UPDATE 5/18/2021: Phase II–full production (voluntary) will begin on June 14th. At that time, the new validation rules will go into effect and the new CV website will be available.
Reed Tech kicked off 2021 with a January webinar to update customers with the most recent information about XML product monograph (XML PM) and how to best navigate them. In the webinar, hosted by Business Review Webinars, Gary Saner, Sr. Manager, Information Sciences, and Katelyn (Zumpino) Clark, Account Executive, discuss 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 speakers 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 include 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  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 speakers of the webinar 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 speakers 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 I and expects to move into phase II in June of 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.
- Gary Saner, Sr. Manager, Information Sciences
- Katelyn (Zumpino) Clark, Account Executive
In the webinar, the speakers discuss the history of Health Canada mandates, product monograph descriptions, timing and submissions and Reed Tech XML Product Monograph Services. Fill out the form here to view the full webinar.
Learn more about Health Canada Upcoming Mandates for XML PM (Product Monograph)