Month: May 2025

Name: Health Canada and FDA Regulatory Compliance Solutions
Brand: Quality Smart Solutions
Rating: 4.8 (44 reviews)

News Regulatory Updates

How to Meet Health Canada’s New Electronic Filing Rules

Post author By Andrew Parshad
Post date May 9, 2025

Health Canada electronic filing updates: Key changes in 2025

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.
Non-eCTD is still allowed for certain products: This includes natural health products and some non-prescription disinfectants, but they must now follow stricter file structure and naming rules.
New validation rules: Health Canada has introduced new technical checks. If your submission doesn’t meet the formatting or structure requirements, it may be rejected immediately.

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If you’re still using paper-based processes or outdated file templates, now’s the time to make changes.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.

Tags Health Canada, OTC Drugs, Regulatory Update

Blog FDA Health Canada Regulatory Compliance

Navigating FDA and Health Canada Rules for Eczema Products

Post author By Andrew Parshad
Post date May 6, 2025

Understanding FDA and Health Canada rules for eczema products

The eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without a plan. FDA and Health Canada rules for eczema products vary widely depending on the formulation and claims. Many companies risk product delays or enforcement action by misclassifying their product or using unapproved claims.

If you’re marketing an eczema treatment in Canada or the United States, your first step is understanding whether your product is a drug, cosmetic, or natural health product (NHP). That classification affects your registration pathway, labelling requirements, and compliance obligations.

Let’s break it down to help you choose the right path and avoid regulatory issues. Keep reading to make an informed decision.

Product classification drives your compliance path

For both Canada and the U.S., the classification of eczema products hinges on their intended use and claims. If your product claims to treat, relieve, or prevent eczema symptoms, like inflammation, redness, or itching, it will likely be considered a drug.

In Canada, some eczema treatments may qualify as NHPs if they contain ingredients such as colloidal oatmeal or calendula and follow approved monographs. If your product only moisturizes the skin without making therapeutic claims, it may be regulated as a cosmetic.

Health Canada maintains a Natural Health Products Ingredients Database (NHPID) where you can verify whether your ingredients are permitted under the NHP framework: Visit the Health Canada NHPID to search ingredients and monographs.

In the U.S., products that meet the conditions of an Over-the-Counter (OTC) Monograph, such as those containing hydrocortisone or colloidal oatmeal, may be marketed without pre-approval. If your product falls outside a monograph or makes new claims, you’ll need to file a New Drug Application (NDA). See the FDA’s OTC Drug Monograph Directory for reference.

What you need to sell eczema products in Canada

If your eczema product is classified as an NHP, you must apply for a Natural Product Number (NPN) before selling it. This requires submitting detailed information about your product’s ingredients, claims, format, and recommended use. You’ll also need bilingual labelling and evidence of Good Manufacturing Practices (GMP).

If your product is a cosmetic, you must submit a Cosmetic Notification Form (CNF) within 10 days of first sale in Canada. The formula must comply with the Cosmetic Ingredient Hotlist, and the label must list all ingredients in descending order of concentration.

Some products fall into a grey area, especially if they include both moisturizing ingredients and therapeutic claims. We can help you determine the proper path to avoid compliance delays.

What’s required in the U.S.

In the U.S., eczema treatments can be classified as OTC drugs or cosmetics, depending on claims and ingredients. For OTC drugs, you’ll need:

An active ingredient listed in a final OTC monograph
Drug Facts labeling format
FDA establishment registration and product listing
Manufacturing in a compliant facility

If your product is a cosmetic only, it must follow the Modernization of Cosmetics Regulation Act (MoCRA), which includes registration and safety substantiation requirements.

Trying to navigate these rules without proper guidance can lead to missteps and slow your time to market.

Get it right the first time

Misclassifying your eczema product or making unapproved claims can result in:

Refused submissions or delisting
Warnings from regulators
Product recalls or label changes
Lost time and money

That’s why it’s critical to classify your product correctly and align with all relevant compliance steps from the start.

Support to streamline your compliance process

At Quality Smart Solutions, our team guides you through every stage of compliance. Whether you need help deciding if your product is an NHP or OTC drug, preparing an NPN application, or updating your Drug Facts label, we’re here to support you.

We offer:

Ingredient and product classification
NPN application support
Cosmetic notification filings
OTC monograph compliance
FDA and Health Canada label reviews

And much more.

Contact us or schedule a free consultation with one of our regulatory experts today to avoid costly mistakes and get your eczema product to market with confidence.

