On December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR).

Health Canada is recommending new provisions for new drug submissions (NDS) and Level I supplements to new drug submissions (SNDS) for human drugs in the proposal. Some of these new provisions include submissions that must now include clinical evidence that has been disaggregated by sex, age, and, race/ethnicity if that evidence has been submitted to the US Food and Drug Administration (FDA) or in Europe with the European Medicines Agency (EMA).

What is Disaggregated Data?

Disaggregated data is “data obtained by breaking down aggregated datasets into subcategories.” The subcategories are based on factors including sex, age, or race/ethnicity among others.

Why is Disaggregating Data Important?

An important part of data collection and analysis in drug development, disaggregating data will:

• Allow sponsors and Health Canada to assess the efficacy and safety of drug products in different subgroups.
• Ensure consistency with the overall results, where possible
• Indicate where post-market monitoring may be needed to further confirm the safety and efficacy in certain populations after the products are approved for sale in Canada.

Health Canada’s sex and gender-based analysis plus (SGBA Plus) Mandate is supported by the collection and analysis of disaggregated data.

Policy Objective

Clinical trial participants should be representative of the whole population who will be using the investigational product/drug. By disaggregating clinical trial data, it can be analyzed meaningfully by subgroups of interest such as sex, age, race, co-morbidities, etc.

Health Canada is using the experience from other jurisdictions by aligning with existing legislation and regulations in the U.S. (the FDA) and Europe (the EMA).

The amendments to the regulations will be to:

• Receive disaggregated data and subgroup analyses that can help assess differences in key efficacy and/or safety parameters between clinically relevant, prognostic subgroups
• Increase transparency by assessing and reporting on the diversity of clinical trial participants for each drug product

Health Canada is seeking feedback on this draft guidance.

Who Can Participate?

Anyone. This consultation is open to academics, consumer and patient safety organizations, the drug and medical device industries, health system partners, and the general public.

How to Participate?

Submission of comments can be done by downloading this fillable PDF form and sending it to hpfb.engagement-mobilisation.dgpsa@hc-sc.gc.ca

Consultation is closing on March 27, 2023

If you have any questions or concerns about this consultation and how it can impact you or your business, please contact us.