Canada’s first Product Monograph in the XML PM format was submitted to Health Canada on August 17. i4i worked closely with the Market Authorization Holder to finalize the XML PM included in their eCTD submission. This submission marks the first XML PM received for an official filing.
XML PM is the new, preferred file format for Canadian Product Monographs in eCTD submissions. It replaces the PDF file format—in which Product Monographs are currently submitted—with a structured XML format based on the HL7 Structure Product Label (SPL) standard. Moving to this structured format will significantly aid the process of Product Monograph creation, management, and submission. It will also help to improve the accessibility and quality of drug product information for Canadians, both patients and physicians alike.
Health Canada is phasing in the new format, with the Production Testing phase having started June 1, 2020. During this phase, Product Monographs of human pharmaceutical drugs, biologic drugs, or radiopharmaceuticals can be submitted to Health Canada in the XML PM format on a “by request” basis. Open, voluntary submissions will begin to be accepted this fall. By the Spring of 2021, Health Canada plans to make the XML PM format mandatory for these Product Monograph submissions.
i4i has a history dedicated to innovation and rich in accomplishment and has been delivering leading XML and structured authoring solutions for nearly thirty years. At the inception of the FDA’s SPL implementation, i4i joined the technical leadership team, helping define and develop its guidance. Today, we continue our involvement as a key member of the SPL Working Group, where our XML knowledge and industry expertise supports the FDA’s SPL initiative.
Our knowledge and expertise of XML and the SPL standard have made us a valued contributor in the development of the new XML PM implementation. As we did with the FDA and SPL, we are working closely with Health Canada to help define and develop the XML PM guidance.
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