Open Government Portal

Found 2972 records

Governments can override patent rights when necessary. In such instances, the government authorizes a third party to use the patented …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime compulsory licences override patent rights authorizes a third party patented invention patent holder's permission.

Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in Canada's Access to Medicines …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Country access Canada's Access to Medicines Regime insufficient or no manufacturing capacity in the pharmaceutical sector import a lower cost drug and medical devices.

We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Public release clinical information confidential information would be made publicly available following regulatory decision.

For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Administrative process of submission and application submission and application of human and disinfectant drugs.

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Special Access to Drugs and Health Products Special Access Programme access to nonmarketed drugs.

The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Improving access to generic drugs regulatory review of drugs and devices.

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Priority review faster access to drugs health care system needs.

This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Early scientific advice Health Canada and Health Technology Assessment.

The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Aligned reviews Health Canada and Health Technology Assessment.

These amendments would introduce a regulatory framework for Drug Shortages within the Food and Drug Regulations.

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Forward Regulatory Plan public list anticipated regulatory changes or actions Development of regulations planned and potential regulatory initiatives identifies public consultation opportunities departmental contact point