Amazon Seller Compliance

Month: November 2024

Categories
Blog News

Health Canada’s New Nicotine Rules: What’s Changing in 2024

Nicotine pouches new regulations

Nicotine pouches in a round container on a wooden surface.

If you’re in the business of nicotine products like pouches, gums, patches, sprays, or lozenges (collectively known as nicotine replacement therapies, or NRTs), you need to know about Health Canada’s new nicotine rules. Major regulatory changes are now in place to ensure NRT products are marketed responsibly, labeled clearly, and sold in ways that prioritize consumer safety.

These new regulations introduce tighter advertising restrictions, comprehensive labeling requirements, and significant limits on where and how nicotine pouches can be sold. So, what do these changes mean for your business?

Whether you’re a manufacturer, supplier, or marketer, they could impact your products, packaging, and promotions. Keep reading to learn what’s changing, how it affects your operations, and how you can stay ahead. 

What’s Changing and Why It Matters

Health Canada’s new regulations are reshaping the nicotine industry, particularly for products like NRTs. These changes intend to tackle growing concerns about youth access and ensure consumers have accurate, transparent information. Here’s a closer look at the updates and their impact on your business:

Clearer Labeling Standards 

All nicotine products must now display nicotine content in milligrams. This gives consumers a clear understanding of product strength, helping them make better choices. Labels also require bold health warnings about addiction risks to ensure safety information is easy to spot. 

For businesses, this is an opportunity to strengthen customer trust. Transparent labelling shows accountability and can help your product stand out in a competitive market. 

Stricter Advertising Guidelines 

Marketing campaigns must focus on adult smokers looking for smoking cessation tools. Claims like “helps reduce cravings” now require solid evidence to back them up. Additionally, anything that could appeal to youth or non-smokers, like colourful imagery or playful language, is strictly prohibited. 

As you may already know, this shift is about responsible promotion. Therefore, aligning your campaigns with these rules keeps your business compliant while ensuring your message resonates with the right audience. 

New Sales and Distribution Rules

The sale of nicotine products, especially pouches, is now only available in pharmacies and must stay behind the counter. Convenience stores and other general retailers can no longer stock them, ensuring tighter control over access.

This change might seem limiting, but it also provides businesses with a sales channel that prioritizes specific goals and follows strict rules. Partnering with pharmacies can streamline distribution and help you reach your target audience more effectively.

How These Changes Impact Your Business

Adapting to Health Canada’s new rules requires strategic adjustments across various aspects of your business:

  • Manufacturers: Labels and packaging need to be updated to meet the new standards. Additionally, products may need reformulation to comply with flavor restrictions, as only mint and menthol are permitted.
  • Suppliers: Distribution channels must shift to focus on pharmacy sales. This may involve building new partnerships and streamlining supply chains.
  • Marketers: Advertising strategies must be reviewed and refined. Focus on clear, evidence-based messaging that targets adult smokers and highlights approved therapeutic benefits.

While these adjustments may seem challenging at first, they also create opportunities to demonstrate your commitment to safety, compliance, and customer trust.

How to Stay Ahead

Navigating these changes doesn’t have to be overwhelming. Here are actionable steps to ensure compliance:

  1. Understand the rules: Start by reviewing Health Canada’s full guidelines on advertising nicotine replacement therapies.
  2. Update your products: Ensure your labels and packaging clearly display the required nicotine content and health warnings in a way that meets the standards. If necessary, you’ll need to adjust product formulations to meet flavor restrictions.
  3. Revise your marketing: Focus on approved claims, like smoking cessation benefits, and target adult smokers. Avoid any messaging that could appeal to youth or non-smokers.
  4. Optimize your sales strategy: Shift your focus to pharmacy sales and strengthen partnerships with regulated distributors.
  5. Get expert support: Compliance can be complex, but it doesn’t have to be. At Quality Smart Solutions, we specialize in helping businesses meet regulatory requirements quickly and effectively.

The Bottom Line

As you’ve learned, Health Canada’s new nicotine rules are all about creating a safer, more transparent market for consumers. By adapting to these changes, you protect your business, build trust with your audience, and position yourself as a leader in the industry.

Need help with the new rules? Quality Smart Solutions can help you meet NRT compliance. Contact us today and let us guide you through the process!

