April 25, 2025
The compliance environment for pharmaceutical and biotech companies operating in Canada is shifting in meaningful ways. Health Canada has announced a critical change in submission requirements that will significantly impact how pharmaceutical, biologic, and radiopharmaceutical products are submitted and maintained. Effective July 18, 2025, certain submission types must include product monographs in the new Structured Product Labeling format known as XML Product Monograph (XML PM).
For regulatory professionals, staying ahead of this mandate is essential for compliance and efficiency. In this blog, we break down these updates and highlight how Freyr's SPL-SPM solution can support your transition.
Understanding the XML PM Mandate
Health Canada's move towards structured, electronic labeling aligns with global regulatory trends that prioritize data standardization, accessibility, and automation. The XML PM format enables machine-readable product monographs, which can improve data interoperability across regulatory and healthcare systems.
Who Is Affected?
From July 18, 2025, the XML PM format will be mandatory for:
- New Drug Submissions (NDS)
- Extraordinary Use New Drug Submissions (EUNDS)
This requirement applies across a range of products, including:
- Prescription and non-prescription pharmaceutical drugs
- Biologic drugs
- Radiopharmaceuticals
While Abbreviated New Drug Submissions (ANDS) and other submission types are not yet required to include XML PMs, Health Canada has encouraged voluntary adoption to prepare for future expansion.
Why XML PM?
The shift to XML PM offers several key benefits:
- Improved Regulatory Review: Structured data allows Health Canada to automate parts of the review process, leading to faster approvals.
- Enhanced Patient Safety: Structured monographs facilitate integration with electronic health records and digital prescribing systems.
- Global Alignment: The XML format brings Canada closer in line with FDA’s SPL standards and similar international frameworks.
Preparing for the 2025 Mandate: Key Steps for Regulatory Teams
Regulatory affairs teams should begin preparations well in advance of the July 2025 deadline. Here are critical steps to take:
- Conduct an Impact Assessment: Determine which products and submission types in your portfolio are affected.
- Review Existing Monographs: Ensure that current monograph content is accurate and ready to be structured in XML.
- Train Your Team: Educate regulatory and labeling personnel on XML PM formatting requirements.
- Invest in Technology: Tools that automate XML conversion, validation, and version control will be essential.
- Engage with Vendors: Evaluate third-party solutions that offer expertise and support for XML PM submissions.
How Freyr SPL-SPM Can Help
As the transition to XML PMs becomes a regulatory necessity, life sciences companies need reliable and scalable solutions. Freyr SPL-SPM is an end-to-end labeling and submission management platform specifically designed to streamline XML PM.
Key Capabilities of Freyr SPL-SPM:
- Automated XML PM Creation: Converts existing product monographs into structured XML compliant with Health Canada’s requirements
- Validation Tools: Built-in XML schema validation ensures submission-ready output
- Version Control: Efficiently manage updates and track regulatory histories
- SPMP Repository: Centralized management of SPMP documentation with alerts for periodic reviews and updates
- Compliance Monitoring: Stay aligned with evolving Health Canada regulations
Conclusion
The 2025 XML PM mandate marks a pivotal step in modernizing Canada’s regulatory infrastructure. By embracing structured labeling and strengthening shortage mitigation strategies, Health Canada is setting a higher standard for product transparency, safety, and responsiveness. For regulatory professionals, early action and the right technology are key to a smooth transition.
With Freyr SPL-SPM, life sciences companies can confidently navigate these new requirements, streamline their regulatory workflows, and focus on what matters most: delivering safe, effective products to the Canadian market.
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