Health Canada is making Structured Product Monograph (SPM) submissions in XML format mandatory starting July 18, 2025, for select drug applications. This move is part of Canada’s broader effort to modernize regulatory submissions and improve drug information accessibility.
The XML SPM is a machine-readable, bilingual version of the product monograph based on Health Canada’s adaptation of the HL7 SPL (Structured Product Labeling) standard. It replaces PDF and Word files with a structured, standardized XML format that’s easier to process and integrate into digital health systems.
Who Must Comply? Starting July 18, 2025, XML PMs will be mandatory at the time of filing for: New Drug Submissions (NDS) Extraordinary Use New Drug Submissions (EUNDS) Applicable to:- pharmaceutical drugs
- prescription drugs and drugs administered by or obtained from a health care provider
- non-prescription drugs regulated under Division 8 of the Food and Drug Regulations
- biologic drugs (Schedule D)
- radiopharmaceutical drugs (Schedule C)
- 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)
- Include the first‑language XML PM (English or French) for:
- All in-scope product lines and submission types:
- New Drug Submissions (NDS)
- Extraordinary Use New Drug Submissions (EUNDS)
- Covering prescription, non‑prescription, biologics, and radiopharmaceuticals
- Any product that already has an authorized XML PM, where any updates are being submitted
- All in-scope product lines and submission types:
- Complete the “XML PM” section on both:
- Labels and Packages Certification Form – Prescription (revised version once available)
- Labels and Packages Certification Form – Non‑Prescription Products (revised version once available)
- File the XML PM in both English and French
- Submit both XML PM files in the same regulatory transaction as the second-language product monograph (PDF)
- Digital readiness: Enables automation, integration with EHRs, and online publication
- Regulatory accuracy: Reduces inconsistencies using controlled vocabulary
- Faster access: Improves searchability for healthcare professionals and the public
- A human-readable HTML version
- The .xml file
- XML conversion and validation
- Regulatory strategy and Health Canada submissions