Health Canada

This is a technical document that provides instructions on how to implement the ICH Electronic Common Technical Document v4.0 (eCTD v4.0) specification for Health Canada Module 1 submission content. The information in this document is provided in a consistent manner with the ICH eCTD v4.0...

The objective of this Ministerial Order is to ensure that Health Canada is able to review all applications for new clinical trials or amendments to ongoing trials within the default period, by extending the default review period for clinical trial submissions and amendments to 45 days, from 30 days.

Health Canada considers cybersecurity a component of the medical device's design and lifecycle that can affect the safety and effectiveness of the medical device. Manufacturers should consider cybersecurity when designing their medical device.

Health Canada is informing Canadians that the prescribing and patient information for Mifegymiso has been updated to reflect that an ultrasound is no longer required before the drug is prescribed. Mifegymiso is a combination product containing two drugs (mifepristone and misoprostol) that are...

Through SAP, health care professionals may request access to drugs that are not currently authorized for sale in Canada to treat patients with serious or life-threatening conditions. Access to these drugs is only considered when conventional therapies have failed, are unsuitable or are unavailable.

Through the emergency drug release (EDR) program, veterinary practitioners (veterinarians) may request authorization to access unapproved drugs for emergency veterinary use.

If you're a health care professional, you can request a drug that is not available for sale in Canada through the Special Access Program (SAP). Your request must be for treating a patient with a serious or life-threatening condition where conventional treatments: have failed, are unsuitable or...

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance E9(R1): Defining the Appropriate Estimand for a Clinical Trial/ Sensitivity Analyses.

The guidance document provides medical device manufacturers with advice on the practices, responses and mitigation measures which can improve the cybersecurity of their device.

Project Orbis is an international partnership designed to give cancer patients faster access to promising cancer treatments. Learn more about the project, eligible products and the steps to apply.

Dental amalgam has been used in North America for more than 150 years, yet there have been recurrent concerns over its safety.

Drugs for rare diseases are also referred to as orphan drugs in some jurisdictions. A rare disease is a life-threatening, seriously debilitating or serious and chronic condition affecting a fairly small number of patients.

The Access to Drugs in Exceptional Circumstances regulatory pathway enables access to drugs which have been authorized for sale in certain foreign jurisdictions, but are not available in Canada, to address urgent public health needs.

A generic drug is a copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand name drug: it contains the identical medicinal ingredients, in the same amounts and in a similar dosage form.

Q8, Q9 and Q10 Questions & Answers (R4). This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its...

Q9: Quality Risk Management. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the...

This document provides guidance on how the fee for the right to sell medical devices will be administered in accordance with the Food and Drugs Act and as stipulated in the Fees in Respect of Drugs and Medical Devices Order and the Regulations Amending and Repealing Certain Regulations Made under...

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

This document is intended to clarify how SaMD fits into Health Canada's regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations.

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.