Categories
Blog

FDA 510(k) Pre-Submission: Steps for Medical Device Approval

Medical diagnostic device with a control panel and digital screen displaying test results, used for optical measurements.Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find themselves wondering where to start, what’s required, and how to get FDA approval for their medical devices. Without a clear plan, it’s easy to waste time and money on unnecessary steps, or worse, miss critical requirements that delay approval by years. 

That’s where the pre-submission process helps by clarifying what’s needed early on. Connecting with the FDA at this stage can prevent costly mistakes, keep your submission on track, and give you a roadmap for moving forward with confidence.  

By engaging with the FDA early, you’ll gain insights that can help avoid unexpected requirements or delays, setting you up for a smoother journey to approval. Keep reading to learn more about how the pre-submission process works and what steps to follow. 

What is the FDA 510(k) Pre-Submission Process? 

The FDA 510(k) pre-submission process is a chance to open a conversation with the FDA before committing to a full application. It begins by creating a structured document package that explains your device’s technology, intended use, and operation.  

This preparation demonstrates to the FDA that you’ve thoroughly researched your regulatory needs and are ready to proceed with compliance. Amit Guruprasad, a Quality Smart Solutions regulatory expert, explains, 

“The pre-submission process actually helps you build your regulatory strategy by connecting with the FDA early. You’re allowed to ask questions on specific topics, like intended use, regulatory strategy, or software validation, to get clear, actionable feedback that helps you avoid missteps.”

And here’s something you might not know: this process is part of the FDA’s Q-Submission Program, which supports several regulatory pathways, including 510(k). Curious to learn more? You can find more details in the FDA’s official guidance on the Q-Submission Program. 

Key Steps in the FDA 510(k) Pre-Submission Process 

Following these steps in the pre-submission process can help you avoid roadblocks and streamline your path to FDA approval. Here are the essential steps to follow in the FDA 510(k) pre-submission process: 

  1. Build your document package 
    To begin, start by putting together a comprehensive package that details your device’s technology, intended use, and comparisons with similar products. This package should reflect your due diligence regarding regulatory requirements and competitive products. 
  2. Ask targeted questions 
    Once your package is ready, you can submit questions on specific topics, such as intended use, regulatory strategy, or validation methods. While you have flexibility, Amit recommends focusing on well-chosen questions for the most practical feedback. “Clients pay us to ensure their document package is clear and to choose the right questions.” FDA responses typically arrive within 60 days, depending on their workload. 
  3. Review FDA responses and follow-up 
    After receiving responses, review the FDA’s feedback carefully. If anything is unclear, schedule a follow-up meeting with FDA specialists to discuss your technology and clarify any points. These one or two-hour meetings are ideal for getting additional insights into questions that may need further discussion.
  4. Reuse pre-submission documents 
    Did you know? One of the biggest advantages is that much of the work done in pre-submission can be reused in your official submission. Documentation developed during pre-submission serves as a foundation for your final 510(k) application, saving time and effort. 

Why the FDA 510(k) Pre-Submission Process Matters 

Many companies feel the pressure to get their devices to market as fast as possible, but skipping or rushing through pre-submission can often lead to setbacks. For complex devices, approval timelines can vary widely, sometimes stretching from two years to five years or even longer if unexpected issues arise. Who wants to face delays like that? 

That’s why the pre-submission process is so valuable: it gives you a clear preview of what the FDA expects, helping you avoid surprises and keep your device on a faster, more reliable path to approval. 

Amit emphasizes the importance of approaching pre-submission with careful planning, saying, 

“The work we do in pre-submission isn’t just about getting FDA feedback, it’s also about creating a foundation for a successful, streamlined approval process. By investing in pre-submission, clients set themselves up for a smoother journey through FDA approval, avoiding costly and time-consuming mistakes.”

Common Questions in FDA 510(k) Pre-Submission 

Here are a few examples of questions that can guide your device approval process: 

  • Is clinical testing required for this device? 
  • What specific performance standards should we meet? 
  • Can we use a particular testing approach, or are alternatives preferred? 

These questions help focus your efforts and make sure you’re on the right path from the start. 

How Quality Smart Solutions Can Help 

Navigating the FDA pre-submission process for medical devices doesn’t have to be overwhelming. At Quality Smart Solutions, our consulting team is here to guide each step, from creating your regulatory strategy to building a well-prepared submission package. 

