Global health authorities are increasingly shifting their regulatory frameworks toward structured submissions, a move that’s reshaping how life sciences organizations manage labeling, CMC, and regulatory content. In Canada, Health Canada has formally signaled this transition by mandating the use of XML-formatted Structured Product Monographs (XML/SPM).
Health Canada’s adoption of XML/SPM submissions is a major step toward modernizing and streamlining the regulatory submission process. This initiative aligns with global regulatory trends and aims to enhance the efficiency, consistency, and accessibility of product information.
Purpose of XML Submissions
The primary goal of adopting XML for Product Monograph (PM) submissions is to enable structured, machine-readable content that facilitates automated processing, validation, and integration with regulatory systems. XML provides a standardized format that improves data quality and supports digital transformation in regulatory affairs.
This requirement will be applied to New Drug Submissions(NDS), Abbreviated New Drug Submissions (ANDS) and supplemental submissions. Moving to an XML format will allow improved quality and facilitate the use of automated systems to generate and process submissions.
Organization of XML PMs
XML PMs are organized using a predefined schema that structures the content into logical sections like indications, dosage, warnings, and clinical trial data. This structure ensures consistency across submissions and allows for easier navigation, validation, and reuse of content across different regulatory and health information systems. The contents of the XML PMs will include PM documents, organization and product data. Coding within the XML PMs will be accomplished with a Health Canada approved Controlled Vocabulary, which provides a well-defined list of different types of information in both English and French.
RELATED: Improve Content Authoring with AI for Speed and Accuracy
Short-Term Impacts on the Pharmaceutical Industry
In the short term, pharmaceutical companies will need to invest in tools and training to prepare XML-compliant submissions. Adjustments will include:
- Updating internal processes, acquiring XML authoring tools and publishing tools
- Acquiring or configuring XML-based authoring tools
- Ensuring staff are familiar with Health Canada’s technical validation requirements.
Legacy submission documentation will need to be reworked to align with the XML schema and controlled vocabularies.
Long-Term Impacts on the Pharmaceutical Industry
Over the long term, the adoption of XML submissions is expected to:
- Reduce administrative burden by automating validation and formatting
- Improve regulatory compliance through standardized data structures
- Support global harmonization of product information and alignment with other health authorities
- Enable integration with digital health and electronic labeling platforms
- Facilitate faster updates and improve version control for product monographs.
Key Benefits for Pharmaceutical Companies
The rollout of XML/SPM submissions offers several strategic advantages for pharmaceutical companies:
- Improved regulatory compliance through standardized structured content
- Reduced manual errors and rework due to automated validation and consistency checks
- Faster time to market by streamlining the submission and review process
- Enhanced integration with digital health systems and electronic labeling platforms
- Better content reuse and version control across product lines and jurisdictions
- Alignment with international regulatory standards, supporting global submissions
- XML’s inherent structured nature leads to better data analysis, which can lead to better policy decisions.
Conclusion
Health Canada’s move to XML/SPM submissions represents a significant step toward digital transformation in regulatory affairs. Companies that proactively adapt to this change will benefit from improved efficiency, compliance, and competitiveness in the evolving regulatory landscape.
Glemser helps life sciences organizations prepare for Health Canada’s XML/SPM requirements by enabling structured content authoring, automated validation, and compliant submission generation. Our solutions streamline the transition to structured submissions by reducing manual work, ensuring compliance, and improving data quality across global markets.
Learn how Glemser can help your team simplify the shift to XML/SPM and beyond. Contact us today to get started.