In 2016, Health Canada announced its intention to adopt a structured format for its drug product monographs. In harmonization with international data standards, Canada selected the HL7 Structured Product Labeling (SPL) authoring standard for its product monograph submissions. The program, called Structured Product Monograph (SPM), falls under the agency’s Health Products and Food Branch (HPFB), the department responsible for regulating and ensuring the safety of drug products.
HPFB is currently running a series of steps to establish and test its SPM program, which Reed Tech has joined in partnership with two large international drug product manufacturers.
Purpose of the SPM Program
Under the existing system, drug product monographs are submitted by industry to HPFB in unstructured (e.g., MS Word and PDF) formats. In order to publish this information to its public Drug and Health Products Register, HPFB must convert the content of each monograph manually into XHTML. This process is labor-intensive and cannot deliver many of the benefits of a structured and standardized format such as SPL.
A structured format allows for automatic validation and publishing. It can leverage a controlled vocabulary to standardize terminology. Data becomes much easier to search and analyze. It also brings Canada into line with other countries by leveraging an international authoring standard (SPL). By adopting SPL, Canada has also made it faster and simpler for technology providers to adapt their existing solutions for SPL composition, rather than starting from scratch. This means companies distributing drug products in Canada will be able to meet a coming mandate more quickly and smoothly by selecting a technology partner, such as Reed Tech, with established expertise in the SPL realm.
Similarities and Differences to FDA SPL Program
Scope – Remember that FDA’s adoption of SPL for various submission types began only with prescription human drugs and has expanded gradually over the course of nearly fifteen years. HPFB is taking a similar first step, applying SPM only to human prescription products. Animal health and over-the-counter products are currently not in scope.
Controlled Vocabularies – Currently, there are over 50 controlled vocabulary lists, which overlap in some places with FDA’s, but are mostly unique. The eventual target is to align these terminologies with international standards, e.g., ISO Identification of Medicinal Products (IDMP).
Implementation Guide and Stylesheet – HPFB is writing its own implementation guide and developing its own stylesheet to render human-readable versions of SPM content.
Language – Canadian SPM narrative content will be required in both English and French.
Health Canada has released a tentative timeline for SPM activities, subject to change based on testing results and stakeholder feedback:
- Q4 2017 to Q1 2018 – Technical testing and system development activities
- 2018 – Publication of SPM documents, including guidance, schema and style sheets
- Beginning Q1 2019 – Pilot program by volunteer drug sponsors using SPM system for live regulatory filings
Though we are early in the process and many issues have yet to be clarified by HPFB, Reed Tech has been participating in pilot activities, reading all available documentation and attending information sessions.
If you have questions about Health Canada’s SPM initiative and how to plan for compliance, please contact us. We’ll be happy to help.