Did you know that Health Canada now requires Drug Labelling in SPM format?

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Health Canada is adapting its systems with advances in science to maximize the safety of Canadians, and one of their initiatives is to improve drug product labels. The Agency recognizes that the publicly available labelling information should be transitioned from unstructured formats, like Portable Document Format (PDF), to an advanced format called Extensible Markup Language (XML) that is better suited to the rapidly modernizing healthcare environment.

What is XML?                                                                                                                             

XML defines a set of rules for encoding labelling information in a structured format that is both human-readable and machine-readable. Health Canada’s new Structured Product Monograph (SPM) format is based on XML and aligns with the international standards like Health Level 7’s (HL7) Structured Product Label (SPL) standard and controlled vocabularies, i.e., standardized, pre-approved terminology.

What is HL7?

HL7 is a not-for-profit standards development organization dedicated to providing standards for the exchange of electronic health information that supports clinical practice and the management of health services.

Why implement the Structured Product Monograph?  

This new approach will help Health Canada to align with other international regulatory bodies like the United States FDA, that have long adopted HL7’s SPL as a mechanism for exchanging product and facility information.

Health Canada will publish the structured XML document received directly from Industry through the gateway on the Drug and Health Product Register (DHPR) to give Canadians easy access to consumer-friendly information.

Drug Product Monographs will now be available in a more user-friendly interface with improved searchability and easy accessibility. The patients, physicians, pharmacists, health care workers, caregivers and anyone dealing with medicines and health product will be able to access the drug prescribing and labelling information on various mobile applications and retrieve and transfer the information digitally through various platforms.

Health Canada’s Announcement  

Health Canada published a Notice of Intent for transition of labelling content into XML format on April 10, 2019, which stated that the SPM implementation will be a phased approach.

Currently, human pharmaceutical, radiopharmaceutical and biologic drugs are targeted for the implementation of structured product labelling. Later, the scope will be expanded to cover other categories of medicines and health products. Health Canada has published draft guidance documents for Structured Product Monograph to assist the stakeholders.

How will it impact Drug Product Manufacturers?                                                                       

Existing drug product monographs will need to be converted from traditional Word and PDF formats, to the XML SPL standard format known as Structured Product Monograph (SPM).

Health Canada timelines for implementation are below:

Phase I•    Production Testing of the XML Product Monograph projectBeginning June 1, 2020
Phase II•    Full Production (Voluntary)Spring 2021 – now!
Phase III•    Full Production (Mandatory)The launch date for Phase III will be announced after evaluating the results of Phase I and II.

 

Currently, you can file Structured Product Monographs for the following submission types:

  • New Drug Submissions (NDS)
  • Where a Canadian Reference Product files in the 2016 format, all Abbreviated New Drug Submissions (ANDSs) and Supplements to Abbreviated New Drug Submissions (SANDSs), Supplements to New Drug Submissions (SNDS)
  • All subsequent submissions of a product filed in the XML format

AXSource is ready to provide assistance with participation in Health Canada’s pilot program to ensure a successful transition of your drug product labelling into the new structured format. Contact us today so we can help you to:

  • Understand the requirements for the technical, scientific, and regulatory aspects of the XML Product Monograph
  • Comply with new labelling Regulations
  • Encode and structure all existing English and/or French product monographs to the new XML format
  • Review of Labelling Content
  • Validation of labelling information
  • File the regulatory activity including the XML SPM to Health Canada
  • Lifecycle Management of the XML PM

Contact us today at info@axsource.com for Structured Labeling labelling and for our preferred client rate.



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