  • Regulatory strategy: We help you find the best path to FDA approval. 
  • Submission package: Our team prepares a clear, complete package that meets FDA standards. 
  • Targeted FDA questions: We guide you in asking the right questions to avoid roadblocks. 
  • Follow-Up support: We’re here to guide you through each step with the FDA. 
  • Efficient 510(k) submission: We make sure all your pre-submission work flows right into your final application, saving you time. 

Let us help you bring your device to market with confidence and clarity, every step of the way. 

Categories
Blog

Canada’s Strict Infant Formula Registration: How Quality Smart Solutions Ensures Compliance and Success

baby Formula
Baby Formula

baby Formula

Are you ready to introduce your infant formula to the Canadian market? Health Canada’s stringent regulations ensure the safety, quality, and nutritional adequacy of all infant formulas. Registering an infant formula in Canada can feel overwhelming, but you can navigate the process smoothly with expert guidance. Quality Smart Solutions offers invaluable expertise to ensure every detail is compliant, so you’re fully prepared to meet Canada’s high standards. 

Step-by-Step: Canada’s Infant Formula Registration Process 

  1. Understand Canada’s Regulatory Requirements

Before applying, it’s crucial to grasp Health Canada’s requirements for infant formula registration, especially since the regulations under the Food and Drugs Act and Food and Drug Regulations (FDR) set strict standards for safety and nutrition. 

Key focus areas include: 

  • Nutritional Composition: Infant formula must meet specific dietary thresholds for proteins, fats, carbohydrates, vitamins, and minerals. 
  • Labeling Requirements: Labels must adhere to detailed guidelines on nutritional claims, ingredient listings, and preparation instructions. 
  • Pre-Market Notification (PMN): To bring an infant formula to market, a PMN must be submitted detailing the formula’s composition, manufacturing process, and safety. 
  1. Pre-Market Notification

A thorough Pre-Market Notification (PMN) submission is required for any new or modified formula. Health Canada assesses whether your formula aligns with Canadian safety and nutritional standards before reaching consumers. 

What you need for a successful PMN: 

  • Nutritional Analysis: Provide detailed nutrient data that aligns with FDR standards. 
  • Safety and Efficacy Data: Include clinical trials or other safety data proving the formula’s safety. 
  • Manufacturing Process: Describe the production process, including ingredient sourcing, quality controls, and safety measures to prevent contamination. 
  1. Conduct Clinical Studies (If Required)

For novel or significantly altered formulas, Health Canada may request clinical studies. These must follow Good Clinical Practices (GCP) to confirm the formula’s safety and that it supports average infant growth and development. 

  1. Adhere to Strict Labeling Guidelines

Compliance with labeling regulations is essential for Health Canada approval. Your formula’s label must clearly present: 

  • Nutrition Information: A complete breakdown of all essential nutrients. 
  • Approved Health Claims: Only regulated claims about nutritional adequacy are permissible. 
  • Preparation Instructions: Clear directions for safe preparation and feeding to avoid misuse. 
  1. Submit Your Application to Health Canada

Once you’ve gathered all documentation, submit your PMN via the Electronic Regulatory Submissions (ERS) Gateway. Ensure every detail is accurate to avoid costly delays. 

  • Typical Review Time: Health Canada’s review can take 90-180 days. Missing information can result in longer delays, so precision is vital. 
  1. Maintain Ongoing Compliance Monitoring

Once your infant formula is approved, maintaining compliance doesn’t end. Canadian regulations require continuous monitoring and adherence to evolving standards: 

  • Adverse Event Reporting: Report any incidents promptly to Health Canada. 
  • Product Recalls: Prompt reporting and recall procedures are mandatory for contamination or safety concerns. 
  • Label Updates: Be prepared to adjust your label when new regulations are implemented. 

 

Common Questions About Registering Infant Formula in Canada 

How long does the approval process take? 

Approval timelines range from 90-180 days, depending on the completeness and complexity of your submission. 

Do clinical studies have to be conducted? 

Not all formulas require clinical studies, but novel products or those with unique claims may require them to verify safety and effectiveness. 

Are health claims permitted on infant formula labels? 

Yes, but only approved claims in line with Health Canada’s nutritional guidelines can be included. 

The Challenge you face 

Navigating Canada’s strict infant formula registration requirements may be challenging but it’s achievable with the proper guidance. From understanding pre-market notifications to ongoing compliance, taking each step with accuracy ensures that your product meets Health Canada’s high standards. By adhering to these steps, your company can confidently enter the Canadian market with a safe, compliant, and nutritionally adequate formula for infants. 

