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Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement, which is set to enhance efficiency, accessibility, and interoperability of drug labeling information across the industry.
Health Canada is introducing the mandatory use of the extensible markup language product monograph (XML PM) in phases, with the first phase taking effect on July 18, 2025. This initial phase will require certain submission types to include the XML PM at the time of filing.
Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files.
Over the years, Global Health Authorities have begun to work towards regulatory harmonization. Of course, the World Health Organization (WHO), a special agency of the United Nations responsible for international public health and established in 1948, is often at the forefront of these efforts.
Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
Reed Tech recently presented a webinar to update customers with the most recent information about XML product monograph (XML PM) and how to best navigate them. In the webinar, Gary Saner, Sr. Manager, Information Sciences, discusses the history of Health Canada...