Health Canada is transitioning from unstructured product monographs to structured product monographs (SPMs) for drug labeling. The move will affect human drug labeling, product monographs, and electronic submission. Veterinary drugs, over the counter drugs, natural health products, and medical food and devices will not be impacted by the transition. SPMs are not mandatory—yet. The draft guidance documents have been posted online and the production pilot is tentatively scheduled to begin late summer, 2019. Get ahead by learning about SPM before the competition.
Currently, product monographs are text only, contain no metadata, and do not conform to any data standards. The move to SPM will create machine-readable documents complete with rich metadata encoded with Extensible Markup Language (XML). Health Canada hopes that this initiative will increase efficiency and provide Canadians with more relevant and concise drug product labeling.
Health Canada adopted XML for SPMs because it is widely used to encode and exchange information. The XML used in SPMs will conform to the Health Level 7 (HL7) structured product labeling (SPL) standard. Furthermore, to meet international standards, SPMs will also attempt to align with other regulatory bodies, like the Identification of Medicinal Product (IDMP) and US SPLs, where possible.
Why is Health Canada transitioning to SPM? SPMs created in XML have a number of advantages over traditional product monographs. Structured information is more searchable. XML will make it easier to index and search products by criteria like ingredients. In addition, structured information is more open to innovation. Access to structured information can have huge implications in areas like electronic prescribing, health records, automation, and others. Finally, structured information leads to more consistency. Controlled vocabularies mean that terminology and definitions stay the same across products and labels. Consistent labeling will make it easier for patients and prescribers to interpret labeling.
i4i, a company with decades of experience with structured content and US SPLs, was one of the lead contributors to the development of US SPLs. As such, i4i is uniquely positioned to help companies transition to SPM. Check back here for more SPM updates!
To get more information, read the drafts of the guidance documents here:
- Preparation of Product Monographs in the Extensible Markup Language Format
- Validation Rules for Product Monographs in the Extensible Markup Language Format
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