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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...

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...

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...

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...

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...

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...

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

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

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance...

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...

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

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...

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...

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...

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...

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...

These guidelines are intended to help you comply with federal laws and to ensure that universally recognized principles, such as patient safety and accessibility, are respected...

You can make the initial request to incorporate a link to an electronic platform on a prescription drug label through existing submission pathways including a prescription...

The legal framework that governs the use of electronic media in prescription drug labelling includes: the Food and Drugs Act (FDA), the Food and Drug Regulations (FDR), and...