- Marianne Calilhanna
Health Canada and Drug Product Information: XML Product Monographs Format
Health Canada reviews and assesses the safety, efficacy, and quality of drug products before they are authorized for sale in Canada. Products are regulated as drugs under the Food and Drugs Act. In 2016, Health Canada announced the goal of adopting a structured format for drug product information.
Drug Monograph Structure
Structured formats for drug information is not new. In the United States, the FDA requires SPL (Structured Product Labeling), which is a document markup standard in XML format. SPL is used by the FDA community to facilitate drug listings, establishment registration, NDC labeler code requests and registrations, and other FDA-required reporting. The standard is a requirement when submitting drug listings to the FDA.
Following is an example of the SPL XML for the drug acyclovir:
Canada and XML Product Monographs
Drug product monographs have historically been submitted to Health Canada in unstructured formats such as Word or PDF. However, to publish that information to the public Drug and Health Product Register, each monograph had to be manually converted to XHTML. This process is not only labor intense but also slow and unsustainable.
On January 13, 2020, Health Canada stated it would begin accepting XML product monographs (XML PM) on a "by request basis." This month (November 2020) a full launch of XML PM submission is underway with a mandatory requirement to submit XML PM in the spring of 2021. Health Canada XML PM content will be required in both English and French for prescription drugs. Currently, OTC drugs, self-care products, natural health products, medical devices, food and vet drugs are not part of this impending XML PM requirement.
XML structured markup is relatively new to this market but here at DCL, we've been working with all types of XML formats for years. Following is a list of 10 reasons to prepare drug information in the XML PM format:
XML is an international data standard with active industry support that ensures the standard stays up to date.
XML's structure contains inherent semantics and improves content discoverability.
XML is machine readable.
XML is also easily read by humans, even by novices.
XML promotes interoperability across systems, enabling the seamless flow of information. For example, XML is completely compatible with Java and 100% portable.
XML is platform independent. Any application that can process XML can use that information regardless of platform.
XML improves the global interchange of content.
XML separates content from format and provides consistency by enforcing structure.
XML is free. Unlike Word or Adobe InDesign, XML does not belong to one company. It is a language construct.
XML support is woven into more applications and tools than ever before.
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