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

1. Document is corrupt or unreadable
2. Document has password protection
3. Document references an attached template located via http or https
4. Document is empty

Note: This rule applies only to Word version 2007 or later (.docx).

1. The document cannot be opened because it is damaged.
2. The document appears to have 0 pages.
3. The document appears to be an application form, but the form content cannot be read.
4. The document contains additional data (more than 1024 characters) after the last %%EOF (End Of File).

Finds all documents with an owner password set, excluding Health Canada application forms regardless of their location in module 1 and literature references in subfolders: 33-lit-ref, 43-lit-ref, 54-lit-ref.

This rule checks for PDF files that contain, dynamic content (e.g., audio, video or special effects), or 3D content. Health Canada application forms are excluded from this check regardless of their location in module 1.

This rule checks for PDF files that contain JavaScript. Health Canada application forms are excluded from this check regardless of their location in module 1.

MD5 checksums for index files will be calculated and compared against the MD5 checksums provided in the MD5 text files (not case sensitive).

When replacing content, the new content should be different from the previous content. This check does not apply to image files provided in module 1.

Valid file extensions include:
Documents:.pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx
Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp
Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg

Coding Language:.xml

Data:.dat,.inf,.txt.

The operation attribute for this leaf element must be "new" when provided for the first time, and "replace"/ "delete" whenever referenced again as part of a subsequent transaction.

Node extensions in module 1 backbone (ca-regional.xml) are not allowed, except in 1.2.6 Authorization for Sharing Information heading, 1.2.7 International Information heading, and 1.6.1 Comparative bioavailability Information heading.

The validator checks all headings and subheadings in the Canadian regional backbone (ca-regional.xml). It generates an error when there is (are) node extension(s) found in any subheadings other than those mentioned above This rule does not apply to leaves with operation "delete".

Node extensions are expected in section 1.2.7 International Information heading.

Note: There is a mixture of node extensions and leaves allowed in the 1.2.7 International Information heading. A warning is generated when there is a (are) leaf (leaves) added under this heading. The warning serves the purpose to notify the user to manually verify the leaves added under this heading. Requirements are outlined below and will result in failure of the transaction if not followed:

When provided, the International Status document and the Foreign review attestation must be added as leaves directly under 1.2.7 subheading. Any other foreign agency (such as FDA,. EMA) related documents must be provided using node extensions This rule does not apply to leaves with operation "delete".

The use of operation "append" is not allowed in module 1.

Valid file extensions include: Documents:.pdf,.doc,.docx,.xls,.xlsx,.wpd,.ppt,.pptx

Images:.png,.gif,.svg,.jpg,.jpeg,.tif,.tiff,.bmp

Audio/Video:.wav,.mp3,.mp4,.wmv,.mov,.mpg,.mpeg

Coding Language:.xml,.xsl,.xsd,.dtd

Data, Modeling and Simulation:.dat,.inf,.txt,.sas,.xpt .wksz,.wksx,.wks (SimCyp workspace files, Pharmaceutical Drugs only) .sdax,.edpdp,.wsp,.epr,.pnf,.psf (Consistency Lot Release Testing Activities, Biologic Drugs only)

• 3.2.R.1 Production Documentation
• 3.2.R.2 Medical Devices
• 3.2.R.3 Lot Release Documentation
• 3.2.R.4 Yearly Biologic Product Report
• 3.2.R.5 Assessment of Similarity
• 3.2.R.6 On Site Evaluation
• 3.2.R.7 Other Regional Information
• 3.2.R.8 Product Lifecycle Management Information

Warning will be reported if the naming of the title is not followed.

Notes:
The requirements above apply only to leaves provided using operation attribute "New". They don't apply to leaves provided using operation attribute "Replace".

The exact naming convention of the titles of node extensions must be used when the node extension(s) is (are) created for the first time under this heading.

Checks the 1.2.1 Application Forms node. Generates error if the RT file is missing from the current eCTD sequence and was provided in the previous eCTD sequence.

Note: This rule is not based on the presence of the RT file in the current sequence. This rule is based on the existence of the RT XML file or MF XML in the previous eCTD sequence. Error must not be generated if there is no RT xml or MF XML file present in the previous eCTD sequence.

Checks the 1.2.1 Application Forms node. Generates error if, in addition to the RT xml file, there is a 3011 form named hc-sc-3011-en.pdf or hc-sc-3011-fr.pdf.

Checks the 1.2.1 Application Forms node. Generates error if in addition to the RT xml and/or PI xml file there are other xml files Error will also be reported if more than one RT XML file is found in this node.

Compares the value in the Dossier ID field in the RT or MF xml file with the top level folder.

The operation attribute value in the leaf element must be "new" when provided for the first time, and "replace" when provided in subsequent transaction.

Checks the Dossier ID field in the RT or MF XML file. It must be lower case letter "e" followed by 6 digits.

Checks the software_version element value of the Regulatory Transaction (RT) and Master File (MF) XML files.

For the latest versions of the RT and MF XML files accepted by Health Canada refer to:

REP Summary Table - for Human Use Drugs (pharmaceutical, biologic and radiopharmaceutical), disinfectants, veterinary drugs and medical devices

Filling submissions electronically - for master files