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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
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 >>
The team at dicentra has been closely monitoring the COVID-19 pandemic and has been active in taking the necessary steps to help protect the health and safety of both our […] Read More >>
With the recent announcement that Coronovirus has gone pandemic, consumers are flooding supermarkets, and preparing for indeterminate periods of self-isolation. All the while the marketplace is reeling, seeing demand for […] Read More >>
Companies following the media coverage surrounding Coronavirus may be interested to know that their Broad Spectrum viricides could be eligible to be used as an Expected Claim related to Emerging […] Read More >>
Based on what is currently known about the novel coronavirus (COVID-19) and similar coronaviruses that cause SARS (Sudden Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome), the most common […] Read More >>
Software is used extensively in medical devices for gathering, monitoring, and transmitting data to healthcare professionals and clinical technicians. Although software can be an extremely useful tool as a medical […] Read More >>
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