Tags Cosmetics, eczema, FDA, Health Canada, NHP, OTC, Regulatory Compliance

Blog Cosmetics Regulatory Compliance

FDA vs Health Canada Cosmetic Compliance

Post author By Andrew Parshad
Post date May 1, 2025

How FDA and Health Canada Regulate Cosmetics Differently

Thinking about launching your cosmetic line in North America? Whether you’re a seasoned brand or just getting started, understanding FDA cosmetic compliance vs Health Canada requirements is a must. Each country has its own set of rules, and missing even one detail can cause delays, product holds, or costly corrections.

This guide is here to help you stay ahead. We’ll break down how the FDA’s Modernization of Cosmetics Regulation Act (MoCRA) stacks up against Health Canada’s Cosmetic Regulations.

If you’re working with skincare, makeup, or personal care products, you’ll find out exactly what it takes to meet the requirements on both sides of the border, and how to do it with confidence.

What qualifies as a cosmetic?

Before diving into compliance rules, it’s important to define what’s considered a cosmetic in each jurisdiction.

Health Canada defines a cosmetic as any substance used to cleanse, improve, or alter the skin, hair, or teeth without affecting the body’s structure or functions. This includes makeup, moisturizers, and shampoos.
The FDA shares a similar definition but draws a sharper line between cosmetics and drugs. Any product claiming to treat or prevent a medical condition (like acne or eczema) could fall under drug regulations instead.

If you’re unsure whether your product is a cosmetic or something else, consult Health Canada’s Cosmetic or Drug Decision Tree or work with a regulatory expert.

Regulatory filing: Who needs to be notified?

One of the most notable differences between FDA and Health Canada compliance lies in mandatory submissions.

In Canada, all cosmetic products must be notified to Health Canada within 10 days of sale through a Cosmetic Notification Form (CNF). This includes a complete ingredient list and company details.
Under MoCRA, cosmetic companies in the U.S. must register their manufacturing facilities and list their products with the FDA. This became mandatory in 2023, marking a significant shift from the previous voluntary model. The FDA’s official page on MoCRA outlines these new requirements in detail.

Failure to complete these steps can result in enforcement actions, product holds at the border, and reputational damage.

Ingredient restrictions and safety substantiation

When comparing FDA cosmetic compliance vs Health Canada, ingredient requirements are another key area to watch.

Health Canada maintains a Cosmetic Ingredient Hotlist, which outlines prohibited or restricted substances. Products must not contain any ingredients that pose health risks or violate this list.
The FDA does not publish a similar hotlist, but MoCRA now requires companies to maintain safety substantiation. This means you must have evidence showing your cosmetic product is safe under its intended use.

In both markets, you need to verify that ingredients comply with each jurisdiction’s requirements, including allergens, preservatives, and colourants.

Labeling requirements: Canadian bilingual rules vs U.S. warnings

Labeling is one of the most common compliance pitfalls. It’s also an area where Canada and the U.S. diverge quite a bit.

Health Canada mandates bilingual labeling (English and French) on all cosmetic packaging, along with INCI ingredient names, product function, and net quantity.
FDA labeling requirements under MoCRA include ingredient lists, product identity, and a responsible person’s contact information. You’ll also need to comply with new fragrance allergen disclosures, expected in future rulemaking.

Make sure your artwork is reviewed by someone who understands these regional requirements, especially if you’re using the same packaging for both countries.

Responsible party and accountability

Under MoCRA, the U.S. now requires each cosmetic to identify a responsible person, typically the brand owner or manufacturer. This person must maintain safety records and submit product listings.

Canada doesn’t currently have an equivalent rule, but you must still provide accurate contact information for the party responsible for the sale of the product in Canada. If you’re an international brand entering the Canadian market, this may require partnering with a Canadian Cosmetic Agent.

Enforcement and penalties

While enforcement has historically been more reactive than proactive in both countries, MoCRA has introduced more structured oversight.

In the U.S., the FDA can now issue mandatory recalls, suspend facility registrations, and conduct inspections with more authority.
In Canada, Health Canada can take enforcement action if a product is found to be non-compliant or if consumer complaints arise. This could include product seizures or public safety alerts.

Staying proactive with your compliance can help you avoid penalties and product disruptions in both regions.

How to enhance your compliance strategy

Whether you’re launching a new cosmetic brand or expanding into the U.S. or Canadian market, understanding the key differences between FDA cosmetic compliance vs Health Canada is essential.

At Quality Smart Solutions, our regulatory experts can support your team with:

MoCRA facility registration and product listings
Health Canada Cosmetic Notification Form submissions
Ingredient and formula assessments
Bilingual label reviews and compliance
Ongoing regulatory monitoring and updates

We simplify the regulatory process so you can focus on building your brand. Contact us today or fill out the form below for a free consultation.

Tags Cosmetics, FDA, Health Canada, MOCRA