Health Canada Upcoming Mandates for XML PM (Product Monograph)

Health Canada is adopting a structured product monograph format for the preparation, submission and approval of human prescription drugs marketed, sold or distributed in Canada.

Health Canada has begun an initiative to capture Product Monograph (PM) information in a structured Extensible Markup Language (XML) format. According to Health Canada guidelines, the XML PM contents should include PM documents, organization and product metadata. These changes will apply to human pharmaceutical, radiopharmaceutical and biologic Rx drugs. All XML Product Monographs must use the 2020 template. The scope includes regulatory activities using electronic Common Technical Documents (eCTD) including new drug submission (NDS), supplements to NDS (SNDS) with PM format or content change and abbreviated new drug submission (ANDS) and supplements (SANDS) where reference product files are in 2016 [2020] format. Through this initiative into Structured Product Language (SPL), Health Canada will reach its goal to improve accessibility and quality, facilitate machine use and adopt international standards.

Phase II-full production (voluntary) is expected to begin on June 14th, 2021 according to the project lead. At that time, the new validation rules will go into effect and the CV website will be available.

Register here for access to:

  • Requirements overview
  • Timeline and XML requirements
  • Webinar recording: Background, understanding SPL files, Health Canada XML PM requirements

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How to Navigate Health Canada XML Product Monograph Requirements