As of July 18, 2025, Health Canada requires all new and supplemental drug submissions—like NDS, SNDS, ANDS, and SANDS—to include a Structured Product Monograph (SPM) in XML format. This initiative marks a significant transformation in how drug labelling data is formatted, submitted, and accessed to improve accuracy, accessibility, and interoperability within Canada’s healthcare ecosystem.

What Is Structured Product Monograph (SPM)?

An SPM is a product monograph encoded in XML using HL7’s Structured Product Labeling (SPL) standard and controlled vocabularies. It consists of three primary components:
  • Narrative content, organized with standardized headings (e.g., Part I: Health Professional Information; Part III: Patient Medication Information)
  • Drug metadata, like active ingredient, strength, dosage form, and packaging
  • Controlled vocabularies, ensuring consistency in terminology like administration routes and units of measure

    • Unlike unstructured PDF monographs, SPMs are machine-readable, facilitating improved searchability, integration with electronic health records, and enhanced data exchange across systems.

    Why Is Structured Product Monograph (SPM) Important?

    1. Improved Public Access
      2. Released on the Drug and Health Product Register, SPMs enable Canadians to access drug information more efficiently via web and mobile platforms
    1. Regulatory Efficiency and Accuracy
      2. XML structure enforces validation rules and controlled formats, dramatically reducing errors during review cycles.
    1. Interoperability with International Standards
      2. SPMs align with FDA’s SPL and EMA’s IDMP initiatives, making cross-border data exchanges smoother and regulatory review more aligned
    1. Future-Proofing Drug Labelling
      2. As digital health tools gain prominence, structured data ensures your product’s labelling is compatible with future workflows and systems.

    What Is a Pre‑Structured Product Monograph (SPM) Submission?

    A Pre‑SPM submission, or technical pre-submission consultation, is the opportunity to engage Health Canada before filing your first SPM in XML format. The goal is to:
    • Confirm technical readiness (schema compliance, metadata fields)
    • Understand controlled vocabulary use
    • Validate your eCTD package structure, especially if transitioning from non-eCTD formats

    How to File a Pre‑Structured Product Monograph (SPM) Consultation Request

    Follow these steps for a seamless pre‑SPM consultation:
    1. Identify Your Need
      2. If you’re submitting your first structured XML Product Monograph or switching to eCTD, a pre‑SPM consultation is vital.
    1. Initiate Contact with Health Canada
      2. Send an email to Health Canada (e.g., hc.ereview.sc@canada.ca) and reference the eCTD technical consultation. Mention that it’s for SPM/XML PM. In your email, include:
      Purpose of the request
      Submission type (e.g., NDS, ANDS)
      Intended file format (XML SPM within eCTD)
      Proposed date and nature of consultation
    1. Submit Sample Transaction
      2. Before the scheduled consultation, provide a sample XML package, including:
      • One mock SPM in XML, with associated images
      • Corresponding eCTD backbone folder structure
      • Source documents (clean and annotated monographs in Word/PDF)
      • Any validation errors for review
    1. Conduct the Consultation
      2. Typically held via teleconference, the session will:
      • Review your XML structure and file format
      • Discuss controlled vocabulary usage and metadata compliance
      • Identify any technical errors and suggest corrections
    1. Post‑Consultation Follow‑up
      2. Health Canada will confirm next steps. Include their feedback in your finalized eCTD sequence. For the actual drug submission, reference this consultation in your cover letter, demonstrating that your SPM aligns with their guidance

    How Masuu Global Can Help

    At Masuu Global Quality and Regulatory Consultants, we guide sponsors through every stage of the Structured Product Monograph (SPM) journey, including:
    • Gap analysis for XML readiness and eCTD formatting
    • Template-based conversion of existing monographs into SPM structure
    • Validation support, running XML against schema and controlled vocabularies
    • Pre‑submission support, preparing consultation requests and sample files
    • Meeting coordination with Health Canada for technical consultations
    • Inclusion of consultation feedback into final drug submission

    Our services help you avoid costly technical rejections and accelerate your path toward compliant market authorisation.

    Frequently Asked Questions

    A Structured Product Monograph (SPM) is an XML-based version of a drug product monograph developed using the HL7 Structured Product Labeling (SPL) standard. Unlike traditional PDF documents, SPMs contain structured, machine-readable information that improves data accuracy, accessibility, and interoperability. They support more efficient regulatory review and digital access to approved drug information.

    Health Canada’s SPM requirements apply to applicable new and supplemental drug submissions, including NDS, SNDS, ANDS, and SANDS. Sponsors must prepare structured labeling in accordance with the applicable technical specifications and submission requirements. The specific requirements and implementation timelines should be confirmed with Health Canada.

    An SPM generally consists of narrative product information, structured drug metadata, and controlled vocabularies. These components cover details such as active ingredients, strength, dosage form, packaging, administration routes, and standardized labeling sections. Together, they ensure consistency and enable electronic systems to process and exchange drug information effectively.

    XML conversion transforms traditional product monographs into a structured format that supports automated validation and standardized data exchange. It helps reduce formatting inconsistencies, improves the accuracy of regulatory information, and facilitates integration with digital healthcare systems. Proper XML preparation also helps sponsors address technical requirements before submission.

    A pre-SPM consultation is an opportunity for sponsors to discuss technical requirements with Health Canada before filing their first structured product monograph. It is particularly useful when transitioning from traditional labeling formats to XML or preparing an initial SPM submission. The consultation helps identify technical gaps and clarify expectations regarding XML structure, metadata, and eCTD formatting.

    Sponsors may need to provide a sample XML monograph, associated images, the corresponding eCTD folder structure, and clean and annotated source documents. Any identified validation errors or technical concerns should also be included for discussion. Preparing these materials in advance helps make the consultation more productive.

    Masuu Global provides end-to-end support for converting existing product monographs into structured XML format. Our team performs gap assessments, applies appropriate templates, and validates XML files against applicable schemas and controlled vocabularies. We also review the content and technical structure to help ensure submission readiness.

    Yes, Masuu Global supports sponsors throughout the pre-submission consultation process, including preparing consultation requests, developing sample XML files, and coordinating technical discussions with Health Canada. We also help assess feedback received during the consultation and incorporate relevant recommendations into the final submission package.

    Common challenges include XML schema errors, incorrect metadata, inconsistent controlled vocabulary usage, and eCTD formatting issues. Converting unstructured monographs into the required format can also require careful content mapping and technical review. Early validation and regulatory guidance help identify these issues and reduce the risk of technical rejection.

    Masuu Global combines regulatory expertise and technical capabilities to support sponsors throughout the SPM submission lifecycle. From XML conversion and validation to pre-submission consultation and final eCTD preparation, we provide tailored support to address Health Canada’s requirements. Our structured approach helps improve submission quality, maintain compliance, and support efficient regulatory review.

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