Consultation on draft Guidance on the collection and analysis of disaggregated data in clinical trials: Notice to stakeholders
The next version of the guidance document will be updated to align with the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) regulatory package that was published in Canada Gazette, Part II on December 18, 2024.
On December 17, 2022, Health Canada pre-published in Canada Gazette, Part I, amendments to the Food and Drug Regulations (FDR). The amendments are titled Regulations Amending Certain Regulations made under the Food and Drugs Act (Agile Regulations).
This regulatory proposal includes new provisions for new drug submissions (NDS) and Level I supplements to new drug submissions (SNDS) for human drugs. These submissions must include clinical evidence that has been disaggregated by sex, age and race/ethnicity, if that evidence has been submitted to the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA).
Health Canada has developed the draft Guidance on the collection and analysis of disaggregated data in clinical trials to:
- clarify Health Canada's expectations when submitting disaggregated data
- provide a consistent interpretation of the provisions in the regulations that pertain to the submission of disaggregated data in clinical trials
- help sponsors understand and apply best practices related to collecting, analyzing and reporting on disaggregated data in clinical evidence
This guidance document applies to drugs for human use regulated by Health Canada's Health Products and Food Branch in accordance with the Food and Drugs Act and its regulations.
We are seeking your feedback on the draft guidance. We recommend that you read the draft guidance along with the proposed regulations.
Please visit the consultation page for more information and to provide feedback.