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This guidance document provides medical device stakeholders with information on the requirements that the Therapeutics Products Directorate will use in recognizing Auditing Organizations under the MDSAP.

This guidance document applies to drugs regulated under Part C, Division 1 of the Regulations that have received a DIN pursuant to Section C.01.014.2. This includes pharmaceuticals for human and veterinary use, as well as disinfectant drugs, but excludes biologics and radiopharmaceuticals and any...

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9: Biopharmaceutics Classification System (BCS) Based Biowaivers.

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance S5(R3): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility.

The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (Regulations) were published on March 2, 2022. They came into effect on February 27, 2022, following the repeal of Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19...

By way of this update, Health Products and Food Branch (HPFB) is reminding sponsors that the mandatory date for use of the Regulatory Enrolment Process (REP) and the Common Electronic Submissions Gateway (CESG) is October 1, 2020 applicable to pharmaceutical, biologic and radiopharmaceutical...

The purpose of this Notice of Intent to Amend is to notify that, as a result of consultation, Health Canada will switch certain uses of Esomeprazole to nonprescription status for human use by modifying the Human Prescription Drug List (PDL).

The purpose of this Notice of Amendment is to announce the revised listing for hydrocortisone on the Prescription Drug List (PDL).

The purpose of this Notice of Amendment is to notify about the addition of hydroquinone or its derivatives to the Prescription Drug List (PDL) for human use when sold in concentrations greater than 2% in topical products.

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing for levonorgestrel on the Prescription Drug List (PDL). Only the Human part of the PDL was revised; the listing for Veterinary use will remain unchanged.