	Information
B13	Hyperlinks - Absolute (Rooted)	Retrieves all non-relative hyperlinks from PDF documents and prints the total count, including the broken ones.	Error
B14a	Hyperlinks – External (www, e-mail)	Retrieves all web links and e-mail links from PDF documents and prints the total count.	Error
B14b	Hyperlinks – External (other)	Retrieves all external hyperlinks other than web links and e-mail links from PDF documents and prints the total count.	Error
B15	Hyperlinks - Inactive	Retrieves all inactive hyperlinks from PDF documents and prints the total count.	Error
B17	Hyperlinks - Inter Application, broken	Retrieves all broken inter-application hyperlinks from PDF documents and prints the total count.	Error
B19	Hyperlinks - Intra Application, broken	Retrieves all broken intra-application hyperlinks from PDF documents and prints the total count.	Error
B21	Hyperlinks - Intra Sequence, broken	Retrieves all broken intra-sequence hyperlinks from PDF documents and prints the total count.	Error
B22	Hyperlinks - Other	Retrieves all unknown hyperlinks (links that could not be identified) from PDF documents and prints the total count.	Warning
B23	Hyperlinks - Count	Reports the number of hyperlinks per document and the total number of hyperlinks in the sequence	Information
B24	PDF Protection	Finds PDF documents with password protection	Error
B25	PDF version checking	Checks all PDF document versions against the list of allowed versions.	Warning
B32	PDF Protection: Owner password	Finds all documents with an owner password set.	Error
B33	PDF Protection: Encrypted	Finds all encrypted documents.	Information
B35	Bookmarks - deep destination check	For all bookmarks, the named destination or destination page will be verified.	Error
		Non existing destinations will be reported (i.e. the destination file exists but the page does not).
B36	Bookmarks - multi action	Finds all bookmarks with multiple actions assigned	Error
B37	Hyperlinks - deep destination check	For all hyperlinks, the named destination or destination page will be verified.	Error
		Non existing destinations will be reported (i.e. the destination file exists but the page does not).
B38	Hyperlinks - multi action	Finds all hyperlinks with multiple actions assigned	Error
B40	PDF documents with attachments are not allowed	This check examines PDF documents and reports all documents having any attachments.	Error
B41	Bookmark does not 'Inherit Zoom''	All bookmarks and hyperlinks should have a magnification setting of “Inherit Zoom”. This rule performs the corresponding checks for bookmarks.	Warning
B42	Link does not 'Inherit Zoom'	All bookmarks and hyperlinks should have a magnification setting of “Inherit Zoom”. This rule performs the corresponding checks for hyperlinks.	Warning
B43	PDF Initial View	Checks for PDF documents with an incorrect initial view. ICH eCTD Specification: Documents with bookmarks must show the bookmarks pane in their initial view. The Magnification and Page Layout should be set as "default".	Warning
C - Referenced Files
C01	HREFs to targets outside application	Checks for broken links in submission files.	Error
		Hyperlinks targeting files outside the application will be identified.
C02	HREFs to targets outside sequence	Checks for broken links in submission files.	Error
		Hyperlinks targeting files outside sequence will be identified.
C03	Life Cycle Management Semantics	This check option refers to the current sequence. It will perform a general verification of the leaf life cycle properties in this sequence only (no deep history scanning).	Error
		For leaf elements with operation “new”, the eValidator verifies that: modified file must not exist / title is given / href must exist.
		For leaf elements with operation “replace”, the eValidator verifies that: modified file must exist / title is given / href must exist.
		For leaf elements with operation “append”, the eValidator verifies that: modified file must exist / title is given / href must exist.
		For leaf elements with operation “delete”, the eValidator verifies that: modified file must exist / title is not required / href must not exist.
		The eValidator verifies that for initial submissions all leaf elements have the operation “new”.
		The eValidator checks modified files in LCM: leaf in previous sequence must exist. It also verifies that when the attribute “modified-file” has been used for a leaf document then the referenced document exists in the previous submission. It is recognized that this attribute is invalid when used for submission sequence number 0000.
		The eValidator checks that all files referenced in the backbone exist.
C04	MD5 Checksum	The eValidator regenerates the MD5 checksums for all referenced files and compares the checksums to the values provided in the backbone file.	Error
C05	Naming Syntax	Checks the syntax all referenced file names (path length, illegal characters, etc.).	Error
C06	Relative References	The eValidator checks that only relative references (href and modified file) are used. Also, only forward slashes "/" are allowed (no backslashes).	Error
		Do the file references in the index files (ICH, Regional, STF) use relative paths? Absolute (i.e. rooted) paths are not allowed.
