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Product Monographs are used to provide information about the appropriate use of a drug to physicians, pharmacists, nurses, healthcare professionals, and consumers. Health Canada aims to harmonize the structure of Product Monographs and convert them into a structured format called Structured Product Monograph (SPM) as a part of a regulatory innovation initiative.  The Agency is actively working on achieving this target by publishing policies, notifications, guidance documents for industry, seeking comments from various stakeholders and responding to queries to promote regulatory transparency and openness.

Benefits of Structured Product Monograph (SPM):                                                                                            

The main objective of SPM implementation is to better protect the health and safety of Canadians. This is well accomplished by SPM through the following features:

    1. Ease of information access
    2. Enhanced search results
    3. Standardization of structure and information
    4. Harmonization with international bodies, e.g., ISO IDMP standards and HL7 standards used by EMA and United States FDA.

The Structured Product Monograph format allows systematic presentation and ease of interpretation of information by intended users including physicians, pharmacists, patients, and other health care providers. The critical product information search and information sharing is enhanced, as the information is in machine-readable format.

The SPM consists of 3 main elements:

    1. Narrative Content – Refers to various sections of the Product Monograph. For example, Title Page, Part I: Health Professional Information, Part II: Scientific Information and Part III: Patient Medication Information, including section headings, text, tables, and figures.
    2. Drug Product Metadata – The use of metadata allows for faster search of product information, e.g., ingredients, strengths, dosage forms, packaging, etc.
    3. Controlled Vocabulary – The use of controlled vocabularies means key terms are standardized, e.g., dosage forms, routes of administration, units of measure, product type, etc. As a result, information is consistent, easier to index, and easier to find during a search. The controlled vocabulary is also aligned with the international standards (e.g., ISO IDMP) that supports global harmonization.

Update on Health Canada’s XML Project:                                                                                                       

Health Canada has successfully completed Phase I – Production Testing of the XML product monograph and Phase II: Full Production launch (Voluntary) begins this month. This means you can start the transition from unstructured PMs to structured PMs for human pharmaceutical drugs, biologic drugs, and radiopharmaceuticals today. Please note: Health Canada plans to make the XML format a mandatory requirement with the launch of the final project phase, Phase III: Full Production (Mandatory). The launch date for Phase III will be announced after Health Canada evaluates the results of Phase II.

What you need to know:

The Product Monograph has undergone a series of modifications, the most substantial being in 2004, 2014, 2016, and most recently in 2020. The 2020 PM Templates is called the Master Template and has replaced its predecessors.

The Product Monograph copies (Clean and Annotated) in Microsoft Word format are still required in regulatory submissions for the Agency’s review. The SPM is submitted upon final approval of Product Monograph content. The SPM consist of an XML file (.xml) and any associated images in .jpg format. Please note that SPM should be submitted in both English and French language. The XML version of the Product Monograph is created by using a specialized, validated software that meets Health Canada specifications. The relevant information is entered under specific sections (Headings and Sub-headings) of the Master Product Monograph template using SPM software. The title of the sections and sub-sections and their order in the SPM are defined. The numbering for the sections and sub-sections is included in the display name of each section or sub-section. SPM software allows users to edit sections, sub-sections, add tables, images, footnotes, hyperlinks and proper referencing of drug information. The final Product Monograph is published and validated. Any validation errors must be resolved prior to submission. The final validated SPM is then submitted to the Agency in either eCTD format via the Common Electronic Submission Gateway (CESG) or non-eCTD format on media (e.g., CD, DVD etc.), depending on the submission type.

Steps for implementation

    1. Get Informed. Gain an in-depth understanding of Health Canada’s current requirements for the Structured Product Monograph format and requirements. Read current guidance documents and notices, and/or contact us to assess the impact on your products.
    2. Review your Product Portfolio. Determine how many products will be impacted by the new SPM format by filtering through your product portfolio. Keep in mind that legacy PMs are also subject to SPM format & requirements.
    3. Create an implementation plan or strategy. It is crucial to plan how to implement structured formatting changes for Product Monographs well ahead of the mandatory deadline. Consider technical software requirements, impact on regulatory validation, vendor qualification and training. This can be accomplished in-house, by outsourcing, or by using a hybrid approach.
    4. Take action. You may choose to purchase a software that meets Health Canada’s specifications for XML product monographs or outsource SPM activities. Either way, it is crucial to follow a methodical and efficient implementation plan that results in compliant Product Monographs by Health Canada’s mandatory deadline.

How AXSource can help.  

Our team consists of qualified and experienced regulatory affairs professionals, with up-to-date knowledge of Regulations and current industry practices. Our technical team can help you to strategize the implementation and/or handling of Regulatory activities, including structured labeling. We can assist in converting legacy unstructured PMs to XML PMs, validating SPMs per Health Canada’s requirements, performing eCTD publishing of regulatory submissions, validation, and electronic submission via CESG.

Contact us for professional Regulatory Affairs and Structured Labeling services at our preferred client rate, available for limited time only.

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