Catalogue - Canadian Urban Data Catalogue (CUDC)

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Catalogue Entry: Adverse reactions, medical device incidents and health product recalls in...

Each year, Health Canada receives thousands of reports of suspected adverse reactions (side effects) about drugs and natural health products and of suspected medical device...
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Catalogue Entry: Submitting risk management plans draft guidance document: Canadian-specific...

A Canadian-specific addendum should address: risks or uncertainties that are unique to the Canadian context, and measures that the manufacturer intends to take that are unique...
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Catalogue Entry: Submitting risk management plans draft guidance document: RMP summary template

The RMP summary should include specific sections, which mirror the EU RMP Summary format sections.
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Catalogue Entry: Submitting risk management plans draft guidance document: Opioid products

Opioid products need to include specific content within their RMP to address: the risk and uncertainties of opioid-related harms in Canada and other risks and uncertainties...
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Catalogue Entry: Submitting risk management plans draft guidance document: Procedures to submit

Information on risk management plan submissions for drugs including when to file, considerations, requirements, and compliance.
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Catalogue Entry: Submitting risk management plans draft guidance document: Introduction

Health Canada has adopted and integrated the use of risk management plans (RMPs) and the International Conference on Harmonization (ICH) E2E Guideline into the regulatory review...
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Catalogue Entry: Regulatory Requirements for Advertising

Only health products that Health Canada authorizes for sale in Canada may be advertised. Specific requirements exist for advertisements of prescription drugs to consumers.
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Catalogue Entry: Regulating health products

Learn how Health Canada makes sure that the health products you use are safe, effective and of high quality.
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Catalogue Entry: Regulating Advertising of Health Products

Health Canada sets the standards for health product advertising material in Canada to help advertisers produce messages that are not false, misleading or deceptive.
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Catalogue Entry: Reporting adverse reactions to marketed health products - Guidance document...

This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural...
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Catalogue Entry: Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making

Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions.
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Catalogue Entry: Notice of clarification to drug manufacturers and sponsors:...

We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the risk management plans (RMPs) for...
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Catalogue Entry: Notice of clarification to drug manufacturers and sponsors - Risk Management...

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled...
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Catalogue Entry: Module 4: Health Canada’s review and communication of safety findings

Educational module provides overview of health product vigilance, report management, post-market surveillance activities and Health Canada risk communications.
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Catalogue Entry: Module 3: Strategies to promote and support mandatory reporting

Educational module helps identify and overcome barriers to hospital mandatory reporting of adverse drug reactions and medical device incidents, recognize opportunities and...
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Catalogue Entry: Module 2: Reporting processes to Health Canada

Educational module includes considerations for mandatory reporting of adverse drug reactions and medical device incidents, reporting options to Health Canada, differentiating...
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Catalogue Entry: Module 1: Overview of Vanessa’s Law and reporting requirements

Educational module includes an outline of Vanessaâ€™s Law, who/what/when of regulations for mandatory reporting of adverse drug reactions and medical device incidents, required...
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Catalogue Entry: Let's talk about acetaminophen

Acetaminophen is safe and effective when used as directed, but there is a limit to how much you can take in one day. Taking more than the recommended dose can cause severe or...
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Catalogue Entry: Laser eye surgery

Thousands of Canadians are turning to laser eye surgery to correct their vision and eliminate their dependency on glasses or contact lenses. Like all medical procedures, laser...
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Catalogue Entry: Health Canada's Response to the Carlin Jury Recommendations Aimed at the...

Health Canada's top priority is protecting the health and safety of Canadians. The department has a strong record of enhancing drug safety in Canada and is continually looking...
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2,942 catalogue entries found