Over the past several years, talk of XML Product Monographs (PM), or Structured Product Monographs and Health Canada have become more and more frequent. Extensible Markup Language (XML) Product Monographs are akin to the Structured Product Labelling (SPL) implemented by the US FDA and represents Health Canada’s efforts to align with the direction set by its regulatory neighbour.
In 2021, Health Canada initiated phase 2 allowing sponsors to voluntarily submit XML PMs and the initial uptake has been slow. Throughout 2023, Health Canada has provided speakers for multiple conferences to address XML PMs ahead of its last consultation on November 05, 2023. The messages from these conferences indicate that Health Canada will soon switch to making XML PMs mandatory and that announcement is expected in 2024.
What challenges does the XML PM present?
During the pilot phase, submission of an XML PM is elective and can be adopted when filing a New Drug Submission (NDS), or supplements to the NDS (SNDS) with PM format or content changes. Generic drugs filing an abbreviated new drug submission (ANDS), or supplements to an ANDS (SANDS) are able to utilize the XML PM format if the reference product has already adopted the 2020 PM format.
Regardless of the submission type, the choice to prepare and submit an XML PM requires strict adherence to Health Canada’s controlled vocabulary and structural requirements for the XML PM. Creating an XML requires extensive knowledge on coding and without the proper resources and coding support is a time extensive effort. Deviations in either can result in validation errors and issues during Health Canada’s review.
Thus the move to XML PM affects the PM’s preparation, electronic submission and approval process.
Is there a way to prepare for when Health Canada makes XML PMs mandatory?
During phase 2 of Health Canada’s XML PM implementation, sponsors are able to voluntarily prepare and submit XML PMs to Health Canada. The benefit of engaging in this voluntary filing is Health Canada’s commitment to provide help with feedback on any errors and test submissions sent during the pilot phase.
Acting early to understand the requirements and unique challenges of the adoption of XML PMs by Health Canada affords ample time to evaluate which products XML PMs will be required for and develop a transition plan for these activities. Completing these activities now, enables peace of mind and no disruptions or delays to your compliant regulatory activities when Health Canada makes XML PMs mandatory.
How can Regxia Help?
Regxia has participated with the XML PM pilot and has successfully prepared, validated and submitted several XML PMs to Health Canada.
Regxia’s experienced regulatory team understands Health Canada’s requirements for PMs, controlled vocabulary, and utilizing a proprietary conversion platform.
Regxia is able to to create your XML PM without you requiring extra training or resources to understanding XML coding.
Regxia will request a copy of your current Word PM and additional drug and company specific information one time and be able to reuse this information for subsequent filings unless there is a change. Provided with these items, the Regxia team will create your XML PM and provide you a complete validation report following HC’s XML PM validation rules.
Regxia will also ensure that there are no differences between the provided PM versus the XML PM. If warnings exist in the validation report, or changes were needed in selecting the currently acceptable controlled vocabulary, our team will provide an explanation of the warnings and what actions may be required prior to submission.
Once validated, all documents needed for the XML submission will be provided to you by Regxia, including access to a viewer friendly HTML version of the XML PM so you know what the end result hosted by Health Canada will be. Additionally, should you require a fully formatted, linked Word PM, Regxia’s team is fully capable of providing this.
Interested in getting a head start? Let Regxia prepare a conversion plan and spear head your XML PM conversion. Contact us to get started.