What is really at stake? 

Incorrect registration can result in costly delays for your infant formula submission, especially considering the volume of correct and verified documentation needed. Another aspect is clinical trials which can be difficult and time-consuming to complete correctly. Quality Smart Solutions is your trusted and experienced partner in this process and save you both time and cost to get your infant formula on the market as quickly as possible.  

How Quality Smart Solutions Can Help You Register Successfully 

Quality Smart Solutions offers expert guidance through every stage of Canada’s infant formula registration process. Our experienced team ensures your submission is accurate, complete, and compliant, reducing the chances of delays or rejections. With Quality Smart Solutions, you gain a partner who understands Health Canada’s regulations profoundly and helps you achieve faster, smoother market entry. Fill out the form below and submit to ask us any questions you have. 

Categories
News

Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

Batch 4B

FDA Warning Letter

Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

The Natural and Non-Prescription Health Products Directorate (NNHPD) invites industry stakeholders to provide feedback on Batch 4b, with consultation open for 75 days. We encourage you to support any suggestions for monograph revisions with published evidence or clear rationale.

What’s Included in Batch 4b?

  • Updated Monographs for Topical Ingredients
    • 16 single-ingredient monographs for traditional plants now represent ingredient quantities as percentages. Your input confirms whether these concentrations are reasonable and align with industry standards.
  • New Topical Analgesics/Antipruritic Monograph
    • This addition, featuring natural health product ingredients, is based on the Nonprescription Drug Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard.

Access all documents in Batch 4b, including new monographs, directly here.

Step-by-Step Instructions to Submit Comments

Follow these steps to access and comment on the documents:

  1. Choose Your Language
    • Double-click the language-specific folder.
  2. Download the Monograph
    • Double-click the monograph you wish to view and click “Download” in the top right corner.
  3. Enable Editing
    • Open the document on your computer and click “Enable Editing” if prompted by a Protected View banner.
  4. Add Comments
    • Go to the “Review” tab in Word and use “New Comment” to add your input.
  5. Send Back Your Edited Document
    • Save your version with comments and email it to: nnhpd.consultation-dpsnso@hc-sc.gc.ca

Prefer Text-Based Comments?
You can also email your comments directly, clearly linking each comment to the corresponding monograph.

Deadline for Submission: January 14, 2025

We appreciate your insights and participation in shaping health product standards. Feedback must be submitted by January 14, 2025.

How Quality Smart Solutions Can Assist

Quality Smart Solutions specializes in guiding businesses through regulatory challenges like this consultation. Our experts clarify the comment submission process, ensuring your insights are aligned with regulatory expectations—partner with us to make your voice heard in compliance consultations like Batch 4b. Reach out to us by filling out the form below.

Categories
Blog

How to Master FDA Audits for Your Dietary Supplement Facility: A Complete Preparation Guide

Introduction 

Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing Practices (GMP) requirements. The FDA regularly inspects dietary supplement facilities to ensure manufacturing, labeling, and safety regulations compliance. But how can you ensure you’re ready? Failing to meet FDA standards can lead to severe consequences, including costly recalls and facility shutdowns. This guide will outline practical strategies to help you confidently and efficiently navigate the FDA audit process. 

What is an FDA Audit and Why is it Essential? 

An FDA audit is a thorough review of your manufacturing facility, focusing on processes, practices, and documentation to verify compliance with the FDA’s Current Good Manufacturing Practices (cGMP). The FDA’s primary concerns during an audit include: 

  • Ensuring safe manufacturing practices. 
  • Validating that product labeling is accurate and non-misleading. 
  • Confirming adherence to testing standards. 

Why Does It Matter? 

Failing an FDA audit could damage your brand’s reputation, disrupt your supply chain, and, in extreme cases, halt operations entirely. Ensuring your facility is always ready for inspection can minimize risk, safeguard your business, and build consumer trust. 

How to Prepare for an FDA Audit: Step-by-Step Guidelines 

1. Review and Update Your SOPs Regularly 

Ensure your Standard Operating Procedures (SOPs) are thorough, up-to-date, and reflect daily operations accurately. SOPs are crucial for: 

a. Detailing manufacturing processes. 

b. Outlining quality control protocols. 

c. Documenting employee training and qualifications. 

d. Ensuring traceability of raw materials. 

