Notice: Product Monograph guidance - Formatting for clinical trials section and administrative updates

June 24, 2021

The changes detailed in this Notice can be implemented immediately.

Master template

As of November 1, 2020, the full adoption of the Guidance Document: Product Monograph (2020) and Product Monograph (PM) Master Template came into effect. In order to support the XML PM, the previous six 2016 templates were amalgamated into one called the Master Template. The PM Guidance was also updated to align with the new Master Template. The changes were primarily administrative in nature, with the scientific content and instructions remaining essentially the same.

Clinical trials section

Since the publication of the Master Template, several comments have been received regarding the Clinical Trials section of the PM. The structure and controlled vocabulary required for the XML PM has resulted in a layout that did not allow for the natural variance in the data across product lines. To address this, Health Canada has modified the Clinical Trials section in the Master Template of the PM to allow more flexibility while maintaining the structure and controlled vocabulary required for the XML PM.

The Clinical Trials section of the Master Template will now be organized by indication, with the "Trial Design and Study Demographics", and "Study Results" provided for each indication. The indication should be written out in Title Case (i.e., with only the first letter of each word capitalized), and be included in the Table of Contents. The indications should NOT be numbered. The image below shows the Clinical Trials section before and after this modification.

The section headings and associated numbers for "Trial Design and Study Demographics" and "Study Results" are no longer required, though the content requirements have not changed. Within the Clinical Trials section, other than the "Biosimilars" statement (as needed), no other text should be placed between the indication heading and the summary table. The image below shows the layout of the revised Clinical Trials section.

From an XML perspective, Health Canada has added a new term to OID 2.16.840.1.113883.2.20.6.63 (Master Template - 2020) Controlled Vocabulary list - the "Clinical Group" (code=CG). In this case, the <title> does not have to match the displayName, which will allow the sponsor to insert the indication. As with all other vocabulary terms, the displayName must match the code and codeSystem. The following table lists all changes made to the CV terms in the Clinical Trials section of OID 2.16.840.1.113883.2.20.6.63.

Hyperlinks

Since the publication of the revised guidance, there have been many questions regarding hyperlinks. Specifically, clarification has been requested regarding the level of detail required for the hyperlinks.

In the past, hyperlinks contained the full path that lead to the data it was referencing. The full path is no longer required, and only the final destination should be included. For example, "See 8.2.1 Clinical Trial Adverse Reactions - Pediatrics" or "See Endocrine and Metabolism".

Health Canada will reflect these additional instructions in subsequent updates of the relevant guidance: is working to revise the Guidance Document: Product Monograph (2020), the Master Template and the Guidance Document: Preparation of Product Monographs in the Extensible Markup Language (XML) Format. More information will be provided in subsequent communications.