Health Canada Proposes a Streamlined Pathway for Certain Low-Risk Non-Prescription Drugs 

Health Canada Proposes a Streamlined Pathway for Certain Low-Risk Non-Prescription Drugs 

Health Canada is proposing a streamlined authorization pathway for certain low-risk non-prescription drugs in Canada. Eligible List D products that fully comply with an applicable Health Canada monograph could be exempted from Division 8 “new drug” requirements and instead apply for a Drug Identification Number (DIN) under Division 1. The proposal may…
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Webinar Recap: Understanding the Organic Certification Process in Canada: What You Need to Know

Webinar Recap: Understanding the Organic Certification Process in Canada: What You Need to Know

The organic certification process in Canada generally involves reviewing the Canadian organic standards, selecting a certification body, preparing an Organic System Plan, completing an inspection, addressing any non-compliances, and maintaining certification through annual renewal. Source Nutraceutical, Inc. (SNI) recently welcomed the Fraser Valley Organic Producers Association (FVOPA) for a guest…
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How Long Does It Take to Get a Natural Product Number (NPN) in Canada?  

How Long Does It Take to Get a Natural Product Number (NPN) in Canada?  

Obtaining a Natural Product Number (NPN) in Canada typically takes approximately 60 calendar days for Class I applications, 90 calendar days for Class II applications, and 270 or more calendar days for Class III applications. Due to current review backlogs, companies submitting Class III applications should plan for timelines closer…
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Canadian Food Inspection Agency (CFIA) Finalizes Labelling Guidance for Plant-Based Egg Alternatives in Canada  

Canadian Food Inspection Agency (CFIA) Finalizes Labelling Guidance for Plant-Based Egg Alternatives in Canada  

CFIA’s guidance explains how plant-based egg alternatives should be labelled and advertised in Canada to avoid misleading consumers. It focuses on clear common names, accurate claims, imagery, packaging, advertising, and the overall impression created by the product. With compliance expected by January 1, 2030, companies should review labels and marketing…
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Industry Insight: June 2026 Update: Health Canada Provides Updates on Human Drug Submission Workload Management

Industry Insight: June 2026 Update: Health Canada Provides Updates on Human Drug Submission Workload Management

As of June 2026, Health Canada is advancing workload management measures intended to address human drug submission backlogs, improve review predictability, and support more transparent communication with sponsors. These measures include enhanced communication protocols, expanded reliance approaches, HTA alignment, and operational review efficiencies, while maintaining Health Canada’s review standards for…
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Industry Insight: June 2026 Update: Health Canada Discusses GMP Inspection Trends, Quality System Expectations, and Compliance Priorities for DEL

Industry Insight: June 2026 Update: Health Canada Discusses GMP Inspection Trends, Quality System Expectations, and Compliance Priorities for DEL

On Tuesday June 23, 2026, at the Pharmaceutical Sciences Group’s (PSG) 9th Annual Day with Health Canada, Karolina Zarichna from Source Nutraceutical, Inc. (SNI) attended discussions on recent Good Manufacturing Practices (GMP) inspection trends and compliance expectations for Canadian and foreign drug establishments.  Health Canada provided insight into inspection observations…
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Industry Insight: June 2026 Update: Health Canada Discusses the Future of NHP Regulation

Industry Insight: June 2026 Update: Health Canada Discusses the Future of NHP Regulation

At the Pharmaceutical Sciences Group’s (PSG) 9th Annual Day with Health Canada Tuesday June 23, 2026, Karolina Zarichna from Source Nutraceutical, Inc. (SNI) attended discussions on the evolving direction of Canada’s Natural Health Product (NHP) regulatory framework.  Health Canada highlighted a continued shift toward a more risk-based and proportionate approach to NHP…
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What Evidence Do You Need to Substantiate Veterinary Health Product (VHP) Claims in Canada?

What Evidence Do You Need to Substantiate Veterinary Health Product (VHP) Claims in Canada?

In Canada, Veterinary Health Product (VHP) claims must be supported by objective and credible evidence aligned with the product’s ingredients, conditions of use, and intended purpose. Claims should focus on maintaining or promoting animal health and must not represent the product as treating, diagnosing, mitigating, preventing, or curing disease. Introduction…
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Health Canada Updates FPS Expectations for NHP Applications

Health Canada Updates FPS Expectations for NHP Applications

As of June 15, 2026, Health Canada no longer expects finished product specifications (FPS) to be submitted upfront with Class II and Class III NHP product licence applications (PLAs) or amendments. However, an FPS must still be established, maintained, and provided to Health Canada upon request. Introduction Health Canada has…
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How to Prepare for a Health Canada NHP Site Licence Inspection 

How to Prepare for a Health Canada NHP Site Licence Inspection 

To sell a natural health product (NHP) in Canada, companies must consider both product licensing and site licensing requirements. A product licence authorizes the sale of a specific NHP, while a site licence is required for the Canadian physical site where NHPs are manufactured, packaged, labelled, or imported for sale.  Obtaining these licences requires…
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