Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files. Along with the draft guidance, Health Canada has opened a comment period, scheduled to conclude on November 5, 2023. According to Health Canada, the purpose of this guidance is to assist sponsors in developing a product monograph in the Extensible Markup Language format (XML PM).

The latest round of revisions to the guidance are based on internal and working group feedback. To request a copy of the draft guidance and sample files, email: [email protected].

Health Canada XML PM Background

In the draft guidance, Health Canada states the following background:

The PM provides the necessary information for the safe and effective use of a drug product. It is comprised of three major sections, two of which target health care professionals. The third section targets the consumer. The PM is submitted by sponsors for review in a MSWord format. Once approved, the document is converted to PDF and published to the DPD Online and the Drug and Health Product Portal.

The XML PM represents a major step towards Health Canada’s goal of improving access to drug information for Canadians. The structure and controlled vocabulary will enable benefits not previously possible – consistency, searchability and innovation. Approved XML PMs will be stored in a fully searchable XML database. Stylesheets will enable transformation into a human readable format. This format will enable the appropriate data to be provided in ways that are most relevant to different user groups, including providing Canadian pharmacies reliable access to the Canadian approved Patient Medicinal Information. It will also facilitate further collaboration with our international partners related to drug clinical trials, risk assessments and potential shortages.

Health Canada Scope

The scope of this guidance and the use of the XML format for PMs is limited to the following product lines:

• Pharmaceutical drugs for Human Use
• Biologic drugs for Human Use
• Radiopharmaceuticals

The following product lines are out of scope:

• Pharmaceutical drugs for Human Use – Non-prescription
• Self-care products
• Natural health products
• Medical devices
• Veterinary

Reed Tech, an industry leader in pharmaceutical structured files, is offering a Health Canada solution that includes data validation, XML-PM build and check, version control, storage and reporting. To learn more about the Reed Tech Health Canada services, please contact us.