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).
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.
An important part of data collection and analysis in drug development, disaggregating data will:
Health Canada’s sex and gender-based analysis plus (SGBA Plus) Mandate is supported by the collection and analysis of disaggregated data.
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.
The amendments to the regulations will be to:
Health Canada is seeking feedback on this draft guidance.
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.
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.