Canadian Product Monograph– Upcoming changes & Implementation Timeline

Author:  Preetha Prabhu

Health Canada is committed towards improving the accessibility and quality of drug product information for Canadians by making it more relevant and easier to understand. This would help consumers and patients to make informed decisions about their medications and health professionals to access critical safety information more quickly.

As part of this work, on Jan. 13, 2020, Health Canada provided an update on following three initiatives related to the Canadian product monograph:

1. Guidance Document: Product Monograph, December 6, 2016

In December 2016, Health Canada had revised Part I: Health Professional Information, and Part II: Scientific Information - Guidance Document: Product Monograph and the five associated templates for prescription products. Since June 9, 2017, these changes have been in effect for biologics, radiopharmaceuticals and prescription pharmaceutical products filed as New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS) where the Canadian Reference Product is in the 2016 format.

Health Canada is now taking steps towards full adoption of this Guidance.

Beginning June 1, 2020, sponsors are expected to file the following submission types under the 2016 Guidance and format for biologics, radiopharmaceuticals and prescription pharmaceutical products:

• NDS
• Where a Canadian Reference Product files in the 2016 format, all ANDSs and Supplemental-ANDSs must also be filed in the 2016 format
• SNDS, where changes are proposed to format or content of the product monograph
• All subsequent submissions of a product already filed in the 2016 format

2. Product Monographs in the XML format

In April 2019, Health Canada announced its intent to transition product monograph templates to a structured format based on XML, Health Level 7's (HL7) Structured Product Label (SPL) standard and controlled vocabularies.

From April 1, 2020 to July 31, 2020, Health Canada will accept XML product monographs on a "by request" basis. Sponsors can submit a request to file XML product monographs, in the 2016 format, under the following submission types:

• NDS
• Where a Canadian Reference Product files in the 2016 format, all ANDSs and SANDSs can also be filed in the XML format
• SNDS, where changes are proposed to format or content of the product monograph
• All subsequent submissions of a product already filed in the XML format.

This period is meant to confirm the readiness of Health Canada and industry systems in advance of a Full Launch. Pending results, the Full Launch is tentatively set to begin Fall 2020. Health Canada aims to make the XML format a mandatory requirement by Spring 2021.

3. Controlled Vocabularies in Product Monographs

In an effort to improve the consistency and searchability of product monograph content, Health Canada will implement a controlled vocabulary framework for product monographs. A controlled vocabulary establishes a list of standardized terms used for indexing and retrieval of information. Controlled vocabularies ensure subjects are described using the same preferred terms across all products. As a result, information is consistent, easier to index and easier to find during a search.

Beginning June 1, 2020, sponsors will be expected to use terminology from Health Canada approved controlled vocabularies when filing product monographs in the 2016 format. Controlled vocabularies are always required when filing product monographs in the XML format.

The list of vocabularies includes the following:

• Dosage Form
• Product Type
• Route of Administration
• Company Name and Identifier
• Units of Measure
• Product Monograph Template Type
• Packaging Type
• Product Characteristics (e.g., colour)
• Ingredient Identifier (Active/inactive)
• Drug Schedule
• Therapeutic Class
• Language Code
• Pharmaceutical Standard
• Drug Identification Number

In response to stakeholder feedback, Health Canada will align its controlled vocabulary framework with international standards where relevant, particularly the standards developed by the International Organization for Standardization (ISO) for the Identification of Medicinal Product (IDMP).

Reference:

Notice: Product Monograph Implementation Plans (Dated Jan. 13, 2020)

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-product-monograph-implementation-plans.html