As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.
These changes are intended to enhance regulatory alignment, improve data quality and integrity, and better support the evolving requirements of the life sciences industry.
Summary of Key Updates in Health Canada Validation Criteria 5.3:
- F09 – Description Updated
- G22 – Additional File Extensions Supported
- H08 – Valid Values Updated (v5 to v6)
- H21 – Introduction of a New Validation Rule
- I05 and I09 – Master File (MF XML) Now Included
Organizations must ensure their electronic submission systems and processes are updated in accordance with these new criteria to avoid potential rejections or delays in processing.
For further details on the updated validation requirements, please visit the official Health Canada guidance page:
Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format – Canada.ca