If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a crucial first step. These regulatory routes can seem a bit confusing at first, but understanding them will save you time, money, and potential setbacks. Whether you’re introducing a new drug, modifying an existing one, or entering the generic market, Health Canada requires that you follow a specific regulatory route.
Each submission type (NDS, SNDS, or ANDS) has its own criteria, data requirements, review timelines, and costs. Choosing the wrong one can slow your approval process, increase expenses, or even result in rejection. But don’t worry, this blog will walk you through each pathway clearly and simply.
Keep reading to learn which submission pathway best fits your product, and how to avoid common regulatory missteps.
What is an NDS?
A New Drug Submission (NDS) is required for drugs with new active ingredients, formulations, or therapeutic uses that haven’t yet been authorized in Canada. This is the most comprehensive submission type and applies to innovative therapies entering the market for the first time.
When to use NDS
- Introducing a new active ingredient
- Launching a drug with a new indication
- Creating a new dosage form or formulation
Key requirements
- Extensive clinical and preclinical data
- Health Canada review time of 300 to 600 days
- CAD 590,346 submission fee
Example: You’ve developed a new treatment for a chronic condition. Since it’s never been marketed in Canada, you’ll need an NDS to apply.
What is an SNDS?
The Supplemental New Drug Submission (SNDS) is used for significant changes to a drug that has already been approved. If those updates could affect the product’s safety, effectiveness, or quality, you must submit supporting documentation for Health Canada’s review.
When to use SNDS
- Changing dosage or formulation
- Adding a new therapeutic use
- Modifying manufacturing or labelling details
Key requirements
- Supporting clinical data (as needed)
- Review time of 180 to 300 days
- CAD 305,690 submission fee
Example: You want to add a secondary indication for your approved blood pressure medication. This requires an SNDS.
What is an ANDS?
The Abbreviated New Drug Submission (ANDS) is for generic drugs. It allows manufacturers to show that their product is bioequivalent to an approved reference drug, without having to conduct new clinical trials.
When to use ANDS
- Launching a generic version of a brand-name drug
- Demonstrating equivalence in absorption and delivery
Key requirements
- Bioequivalence studies
- Review time of 180 to 300 days
- CAD 305,690 submission fee
Example: You’re creating a generic cholesterol-lowering drug. You’ll file an ANDS to show it matches the reference product.
Comparing NDS, SNDS, and ANDS pathways
Now that we’ve gone through each submission pathway, let’s look at them side by side in the comparison chart below. The visual summary below helps clarify how the three options differ in scope, requirements, and timelines. Whether you’re launching a new drug, modifying an approved one, or developing a generic, the chart makes it easier to spot the best fit for your product.
Frequently asked questions
Still unsure which path is right for your product? You’re not alone. Here are some common questions we hear from businesses trying to figure out Health Canada’s drug submission process. We’ve expanded the answers to help you understand what to expect and make informed decisions.
- I’m reformulating a drug. Which pathway do I use?
If the changes affect the product’s safety, quality, or intended use, you’ll need to go through the SNDS process. This includes updates to dosage forms, manufacturing methods, new therapeutic indications, or significant labelling changes. - How long does the ANDS process take?
It usually takes between 180 and 300 days. That said, a complete and accurate submission can prevent delays. Make sure your bioequivalence studies and supporting documents are in order. - Can I use the NDS pathway for a generic?
No. Generics must follow the ANDS route. You’ll need to demonstrate that your product is bioequivalent to an approved reference drug, without having to submit new clinical trial data. - Do I need clinical trial data for an SNDS?
It depends on the nature of the change. If you’re changing the dosage or therapeutic indication, you may need to include new clinical data. For more minor changes, such as manufacturing site updates, this might not be required. - What if my product falls between two categories?
If your submission doesn’t clearly meet the requirements for one pathway, it’s best to consult Health Canada or work with a regulatory expert. Submitting under the wrong pathway can lead to unnecessary delays or rejections.
How regulatory experts can help
Navigating drug submission pathways doesn’t have to be stressful. Our regulatory team at Quality Smart Solutions can help you evaluate your product, prepare the necessary documentation, and ensure your submission meets Health Canada’s expectations.
Whether you’re preparing an NDS, SNDS, or ANDS, we’ll guide you from strategy through to approval. You can visit our Contact page or simply fill out the form below to schedule a free consultation with one of our regulatory experts.
References
Health Canada. (2024). Fees for the Examination of Drug Submissions and Applications. Government of Canada. Retrieved from https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submission-applications/fees.html
Canada Gazette, Part 1, Volume 158, Number 13. (2024). Notice amending Health Canada’s National Dosimetry Services Products, Services, and Fees Schedule. Government of Canada. Retrieved from https://gazette.gc.ca/rp-pr/p1/2024/2024-03-28/html/notice-avis-eng.html
Health Canada. (2023). Drug Submission Application Review Fees. Government of Canada. Retrieved from https://www.canada.ca/en/health-canada/services/submission-applications/review-fees.html
