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Found 10 records similar to Improving the regulatory review of drugs and devices: Early scientific advice to manufacturers
The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada and Canadian HTA reviews are better aligned.
The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.
The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.
This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.
This notice outlines the safety and effectiveness requirements for closed system devices that decontaminate medical devices using ultraviolet (UV) radiation. The notice is for manufacturers using an interim order (IO) authorization or medical device licence application.
COVID-19 is a new disease. A vaccine or therapy to treat or prevent this disease has not yet been developed. However, the COVID-19 pandemic has resulted in a global review of therapies that may be used to treat or prevent the disease. Canada is speeding up the importation and sale of medical devices used to diagnose, treat or prevent COVID-19.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.
The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.
This website provides continually updated official Government of Canada advice and information to help ensure the safety and well-being of Canadians travelling and living abroad, with a focus on the Security, Entry/Exit Requirements, Health, Laws & Culture, Natural Disasters & Climate, and Help Abroad of destinations around the world.