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This document is intended to clarify how SaMD fits into Health Canada's regulatory framework for medical devices, based on current …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document medical devices software software as medical-device SaMD definition and classification regulatory framework

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice International Council for-Harmonisation ICH Technical Requirements guidance M9 ICH M9 biopharmaceutics classification system M9 BCS based biowaivers pharmaceuticals for human-use

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice International Council for-Harmonisation ICH Technical Requirements guidance S5(R3) detection of toxicity reproduction for medicinal-products toxicity to male-fertility

The purpose of this Notice of Amendment is to notify that Health Canada will add Epinephrine topical solution for hemostasis …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment prescription drug list PDL epinephrine topical solution

The purpose of this Notice of Amendment is to notify that Health Canada has added phytocannabinoids to the Human and …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment prescription drug list PDL phytocannabinoids

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing of "brimonidine or …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment prescription drug list PDL revision of brimonidine

The purpose of this Notice of Amendment is to notify that Health Canada has removed tramadol from the Prescription Drug …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice of amendment prescription drug list PDL tramadol

Health Canada is issuing this notice to clinical trial sponsors to clarify the approach to clinical research with psilocybin. Health …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice to stakeholders clarification of requirements Food-and-Drug Regulations Controlled Drugs-and-Substances Act clinical-research with psilocybin

Health Canada is aware of the growing interest in the use of psilocybin, including psilocybin that occurs naturally in certain …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice to stakeholders psilocybin mushroom species use of psilocybin special access program SAP drug accessed through-SAP

Health Canada is aware of the growing interest in the use of psilocybin, including psilocybin that occurs naturally in certain …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: notice to stakeholders psilocybin mushroom species use of psilocybin special access program SAP drug accessed through-SAP