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24

Apr 2026

Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
By
Health Canada has announced a significant regulatory update affecting sports electrolyte products, formally transitioning them from the Natural Health Product (NHP) framework to the food regulatory framework. This change reflects […] Read More >>

27

Mar 2026

Does My Product Need an NPN in Canada
Does My Product Need an NPN in Canada
By
Many companies entering the Canadian market ask the same question: does my product require an NPN? The answer depends on scope. In Canada, a product may require a Natural Product […] Read More >>

18

Mar 2026

Health Canada Updates the NHP MAP: What Industry Needs to Know
Health Canada Updates the NHP MAP: What Industry Needs to Know
By
Health Canada has released an updated version of the Natural Health Products Management of Applications Policy (NHP MAP), replacing the previous guidance published in April 2019. The revised NHP MAP […] Read More >>

12

Mar 2026

Updates to the Safe Food for Canadians (SFC) Licensing Process: What Industry Needs to Know
Updates to the Safe Food for Canadians (SFC) Licensing Process: What Industry Needs to Know
By
The Canadian Food Inspection Agency (CFIA) has announced important updates to the Safe Food for Canadians (SFC) licensing process, introducing additional information requirements, enhanced pre-issuance review procedures, and significantly longer […] Read More >>

25

Feb 2026

Health Canada Is Abolishing Foreign Site Reference Numbers: What NHP Companies Need to Know
Health Canada Is Abolishing Foreign Site Reference Numbers: What NHP Companies Need to Know
By
Health Canada is abolishing Foreign Site Reference Numbers (FSRNs). The details are outlined below, but the key takeaway is this: FSRNs are no longer available or accepted, and foreign site […] Read More >>

06

Feb 2026

Health Canada Consultation: Draft Prebiotics Monograph for Natural Health Products
Health Canada Consultation: Draft Prebiotics Monograph for Natural Health Products
By
Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has launched a 15-business-day consultation on a new draft Prebiotics Monograph for Natural Health Products (NHPs). Stakeholders have until February 20, […] Read More >>

21

Nov 2025

Health Canada Releases Two New Regulatory Tools: What NHP Companies Need to Know
Health Canada Releases Two New Regulatory Tools: What NHP Companies Need to Know
By
On November 18, 2025, the Natural and Non-prescription Health Products Directorate (NNHPD) introduced two important regulatory tools designed to bring greater clarity, predictability, and flexibility to Canada’s Natural Health Product […] Read More >>

31

Oct 2025

Health Canada Postpones Implementation of NHP Cost Recovery Fees
Health Canada Postpones Implementation of NHP Cost Recovery Fees
By
Health Canada has confirmed that implementation of the proposed cost recovery fees for Natural Health Products (NHPs) will not proceed on December 1, 2025, as originally planned. According to correspondence […] Read More >>

05

Sep 2025

Health Canada Finalizes New Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs)
Health Canada Finalizes New Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs)
By
In October 2024, Health Canada launched a consultation to update the 2015 Good Manufacturing Practices (GMP) Guidance Document (Version 3.0). That draft focused on simplifying language, aligning with international quality […] Read More >>

27

Aug 2025

Integrated framework for point-of-care diagnostic validation
Integrated framework for point-of-care diagnostic validation
By
dicentra published a new JALM article (Aug 2025) presenting a staged framework that integrates analytical validity, clinical validity, clinical utility, regulatory strategy, and integrated evidence generation. Regulatory Approved Point-of-Care Diagnostics Read More >>

25

Aug 2025

Understanding Health Canada’s Cosmetic Notification Form: What You Need to Know
Understanding Health Canada’s Cosmetic Notification Form: What You Need to Know
By
If you plan to sell cosmetics in Canada, one of the first compliance steps is completing Health Canada’s Cosmetic Notification Form (CNF). This form is an essential regulatory requirement under […] Read More >>

11

Jul 2025

HS-Codes, Health Products, and the Ongoing Trade War
HS-Codes, Health Products, and the Ongoing Trade War
By
As Canada continues to engage in an ongoing global trade war, it is important that you ensure your products are properly classified, both from a regulatory and a commercial perspective. […] Read More >>

01

Jul 2025

“Made in Canada” Label Claims: What You Need to Know to Stay Compliant
“Made in Canada” Label Claims: What You Need to Know to Stay Compliant
By
As Canadian businesses prepare to celebrate Canada Day, many are looking to highlight their national pride by adding “Made in Canada” or “Product of Canada” claims to their product labels. […] Read More >>

14

Mar 2023

Reminder: Annual Licence Renewal (ALR) Application Due Date for MDELs is April 1, 2023
Reminder: Annual Licence Renewal (ALR) Application Due Date for MDELs is April 1, 2023
By
The ALR application due date for MDELs is April 1, 2023. If you hold a Medical Device Establishment Licence (MDEL), you must submit your completed ALR application before April 1. […] Read More >>

17

Feb 2023

Proposed Changes to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
Proposed Changes to the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs)
By
On December 22, 2022, Health Canada opened consultation on a proposal to amend the Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs). The […] Read More >>

17

Feb 2023

Health Canada Proposes to Update Regulations for Biologic Drugs
Health Canada Proposes to Update Regulations for Biologic Drugs
By
On December 16, 2022, Health Canada issued a notice to stakeholders regarding their proposal to amend the regulations for Biologic Drugs (Schedule D drugs) in Division 4, Part C, of […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials
Health Canada Draft Guidance Document: On the Collection and Analysis of Disaggregated Data in Clinical Trials
By
On December 17, 2022, Health Canada pre-published in Canada Gazette Part I, amendments to the Food and Drug Regulations (FDR). Health Canada is recommending new provisions for new drug submissions […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: Management of Rolling Reviews for Drug Submissions
Health Canada Draft Guidance Document: Management of Rolling Reviews for Drug Submissions
By
Health Canada is proposing new amendments to the Food and Drug Regulations and Medical Devices Regulations. Part of these amendments include “new provisions that enable the rolling review of a […] Read More >>

17

Feb 2023

Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
Health Canada Draft Guidance Document: Proposed Changes to Labelling of Pharmaceutical Drugs for Human Use
By
On December 21, 2022, Health Canada opened a consultation on a proposal to amend the labelling of pharmaceutical drugs for human use guidance document. The amendments that have been proposed […] Read More >>

06

Feb 2023

What is a CRO in Clinical Trials?
What is a CRO in Clinical Trials?
By
A CRO, or Contract Research Organization, is an outsourced service provider that manages clinical trials. CROs are designed to help make research more feasible. It should then come as no […] Read More >>

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