Health Canada's Transition to XML: What Regulatory Teams Need to Know

In a continued push toward modernization and transparency, Health Canada has entered the next phase of its digital transformation with a mandate requiring the use of advanced extensible markup language product monograph (XML PM) files. This change builds on earlier initiatives and introduces new filing requirements that will impact how regulatory, compliance, and medical writing professionals prepare, submit, and manage product monograph (PM) content.

If your team is responsible for authoring, updating, or submitting regulatory documents in Canada, here’s what you need to know about this major change:

The Transition from Word Docs to XML: What’s Changing and Why?

Health Canada has historically accepted product monographs in Word or PDF format, based on its structured Master Template. While this approach made regulatory content easier to manage and ensured consistency across operating systems, it lacked the machine readability and searchability needed in today’s data-driven regulatory environment. 

XML files, however, enable greater interoperability with powerful data processing and AI-based tools. As these technologies are increasingly changing the life sciences space, the move from Word and PDF to XML-only submissions is meant to streamline Health Canada’s review processes, reduce errors, and ultimately make drug information more accessible to Canadian healthcare professionals and patients.

So, what exactly does this mean for life sciences companies? Well, for starters, Health Canada’s updated guidance mandates that organizations prepare and submit PMs using XML, a format that enables faster content validation, easier reuse, and greater public accessibility. As of the most recent policy update:

• Filing product monographs in XML format is now required for a specific list of submission types.
• The XML PM must follow Health Canada’s controlled vocabulary, validation rules, and use the structured Master Template available in Word or PDF format as a reference.
• Organizations must strip out instructional square brackets and replace them with submission-specific data before converting to XML.

When Do These Changes Happen?

The first phase of major changes will take effect on July 18, 2025. 

Additional requirements will be implemented in later phases that have yet to be scheduled by Health Canada at this time. 

Which Types of Submissions are Affected in Phase One?

Beginning on July 18, 2025, the XML PM will be a mandatory filing requirement for:

• New drug submissions (NDS)
• Extraordinary use new drug submissions (EUNDS)
• Pharmaceutical drugs
  • Prescription drugs and drugs administered by or obtained from a healthcare provider
  • Non-prescription drugs regulated under Division 8 of the Food and Drug Regulations
• Biologic drugs (Schedule D)
• Radiopharmaceutical drugs (Schedule C)

To help ease the transition to this new file standard across the industry, Health Canada is encouraging the use of the XML PM file format for the majority of submissions. Unless specified in the list above, other file types are still permitted for submission for the time being.

Please be aware that the mandatory XML PM file requirement will not apply to:

• Administrative new drug submissions (Admin NDS)
• New drug submissions for priority review
• New drug submissions–COVID (NDS-CV)
• New drug submissions where advanced consideration notice of compliance with conditions (NOC/c) was granted
• Abbreviated new drug submissions (ANDS)

Challenges in the Transition to XML:

While XML product monographs promise greater efficiency and accessibility, the transition comes with its share of hurdles. Regulatory and compliance teams should be aware of several potential complications that can disrupt workflows and impact compliance if not proactively addressed:

Disruption to Content Flow and Document Conversion

Shifting from Word-based files to XML introduces structural changes that can displace content or break formatting during file conversion when using standard file conversion methods. This is especially true when legacy documents don’t align perfectly with Health Canada’s Master Template. To mitigate issues, organizations should perform a thorough content audit and use automated tools to map existing content into the XML framework, preserving intent and structural hierarchy.

Risk of Regulatory Misalignment

While the Health Canada XML PM update is new, existing regulatory expectations still apply. All updates made to your product monographs—XML or another format—must continue to comply with broader Health Canada regulations. That means your teams need to maintain alignment with labeling, safety, and efficacy requirements, even as they shift to a new format. It’s critical to ensure that converting existing files to the XML doesn’t inadvertently render your files noncompliant with existing Health Canada regulations.

Version Control Challenges

As teams update and reformat PMs, version tracking becomes more complex. A single XML update can trigger repetitive downstream edits that are difficult to trace or verify. Without a strong version control system in place, teams risk duplicating efforts—or worse, submitting outdated or conflicting content.

Access Control vs. Efficiency

To protect data integrity, not just anyone should be able to edit or publish XML PMs. However, overly restrictive access controls can create major bottlenecks in your process. The key is to implement role-based permissions that secure sensitive content while enabling the right contributors—like regulatory leads or medical writers—to make updates without delay.

Future-Proof Your Regulatory Content with CCMS + Veeva RIM Integration

To manage increasing content complexity, version control, and compliance demands, life sciences organizations are turning to component content management systems (CCMS), also known as structured content management systems (SCMS).

Unlike traditional document-based systems, an SCMS manages content at the component level—think sections, paragraphs, tables, or data points—allowing teams to reuse, update, and track content across multiple documents and markets. This granular approach not only accelerates updates but also ensures consistency and reduces the risk of manual errors.

When integrated with regulatory platforms such as Veeva RIM, the benefits of an SCMS multiply. Keeping translation and multilingual content activities inside the regulatory platform enables life sciences companies to:

• Automatically generate compliant XML files
• Align with Health Canada’s structured templates and validation rules
• Collaborate efficiently across global teams
• Maintain secure, role-based access for content integrity and control

By integrating SCMS/CCMS capabilities with your existing regulatory infrastructure, your organization can improve operational efficiency, reduce risk, and ensure long-term compliance in an increasingly structured regulatory landscape.

Ready to see how it works? Learn more about TransPerfect’s GlobalLink CCMS and Veeva RIM’s integration here, or connect with our team to schedule a walkthrough tailored to your specific needs.