As of March 21, 2023, the Natural and Non-prescription Health Product Directorate (NNHPD) began applying new refusal criteria against Site Licence (SL) and Foreign Site Reference Number (FSRN) submissions, as […] Read More >>
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 >>
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 >>
The cost to obtain an MDEL (Medical Device Establishment Licence) and MDL (Medical Device Licence) in Canada depends on the medical device’s classification. In this blog, we will break down […] Read More >>
Bioanalysis is the quantitative evaluation of analytes/substances in biological matrices such as tissue, blood, serum, urine, or other body fluids. Bioanalytical testing involves using a validated bioanalytical method for the […] 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 >>
Regardless of whether you are developing a new food or dietary supplement/natural health product (NHP) that you intend to sell in either the United States, or Canada, you must follow […] Read More >>
Clinical research in Canada has seen a significant uptick in interest from Sponsors and Investigators since the onset of the COVID-19 pandemic. This interest is perhaps a precipitate of increasing […] Read More >>
Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and caffeinated energy drinks) which are set to expire on December 31, 2021, […] Read More >>
If you are currently using a COVID-19 Site Licence to manufacture, package, label, or import alcohol-based hand sanitizers, your licence will expire September 30, 2021. Background In August of 2020, […] Read More >>
On July 16, 2021, Health Canada issued a Notice to Interested Parties about a Proposal to amend the Cosmetic Regulations.According to the notice, the Proposal is open to pre-consultation from […] Read More >>
This website uses cookies, as described in the Privacy Policy. By clicking on the Accept All Cookies button, or by continuing to use our website, you consent to all cookies.
This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may have an effect on your browsing experience.
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
Please provide your details below to connect with us at the event
Please complete the form below to access the recording
Please complete the form below to access our free whitepaper
Please complete the form below to access our free webinar
Apply Now
2021 Digital Conference Registration
Please complete the form below to register for the summit. All fields are required.