C07	Unreferenced Files	Searches for files not referenced in an index file (ICH, Regional or STF).	Error
D - XML Analysis
D01	DTD/Schema Checksums	Rule compares the checksums of the DTD and schema against the following checksums:	Error
		ca-regional-1-0.dtd: 3d2ce6692d8727aa4cc9463b4ca18f00	Error
		ich-ectd-3-2.dtd: 1d6f631cc6b6357f0f4fe378e5f79a27	Error
		ca-regional-2-2-.xsd: ff564d6e69adebd9a9b4f274e65cf5f1	Error
		xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5	Error
		xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a	Error
		ich-stf-v2-2.dtd: 0972c10a4dadf3df5d2f41b2026a4a5c	Error
D02	Existence of Node extensions	The eValidator checks for "node-extension" elements being used and reports them for informational purposes.	Information
D03	MD5 for Index files	MD5 checksums for index files will be calculated and compared against the MD5 checksums provided in the MD5 text files.	Error
D04	Validate against delivered DTD	Performs XML validation for ICH Backbone and Regional backbones.	Error
		Uses the DTD or Schema given in the application folder (util/dtd).
E - CA Regional 1.0
E01	All files should have one and only one file extension	Checks if referenced files have exactly one file extension.	Error
E02	Attribute checksum-type	The checksum-type attribute must have the value md5 or MD5.	Error
E03	Attribute submission-type	Checks if the submission-type attribute is present.	Error
E04	Cover letter operation attribute	Cover letter should have 'new' operation attribute	Warning
E05	Element 3011 form = {en/fr}	Check that the 3011 form is named hc-sc-3011-en.pdf in the English version, or hc-sc-3011-fr.pdf in the French version.	Warning
E06	Element applicant	Checks if the applicant value is present.	Warning
E07	Element must have leaf	Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'.	Error
E08	Element product-name	Checks if the attribute value is present.	Warning
E11	Element sequence-number	The value of the sequence-number element must match the sequence folder name.	Error
E12	Element sequence-number format	The value of the sequence-number element must consist of 4 digits.	Error
E13	Element submission-date	The value of the submission-date element must be given in format YYYY-MM-DD	Error
E14	Element submission-identifier format	The value of the application-identifier element must start with an e, followed by 6 digits.	Error
E15	Element submission-identifier value	The value of the application-identifier element must match the application folder name.	Error
E16	Folder m1\ca exists	The m1\ca folder must exist	Error
E17	No subfolders in ca-subfolder	The folder m1\ca must not have any subfolders.	Warning
E18	Leaf title must not be empty	For operations other than 'delete', all leafs must have a 'title' child. The title must be present.	Error
E19	Module 1 (regional xml file) exists	The regional backbone ca-regional.xml file must exist in folder m1\ca.	Error
E20	Multiple operations on same document in same sequence	Checks for documents in the regional backbone, which are used as modified-file more than once.	Error
E21	File reuse	Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence)	Information
E22	Replace or append should not provide identical content	When replacing or appending content, the new content should be different from the previous content.	Error
E23	Invalid file extension	Valid file extensions include: pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .xml, .dat, .inf, .txt, .jpg, .png, .gif, .svg	Warning
E24	Detect invalid life cycle:  Append	Detect invalid life cycle pattern: Append operations causing branches	Error
E25	Detect invalid life cycle: Delete	Detect invalid life cycle pattern: Delete operations causing branches	Error
E26	Detect invalid life cycle: Replace	Detect invalid life cycle pattern: Replace operations causing branches	Error
E27	Detect invalid life cycle: Delete	Detect invalid life cycle pattern: Operation on deleted leaf content	Error
E28	Detect invalid life cycle: Append	Detect invalid life cycle pattern: Append on Append	Warning
F - CA Regional 2.2
F01	All files should have one and only one file extension	Checks if referenced files have exactly one file extension.	Error
F02	Element 3011 form = {en/fr}	Check that the 3011 form is named hc-sc-3011-en.pdf in the English version, or hc-sc-3011-fr.pdf in the French version.	Warning
F03	Element must have leaf	Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'.	Error
F04	The folder m1\ca must exist.	The sequence folder must have a subfolder m1 with a subfolder ca.	Error
F05	No subfolders in ca-subfolder	The folder m1\ca must not have any subfolders.	Warning
F06	Leaf title must not be empty	For operations other than 'delete', all leafs must have a 'title' child. The title must be present.	Error
F07	Module 1 (regional xml file) exists	The regional backbone ca-regional.xml file must exist in folder m1\ca.	Error
F08	Application folder name must match dossier-identifier	The element value for the dossier-identifier must match the name of the parent folder of the sequence folder.	Error
F09	Element sequence-description	Please refer to the CA M1 guidance document for the list of valid values for the sequence-description element.	Error
F10	Cover letter operation attribute	Cover letter should have 'new' operation attribute	Warning
F11	Multiple operations on same document in same sequence	Checks for documents in the regional backbone, which are used as modified-file more than once.	Error
F12	File reuse	Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence)	Information
F14	Replace or append should not provide identical content	When replacing or appending content, the new content should be different from the previous content.	Error
F15	Invalid file extension	Valid file extensions include: pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .xml, .dat, .inf, .txt, .jpg, .png, .gif, .svg	Warning
