Understanding XML Product Monographs

The way product monograph (PM) information is shared in Canada is undergoing a major transformation. Health Canada is shifting from traditional PDF and Word-based product monographs to a modern, structured XML format. As of July 18, 2025, this new format, known as XML product monographs (XML PMs), will become a mandatory requirement for filing New Drug Submissions (NDSs) and Extraordinary Use New Drug Submissions (EUNDSs). Here’s what you need to know about XML PMs and how Innomar can help you navigate this transition.

What is an XML PM?

An XML PM is a structured, electronically validated document containing detailed information about a drug product. Unlike traditional formats, XML PMs are web-based and dynamic, enabling better standardization and improved accessibility. Once approved, these XML PMs will be posted on Health Canada’s searchable Drug and Health Products Portal (DHPP).

With features like controlled vocabulary and filtering options, this portal enhances the ability of healthcare practitioners and patients to quickly locate relevant information, such as therapeutic classes or specific ingredients.

Key requirements for XML PMs

Health Canada’s transition to XML PMs includes several requirements for compliance:

All new PMs must be prepared using the latest Health Canada template.
Older product monographs must first be converted into the current template before transitioning to XML.
Once in the current template, XML-authoring capabilities are required to create the XML PM.
In addition to the main content, XML PMs must include specific data elements about the sponsor company and product, all adhering to Health Canada’s controlled vocabulary.
XML PMs must pass Health Canada’s electronic validation criteria and be submitted within the corresponding eCTD sequence.

How Innomar supports

Transitioning from traditional PMs to XML PMs can be complex, but Innomar is here to simplify the process. Whether you need guidance or end-to-end support, we offer customized XML PM services tailored to your needs. Our services include:

English and French language support.
Conversion of outdated PMs into Health Canada’s current template.
Creation, validation, and submission of error-free XML PMs.
Management of controlled vocabulary to ensure compliance.

Since the pilot program in 2021, we have been actively submitting XML PMs with a 100% success rate. Our expertise allows us to provide reliable guidance and support throughout every step of this transition.

Preparing for the future

While XML PMs will be mandatory for NDSs and EUNDSs starting in July 2025, Health Canada is taking a phased approach and plans to expand this requirement to additional submission types in the future. Staying ahead of these regulatory changes is critical for ensuring compliance and avoiding delays.
If you need assistance with XML PM creation, conversion, or submission, Innomar is here to help.

Contact our team today to learn more about how we can support your transition to XML PMs and ensure you’re ready for the upcoming July deadline.