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Found 47346 records

Drug shortages are a complex and pressing global issue with serious implications for the health and well-being of Canadians. Sudden …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Drug Shortages drug supply chain patients health care professionals health care system mandatory notification notification of drug-shortages

Notification and communication of drug shortages by drug manufacturers and importers is an essential component of preventing and mitigating shortages. …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Drug Shortages drug supply chain patients health care professionals health care system information on drug-shortages

Health Canada is responsible for helping the people of Canada maintain and improve their health. This is done, in part, …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Canadian drug supply drug shortages GUI-0146 requirements for providing-information Canadian drug market drug use-outside Canada access to drugs stakeholders across drug-supply-chain stability of drug-supply

Organizations and the provinces/territories continue to make progress in the marketing and reimbursement of edaravone (brand name Radicava). Currently, all …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: notice of update edaravone marketing of edaravone reimbursement of edaravone Radicava prescription status personal importation drug formularies

Health Canada and the U.S. Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: HC USA Food and Drug Administration Joint Public Consultation International Council for Harmonisation ICH Technical Requirements Pharmaceuticals for Human Use

Health Canada is pleased to announce the release of five associated revised draft guidance documents on Post-Notice of Compliance (NOC) …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: draft revised guidance post-notice of compliance changes for pharmaceutical changes for biologic changes for radiopharmaceutical drugs for human-use for stakeholder consultation

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process, which includes the …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: notice of clarifications access to restricted-drugs Special Access Program SAP drug review process access to drugs not-available for emergency-treatment life-threatening conditions other treatment options

Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This document provides sponsors …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: revising guidance document drug submissions drug applications post-market documents submissions operational direction

Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Food and Drug Regulations clarification of requirements clinical trial sponsors clinical-research with cannabis cannabis clinical research

Health Canada is issuing this Notice to clinical trial sponsors to clarify the approach to various types of clinical research …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Food and Drug Regulations clarification of requirements clinical trial sponsors clinical-research with cannabis cannabis clinical research