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This guidance document explains the regulatory information requirements and conditions for practitioners and manufacturers when drugs are requested through the Special Access...

This notice applies to energy-based medical devices for therapeutic or cosmetic indications intended for sale in Canada.

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to: company, dossier and product, regulatory activity, and...

Regulatory Decision Summaries (RDSs) explain Health Canada's decision for certain health products seeking market authorization.

Health Canada's approach to the registration and disclosure of Canadian clinical trial information

Guidance on the regulatory requirements for prescription labelling of opioid drugs.

Q&A Regarding the Adoption of Periodic Benefit Risk Evaluation Report.

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E5 Q&A(R1).

In order to facilitate the implementation of the E3 Guideline, the International Conference on Harmonisation (ICH) Experts have developed a series of Questions and Answers.

Health Canada questions and answers regarding applicability and recognition, acceptance of study data and the Standards Council of Canada

Urgent public health needs can occur, for example, during a flu pandemic, situations such as the opioid crisis or a military health emergency. Sometimes a drug that is needed...

Prescription drugs are an increasingly important part of our health care system, helping prevent and cure disease as well as save lives. However, Canada’s drug spending, which...

The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for postmarket changes and the data recommendations to support those...

The purpose of this document is to provide the performance standards to be used to determine whether a remission should be granted, under the Fees in Respect of Drugs and...

The purpose of the pause-the-clock is to allow applicants the opportunity to address application deficiencies during the review of the application, without impacting Health...

2009 article from Health Canada and the Public Health Agency of Canada regarding the safe use of Opioid drugs

Health Canada has identified the need for patients to receive clear information about the safe use of opioids and the risks associated with their use. As such, requirements have...

Opioid pain medications include a broad range of drugs, such as morphine, codeine and oxycodone. When used as directed, opioid pain medications are effective and the side...

Information on opioids medicines for patients and families.

Opioid warning label to be distributed with prescription opioid drugs.