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47542 records

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)

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

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A periodic-benefit-riske-evaluation report PBRER

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

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A prescription opioids sticker-and-handout requirements Pharmacists and Practitioners