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Found 2972 records

Health Canada has identified the need for patients to receive clear information about the safe use of opioids and the …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: opioid warning sticker patient information handout risk management plans safe use-of opioids risk of using opioids prescription opioids “List of Opioids”

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

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: opioid pain medications frequently asked questions safe-use of opioid-drugs

The purpose of the pause-the-clock is to allow applicants the opportunity to address application deficiencies during the review of the …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: pause-the-clock proposal drug-and-medical-device establishment licence-applications application deficiencies review of application review timelines

The purpose of this document is to provide the performance standards to be used to determine whether a remission should …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: performance standards fees Drugs-and-Medical-Devices Order

The guidance is intended to advise both internal and external stakeholders regarding the filing requirements for postmarket changes and the …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: guidance document drug Identification number DIN post- DIN changes postmarket changes filing requirements internal-and-external stakeholders

Prescription drugs are an increasingly important part of our health care system, helping prevent and cure disease as well as …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: protecting Canadians excessive drug prices proposed amendments Patented Medicines Regulations prescription drugs prescription drugs price Canada’s drug spending

Urgent public health needs can occur, for example, during a flu pandemic, situations such as the opioid crisis or a …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A access to drugs exceptional public-health crisis urgent public-health needs flu pandemic opioid crisis military health emergency drug for immediate-use authorized for-sale in-another-country regulatory-process under Division-10 ...

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

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A guidance document non-clinical laboratory-study data drug product applications-and-submissions good laboratory practice

In order to facilitate the implementation of the E3 Guideline, the International Conference on Harmonisation (ICH) Experts have developed a …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A Document clinical study reports ICH Topic E3(R1)

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E5 …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A Document ethnic factors acceptability-of foreign clinical-data ICH Topic E5(R1)