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Found 2972 records

A generic drug is a copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand …

Record Modified: Nov 1, 2023
Record Released: Oct 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: generic drugs access to generic-drugs brand name drug pharmaceutically equivalent identical medicinal ingredients same amounts similar dosage form

Q8, Q9 and Q10 Questions & Answers (R4). This guidance has been developed by the appropriate ICH Expert Working Group …

Record Modified: Nov 1, 2023
Record Released: Oct 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: international-conference on harmonisation ICH ICH of technical-requirements registration of pharmaceuticals pharmaceuticals for human-use ICH guidance Q8 Q9 Q10 Questions & Answers (R4)

Q9: Quality Risk Management. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject …

Record Modified: Nov 1, 2023
Record Released: Oct 30, 2023
Publisher: Health Canada
Formats: HTML
Keywords: international-conference on harmonisation ICH ICH of technical-requirements registration of pharmaceuticals pharmaceuticals for human-use ICH guidance Q9 quality risk management

This document provides guidance on how the fee for the right to sell medical devices will be administered in accordance …

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document medical device licence-renewal fees-for the-right-to-sell licensed-medical-devices

This document outlines the way in which Health Canada manages applications for medical device licences.

Record Modified: Oct 29, 2023
Record Released: Oct 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document management of applications medical device licences

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