Action: Appoint a dedicated team to review SOPs regularly and ensure employees understand these protocols inside and out. 

2. Conduct Routine Internal Audits 

Internal audits allow you to identify issues before an official inspection. Prioritize areas such as: 

a. Documentation accuracy. 

b. Maintenance logs for equipment. 

c. Sanitation and cleanliness. 

d. Traceability of ingredients and products. 

Action: Schedule quarterly internal audits to address any potential gaps in compliance. Use these audits as practice to refine your processes for the real audit. 

3. Invest in Comprehensive Employee Training 

The FDA assesses employee training quality, as untrained staff can contribute to errors in manufacturing, packaging, and documentation. 

Action: Develop a training program that includes onboarding and ongoing education for all staff. Keep detailed training records to demonstrate competency and compliance readiness. 

4. Ensure Accurate, Detailed Record-Keeping 

Record-keeping is crucial for FDA audits, covering areas like: 

a. Batch production records. 

b. Results of quality control tests. 

c. Supplier qualification documents. 

d. Product labeling approvals. 

Action: Implement a structured system to ensure all records are up-to-date, complete, and readily accessible. Automating this process reduces the risk of errors and ensures records are audit-ready. 

5. Enhance Product Testing and Quality Control 

Dietary supplements require rigorous quality control to guarantee product safety including: 

a. Testing raw materials and finished products for contaminants. 

b. Keeping records of all testing for each batch. 

c. Ensuring validated testing methods. 

Action: Partner with a reliable third-party lab to conduct product testing and ensure your protocols meet FDA standards. Organize testing records for easy access during inspections. 

6. Verify Your Product Labeling and Claims 

The FDA scrutinizes dietary supplement labels to verify compliance with regulatory guidelines. Misleading or exaggerated claims can lead to penalties. 

Action: Review all product labels to ensure they align with FDA regulations. Avoid claims suggesting your product treats, cures, or prevents diseases, as these could reclassify the supplement as a drug. 

7. Schedule Mock Audits for Stress-Free Preparation 

Mock audits simulate the inspection process, allowing you to identify weaknesses and make improvements. 

Action: Hire a third-party consultant to conduct a mock FDA audit. This external perspective provides invaluable insights and allows you to fine-tune operations before the actual audit. 

Frequently Asked Questions (FAQs) 

  1. How frequently does the FDA audit dietary supplement facilities?

Typically, the FDA audits facilities every 2-3 years, but high-risk or more extensive facilities may see more frequent inspections. 

  1. What if my facility fails an FDA audit?

A failed audit can result in warning letters, product recalls, or even legal action. Fortunately, manufacturers often have an opportunity to address deficiencies before facing penalties. 

  1. How long does an FDA audit usually last?

Audits can last from a few days to several weeks, depending on the facility’s complexity and size. 

Conclusion 

Preparing for an FDA audit doesn’t have to be stressful. You can ensure your facility is always audit-ready by following these steps—regular SOP reviews, internal audits, staff training, accurate record-keeping, thorough testing, compliant labeling, and mock audits. Staying proactive and addressing any issues early will strengthen your compliance and help you confidently face FDA inspections. 

How Quality Smart Solutions Can Help 

At Quality Smart Solutions, we specialize in comprehensive FDA audit preparation for dietary supplement manufacturers. Our expert team offers services ranging from SOP development and employee training to mock audits, helping you achieve compliance with ease. Trust us to guide you through every step of the audit process so you’re fully prepared to meet FDA standards and build lasting consumer confidence. 

Categories
Blog

Unlocking Health Canada’s ANDS, SNDS, and NDS Pathways: Which is Right for Your Product?

Navigating Health Canada’s drug submission pathways can be daunting. How do you know which pathway—ANDS, SNDS, or NDS—best suits your product? Each submission route holds unique requirements and implications for compliance, review time, and cost. Choosing the right one can accelerate your time to market, streamline the regulatory process, and significantly impact your business’s bottom line.  This article breaks down each pathway, helping you determine which aligns with your goals, regulatory needs, and product type. Here’s what you need to know to make an informed decision on your drug submission. 

What is a New Drug Submission (NDS)? 

