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Health Canada increasing oversight of marketed drugs and …

WEBYu Seon Gadsden-Chung. Health Canada recently proposed amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) to …

Actived: 8 days ago

URL: https://www.torys.com/en/our-latest-thinking/publications/2023/06/health-canada-increasing-oversight-of-marketed-drugs-and-medical-devices

At long last! Health Canada delivers long-promised, revamped …

WEBIn Canada, advertising health products to healthcare professionals (HCPs) and the public is restricted by regulations under the Food and Drugs Act 1 and the …

Category: Food Go Health

Health Canada updates guidance on switching of a …

WEBOnce Health Canada is satisfied with the NDS/SNDS, the existing PDL amendment process 6 will be initiated. For switches to NPDs, Health Canada will issue a Drug Notification Form with the assigned …

Category: Health Go Health

Health Canada launches eSTAR pilot programs to simplify medical …

WEBRecently, Health Canada announced two pilot programs for eSTAR, an interactive PDF form that guides an applicant through the process of preparing a …

Category: Health Go Health

AI healthcare companies: navigating the cutting edge of …

WEBHealth Canada must, therefore, balance the need to identify emerging risks associated with these products versus the impracticality of repeatedly re-evaluating products for …

Category: Health Go Health

Drug pricing and reimbursement: Canada’s healthcare …

WEBAuthors. This video is the first in a series of four which will explain the legal framework of the health care system, and regulation of drugs and drug pricing, in Canada at the federal and provincial levels. The series is …

Category: Health Go Health

Health Canada streamlines program for access to unapproved …

WEBHealth Canada’s online guidance states that these programs are not intended to promote the early use of drugs, or to bypass the clinical trial or regulatory review and approval …

Category: Health Go Health

Drug pricing and reimbursement: The role of provinces and

WEBThis video is the fourth and final in a series which will explain the legal framework of the health care system, and regulation of drugs and drug pricing, in …

Category: Health Go Health

Drug pricing and reimbursement: Overview of the approval …

WEBManpreet Singh. This video is the second in a series of four which will explain the legal framework of the health care system, and regulation of drugs and drug …

Category: Health Go Health

Public access to clinical information on drugs and medical

WEBHealth Canada has signaled its intention to adopt an internationally harmonized format for medical device applications, and the delayed implementation of proactive publication for …

Category: Medical Go Health

Software as Medical Devices and Digital Health in Canada: What's …

WEBHealth Canada is expected to take SAP-SaMD’s comments into account prior to releasing the draft SaMD Guidance Document for external consultation with medical device …

Category: Medical Go Health

Health Canada updates its guidance on promotion of health …

WEBHowever, Health Canada provides examples of additional circumstances in which a message or activity related to a health product may be considered non-promotional. The …

Category: Health Go Health

Gene-edited plants get lighter regulatory touch in new Health …

WEBHealth Canada has signaled a favourable regulatory environment for foods derived from gene-edited plants in new guidance on novel foods (Guidance on the …

Category: Food Go Health

Time for reform: cannabis regulations to undergo amendment to …

WEBHealth Canada has published a Notice of Intent 1 to review the Cannabis Regulations (Regulations) with the aim of streamlining and clarifying existing …

Category: Health Go Health

Update on Canada’s finalized framework for supplemented foods …

WEBThe federal government finalized amendments to the Food and Drug Regulations (FDR) 1 and the Natural Health Products Regulations (NHPR) 2, which …

Category: Food Go Health

Increased post-market surveillance for medical devices coming to …

WEBIn 2014 the Canadian federal government passed Bill C-17, known as Vanessa’s Law, amending the Food and Drugs Act and increasing Health Canada’s powers to obtain …

Category: Food Go Health

Get your daily dose! Regulatory framework for supplemented …

WEBHealth Canada has recently proposed amendments to the Food and Drug Regulations (FDR) 1 and the Natural Health Products Regulations (NHPR) 2, to …

Category: Food Go Health

Private health centres in Ontario: changes to current regime

WEBOn February 23, 2023, the Ontario government introduced Bill 60 as a means to “expand access to publicly funded community-based health services” 1 …

Category: Health Go Health

Health Canada instructed to reconsider scope of CSP protection …

WEBOn July 10, the Federal Court of Canada released its decision in a judicial review of the Minister of Health’s refusal to grant a Certificate of Supplementary …

Category: Health Go Health

High hopes: proposed changes to the Canadian cannabis regime …

WEBHealth Canada is consulting stakeholders on the expansion of non-therapeutic cannabis research involving human participants. Input is also being solicited …

Category: Health Go Health

What to use vs. how to treat: Important distinction for

WEBIf the essential elements of a claim give instruction to health care professionals on “what” to use to treat a patient, then the claims are not directed to a …

Category: Health Go Health