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What’s Been Happening with Health Canada XML PM Mandates?

Jun 23, 2022 | Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

Reed Tech recently presented a webinar to update customers with the most recent information about XML product monograph (XML PM) and how to best navigate them. In the webinar, Gary Saner, Sr. Manager, Information Sciences, discusses the history of Health Canada mandates, XML product monograph descriptions, timing and submissions and Reed Tech XML Product Monograph Services. Below, we break down some of the key points of this discussion, but you can also view the full webinar here.

XML Product Monograph Description

The speaker began with a bit of history of the overall initiative, that can be accessed via the full recording, and then moved into explaining Health Canada XML and what that means to most pharmaceutical companies.

Health Canada is moving into the world of Structured Product Labeling (SPL) and 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.

Health Canada’s goal for moving to structured product labeling is to improve accessibility and quality, facilitate machine use and adopt international standards. The speaker explained each of these requirements and formats. Additionally, the webinar delved into the many regulatory similarities and differences between Health Canada XML Product Monograph and FDA SPL.


XML Product Monograph Timing & Submission

Next, the speaker explained the Health Canada XML PM Implementation Timeline. Furthermore, they discussed all guidance, delays and the detailed phased approach. In simplest terms, the submission timeline can be broken down into 4 phases:

  • Phase I – “Limited” Production Submissions: By request only
  • Phase II – “Voluntary” Production Submissions: Open to industry
  • Phase III – “Mandatory” Product Submissions: New/changed product monographs
  • Phase IV – “Mandatory” Product Submissions: Legacy product monographs

 Currently, Health Canada is in phase II, as of June 14, 2021.

XML Product Monograph Service

The above graphic (used in the webinar presentation) explains the process of creating and submitting your Health Canada XML Product Monograph Information. Specifically, you will see the box called out with the red type “XML-PM (Build).” This is a new task required by the upcoming mandates which contains about 70 product metadata elements that are required. There is no information authoring or validating tool being offered by Health Canada so you have the options of creating your own software, buying a software or outsourcing to a trusted partner, such as Reed Tech for your submissions.

The Reed Tech Health Canada solution includes data validation, XML-PM build and check, version and storage and reporting. Reed Tech is currently supporting phase I and will support future production phases II, III and IV. To learn more about the Reed Tech Health Canada services, please contact us.