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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.

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Canada’s regulatory approach to drugs for rare diseases: orphan drugs From Health Canada Canada's regulatory approach Clinical trials: apply and register Find a clinical trial Find drug reviews and decisions About orphan drugs and rare diseases Our role in bringing drugs to…

Consultations on improving the regulatory review of drugs and devices Current Status: Open We are improving the regulatory review process of drugs and medical devices in Canada. We are committed to openness and transparency and we want you to have your say throughout the process.…

Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview New products under serious adverse reaction hospital reporting requirements: Notice [2023-02-15] Related acts and regulations Food and Drugs Act Food and Drug Regulations…

How else we use or share your personal information The Canada Vigilance Program may share your personal information with other programs within Health Canada that support mandatory reporting by hospitals.

Suspect a serious adverse drug reaction or medical device incident Download the alternative format (PDF format, 674 KB, 1 page) Organization: Health Canada Type: Poster Published: 2019-06-26 There are new reporting requirements for hospitals Every report counts Together they tell…

Mandatory reporting by hospitals of serious adverse drug reactions related to biocides: Notice Learn how the new Biocides Regulations will change mandatory reporting obligations for hospitals. On this page New regulations for biocides About mandatory reporting and biocides…

New products for serious adverse drug reaction hospital reporting: Notice February 15, 2023 Our file number: 23-101396-13 New products have been added to those that fall under the serious adverse drug reaction (ADR) reporting requirements for hospitals. The additions are a result…

Health products post-market surveillance cycle Download in PDF format (542 KB, 2 pages) Organization: Health Canada Date published: August 2024 Recognize All health products have risks and benefits associated with their use. Drug and medical device safety knowledge and issues…

Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary From Health Canada Overview This guidance document provides information on applications for Investigational Testing Authorization (ITA). This includes ITA review process…

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