F16	Detect invalid life cycle:  Append	Detect invalid life cycle pattern: Append operations causing branches	Error
F17	Detect invalid life cycle: Delete	Detect invalid life cycle pattern: Delete operations causing branches	Error
F18	Detect invalid life cycle: Replace	Detect invalid life cycle pattern: Replace operations causing branches	Error
F19	Detect invalid life cycle: Delete	Detect invalid life cycle pattern: Operation on deleted leaf content	Error
F20	Detect invalid life cycle: Append	Detect invalid life cycle pattern: Append on Append	Warning
G - ICH Backbone 3.2
G01	All files should have one and only one file extension	Checks if referenced files have exactly one file extension.	Error
G02	Attribute checksum-type	The checksum-type attribute must have the value md5 or MD5.	Error
G03	Attribute dosage form	Checks if the attribute value is present.	Error
G04	Attribute excipient	Checks if the attribute value is present.	Error
G05	Attribute Indication	Checks if the attribute value is present.	Error
G06	Attribute Manufacturer	Checks if the attribute value is present.	Error
G07	Attribute Product-Name	Checks if the attribute value is present.	Error
G08	Attribute Substance	Checks if the attribute value is present.	Error
G09	Element must have leaf	Checks for elements not having any leaf child nodes. This only affects elements with a name that starts with 'm'.	Error
G10	File index.xml exists	The index.xml file must be present	Error
G11	File index-md5.txt exists	The MD5 checksum file index-md5.txt must be present.	Error
G12	Folder m1 exists	The m1 folder must be present.	Error
G13	Folder util exists	The util folder must be present	Error
G14	Leaf title must not be empty	For operations other than 'delete', all leafs must have a 'title' child. The title must be present.	Error
G15	m1-administrative element must exist	The element m1-administrative-information-and-prescribing information must be present.	Error
G16	No other files in m1	The m1 folder must not have any other files in addition to the files explicitly allowed.	Error
G17	No other files in root	The root folder (the application root) must not have any other files in addition to the files explicitly allowed.	Error
G18	Node Extension title must not be empty	For node extensions, the title child must be present (value must be present).	Error
G19	Regional backbone(s) referenced operations	Regional backone(s) referenced (ca-regional.xml) should have 'new' operation attribute.	Warning
G20	Multiple operations on same document in same sequence	Checks for documents in the ICH backbone, which are used as modified-file more than once.	Error
G21	File reuse	Checks for file reuse scenarios (Same values for xlink:href used multiple times in the regional backbone for this sequence)	Information
G22	Invalid file extension	Valid file extensions include: .pdf, .doc, .docx, .xls, .xlsx, .wpd, .ppt, .pptx, .xml, dat .inf, .txt, .jpg, .png, .gif, .svg, .sas, .xpt, .xsl, .dtd, .xsd	Warning
G23	Replace or append should not provide identical content	When replacing or appending content, the new content should be different from the previous content.	Error
G25	Detect invalid life cycle: Append	Detect invalid life cycle pattern: Append operations causing branches	Error
G26	Detect invalid life cycle: Append	Detect invalid life cycle pattern: Append operations not appending to most recent STF leaf	Error
G27	Detect invalid life cycle: Delete	Detect invalid life cycle pattern: Delete operations causing branches	Error
G28	Detect invalid life cycle: Replace	Detect invalid life cycle pattern: Replace operations causing branches	Error
G29	Detect invalid life cycle: Delete	Detect invalid life cycle pattern: Operation on deleted leaf content	Error
G30	Detect invalid life cycle: Append	Detect invalid life cycle pattern: Append on Append	Warning
H - STF 2.2
H01	Check Index Reference	Verifies that the href target exists and has the correct value.	Error
H02	Check Index Reference (title - match)	Verifies that the href target exists and matches the title value.	Warning
H03	Content Block are not accepted	Reports any used content-block element.	Warning
H04	No backslash in HREF	Verifies that href values do not contain backslashes.	Error
H05	Study Identifier category must not be empty	The value of the study-identifier/category element must not be empty.	Warning
H06	Study Identifier study-ID must not be empty	The value of the study-identifier/study-id element must not be empty.	Warning
H07	Study Identifier title must not be empty	The value of the study-identifier/title element must not be empty.	Warning
H08	Categories and file tags	Checks file tag values and category values against definitions in valid-values.xml file	Warning
H09	STF leaf element must reference other STF leaf upon append	STF leaf element must reference other STF leaf upon append.	Error
		Such leaf elements must not reference PDF files as modified files.
H10	Category information must be provided for certain STFs	Category information must be provided for certain STFs	Warning
H12	STF cannot reference another STF	Leaf references in STFs must always target content files, not STFs.	Warning
H13	STF does not relate to any leaf elements	STF files must reference at least one leaf.	Warning
H14	Study ID for STF must remain constant	The STF study IDs must not change in the application life cycle.	Warning
H15	Invalid STF TOC location	STFs should only be associated with certain headings under Modules 4 or 5.	Warning
H16	STF doc-content file tag count	There should be one and only one file tag for each doc-content.	Warning
H17	STF XML title and leaf element title do not match	For all leaf elements in the STF, the leaf title must be identical to the title of the corresponding leaf in the ICH backbone.	Warning