A New Drug Submission (NDS) is essential when launching a new drug in Canada. This pathway applies to drugs with new active ingredients, formulations, or therapeutic uses that haven’t been marketed in Canada.  Critical Characteristics of NDS: 
  1. Comprehensive Data Requirement: An NDS requires detailed clinical trial data showcasing the drug’s safety, efficacy, and quality. Preclinical data may also be required based on the drug’s nature. 
  2. Longer Review Time: NDS applications undergo rigorous review, typically lasting between 300-600 days. 
  3. When to Use: Choose the NDS pathway for introducing an entirely new drug or a novel therapeutic use for an existing drug not previously approved in Canada. 
Example: If you’re developing a breakthrough treatment for a chronic illness, you’ll need an NDS to gain Health Canada approval. 

What is a Supplemental New Drug Submission (SNDS)? 

The SNDS pathway is for significant changes to an already approved drug. These modifications can impact a drug’s safety, efficacy, or quality, necessitating regulatory review to ensure compliance. 
Key Characteristics of SNDS: 
  1. Modification Coverage: SNDS is needed for alterations in formulation, manufacturing, labeling, dosage, or therapeutic use. 
  2. Clinical Data: New clinical trial data may be required if changes affect the drug’s intended use or safety profile. 
  3. Moderate Review Time: SNDS submissions generally take 180-300 days for approval. 
  4. When to Use SNDS: Use the SNDS pathway when making substantial modifications to an approved drug. 
Example: If you have an approved drug for high blood pressure and want to add a therapeutic use for diabetes, submit an SNDS to ensure regulatory approval for the new indication. 

What is an Abbreviated New Drug Submission (ANDS)? 

Designed for generic drug products, the ANDS pathway allows manufacturers to show their product is bioequivalent to an already approved reference drug without conducting new clinical trials. 
Key Characteristics of ANDS: 
  1. Bioequivalence: This is the main requirement; manufacturers must prove that their generic product matches the brand-name drug in bioavailability through bioequivalence studies. 
  2. No Need for New Clinical Trials: New clinical data isn’t required since safety and efficacy are already established. 
  3. Shortest Review Time: ANDS submissions are reviewed within 180-300 days. 
  4. When to Use ANDS: Choose the ANDS pathway for bringing a generic version of a previously approved drug to market. 
Example: Developing a generic version of a cholesterol medication already available in Canada would require an ANDS submission. 

Comparing Health Canada’s ANDS, SNDS, and NDS Pathways: Which to Choose? 

1. Type of Product: 
a. NDS: For new drugs with unapproved ingredients or therapeutic uses.  b. SNDS: For significant changes to an existing, approved drug.  c. ANDS: For generics proving bioequivalence. 
2. Data Requirements: 
a. NDS: Requires full clinical data for safety, efficacy, and quality.  b. SNDS: Requires data based on the modification’s impact on the drug.  c. ANDS: Focuses on bioequivalence studies; no extensive clinical trials. 
3. Review Times: 
a. NDS: Longest review time of 300-600 days.  b. SNDS: Moderate review time of 180-300 days.  c. ANDS: Shortest review time, typically 180-300 days. 
4. Associated Fees: 
a. NDS: CAD 590,346.  b. SNDS: CAD 305,690.  c. ANDS: CAD 305,690.  These pathways represent a regulatory requirement and a strategic business choice. Submitting under the correct pathway ensures a more streamlined review process, reducing potential delays and fees. 

Frequently Asked Questions 

  1. Which pathway is appropriate if I’m reformulating a drug?
If the reformulation significantly impacts safety, efficacy, or quality, an SNDS is required. 
  1. How long does the ANDS approval process take?
An ANDS typically takes between 180-300 days, depending on the submission’s completeness. 
  1. Can I use the NDS pathway for a generic drug?
No, generics follow the ANDS pathway to demonstrate bioequivalence to an approved reference product. 

How Quality Smart Solutions Can Help 

Quality Smart Solutions specializes in guiding pharmaceutical companies through Health Canada’s regulatory pathways, including ANDS, SNDS, and NDS submissions. With expert insights and thorough support, they help streamline the submission process, ensure complete and accurate documentation, and expedite regulatory approval. Partnering with Quality Smart Solutions could save your business time, reduce costs, and prevent unnecessary setbacks in bringing your product to market. References 
  1. 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 
  1. 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 
  1. 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 
 
Get Updates And Stay Connected -Subscribe To Our Newsletter
Subscribe Now
About us

Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

Know More
Twitter Facebook-f Youtube Linkedin Instagram
Compliance Solutions
Quick Links
Contact Us

Subscribe to global regulatory updates

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.