Notice of Intent: Transitioning Product Monographs to a Structured Format

April 10, 2019
Our file number: 19-107892-703

Health Canada is pleased to announce its intent to transition product monograph templates to a new structured format based on Extensible Markup Language (XML), Health Level 7 (HL7) standards and controlled vocabularies.

In this context, 'structured format' refers to the process of using XML to encode the product monograph's content in such a way that it is more usable and machine readable. The structured format encodes narrative content (e.g., section headings, text, tables and figures); drug product metadata (e.g., ingredients, strengths, dosage forms, packaging); and applies standardized terminology (e.g., dosage forms, routes of administration, units of measure).

The XML product monograph will allow Health Canada and stakeholders to deliver benefits not previously possible with PDF. For example,

• Search: Structured information increases the level of detail that is available to the public for search. Together with its machine readable nature, it will be easier to index and search drug product information; particularly for drug product ingredients.
• Innovation: Stakeholders will have open access to encoded drug product and prescribing information. This can facilitate different use cases such as electronic prescribing, electronic health records, automation, multi-channel publishing and mobile applications.
• Consistency: Controlled vocabularies will introduce a consistent use of scientific terminology and definitions across all drug products and product monographs.

Transition to the new XML format will be on a voluntary basis and is limited to drugs for human use. In order to provide industry with sufficient time to transition to the new format, there will be a phased implementation. The first phase will be a production pilot involving a limited number of volunteers and real regulatory activities.

Further details on this project, the production pilot, implementation timelines and controlled vocabularies will be provided in subsequent communications. In the meantime, questions regarding this notice can be sent to hc.dhpr-rmps.sc@canada.ca.