Notice: Product Monograph Implementation Plans
May 12, 2020
Our Reference No: 19-123473-315
UPDATE: In light of current priorities and circumstances related to COVID-19, Health Canada is revising the Product Monograph Implementation timelines.
Health Canada will initiate Phase I: Production Testing of the XML product monograph project beginning June 1, 2020. The timeline for adoption of the 2016 Guidance Document: Product Monograph and the 2016 template will move to November 1, 2020.
More information will follow in the coming weeks to solicit interest in participating in Phase I of the XML product monograph project and to provide further supporting guidance.
Health Canada remains committed to the overall implementation plan and the objective of improving the accessibility and quality of drug product information for Canadians, along with the adoption of digital health technology.
Health Canada continues to implement commitments made to improve the accessibility and quality of drug product information for Canadians. The Department is making drug product information more relevant and easier to understand so that Canadians can make informed decisions about their medications and health professionals can access critical safety information more quickly.
As part of this work, Health Canada is pleased to provide an update on the following three initiatives related to the Canadian product monograph:
- Guidance Document: Product Monograph, December 6, 2016
- Consultation on the Draft Guidance: Preparation of Product Monographs in the Extensible Markup Language (XML) format
- Controlled vocabularies
These initiatives will help make drug product information more consistent, easier to read, easier to find and will encourage the adoption of digital health technology.
2016 Guidance Document: Product Monograph
In December 2016, Health Canada announced updates to Part I: Health Professional Information, and Part II: Scientific Information of the Guidance Document: Product Monograph and the associated templates. 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. In order to provide industry with sufficient time to transition to the requirements under the 2016 Guidance, there will be approximately a 6 month period before full implementation takes effect.
Beginning November 1, 2020, sponsors are expected to file the following submission types under the 2016 Guidance and format for biologics, radiopharmaceuticals and prescription pharmaceutical products:
- 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) must also file in the 2016 format
- Supplements to a New Drug Submission (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, are also required to continue filing in the 2016 format
Sponsors are encouraged to discuss, with Health Canada, in advance, any anticipated complex or large volume product monograph filings with the appropriate review area to manage target review timelines.
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 format, Health Level 7 (HL7)'s Structured Product Label (SPL) standard and controlled vocabularies.
From May 15, 2019 to June 29, 2019, the following XML Product Monograph guidances were posted on the Health Canada website for public consultation:
- Preparation of Product Monographs in the Extensible Markup Language Format
- Validation Rules for Product Monographs in the Extensible Markup Language Format
Consultation feedback reflected support for adopting a structured format, identified controlled vocabularies as a critical factor for implementation, and the importance of Health Canada to align with other international regulators and international standards.
Beginning June 1, 2020, Health Canada will initiate Phase I: Production Testing of the XML product monograph project. During Production Testing, sponsors can submit requests to participate and, if accepted, can file XML product monographs for review via 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) can also file in the XML format
- Supplements to New Drug Submissions (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, are also required to continue filing in XML format
The Production Testing period has been established to ensure both Health Canada and industry systems are in place for the launch of Phase II: Full Production (Voluntary) scheduled for Spring 2021. Health Canada plans to make the XML format a mandatory requirement with the launch of Phase III: Full Production (Mandatory). The launch date for Phase III will be announced after evaluating the results of Phase I and II.
More information will be provided in subsequent communications.
Controlled Vocabularies in product monographs
A controlled vocabulary establishes a list of standardized terms used for indexing and retrieval of information and ensures 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.
In an effort to improve the consistency and searchability of product monograph content, Health Canada will implement a controlled vocabulary framework for product monographs.
Beginning November 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).
More information on the controlled vocabularies will be provided in subsequent communications.
Questions related to the Guidance Document: Product Monograph should be directed to:
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Questions related to the XML Product Monograph and controlled vocabularies should be directed to:
Business Informatics Division
Resource Management and Operations Directorate
Health Products and Food Branch
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