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. The 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 mandate has created many questions within industry and it can be challenging to keep up with the most recent information about Health Canada XML PM mandates and how to best navigate them. Below is a breakdown of some of the key points of history of Health Canada mandates, product monograph descriptions and timing and submissions.

XML Product Monograph Description

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 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.

The goal of moving to structured product labeling is to improve accessibility and quality, facilitate machine use and adopt international standards.

XML PM Timing & Submission

The Health Canada XML PM Implementation Timeline has been ever evolving since this mandate was first announced. The most recent guidance detailed a phased approach. In simplest terms, the 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 II – "Mandatory" Product Submissions: New/changed product monographs
• Phase IV – "Mandatory" Product Submissions: Legacy product monographs

Currently, Health Canada is in phase I and expects to move into phase II in spring of 2021.

The above graphic explains the process of creating and submitting your Health Canada XML Product Monograph. Specifically, the box called out with the red type "XML-PM (Build)" is a new task required by the upcoming mandates which contains about 70 product metadata elements that are required. There is no authoring or validating tool being offered by Health Canada, so the options exist to create your own software, buying a software or outsourcing to a trusted partner, such as Reed Tech.

Reed Tech has recently presented a webinar focused on Health Canada XML PM mandates in more detail, as well as their solution including 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.

For more information or any questions: [email protected] or +1-215-557-3010