Posted April 24, 2020 | By Pallab Roy
Back in 2016, when Health Canada for the first time informally announced its thought process on adopting the ISO standard, Identification of Medicinal Product (IDMP), the road ahead was full of significant challenges but with opportunities galore. The goal was to improve patient access to drug labeling information to help them make informed decisions about their medications; and encourage the adoption of digital health technology to increase efficiency.
Introducing a structured content for product monographs was one of the key components of this data standard in a move towards e-prescribing to promote interoperability. The program initially referred to as “Structured Product Monograph (SPM)” approach, fell under the Agency’s Health Products and Food Branch (HPFB), the department responsible for regulating and ensuring the safety of drug products, and was likely to affect product monograph preparation, electronic submission, and approval processes for human prescription drugs.
Under the currently existing system, drug product monographs are submitted in unstructured formats (e.g., MS Word, PDF). As part of this initiative, the HPFB recognized that unstructured formats are not adequately positioned to support the identified objectives of publishing such information to its public Drug and Health Product Register, and therefore need to transition to more advanced technology formats that are open source as well as supported by international standards.
Over the next couple of years, HPFB authored SPM documentation, developed infrastructure, and performed testing in collaboration with an industry focus group. In April 2019, Health Canada formally announced its intent to transition product monograph templates to a structured format based on Extensible Markup Language (XML) format, Health Level 7 (HL7)’s Structured Product Label (SPL) standard 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). Such a structured format would allow for automated validation and publishing. It could leverage a controlled vocabulary to standardize terminology thereby rendering data to become much easier to search and analyze.
From May 15, 2019 to June 29, 2019, the following XML Product Monograph guidances were posted on the Health Canada website for public consultation:
Consultation feedback reflected support for adopting a structured format and the importance of Health Canada to align with other international regulators and international standards.
As part of this project, on January 13, 2020, Health Canada announced that from April 1, 2020 to July 31, 2020, it will start accepting XML product monographs on a “by request” basis. An anticipated full launch of the XML PM initiative is scheduled for Fall 2020, before the mandatory requirement comes into effect tentatively in the Spring of 2021.
Sponsors can submit a request to file XML product monographs, in the 2016 format, under the following submission types:
The Health Canada XML PM content will be required in both English and French. Please note, over the counter (non-prescription) drugs, self-care products, natural health products, medical devices, food and veterinary drugs are currently outside the scope of this requirement.
The phased implementation plan will help establish both Health Canada and industry systems in advance of a full production launch later this year. Health Canada suggests that companies will be able to meet the upcoming mandate more smoothly by adopting to start the process now before the mandatory requirement sets in.