If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want to take a closer look at. As of April 1, 2025, new electronic filing rules are now in place for both eCTD and non-eCTD formats.
These updates aim to make the submission process more streamlined and easier to manage on both sides. For many companies, it’s also a good opportunity to revisit internal systems, templates, and workflows. In this article, we’ll walk you through what’s changed, why it’s relevant, and how you can adapt with confidence.
What changed in April 2025?
Health Canada released new guidance on how drug product submissions should be filed. This applies to both new submissions and those already in progress, especially if you’re using the non-eCTD format. Here’s a quick overview of the changes:
- Electronic-only submissions: All submissions must be sent electronically. Paper copies are no longer accepted.
- eCTD format now required for many product types: If you’re submitting to the Therapeutic Products Directorate (TPD) or Biologics and Genetic Therapies Directorate (BGTD), you need to use the eCTD format. Depending on the regulatory activity type, this may be either the mandatory or recommended format.
- Non-eCTD is still allowed for certain products: This includes natural health products and some disinfectants, but they must now follow stricter file structure and naming rules.
- New validation rules: Health Canada has updated its validation process for both eCTD and non-eCTD submissions. These rules are designed to ensure that sponsors submit properly structured and formatted transactions, reducing the chance of errors or the need for follow-up. Sponsors are encouraged to use a commercially available validation tool before filing. Once a submission is received, Health Canada performs a technical validation check. If issues are found, a validation report outlining the errors will be sent to the sponsor by email as a PDF attachment.
You can read the full guidance on the Health Canada website.
Why does this matter to you?
This isn’t just a technical update. If your tools, templates, or workflows aren’t ready for these changes, you could face:
- Delays in product approvals
- Extra costs for re-submissions
- Compliance issues
If you’re still using paper-based processes or outdated file templates, now’s the time to make changes. Being proactive can help you avoid last-minute setbacks and keep your submissions moving forward.
How to prepare for compliance
Here are five practical steps to help you adjust:
- Review your current process
Look at how your team prepares and submits applications. Highlight areas that may need updates. - Update templates and file structures
Make sure your documents and folders match Health Canada’s new format and naming rules. - Use the right eCTD software
Choose a reliable tool that supports Health Canada’s updated validation checks. - Train your team
Everyone involved in submissions should be familiar with the new rules. Provide training if needed. - Ask for help if needed
If you’re unsure about anything, a regulatory partner can save you time and reduce risks. Contact us to see how we can support you.
Final thoughts
Health Canada’s push for standardized electronic submissions is meant to improve review timelines and consistency. But to keep up, companies need to adjust how they prepare and submit documentation.
Whether you’re working on an NDS, SNDS, or DIN application, it’s a good time to review your internal processes. Getting ahead of these changes helps reduce the chance of delays and compliance problems.
Not sure how this update affects your next submission? Reach out to our regulatory experts or fill out the form below for personalized guidance.
