Health Canada is introducing the mandatory use of the extensible markup language product monograph (XML PM) in phases, with the first phase taking effect on July 18, 2025. This initial phase will require certain submission types to include the XML PM at the time of filing.
Key Points:
- Mandatory for new drug submissions (NDS), extraordinary use new drug submissions (EUNDS)
- Not mandatory for administrative NDS, priority review NDS, NDS-CV, NDS with advanced NOC/c and abbreviated new drug submissions (ANDS)
- Applies to pharmaceutical drugs, prescription drugs, non-prescription drugs, biologic drugs and radiopharmaceutical drugs
- Voluntary transition to XML PM continues for other submission types
Actionable Items for Drug Manufacturers:
- For new drug submissions and extraordinary use submissions after July 18, 2025, include the XML PM at filing
- For generic products, wait until the Canadian Reference Product has an authorized XML PM before submitting
- For cross-licensed products, wait until the licensor’s product has an authorized XML PM before submitting
- For biosimilar products, XML PM can be submitted without waiting for the reference biologic drug
- Include package label mock-ups if aligning terminology results in labeling changes
- Complete the XML PM section of the revised Labels and Packages Certification Forms
Timeline:
- July 18, 2025: Mandatory XML PM for NDS and EUNDS
- Before July 18, 2025: Health Canada will publish final XML PM guidance, samples and authorized XML PMs on the Drug and Health Products Portal
Health Canada is taking steps to support the transition, including publishing guidance, samples and authorized XML PMs before the mandatory phase begins.
Background:
Health Canada has created an initiative to adopt a structured product monograph format to increase efficiency and provide Canadians with more relevant and concise drug product information. This effort will improve the treatment experience by making drug information easier for patients and prescribers alike to interpret.
This move to XML PM affects the product monograph preparation, electronic submission and approval process for human prescription drugs marketed, sold or distributed in Canada. This transition does not have any impact on human OTC drugs, veterinary drugs, natural health products and medical food and devices. Voluntary submissions have been accepted since 2021.
Next Steps:
LexisNexis Reed Tech is in a unique position to offer the best support to drug manufacturers needing to make XML PM submissions. Reed Tech has participated in the Health Canada pilot since 2017 and supported FDA SPL since 2005. We have assisted some of the world’s largest pharma companies in 25+ successful voluntary submissions. To learn more about our Health Canada capabilities, reach out to [email protected] or +1 (215) 557-3010. We are ready to assist you NOW.
Additional Health Canada educational assets are available here.