Did you know that Health Canada, the department of the Canadian government that regulates drug products, is engaged in a pilot program to introduce electronic submissions of drug product information in Structured Product Labeling (SPL) format?
Officially named the “Structured Product Monograph (SPM) Technical Testing Pilot,” this program is running from May through August of this year. During this period, Health Canada is working with volunteer manufacturers and sponsors, as well as technology vendors, to test the application of the HL7 SPL standard to the content of drug product monographs.
SPM is a strategic move by Health Canada to standardize and structure the content associated with regulated drug products. By adopting the SPL standard, Canada is harmonizing its electronic submission requirements with international data standards used by the U.S. FDA and targeted by the European Medicines Agency (EMA) for their IDMP initiative currently in development.
Currently, Health Canada receives drug product monographs in unstructured formats (e.g., MS Word), converts the portion most relevant to patients into a structured format (XML) and publishes that content to the Drug and Health Product Register (DHPR). Requiring manufacturers and sponsors to submit drug product monograph content in SPL will reduce the burden on the agency and enable Health Canada “to automatically publish the entire product monograph directly to the DHPR without having to perform any manual conversions.”
What Does this Mean for You?
After finishing the SPM technical and functional testing phases, it is expected that Health Canada will launch SPM in production in the 2018 timeframe with an eventual mandate requiring manufacturers and sponsors to submit drug product monographs in SPL format. Health Canada has not yet disclosed details regarding proposed timelines for a mandate or whether the implementation will be phased.
Based on the pilot requirements, both the English and French versions of the product monograph will be required, packaged in separate SPL-XML files.
Reed Tech is participating in the pilot program, in partnership with a global drug product manufacturer. Our team is working hard to be prepared to help your organization when Health Canada’s guidance and compliance timeline is released. Reed Tech has a long track record of helping drug product labelers meet SPL submission requirements, beginning with FDA’s initial SPL mandate in 2005.
Questions about this or other issues related to drug product data management and submission? Contact Reed Tech to speak with an SPL expert.