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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
Monkeypox, the disease caused by the animal-to-human transmission of the Monkeypox virus, is a zoonosis of the Orthopoxvirus genus within the Poxviridae family. While appearing similar to smallpox, it is […] Read More >>
On July 20, 2022, Health Canada published amendments to the Food and Drug Regulations (FDR), introducing new regulations for supplemented foods as a category. These new regulations continue to protect […] Read More >>
New labelling requirements announced by Health Canada in Canada Gazette, Part II, Volume 156, Number 14 titled “Regulations Amending the Natural Health Products Regulations” have come into effect as of […] Read More >>
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 >>
In regulatory affairs, a dossier is a term used to describe a compilation and array of documents regarding the safety, efficacy, and quality information of a medical product. The dossier […] Read More >>
One of Health Canada’s largest initiatives in the past few years has been the Self-Care Framework, which implements a different approach to regulating products, that are purchased and applied directly […] Read More >>
Prop 65, California’s right-to-know law that requires a clear and reasonable warning for chemicals known to cause cancer or reproductive harm, finds that coffee does not require a cancer warning. […] Read More >>
Last summer, Health Canada implemented the Plain Language Labelling criteria for non-prescription products and has mandated that by June 30, 2021, all products must be compliant at the retail level. […] Read More >>
In early January 2018, the Advertising Standards Canada (ASC), the non-profit industry group that provides guidance to industry and Health Canada on acceptable marketing claims, provided an update to the […] Read More >>
Service(s) related to this article: Food & Beverages Health Canada is proposing to restrict marketing unhealthy foods and beverages to children under 17 years. As part of Health Canada’s Healthy […] Read More >>
December 14, 2016 Canada Gazette II Publishes Amended Food Label Regulations On December 14, 2016 Health Canada announced amendments to the Food and Drug Regulations in reference to the labelling […] Read More >>
Healthy eating can be challenging due to several factors, some beyond the control of the consumer. This is why the Government of Canada is taking actions to make the healthier […] Read More >>
If you are at all involved in the manufacturing and/or sale of Natural Health Products, you no doubt have heard of Health Canada’s proposal concerning the Regulation of Self-Care Products […] Read More >>
On September 8, Health Canada’s Food Directorate issued a call for scientific data and information on Cyclospora cayetanensis on fresh leafy vegetables. Cyclospora cayetanensis is a microorganism that causes disease […] Read More >>
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