Health Canada is committed to enhance the access to approved regulatory health information by developing a consistent solution using XML format, data standards and controlled vocabulary.
The Structured Product Monograph (SPM) is an initiative to standardize and structure the content associated with regulated drug products. The objective of this project is to transition Product Monographs from unstructured formats (Word and PDF) to a structured format using the Structured Product Label (SPL) standard; which is based on Extensible Markup Language (XML).
By adopting the SPL standard, Canada is harmonizing its electronic submission requirements with the international data standards used by the FDA and envisaged by the EMA for its ongoing IDMP initiative.
The SPM initiative is going through a technical testing and system development phase, which will result in the publication of draft technical guidelines. Also, a pilot phase will start beginning of 2019 for volunteer sponsors using the SPM in real regulatory activities. So far, Health Canada has not released details regarding timelines for a mandate submission of drug product monographs in SPL format.
Asphalion has experience assisting drug product labelers for the submission of regulatory information using the SPL standard since its implementation in FDA. If you are interested in participating in the pilot phase do not hesitate to contact us at [email protected]. We are looking forward to helping you prepare for a quick and seamless transition to the upcoming requirements.
