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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 >>

01

Feb 2023

Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
Health Canada Draft Guidance Document: Terms and Conditions for Medical Devices
By
Health Canada is proposing expanding the Terms and Conditions (T&Cs) on Class II to IV medical device licences to support the life cycle approach for regulating medical devices. This is […] Read More >>

19

Apr 2022

Interim Order Number 3 for Medical Devices is Now in Effect.
Interim Order Number 3 for Medical Devices is Now in Effect.
By
Health Canada’s use of Interim Orders (IOs) has allowed for the exceptional importation and sale of Medical Devices (MDs) to help prevent shortages in relation to COVID-19. To date, Health […] Read More >>

28

Mar 2022

How is Digital Health Regulated in Canada?
How is Digital Health Regulated in Canada?
By
As innovation continues to evolve in digital health technologies, Health Canada is undertaking an adaptive initiative to support better access to those therapeutic products, especially in relation to medical devices. […] Read More >>

18

Mar 2022

New Compliance Date Set for Health Canada’s 5-year Food Labelling Changes Plan
New Compliance Date Set for Health Canada’s 5-year Food Labelling Changes Plan
By
Health Canada has announced December 14, 2022, as the new date for when the Canadian Food Inspection Agency’s (CFIA) updated food labelling regulations (which came into effect on December 14, […] Read More >>

21

Aug 2020

NNHPD Interim Measures Update Regarding Product and Site Licensing for Hand-Sanitizers
NNHPD Interim Measures Update Regarding Product and Site Licensing for Hand-Sanitizers
By
The temporary exemptions for the importation of hand sanitizers, which was announced March 27, 2020, as part of the Natural and Non-Prescription Health Products Directory (NNHPD)’s interim measures have now […] Read More >>

26

Jun 2020

COVID-19’s Impact on Natural Products & Nutraceutical Clinical Research in Canada – An Unlikely Advantage
COVID-19’s Impact on Natural Products & Nutraceutical Clinical Research in Canada – An Unlikely Advantage
By
In addition to governing pharmaceutical and medical device research, Health Canada provides oversight and approval of nutraceutical clinical research and natural health products conducted in Canada. This integrated approach allows […] Read More >>

17

Apr 2020

CFIA Compliance Date Postponed
CFIA Compliance Date Postponed
By
The Safe Food for Canadians Act & Regulations came into force on January 15, 2019, and had outlined compliance dates in 2020 and 2021 based on the type of food […] Read More >>

01

Apr 2020

Canada COVID-19 Update: $50 Million Ontario Fund
Canada COVID-19 Update: $50 Million Ontario Fund
By
On April 1, the Ontario Government announced a $50 million fund called “The Ontario Together Fund” which is intended to help businesses produce essential medical products amid the COVID-19 pandemic. […] Read More >>

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