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Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews From: Health Canada News release Health Canada approves new drug to treat metastatic breast cancer through international and domestic joint reviews April 9, 2019 -…
Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making Health Products and Food Branch Notice April 16, 2019 Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions Health Canada is delighted to announce that…
Consultation on Draft Guidance: Accelerated Review of Human Drug Submissions Current status: Closed The consultation ran from May 7, 2019 to July 21, 2019. Health Canada is announcing a 75 day consultation on the draft Guidance: Accelerated Review of Human Drug Submissions. The…
Consultation on the Draft Guidance: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling From Health Canada Current status: Closed This consultation ran from May 10, 2019 to July 19, 2019. This draft guidance provides information on the…
Consultation - Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs From Health Canada Current status: Closed This consultation ran from May 10, 2019 to July 19, 2019. This draft guidance provides information on the interpretation…
Foreign Risk Notification, Annual Summary Reports, and Issue-related Analysis of Safety and Effectiveness for Medical Devices - Draft Guidance Document June 2019 PDF Version (465 K) Table of Contents Introduction Definitions Foreign Risk Notification (Sections 61.2 and 61.3)…
Public release of clinical information We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical devices. This information can have widespread benefits for: patients the health care system For example, giving more…
Health products cost recovery initiatives On this page Our approach to fees History of fees for health products Consultation and engagement Contact us Our approach to fees Health Canada's approach to cost recovery regimes for health products is guided by the principles of:…
Strengthening the use of real world evidence and regulations for medical devices This project aims to improve our ability to monitor medical device safety and effectiveness across the product life cycle. It will also help us to develop new regulatory options to prevent and…
Strengthening the use of real world evidence for drugs From Health Canada This project aims to improve our ability to assess and monitor the safety, efficacy and effectiveness of drugs across the drug life cycle. It will do this by optimizing the use of real world evidence (RWE)…
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