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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

Health Canada is working on a strategic approach to support the transition of all product monographs into the XML format, …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: Extensible Markup Language XML format product monographs XML PM Project phase II

Health Canada is issuing this notice to communicate the Department's interim approach on the exemption of certain medical gases and …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: medical-gases expiration-dating for medical-gases exemption of certain medical-gases medically appropriate mixtures product label Division 1 of Part C Food and Drug-Regulations

Health Canada is pleased to announce the fourth publication of the Guidance Document: Certificates of Supplementary Protection.

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: certificates of supplementary-protection guidance document certificates-supplementary-protection regulations CSP Regulations

Health Canada recommends modified wording for the indications and clinical uses of fludeoxyglucose (F-18 FDG) products in their product monographs. …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: harmonizing product monographs fludeoxyglucose F-18 FDG indications-and-clinical-uses indications-and-clinical-uses for F-18 FDG

This document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) or …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: pharmaceutical product Certificate of Pharmaceutical-Product CPP good-manufacturing-practice certificate of Good-Manufacturing-Practices GMP GUI-0024

Health Canada will continue to post a monthly table on the Department website which reflects updated and/or new safety information …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: safety labelling changes product monographs PMs pharmaceutical drug products a monthly table safety information

The Health Product InfoWatch is a monthly publication intended primarily for healthcare professionals. It provides clinically relevant safety information on …

Record Modified: Dec 29, 2021
Record Released: Dec 29, 2021
Publisher: Health Canada
Formats: HTML
Keywords: InfoWatch InfoWatch November 2021 medeffect Canada health product monthly publication healthcare professionals clinically relevant safety information pharmaceuticals biologics medical devices natural health products